Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Symptoms and General Pathology

Digestive System Diseases

Rare Diseases

Lung Neoplasms

Carcinoma

Adenocarcinoma

Neoplasm Metastasis

Liver Neoplasms

Carcinoid Tumor

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplastic Processes

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Neuroendocrine Tumor

Neuroepithelioma

Antineoplastic Agents

All Drugs and Chemicals

Micronutrients

Hematinics

Gastrointestinal Agents

Gemcitabine

Irinotecan

Docetaxel

Leucovorin

Fluorouracil

Cisplatin

Oxaliplatin

Liver Extracts

Folfirinox

Pancrelipase

Pancreatin

If you are assigned to this arm, study doctors will sequentially remove and treat all visible cancer spots with surgery, radiation, ablation, or other procedures. These interventions might include surgical removal of the diseased part of your lung, liver, lymph nodes, and/or the lining of your belly. In addition, if surgery could not be done, we could treat these diseased spots with other modalities such as radiation and/or radiofrequency/microwave ablation.

If you're selected to be in this arm, the type of procedure you receive will vary based on your cancer and what the study doctor recommends for treatment.

Participants in this arm receive the current standard of care chemotherapy for their specific type of gastrointestinal cancer. This treatment may include the continuation of chemotherapy and a few procedures which may improve your quality of life.

* If you have cancer of the stomach or food pipe (esophagus): the preferred chemotherapy regimen includes two or three medications. These drugs include Cisplatin or Oxaliplatin and 5-fluorouracil (5 FU) in combination with Docetaxel.
* If you have cancer of the pancreas or ampulla: the preferred chemotherapy medicines include Gemcitabine or a three-drug combination chemotherapy called FOLFIRINOX, which includes 5FU, Leucovorin, Irinotecan, and Oxaliplatin.
* If you have bile duct cancers: a combination of Gemcitabine, platinum agents, or fluoropyrimidine will be considered.

Standard of Care Chemotherapy

If you have lung cancer, you may receive video-assisted thoracic surgery (VATS): a type of minimally invasive thoracic surgery of the chest, performed with a thoracoscope (small videoscope) using small incisions and special instruments to minimize trauma.

Video-Assisted Thoracic Surgery (VATS)

If you have lung cancer, you may receive a lobectomy:

A major/invasive surgical procedure where an entire lobe of your lung is removed.

Lobectomy

A type of radiation treatment used to kill any cancer cells that may be left in the body. It may also include a stem cell transplant or treatment with drugs that kill cancer cells.

Consolidative Radiation

Depending on the location of you cancer and the state of your cancer after chemotherapy, you may receive on the the following ablation treatments:

-Microwave or Radiofrequency Ablation: Radiofrequency ablation (RFA) and microwave ablation (MWA) are treatments that remove liver tumors by placing a needle through the skin into the tumor. In RFA, high-frequency electrical currents are passed through an electrode in the needle, creating a small region of heat. In MWA, microwaves are created from the needle to create a small region of heat. The heat destroys the liver cancer cells.

-General Tumor Ablation Treatment: a minimally invasive surgical method to treat solid cancers. Special probes are used to "burn" or "freeze" cancers without the usual surgery. Doctors use images of your tumor to guide where they place the needle. This requires only a tiny hole, usually less than 3 mm via which the probe is introduced.

Ablation Treatment

Depending on the type of GI cancer you have and the state of your cancer after chemotherapy, you may receive a resection or excision: a surgical procedure that focuses on removing all or part of a tumor/organ/body using a sharp knife (scalpel) or other cutting instrument.

Resection or Excision

Peritonectomy is a surgery used to remove peritoneal tumors (tumors in the lining of the abdomen/stomach) from a patient. Following surgery, a heated chemotherapy bath (HIPEC) is commonly administered.

Peritonectomy

If you have cancer in your biliary tract (gallbladder, pancreas or liver), you may receive transarterial radioembolization known as TARE.

TARE allows doctors to deliver radiation treatment directly to the liver using a minimally invasive technique that is designed to cause few side effects. TARE allows doctors to thread a catheter through a small incision in the participant's upper thigh through the artery that goes directly to the liver.

