Neoplasms

All Conditions

Rare Diseases

Cholangiocarcinoma

Adenocarcinoma

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Bile Duct Cancer

Intrahepatic Cholangiocarcinoma

All Drugs and Chemicals

Antineoplastic Agents

Antibodies

Antibodies, Monoclonal

Immunomodulating Agents

Durvalumab

Immunoglobulins

Antibodies, Blocking

Antineoplastic Agents, Immunological

Participants will receive Durvalumab and SNDX-6352.

1. Durvalumab - 1500 mg via IV infusion over 60 minutes (-5/+10 min) on day 1 of each 28-day cycle (every 4 weeks).
2. Drug - 1500mg IV

1. SNDX-6352 - 3mg/kg via IV infusion over 30 minutes (-5/+10 min) on days 1 and 15 of each 28-day cycle (every 2 weeks), starting with cycle 2 (not given during cycle 1).
2. Drug - 3mg/kg IV

SNDX-6352

Lei Zheng, MD

The purposed of this research is to study the safety and clinical activity of the combination of durvalumab and a CSF-1R inhibitor (SNDX-6352) in people with Intrahepatic Cholangiocarcinoma.

Durvalumab and SNDX-6532 Following Chemo or Radio-Embolization for Patients With Intrahepatic Cholangiocarcinoma

A Phase II Study of Durvalumab (MEDI4736) in Combination With a CSF-1R Inhibitor (SNDX-6532) Following Chemo or Radio-Embolization for Patients With Intrahepatic Cholangiocarcinoma.

ORR is defined as the number of patients achieving a complete response (CR) or partial response (PR) based on the Response Evaluation Criteria in Solid Tumors (mRECIST) at any time during the study. CR = disappearance of all target lesions, PR is =\>30% decrease in sum of diameters of target lesions, progressive disease (PD) is \>20% increase in sum of diameters of target lesions, stable disease (SD) is \<30% decrease or \<20% increase in sum of diameters of target lesions. Estimation based on the Kaplan-Meier curve.

Number of participants who experience treatment related adverse events ≥ grade 3 as defined by CTCAE 5.0.

OS will be measured from date of first dose until death or end of followup (OS will be censored on the date the subject was last known to be alive for subjects without documentation of death at the time of analysis). Estimation based on the Kaplan-Meier curve.

PFS is defined as the number of months from the date of treatment to disease recurrence \[disease recurrence (DR) progressive disease (PD) or relapse from complete response (CR) as assessed using mRECIST criteria\] or death due to any cause. Per mRECIST criteria, CR = disappearance of all target lesions, Partial Response (PR) is =\>30% decrease in sum of diameters of target lesions, Progressive Disease (PD) is \>20% increase in sum of diameters of target lesions, Stable Disease (SD) is \<30% decrease or \<20% increase in sum of diameters of target lesions.

Number of weeks from the start date of PR or CR (whichever response is recorded first) and subsequently confirmed to the first date that recurrent or progressive disease or death is documented. Per mRECIST, CR = disappearance of any intratumoral arterial enhancement in all target lesions, PR is =\>30% decrease in sum of diameters of target lesions.

Syndax Pharmaceuticals

AstraZeneca

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Adverse reporting collection was conducted by regular investigator assessment and laboratory measurements.

Participants received Durvalumab and SNDX-6352.

Durvalumab: 1500 mg IV over 60 minutes on day 1 of each 28-day cycle (every 4 weeks).

SNDX-6352: 3mg/kg IV over 30 minutes on days 1 and 15 of each 28-day cycle (every 2 weeks), starting with cycle 2 (not given during cycle 1).

Durvalumab and SNDX-6352

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

The ECOG scale measures performance status, with scores ranging from 0-5; 0= fully active, performs without restriction, 1= can ambulate, but restricted in physically strenuous activity, 2= ambulatory and capable of self-care, but unable to work, active for \>50% of waking hours, 3= limited self-care, confined to bed or chair for \>50% of waking hours, 4= completely disabled, totally confined to bed/chair, 5= deceased

Eastern Cooperative Oncology Group (ECOG) Performance Status

Lei Zheng, MD PhD

Objective Response Rate (ORR) Per mRECIST (Modified RECIST)

Number of Participants Experiencing Study Drug-related Toxicities

Overall Survival (OS)

Progression-free Survival (PFS) Per mRECIST

Duration of Response (DOR)

Overall Study

Digestive System Diseases

Biliary Tract Neoplasms

Gallbladder Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Biliary Tract Diseases

Gastrointestinal Diseases

Gallbladder Diseases

Biliary Tract Cancer

Gallbladder Cancer

Gemcitabine

Cisplatin

Antimetabolites

Jeffrey A Meyerhardt, MD

In the United States, the incidence of biliary tract cancer and gallbladder cancer has been estimated to be 6,000-8,000 patients per year. Currently, there is no standard therapy for these tumors once the disease has spread and is inoperable. Recent small studies with gemcitabine have shown a positive response rate. The investigators plan to test the combination of gemcitabine with cisplatin for biliary tract and gallbladder cancers.

Gemcitabine and cisplatin will be administered weekly for two weeks (on day 1 and day 8) followed by a one week rest period (1 cycle is 3 weeks). On day one and eight of each cycle the patient will have a physical exam and blood work. During the first two cycles, additional blood work will be drawn on day 15 as well. Reassessment of the tumor will be performed at 6 weeks, 12 weeks, and every 9 weeks thereafter. Patients will remain on treatment until further evidence of disease progression or unacceptable side effects occur.

