Neoplasms

All Conditions

Digestive System Diseases

Carcinoma

Carcinoma, Hepatocellular

Liver Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Hematinics

All Drugs and Chemicals

Antineoplastic Agents

Liver Extracts

Ethiodized Oil

Patients in the experimental arm will be treated with 188Re-SSS lipiodol Selective Internal Radiotherapy (SIRT).

The treatment with 188Re-SSS lipiodol SIRT requires two steps during the patient's hospitalization: the pre-treatment simulation step and the treatment step itself.

Pre-therapeutic simulation is performed during the screening phase, before definite patient inclusion, and is composed of two procedures: a diagnostic liver angiography and a liver perfusion scintigraphy (MAA scan and SPECT/CT).

The therapeutic stage is also composed of two procedures a therapeutic liver angiography with 188Re-SSS lipiodol and a 188Re-SSS lipiodol SPECT/CT.

Selective Internal Radiation Therapy with 188Re-SSS lipiodol

Marion Trochet

Valérie Jolaine

Etienne Garin, MD PHD

The goal of this monocentric interventional study is to evaluate the efficacy, in terms of objective response rate, of the 188Re-SSS lipiodol SIRT in patients with non-operable HCC.

This study is an open-labelled treatment administration study conducted with an exact one-stage one-arm study plan.

The study plans to included 35 patients and to treated 26 patients (take into account screen failures and SIRT contraindications).

The treatment is delivered by a one-day procedure leading to the injection of 188Re-SSS lipiodol. In details, the patient is hospitalized for one night. Two steps are performed while the patient is hospitalized: the pre-treatment simulation step and the treatment step itself.

After treatment, patients are followed until progression, new systemic or locoregional (in the same treatment area) antineoplastic therapy or death, within a maximum 24-month period following the SIRT.

Selective Internal Radiation Therapy and 188Re-SSS Lipiodol Treatment for Liver Cancer (Lip-Re2)

Efficacy Evaluation of 188Re-SSS Lipiodol Selective Internal Radiation Therapy of Non Operable Hepatocellular Carcinoma Patients, a Phase II Study

Defined as the best overall response occurring within 6 months' post 188Re-SSS lipiodol injection according to the modified RECIST criteria for hepatocellular carcinoma

Center Eugene Marquis

The patients will receive 1-2 sessions of SIRT. If the patients have invasive tumors, extensive liver involvement or vascular invasion, systematic treatment will be added.

SIRT

Mingyue Cai, Dr.

Kangshun Zhu, Dr.

This study is conducted to evaluate the efficacy and safety of Y-90 selective internal radiation therapy (SIRT) in patients with potentially resectable hepatocellular carcinoma (HCC).

This is a bi-center, prospective study to evaluate the efficacy and safety of SIRT in patient with potentially resectable HCC.

35 patients with potentially resectable (initially unresectable) HCC will be enrolled in this study. The patients will receive 1-2 sessions of SIRT. If the patients have invasive tumors, extensive liver involvement or vascular invasion, systematic treatment will be added. If the patients are evaluated as resectable during follw-up, liver resection will be recommended.

The primary end point of this study is success rate of conversion to resection. The secondary endpoints are objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), time to progression (TTP), duration of response (DOR), overall survival (OS) and adverse events (AEs).

SIRT for Potentially Resectable HCC

Y-90 Selective Internal Radiation Therapy for Potentially Resectable Hepatocellular Carcinoma: a Prospective, Single Arm Trial

The proportion of patients with initially unresectable HCC who were evaluated by the surgical team as suitable for second-stage surgical resection after SIRT

The percentage of patients who have a best overall tumor response rating of complete response (CR) or partial response (PR)

The percentage of patients who have a tumor response rating of CR, PR, or stable disease (SD)

The time between the first treatment and the first occurrence of disease progression (PD) or death from any cause, whichever occurs first

the time interval from first treatment to the first occurrence of disease progression

the time from initial objective response (CR or PR) until PD or death, whichever occurs first

The time from initiation of treatment until the date of death from any cause

Number of patients with AEs assessed by NCI CTCAE v5.0.

Second Affiliated Hospital of Guangzhou Medical University

Rare Diseases

Cholangiocarcinoma

Bile Duct Cancer

Intrahepatic Cholangiocarcinoma

Central Nervous System Depressants

Capecitabine

Anesthetics

Antimetabolites

Patients in the experimental arm will be treated with capecitabine combined with Selective Internal Radiotherapy (SIRT) before surgery.