Transarterial Radioembolization

Kiran Turaga, MD

This study is designed for participants who have cancer of the upper gastrointestinal (GI) tract such as cancer of the esophagus, stomach, duodenum (the initial portion of your small intestine), pancreas, bile duct (Cholangiocarcinoma), ampulla, or gall bladder with limited sites of spread (metastases). Doctors leading this study are looking to see if treating the disease using sequential procedures (more than one procedure given one after another) such as surgeries or radiation can lead to better survival and if these surgeries, combined with standard of care treatment, are safe for the treatment of upper GI cancers.

This study is designed for participants who have cancer of the upper gastrointestinal (GI) tract such as cancer of the esophagus, stomach, duodenum (the initial portion of your small intestine), pancreas, bile duct (Cholangiocarcinoma), ampulla, or gall bladder with limited sites of spread (metastases).

Doctors leading this study are looking to see if treating the disease using sequential procedures (more than one procedure given one after another) such as surgeries or radiation can lead to better survival and if it is safe for the treatment of upper GI cancers.

The purpose of the proposed study is to identify a group of patients with metastatic cancer of the upper GI and biliary tract that may benefit from sequential procedures such as surgeries or radiation compared to the current standard of care chemotherapy treatment alone.

Study Comparing Standard of Care Chemotherapy With/ Without Sequential Cytoreductive Surgery for Patients With Metastatic Foregut Cancer and Undetectable Circulating Tumor-Deoxyribose Nucleic Acid Levels

Phase II Prospective, Open-Label Randomized Controlled Trial Comparing Standard of Care Therapy With and Without Sequential Cytoreductive Interventions for Patients With Metastatic Foregut Adenocarcinoma and Undetectable Circulating Tumor-Deoxyribose Nucleic Acid (ctDNA) Levels

The progression free survival (PFS) of participants undergoing sequential procedures (Arm A of study) vs standard of care chemotherapy (participants in Arm B - control group) as assessed by clinical records. Progression free survival will be defined as the time from randomization to first documented disease progression or death as assessed by clinical records.

The percentage of participants in each arm without disease progression/death at 6 months as assessed by clinical records.

The percentage of participants in each arm without disease progression/death from randomization to progression on second line therapy, which includes repeat interventions.

The percentage of participants in each arm without disease progression/death at 12 months as assessed by clinical records.

The median overall survival of participants undergoing sequential procedures (Arm A) vs standard of care therapy (Arm B) as assessed by clinical records. Median overall survival will be defined as the time from randomization to death from any cause.

Health-related quality of life (HRQoL) for participants undergoing sequential procedures (Arm A) vs. the HRQoL for participants receiving standard of care treatment (Arm B). This will be assessed by quality of questionnaires completed by participants at baseline and after treatment.

The financial burden and its consequences faced by participants undergoing sequential procedures vs. the financial burden experienced by participants receiving standard of care treatment (Arm B). This financial burden/toxicity will be assessed by the Comprehensive Score for Financial Toxicity (COST) questionnaire, a standardized participant-friendly questionnaire used to measure financial toxicity/burden of treatment.

The morbidity (the state of having a particular illness) of participants after undergoing sequential cytoreductive procedures (procedures used to remove tumors) as assessed by clinical records.

The mortality (the number of deaths) of participants after undergoing sequential cytoreductive procedures (procedures used to remove tumors) as assessed by clinical records.

The safety/ tolerability of standard of care treatment as assessed by reported adverse events from participants in Arm B. Adverse Events will be measured using the Common Terminology Criteria for Adverse Events (CTCAE) v.5.

The median circulating tumor DNA (ctDNA) progression free survival, which will be defined as the time from randomization to first documented disease progression, positive ctDNA detection, or death as assessed by the radiology team in participants with undetectable ctDNA. ctDNA levels in participants will be tested/assessed using liquid biopsies.

The effect of interventions on circulating tumor DNA (ctDNA) levels in participants who receive aggressive interventions (Arm A) versus standard of care treatments (Arm B). The effect of interventions on ctDNA will be assessed based on recorded ctDNA levels measured using liquid biopsies at baseline and after treatment.

University of Chicago

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

(TARE)Transarterial radioembolization is a transcatheter intra-arterial procedure performed by the interventional radiologist for the treatment of primary and secondary hepatic cancers.

Konstantinos Katsanos, Professor

Theoni Kaplanidou

Platon Dimopoulos, Resident

Subjects with large inoperable liver tumors defined as at least 1 lesion larger than 5cm in maximum diameter. For the purposes of the present study, we define the AMARA principle in intensified regional TARE as a planned irradiated tumor dose \>200Gy by the partition model. The purpose of the study is to evaluate the safety and efficacy of Y90 high dose radioembolization for the management of large inoperable liver tumors. In addition, to correlate the safety and efficacy with the post-treatment dosimetry analysis (by MIM Software Inc) based on 90Y-PET/CT imaging.

The AMARA (As Much As Reasonably Achievable) Study

The AMARA (As Much As Reasonably Achievable) Study: Radioembolization of Large Inoperable Liver Tumors

Adverse Events related with the procedure

Liver Progression Free Survival after the procedure

Complete Response will be measured with the LI-RADS criteria for treatment response (LR-TR). In addition, RECIST v1.1, mRECIST, and PET-RECIST criteria will be further evaluated.

Correlate the safety and efficacy with the post-treatment dosimetry analysis

University Hospital of Patras

Associate Professor of Interventional Radiology

Carcinoma, Hepatocellular

Chlorotrianisene

Intervention:

Yttrium-90 Transarterial Radioembolization

* Patients with measurable, locally advanced HCC those are not suitable to have or have failed potentially curable intervention (Radio frequency ablation for small tumor, resection or transplantation).
* The diagnosis of HCC should be established either by cyto/histology; or, by characteristic imaging studies in patients with cirrhosis of the liver and/or chronic viral hepatitis B or C infection.
* Patients must not be less than 18 and not more than 80 and can be either gender.
* Patients must have a performance status of ECOG score equal to or less than 2.
* Child-Pugh's A or Early B, score 8 and above

Intervention:

Trans-arterial chemo-embolization using Drug-eluting beads

* Patients with measurable, locally advanced HCC those are not suitable to have or have failed potentially curable intervention (Radio frequency ablation for small tumor, resection or transplantation).
* The diagnosis of HCC should be established either by cyto/histology; or, by characteristic imaging studies in patients with cirrhosis of the liver and/or chronic viral hepatitis B or C infection.
* Patients must not be less than 18 and not more than 80 and can be either gender.
* Patients must have a performance status of ECOG score equal to or less than 2.
* Child-Pugh's A or Early B, score 8 and above

Yttrium-90 radioembolization (90Y) is a relatively new technique involving the trans-arterial administration of glass or resin microspheres loaded with Yttrium-90, a β-emitting isotope, delivering selective internal radiation to the tumor.

TACE is a procedure in which a catheter is introduced into the branches of the hepatic artery supplying the tumor. Embolic material and chemotherapeutic agents are deployed through the catheter directly into the tumor vasculature. This technique potentially enhances the cytotoxic effect by inducing ischemia and retention of the therapeutic agent in the vicinity of the tumor.

The drug-eluting beads (DEBs) enable standardization of TACE since DEBs act as both an occluding agent as well as a drug-loaded carrier, achieving local ischemia and cytotoxic death of the tumor with one device.

Transarterial Chemoembolization using drug-eluting beads

Mohamed I Al Sebayel, Prof.

Mohamed I Al Sebayel, Prof

Hamad AlSuhaibani, MD, FRCP

Faisal Aba AlKhail, MD

Ahmad M Al Zahrani, MD

Hussien A Elsiesy, MD

Hepatocellular Carcinoma (HCC) is a primary liver cancer. It is the 6th most common malignancy and the 3rd killers of all tumors worldwide with an incidence of 626,000 new patients a year. The intermediate stage of HCC is controlled by radiological interventions such as Transarterial Chemoembolization (TACE) or Radioembolization. Although 90Y radioembolization is increasingly being used in clinical practice, there is no high quality clinical evidence to justify this. To date, no prospective studies have been performed comparing both treatment modalities (TACE vs 90Y) in a randomized setting. This randomized controlled trial is designed to prospectively compare TACE and 90Y for treatment of patients with unresectable (BCLC intermediate stage) HCC. This will be done by recruiting 75 patients in each arm from. Investigators will compare between the two groups the time to progression (TTP) as the primary outcome and also examine time to local progression (TLP) as well as other factors like overall survival, response to therapy, toxicities and adverse events, quality of life and treatment-related costs.