Patients in the control group will receive surgery only.

Capecitabine will given at 1250mg/m², 2 times a day with an interval of about 12 hours between two intakes, 2 weeks on, 1 week off, for 4 pre-surgery cycles.

During the first week of cycle 2 of capecitabine, patients will receive SIRT using Yttrium-90 glass microspheres. Treatment with Yttrium-90 glass microspheres requires two steps, one or two weeks apart. Both stages are performed under local anesthesia after a short hospitalization : the treatment simulation and therapeutic angiography.

Selective Internal Radiotherapy (SIRT)

Surgery will be performed according to local practice.

Surgery

Julien Edeline, MD

Treatment of intrahepatic cholangiocarcinoma (ICC) remains difficult. Many patients have unresectable tumors, and survival after resection was only slightly improved with the use of adjuvant capecitabine. One of the major prognostic factors is the resection margin, patients with invaded (R1) or narrow (\<5mm) margins having a higher risk of recurrence.

Selective Internal Radiation Therapy (SIRT) with Yttrium-90 microspheres (also known as SIRT) is an interesting treatment in unresectable ICC. In a phase 2 study, the investigators showed a response rate of 39% and a disease control rate of 98%. Interestingly, 9 of the 41 patients were able to see their tumors downstages to surgery. It was also recently suggested in a retrospective study that patients resected after SIRT had a better prognosis than patients that could be operated upfront, despite less favorable initial tumor characteristics.

Given the absence of validated neoadjuvant treatment, the promising activity of SIRT and chemotherapy combination in the unresectable setting, and the prognostic significance of close surgical margins, the aim of this trial is therefore to study this combination treatment in the neoadjuvant setting of resectable ICC.

The study plans to randomized eligible and consent patients in two balanced parallel groups, the one defined as the experimental arm while the second consisting in the actual standard of care is defined as the control standard arm.

The experimental arm consists in 12 weeks of capecitabine combined with SIRT as neoadjuvant treatment followed by surgery. After SIRT, patients will be assessed at 10 weeks with thoracic-abdominal and pelvic CT scan and liver MRI. If the tumour is still deemed resectable, surgery will be performed at 16 weeks.

In case of discovery of contra-indication to SIRT after inclusion (such as described in the SIRT exclusion criteria section) patients will stop chemotherapy and proceed to surgery within one month. The concerned patients are still included in the study and continue the post-surgery follow-up as expected by the protocol.

In the control arm, patients will proceed to upfront surgery.

The follow - up period begins just after the surgery in both arm, and the patients are evaluated every 3 months for 2 years, then every 6 months for 3 additional years, clinically by an oncologist and radiologically with thoracic-abdominal and pelvic CT scan.

Whether progression occurred, patients will no longer be followed according to the protocol; only vital status continues to be collected until the end of the study (i.e. the last visit of the last patient).

Selective Internal Radiation Therapy and Capecitabine (Chemotherapy) Treatment for Liver Cancer

A Multicenter Open-label Randomized Controlled Prospective Phase II Study Evaluating the Efficacy of Selective Internal Radiation Therapy (Yttrium-90 Glass Microspheres) Combined With Capecitabine in the Neoadjuvant Setting of Operable Intrahepatic CHOlangiocarcinoma

The primary endpoint will be the frequency of subjects with adequate surgical margins, defined as the number of resections AND margin ≥ 5mm.

Symptoms and General Pathology

Neoplasm Metastasis

Colonic Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Colonic Diseases

Intestinal Diseases

Neoplastic Processes

Herbal and Botanical

Cola

Louise B Callesen, MD

Louise B Callesen

Observational, feasibility study investigating biological aspects in patients with liver metastasis from colorectal cancer undergoing treatment with SIRT, by translational analysis of biological samples.

In this study, the investigators seek to investigate biological aspects in patients with colorectal cancer liver metastasis undergoing treatment with Selective Internal Radiation Therapy, by translational analysis of biological samples.

SIRT will be conducted as per standard procedure at Aarhus University Hospital. Translational blood samples will be drawn pre-treatment and during follow up.

The total cell free DNA level will be quantified in all samples. The samples will be analysed for tumour specific mutations such as the KRAS, BRAF and NRAS oncogenes.

The investigators expect to include up to 30 patients.

This is a purely observational translational study. Results will be analysed in relation to outcome data.