Study Rationale:

Although 90Y increasingly used in clinical practice, there is no high quality clinical evidence to justify this. Most of the comparison studies are retrospective. Three studies compared TACE with 90Y retrospectively. The first was by Kooby et al in which patients treated with TACE were retrospectively compared to those treated with 90Y suggested that both treatment modalities have similar effectiveness and safety profiles in patients with unresectable HCC. Earlier Carr et al carried out a similar retrospective analysis and concluded that Chemoembolization or Radioembolization appeared to be equivalent regional therapies for patients with unresectable, non-metastatic HCC. More recently Salem et al retrospectively compared 122 HCC patients who received chemo-embolization with 123 patients who received Radioembolization and concluded both patient groups had similar survival times. Radioembolization resulted in longer time-to-progression and less toxicity than chemo-embolization.

A study on down-staging of HCC beyond Milan criteria compare 90Y with TACE of and concluded that 90Y outperforms TACE for down-staging HCC to within transplant criteria.

TACE-DEB is the standardized form TACE with better efficacy and safety profile and will be ideal to use to define the position of 90Y in the of locoregional treatment of HCC.

To date, no prospective studies have been performed comparing both treatment modalities in a randomized setting. This randomized controlled trial is designed to prospectively compare TACE and 90Y for treatment of patients with unresectable (BCLC intermediate stage) HCC.

Known Potential Benefits:

Chemo-embolization is the standard treatment for intermediate HCC with known efficacy and predicted toxicity. The arrival of TAC-DEBs made TACE more efficient, less toxic and more standardized. Y90 Radioembolization is of known efficacy and minimal toxicity base on cohort studies. Head to head comparison has never been conducted.

Transarterial Radioembolization Versus Chemoembolization for the Treatment of Hepatocellular Carcinoma

Transarterial Radioembolization Versus Chemoembolization for the Treatment of Advanced Hepatocellular Carcinoma

King Faisal Specialist Hospital & Research Center

Chairman, Liver transplant department at KFSH&RC

Nootropic Agents

Lipid Regulating Agents

Vitamins

Choline

Hypolipidemic Agents

Antimetabolites

before first TARE administration (after work-up procedure) and one month after TARE administration

Simultaneous 18F-Choline PET-MRI

Valérie VILGRAIN

Françoise KRAEBER - BODERE

Mohamed BOUATTOUR

Yann TOUCHEFEU

Catherine ANSQUER, Dr

OPERANDI project aims to address unmet clinical needs in the current management of advanced-stage HCC treated with TARE by exploring new opportunities provided by imaging-based artificial intelligence (AI) and data augmentation, simultaneous PET-MRI imaging, and novel approaches to increase patient selection and TARE efficacy (genomic profiling, radiopotentiators, and new radionuclides). The research aim to identify predictive and early markers indicative of TARE effectiveness based on a large prospective cohort of HCC patients. This cohort will be used to uncover relevant predictive signatures within the morphological, functional, and molecular imaging data using novel imaging-based AI approaches with a new patient imaging pathway including simultaneous 18F-Choline PET-MRI.

Considering this global objective, the objective of this clinical research protocol is to provide clinical, molecular and imaging data in a prospective standardized study, notably by performing systematic pretherapeutic and follow-up PET-MRI, in patients with HCC treated with TARE.

Hepatocellular carcinoma (HCC) is the most common primary malignant liver tumors, considered the sixth most common cancer and the third major cause of cancer-related death. Its worldwide incidence is expected to increase in the future. Additionally, it shows marked intertumor and intratumor heterogeneity at the microscopic and molecular levels, and there are currently no reliable imaging markers for predicting response to TARE.

TARE is a highly advanced treatment that consists in intra-arterial injection of radioactive microspheres. TARE is already approved for liver metastases and HCC in most countries. So, TARE for HCC, is part of the therapeutic Armamentarium exerting antitumor effects based on radio-biological (DNA damage) and immunological mechanisms. TARE using most currently 90Y-loaded microspheres has proven its non-inferiority with better tolerance and better tumor response in comparison with systemic treatments in patients with HCC.

While highly promising, patient stratification and early identification of responders are currently insufficient due to the lack of pertinent imaging biomarkers, either non-invasive or invasive. Furthermore, prior therapy-induced DNA damages may lead to tumor resistance, therefore reducing TARE efficacy. Hence, the absence of a personalized treatment strategy is an unmet need for patients with HCC. This may result in survival disadvantage for non-responders, who could benefit otherwise from early treatment change, with expected more favorable outcomes.

Simultaneous PET-MRI: OPERANDI proposes a completely innovative and holistic approach via PET-MRI guided therapy. The research hypothesis is that simultaneous PET-MRI imaging provides more robust non-invasive predictive biomarkers than classical approach and better correlation between quantification of radiation therapy dosimetry and clinical outcomes than PET-CT. This requires technological development of PET-MRI, with most methodological challenges being attenuation correction, reducing the impact of organ motion due to respiration and cardiac motion, and minimizing truncation and susceptibility artifacts.

A PET/MRI scan is a two-in-one test that combines images from a positron emission tomography (PET) scan and a magnetic resonance imaging (MRI) scan. This new hybrid technology harnesses the strengths of PET and MRI to produce some of the most highly detailed images currently available. MRI scans use a strong (1.5 to 3T for clinical use) magnetic field to produce detailed morphologic images and some sequences provide functioning information (such as diffusion-weighted, dynamic contrast-enhanced, MR elastography sequence). PET scans use tracers according to the clinical indications to highlight metabolism changes. In HCC, the most common radiotracers are fluorodeoxyglucose (FDG) or Choline, which detect metabolically active malignant lesions.

OPERANDI project aims to address unmet clinical needs in the current management of HCC treated with TARE by exploring new opportunities provided by imaging-based artificial intelligence (AI) and data augmentation, simultaneous PET-MRI imaging, and novel approaches to increase patient selection and TARE efficacy (genomic profiling, radiopotentiators, and new radionuclides). Investigators aim to identify predictive and early markers indicative of TARE effectiveness based on a large prospective cohort of HCC patients. This cohort will be used to uncover relevant predictive signatures within the morphological, functional, and molecular imaging data using novel imaging-based AI approaches with a new patient imaging pathway including simultaneous PET-MRI.

Considering this global objective, the objective of this clinical research protocol is to provide clinical, molecular and imaging data in a prospective standardized study, notably by performing systematic pretherapeutic and follow-up PET-MRI, in patients with HCC treated with TARE.

Multi-modal Characterisation of Hepatocellular Carcinoma (HCC) Treated With Targeted Radionuclide Therapy (TRT): Prospective Interventional Multicentre National Cohort

Clinical response defined by the PFS as the time measured from the day of first administration of TARE to first progression or death at 12 months, whichever occurs first

Assistance Publique - Hôpitaux de Paris

Capecitabine

Temozolomide

Antineoplastic Agents, Alkylating

Alkylating Agents

Capecitabine 750 mg/m2 twice daily orally for 14 days and temozolomide 200 mg/m2 orally on Days 10-14, with 14 days between cycles, to be continued until 1) disease progression or 2) intolerable toxicities.

Trans-arterial radioembolization (TARE) on Day 7 of cycle 2 and, if needed for the other lobe, Day 7 of either cycle 3 or 4.

Capecitabine 750 mg/m2 twice daily orally for 14 days

Capecitabine Oral Product

temozolomide 200 mg/m2 orally on Days 10-14, with 14 days between cycles

Temozolomide Oral Product

Trans-arterial radioembolization (TARE) on Day 7 of cycle 2 and, if needed for the other lobe, Day 7 of either cycle 3 or 4.

transarterial radioembolization

Michael Soulen, MD

Kathleen Thomas

Deepon Paul Singh

Renuka Iyer, MD

Abashai Woodard

Michael Soulen

This is a Phase 2 evaluation of hepatic-progression free survival among patients with Grade 2 liver-dominant NET metastases undergoing combination therapy with CapTem and Y90 radioembolization.The hypothesis is to confirm safety and to assess if disease control is improved relative to expectation from either therapy alone.