The study is conducted in collaboration with:

Department of Gastroenterology and Hepatology, Aarhus University Hospital Department of Radiology, Aarhus University Hospital Department of Nuclear Medicine, Aarhus University Hospital

Selective Internal Radiation Therapy With 90Y Resin Micropheres for Refractory Colorectal Cancer Liver Metastases

Selective Internal Radiation Therapy With 90Y Resin Micropheres for Refractory Colorectal Cancer Liver Metastases - SIRT - A Translational Feasibility Study

Investigating potential prognostic and predictive markers for efficacy by molecular characteristics and mutational analysis

Aarhus University Hospital

Principal Investigator

Patients will be administered a single dose of NRT6003 Injection, and then they will be assessed by SPECT-CT imaging within 24 hours for its distribution in the chest and upper abdomen, including extrahepatic shunts, intrahepatic distribution, and target lesion distribution as expected.

Nine Patients will be tested for the radioactivity of Yttrium-90 in blood, urine, and feces (if available).

Selective internal radiation therapy (SIRT) with Yttrium-90 carbon microspheres

NRT6003 Injection

Gaojun Teng

Lianxin Liu

Hailan Lin

Jinxiong Huang

Hao Xu

Hailiang Li

Hui Yang

Hua Xiang

Gaojun Teng, MD

Haibo Shao

Hong Wu

Yue Chen

Guoliang Shao

Tingbo Liang

Chang Yu

Leida Zhang

Wentao Li

Changjing Zuo

Hui Liu

Zhiping Yan

Hongcheng Shi

Wei Lu

The goal of this clinical trial is to evaluate the safety and efficacy of NRT6003 Injection in patients with unresectable HCC.

The efficacy and safety of Yttrium-90 carbon microspheres in patients with unresectable HCC remain unknown. This trial is a prospective, multicenter, open-label, single-arm phase I trial designed to evaluate the safety and efficacy of NRT6003 injection.

The primary objective is to evaluate the safety of NRT6003 Injection. While the secondary objectives include the assessments of the antitumoral efficacy, the improvement of patients´ quality of life, and the distribution characteristics of Yttrium-90 in body.

Safety and Efficacy of NRT6003 in Patients With Unresectable Hepatocellular Carcinoma

Study on the Safety and Effectiveness of NRT6003 Injection in Patients With Unresectable Hepatocellular Carcinoma (HCC)

Relevant results will be selectively disclosed in the future.

Occurrence of adverse events/severe adverse events

Liver target lesions, evaluated based on the mRECIST criteria

Time to progression of liver target lesions, evaluated by the investigator and independent image review committee respectively (mRECIST)

Time without imaging progression, evaluated by the investigator and independent image review committee respectively (mRECIST)

Time with tumor progression, evaluated by the investigator and independent image review committee respectively (mRECIST)

Duration from the administration to the first evidence of progression or death from any cause, evaluated by the investigator and independent image review committee respectively (mRECIST)

The variation of QoL with the EORTC (European organization for Research and Treatment of Cancer) QLG (Quality of Life Group) Core Questionnaire (EORTC QLQ-C30)

Assessed by SPECT-CT imaging in the chest and upper abdomen, including extrahepatic shunts, intrahepatic distribution, and target lesion distribution as expected.

Detect the radioactivity of Yttrium-90 in blood, urine, and feces (if available) in liquid scintillation counter

Chengdu New Radiomedicine Technology Co. LTD.

Gland and Hormone Related Diseases

Pancreatic Neoplasms

Endocrine Gland Neoplasms

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Micronutrients

Gemcitabine

Paclitaxel

Albumin-Bound Paclitaxel

Oxaliplatin

Leucovorin

Fluorouracil

Irinotecan

Folfirinox

In this study, participants shall receive NRT6008 injection in combination with chemotherapy.

-Systematic chemotherapy The chemotherapy regimen is selected by the investigators at the consideration of participants' conditions, with either GN or (m)FOLFIRINOX.

GN: gemcitabine 1000 mg/m\^2 and nab-paclitaxel 125 mg/m\^2, every 21 days (3 weeks/cycle).

FOLFIRINOX: oxaliplatin 85 mg/m\^2, irinotecan 180 mg/m\^2, leucovorin 400 mg/m\^2 and fluorouracil 400 mg/m\^2 given as a bolus followed by 2400 mg/m\^2 given as a 46-hour continuous infusion, every 2 weeks (4 weeks/cycle).

mFOLFIRINOX: oxaliplatin 85 mg/m\^2, irinotecan 180 mg/m\^2, leucovorin 400 mg/m\^2, and fluorouracil 2400 mg/m\^2 given as a 46-hour continuous infusion, every 2 weeks (4 weeks/cycle).