Patients with liver-dominant Grade 2 NET metastases from any primary will start CapTem and undergo simulation angiography for radioembolization planning during the first cycle. If they tolerate CapTem and are not excluded from radioembolization, then TARE will be performed on Day 7 of Cycle 2, with additional TARE of Day 7 of cycle 3 or 4 as needed to treat the entire tumor burden. Patients will remain on CapTem until progression or intolerance.

Primary outcome measure is hepatic progression-free survival.

CapTemY90 for Grade 2 NET Liver Metastases

UPCC 04219 Phase 2 Study of Capecitabine-Temozolomide(CapTem) With Yttrium-90 Radioembolization in the Treatment of Patients With Unresectable Metastatic Grade 2 Neuroendocrine Tumors

Intra-hepatic progression-free survival by RECIST 1.0 is defined as the time from initiation of study therapy until first documented intra-hepatic disease progression, death due to any cause or last scan date that documented intra-hepatic progression-free status.

Overall progression-free survival is defined as the time from initiation of study therapy until first documented intra- or extra-hepatic disease progression, death due to any cause or last scan date that documented progression-free status

Intra-hepatic tumor responses will be evaluated by RECIST.

Intra-hepatic tumor responses will be evaluated by EASL criteria.

extra-hepatic tumor responses will be evaluated by RECIST.

Systemic toxicities will be individually assessed by NCI CTCAE Version 4.

Hepatic toxicities will be individually assessed by NCI CTCAE Version 4.

The primary marker is CgA. Additional cancer site-specific (i.e., gastrinoma) markers may also be assayed.

Quality of Life will be measure by a validated NET-specific instrument, EORTC. Scale is 0-100, higher scores indicate worse symptoms/functioning

Roswell Park Cancer Institute

CARTI

Abramson Cancer Center at Penn Medicine

Behaviors and Mental Disorders

Sarcoma

Rhabdoid Tumor

Hepatoblastoma

Neoplasms, Connective and Soft Tissue

Quality of Life

Soft Tissue Sarcoma

Embryonal Sarcoma

Evaluation of change of HRQOL survey responses will be performed:

* at baseline (time of treatment) and
* 1 month post treatment
* 6 months post treatment
* 12 months post treatment
* 5 years post-treatment

The HRQOL will be done by phone, mail or email. Responses will be captured and entered into a REDCAP database

Quality of Life Assessment

Deliver catheter directed yttrium-90 directly to liver tumors and assess -Progression Free Survival - Local and Metastatic

* Local Tumor Response by calculating the decreases in tumor size and enhancement after treatment. This will be assessed by modified Response Evaluation Criteria for Solid Tumors (mRECIST).
* Resection Rate following treatment
* Transplant Rate following treatment
* Histologic Response by assessing tumor histopathology in patients who undergo tumor resection or liver transplant
* Biologic Response by monitoring serum tumor markers (e.g. alphafetoprotein-AFP) in AFP secreting tumors
* Review of clinical course post-treatment-rehospitalization rate

Howard Katzenstein

Allison Aguado

Stephen Dunn

This study will be performed to evaluate the Clinical Outcomes and Quality of Life after Transarterial Radioembolization with Yttrium-90 (TARE-Y90) in Children, Adolescents, and Young Adults with Liver Tumors. The treatment and techniques used here are well established in adults.

The purpose of this study is to evaluate:

1. the response to treatment and clinical outcomes of treatment with TARE Y-90 as part of standard therapy and
2. to assess the change in the patient's quality of life before, during and after treatment with TARE-Y90

* Referral to Nemours Liver Tumor Program is made by the primary team (oncologist/surgeon).
* Phone discussion between the Nemours Liver Tumor Program Team will occur with the referring team about the patient.
* Phone call between the Nemours Liver Tumor Program Team and the family will occur prior to any visit to discuss the potential plan of care and the basics of the TARE-Y90 procedure and the Quality of Life surveys.

Review of medical records provided by referring institution will be done by the Nemours Liver Tumor Program Team including:

History, Scans-actual imaging required, Path report-slide submission required, Roadmaps, Labs, Other pertinent medical history and records

-Visit to Nemours/AI DuPont Children's Hospital for initial consultation will be arranged by the Nemours Liver Tumor Program Team.

The patient and family will meet with the team including:

Liver transplant surgeon (Dr Dunn), Interventional Radiologist (Dr Aguado), Social worker, Child life specialist, Pediatric oncologist (Dr Gresh - on site, Dr Katzenstein by telemedicine)

* Attempt will be made to schedule the pre-planning angiogram as part of initial visit (2nd day of visit). The angiogram requires the following 3-4 hours (mapping of blood vessels in and around tumor - determines whether patient can receive Y90, Angiogram is done with the patient sedated and having been after midnight the night before, The patient is expected to be discharged on the same day of the angiogram- no admit is planned but occasionally the patient may need overnight observation to occur due to age of the patient or the length of the procedure.
* Return to home.
* Potential additional single cycle of chemotherapy may be given prior to return to Nemours for Y90.

All further Chemotherapy Care is coordinated with Nemours Liver Tumor oncologists

-A 2nd visit to AIDHC will occur for TARE-Y90 treatment: The procedure lasts about 2-3 hours. There is no planned admit but possible if any problems occur.

* 2 weeks post procedure a phone call follow-up after treatment will occur with the Nemours team
* 2 weeks post procedure the patient may resume chemotherapy when cleared by the Nemours team
* 4-6 weeks post Y90 treatment - a repeat CT/MRI will be done as well as lab tests.
* If possible, the CT/MRI to be done at AIDHC/Nemours but can be done locally if travel barriers exist.
* If the tumor is now resectable, planning will be made for resection at AIDHC/Nemours.
* Evaluation and change of HRQOL survey responses will be performed at baseline (time of treatment) and 1, 6, 12 months and 5 years post-treatment. These surveys will be done by phone, mail or email. Responses will be captured and entered into a REDCAP database

Yttrium-90 (TARE-Y90) in Children, Adolescents, and Young Adults With Liver Tumors

Clinical Outcomes and Quality of Life After Transarterial Radioembolization With Yttrium-90 (TARE-Y90) in Children, Adolescents, and Young Adults With Liver Tumors

Evaluation of change of HRQOL survey responses will be performed:

-at baseline (time of treatment)

The HRQOL will be done by phone, mail or email. Responses will be captured and entered into a REDCAP database

Evaluation of change of HRQOL survey responses will be performed:

- 1 month post treatment

The HRQOL will be done by phone, mail or email. Responses will be captured and entered into a REDCAP database

Evaluation of change of HRQOL survey responses will be performed:

- 6 months post treatment

The HRQOL will be done by phone, mail or email. Responses will be captured and entered into a REDCAP database

Evaluation of change of HRQOL survey responses will be performed:

- 12 months post treatment

The HRQOL will be done by phone, mail or email. Responses will be captured and entered into a REDCAP database

Evaluation of change of HRQOL survey responses will be performed:

- 5 years post-treatment

The HRQOL will be done by phone, mail or email. Responses will be captured and entered into a REDCAP database

Deliver catheter directed yttrium-90 directly to liver tumors and assess -Progression Free Survival - Local and Metastatic

-

Deliver catheter directed yttrium-90 directly to liver tumors and assess -Progression Free Survival - Local and Metastatic

Deliver catheter directed yttrium-90 directly to liver tumors and assess

-Local Tumor Response by calculating the decreases in tumor size and enhancement after treatment. This will be assessed by modified Response Evaluation Criteria for Solid Tumors (mRECIST).

Deliver catheter directed yttrium-90 directly to liver tumors and assess

-Resection Rate following treatment

Deliver catheter directed yttrium-90 directly to liver tumors and assess

-Transplant Rate following treatment

Deliver catheter directed yttrium-90 directly to liver tumors and assess

-Histologic Response by assessing tumor histopathology in patients who undergo tumor resection or liver transplant

Deliver catheter directed yttrium-90 directly to liver tumors and assess

-Biologic Response by monitoring serum tumor markers (e.g. alphafetoprotein-AFP) in AFP secreting tumors

Deliver catheter directed yttrium-90 directly to liver tumors and assess

-Review of clinical course post-treatment-rehospitalization rate

Alfred I. duPont Hospital for Children

Nemours Children's Clinic

Principal Investigator

transarterial radioembolization (TARE)

transarterial chemoembolization (TACE)

Jung-Hwan Yoon, M.D., Ph.D.