-NRT6008 injection administration: NRT6008 injection is implanted into pancreatic tumor via endoscopic ultrasound (EUS)-guided fine-needle injection, at the instruction of the investigator. The dose of NRT6008 injection is determined by tumor volume and estimated tumor average absorbed dose.

NRT6008 Injection + Systematic chemotherapy

Zhaoshen Li

Suxia Luo

Duanmin Hu

Weiqing Chen

Bangmao Wang

This is a single arm, open label, multi-center phase I study, including phase Ia dose escalation and phase Ib dose expansion. Safety review committee (SRC) will be formed to monitor safety and efficacy data through the study. And the independent review committee (IRC) will be formed to monitor efficacy data through the study.

The efficacy and safety of Yttrium-90 carbon microspheres in patients with unresectable LAPC remain unknown. This trial is a prospective, multicenter, open-label, single-arm phase I trial designed to evaluate the safety and efficacy of NRT6008 injection. The primary objective is to evaluate the safety of NRT6008 Injection. While the secondary objectives include the assessments of the preliminary efficacy. In addition, the distribution of NRT6008 injection in human body, and the changes of tumor biomarkers and the improvement of cancer pain status of participants after administration will also be evaluated.

Safety and Efficacy of NRT6008 in Patients With Unresectable Locally Advanced Pancreatic Cancer (LAPC)

A Phase I Study to Evaluate the Safety, Tolerance and Efficacy of NRT6008 Injection in Unresectable Locally Advanced Pancreatic Cancer (LAPC)

Changes of tumor biomarkers through the study

Distribution of NRT6008 injection in human body and radioactivity of Yttrium-90 in blood, urine, and feces (if available)

Incidence rate and severity of AE and SAE

According to Response Evaluation Criteria in Solid Tumors (RECIST) guidelines, version 1.1 (evaluated by the investigator and Independent Review Committee respectively)

How long the participant lives after the administration

R0 (≥1 mm margin), R1 (\<1 mm clearance)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Selective Internal Radiation Therapy and 188Re-SSS Lipiodol Treatment for Liver Cancer (Lip-Re2)	NCT05797870	Hepatocellular ...	Selective Inter...	18 Years -	Center Eugene Marquis
SIRT for Potentially Resectable HCC	NCT05994859	Hepatocellular ...	SIRT	18 Years - 75 Years	Second Affiliated Hospital of Guangzhou Medical University
Selective Internal Radiation Therapy and 188Re-SSS Lipiodol Treatment for Liver Cancer (Lip-Re2)	NCT05797870	Hepatocellular ...	Selective Inter...	18 Years -	Center Eugene Marquis
Selective Internal Radiation Therapy and Capecitabine (Chemotherapy) Treatment for Liver Cancer	NCT05265208	Resectable Intr...	Capecitabine Selective Inter... Surgery	18 Years -	Center Eugene Marquis
Selective Internal Radiation Therapy With 90Y Resin Micropheres for Refractory Colorectal Cancer Liver Metastases	NCT04491929	Liver Metastasi...		18 Years -	Aarhus University Hospital
Safety and Efficacy of NRT6003 in Patients With Unresectable Hepatocellular Carcinoma	NCT06310590	Unresectable He...	NRT6003 Injecti...	18 Years - 80 Years	Chengdu New Radiomedicine Technology Co. LTD.
Safety and Efficacy of NRT6008 in Patients With Unresectable Locally Advanced Pancreatic Cancer (LAPC)	NCT06278454	Unresectable Pa...	NRT6008 Injecti...	18 Years -	Chengdu New Radiomedicine Technology Co. LTD.
Selective Internal Radiation Therapy With 90Y Resin Micropheres for Refractory Colorectal Cancer Liver Metastases	NCT04491929	Liver Metastasi...		18 Years -	Aarhus University Hospital
Safety and Efficacy of NRT6003 in Patients With Unresectable Hepatocellular Carcinoma	NCT06310590	Unresectable He...	NRT6003 Injecti...	18 Years - 80 Years	Chengdu New Radiomedicine Technology Co. LTD.

Spots Global Cancer Trial Database for selective internal radiation therapy