The aim of this study is to compare the efficacy of conventional transarterial chemoembolization(TACE) and transarterial radioembolization in patients with unilobar advanced hepatocellular carcinoma.

Potentially curative treatments for hepatocellular carcinoma (HCC) include surgical resection, liver transplantation, and local ablative therapy.

However, HCC patients are diagnosed at advanced stages in Korea. Unresectable advanced HCCs are not suitable for other curative therapies. For these patients, the optimal treatment remains largely controversial. As a palliative treatment, the benefit of transarterial chemoembolization (TACE) had been shown in patients with unresectable HCC by several trials. Recently,transarterial radioembolization (TARE) has been introduced for the treatment of advanced HCC. However, the efficacy of TARE compared to TACE is uncertain.

The aim of this study is to compare the efficacy of conventional transarterial chemoembolization(TACE) and transarterial radioembolization in patients with unilobar advanced hepatocellular carcinoma.

A Phase 3 Trial Comparing TACE and TARE in Unilobar Advanced Hepatocellular Carcinoma

A Randomized, Multi-center, Open Label, Phase 3 Trial Comparing Conventional TACE and Transarterial Radioembolization in Patients With Unilobar Advanced Hepatocellular Carcinoma

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study Comparing Standard of Care Chemotherapy With/ Without Sequential Cytoreductive Surgery for Patients With Metastatic Foregut Cancer and Undetectable Circulating Tumor-Deoxyribose Nucleic Acid Levels	NCT04931420	Metastatic Canc... Foregut Carcino... Gastric Adenoca... Gallbladder Ade... Liver Cancer GI Cancer GI Carcinoma Lung Cancer	Standard of Car... Video-Assisted ... Lobectomy Consolidative R... Ablation Treatm... Resection or Ex... Peritonectomy Transarterial R...	18 Years -	University of Chicago
The AMARA (As Much As Reasonably Achievable) Study	NCT06257030	Liver Cancer	Transarterial R...	18 Years -	University Hospital of Patras
Transarterial Radioembolization Versus Chemoembolization for the Treatment of Hepatocellular Carcinoma	NCT02729506	Hepatocellular ...	Transarterial R... Transarterial C...	18 Years - 80 Years	King Faisal Specialist Hospital & Research Center
Transarterial Radioembolization Versus Chemoembolization for the Treatment of Hepatocellular Carcinoma	NCT02729506	Hepatocellular ...	Transarterial R... Transarterial C...	18 Years - 80 Years	King Faisal Specialist Hospital & Research Center
The AMARA (As Much As Reasonably Achievable) Study	NCT06257030	Liver Cancer	Transarterial R...	18 Years -	University Hospital of Patras
Multi-modal Characterisation of Hepatocellular Carcinoma (HCC) Treated With Targeted Radionuclide Therapy (TRT): Prospective Interventional Multicentre National Cohort	NCT06334965	Hepatocellular ... Radioembolizati...	Simultaneous 18...	18 Years -	Assistance Publique - Hôpitaux de Paris
CapTemY90 for Grade 2 NET Liver Metastases	NCT04339036	Neuroendocrine ... Neuroendocrine ...	Capecitabine Or... Temozolomide Or... transarterial r...	18 Years -	Abramson Cancer Center at Penn Medicine
CapTemY90 for Grade 2 NET Liver Metastases	NCT04339036	Neuroendocrine ... Neuroendocrine ...	Capecitabine Or... Temozolomide Or... transarterial r...	18 Years -	Abramson Cancer Center at Penn Medicine
Yttrium-90 (TARE-Y90) in Children, Adolescents, and Young Adults With Liver Tumors	NCT04315883	Hepatoblastoma Hepatocellular ... Rhabdoid Tumor ... Undifferentiate... Pediatric Liver... Liver Tumors	Quality of Life... Transarterial R...	0 Years - 21 Years	Nemours Children's Clinic
A Phase 3 Trial Comparing TACE and TARE in Unilobar Advanced Hepatocellular Carcinoma	NCT02004210	Hepatocellular ...	transarterial r... transarterial c...	20 Years - 80 Years	Seoul National University Hospital

Spots Global Cancer Trial Database for transarterial radioembolization