Gemcitabine and Cisplatin for Gallbladder and Biliary Tract Cancer

A Phase II Trial of Gemcitabine and Cisplatin In Unresectable Or Metastatic Biliary Tract and Gallbladder Cancer

Brigham and Women's Hospital

Massachusetts General Hospital

Beth Israel Deaconess Medical Center

Eli Lilly and Company

Dana-Farber Cancer Institute

Symptoms and General Pathology

Neoplasm Metastasis

Carcinoma, Hepatocellular

Cholecystitis

Acalculous Cholecystitis

Prior to surgery these patients will be given a ICG dose of 0.05 mg IV.

Prior to surgery these patients will be given the ICG standard dose of 2.5 mg IV.

Low dose or standard dose ICG will be administered by the anesthesiologist as guided by the study coordinator at the beginning of the case, at two points during the operation (1- prior to the dissection of the biliary tract and 2- upon completion of the dissection and establishment of the critical view of safety).

Indocyanine green

The PINPOINT Endoscopic Fluorescence Imaging System (Stryker Corporation, Kalamazoo, Michigan) will be used. This device enables the surgeon to simultaneously see real-time, high-definition visible-range and NIR fluorescence videos and to superimpose them. It is currently approved by the FDA for intraoperative near-infrared fluorescence imaging.

PINPOINT Endoscopic Fluorescence

Ali Zarrinpar, MD, PhD

Near-infrared fluorescence (NIRF) imaging after an intravenous injection of indocyanine green (ICG) allows for the intraoperative identification of liver anatomy. The investigators have new data that a much lower dose improves this visualization. Confirmation of this hypothesis would mean that ICG can be administered on the same day of surgery in order to augment real-time intraoperative visualization, thereby providing a safe, feasible, and cost-effective strategy for the surgical treatment of liver disease.

The investigators have a series of surgical cases in which the investigators have been able to achieve excellent intraoperative biliary visualization with a greatly decreased (50-200 fold lower) dose of ICG than the previously published dose. Furthermore, this decreased dose was visible in about 15-20 minutes from the time of injection with low liver background fluorescence, a significant improvement that would make its utilization in the operating room more practical. The investigators hypothesize that a lower dose will: 1) allow adequate visualization of the extrahepatic biliary tree, including the cystic, common hepatic, and common bile ducts. Confirmation of hypotheses would mean that a lower dose of ICG can be administered on the same day of surgery in order to augment real-time intraoperative localization of the extrahepatic biliary tree, thereby providing a safe, feasible, and cost-effective strategy for the surgical treatment of liver disease.

The investigators intend to test our hypothesis with the following specific aims:

Aim 1: To compare the efficacy and utility of a low dose ICG (0.05 mg) protocol with a previously published dose (2.5 mg) in imaging the extrahepatic biliary tract.

Adult patients scheduled to undergo a laparoscopic hepatic or biliary operation will be randomized to two groups 1) low dose (0.05 mg) or 2) standard dose (2.5 mg) of ICG preoperatively on the day of surgery. Patients with a history of adverse reactions or known allergy to ICG, iodine, or iodine dyes will be excluded.

To mask the investigator randomization will be done with envelopes for this study and the dose given to the patient prior to surgery with the investigator not being aware of the amount given.

Low Dose ICG for Biliary Tract and Tumor Imaging

Low Dose ICG for Near-infrared Fluorescence Imaging of Biliary Tract and Tumors

We are not sharing individual participant data with other researchers

Measurement is performed by dividing the fluorescence intensity signal of the common bile duct by that of the liver

A qualitative assessment will be made based on the quality of the intraoperative visualization of the extrahepatic biliary tree on a scale of 1 to 5 (1 = no improvement/identification not confirmed; 2 = marginally improved; 3 = sufficiently improved; 4 = well improved; 5 = greatly improved/exceeds expectations).

Measurement is performed by dividing the fluorescence intensity signal of the common bile duct by that of the background fat

Society of University Surgeons

University of Florida

ICG is a very safe drug with minimal risk for adverse advents. Participants were given a very low dose

Study participants who received low dose ICG.

Low Dose

Study participants who received standard dose ICG.

Standard Dose

Prior to surgery these patients will be given a ICG dose of 0.05 mg IV.

Indocyanine green: Low dose or standard dose ICG will be administered by the anesthesiologist as guided by the study coordinator at the beginning of the case, at two points during the operation (1- prior to the dissection of the biliary tract and 2- upon completion of the dissection and establishment of the critical view of safety).

Prior to surgery these patients will be given a ICG dose of 2.5 mg IV.

Indocyanine green: Low dose or standard dose ICG will be administered by the anesthesiologist as guided by the study coordinator at the beginning of the case, at two points during the operation (1- prior to the dissection of the biliary tract and 2- upon completion of the dissection and establishment of the critical view of safety).

Total

Age, Categorical

White

Black

Asian

Race/Ethnicity, Customized

5 enrolled and randomized patients were excluded from analysis because their videos were either too dark or unusable due to technical issues with the scope, camera, or device tower.

Dr. Ali Zarrinpar

Quantitative Assessment - Bile Duct-to-liver Fluorescence Intensity Ratio

Qualitative Assessment of Overall Intraoperative Visualization of the Extrahepatic Biliary Tree - NIRFC Versus White Light

Prior to surgery these patients will be given a ICG dose of 2.5 mg IV.

Indocyanine green: Low dose or standard dose ICG will be administered by the anesthesiologist as guided by the study coordinator at the beginning of the case, at two points during the operation (1- prior to the dissection of the biliary tract and 2- upon completion of the dissection and establishment of the critical view of safety)

Quantitative Assessment - Bile Duct-to-background Fat Fluorescence Intensity Ratio

Common Hepatic Duct

Cystic Duct

Common Bile Duct

Aberrant Duct

Qualitative Assessment of Overall Intraoperative Visualization of the Extrahepatic Biliary Tree (Common Hepatic Duct, Cystic Duct, Common Bile Duct, Aberrant Ducts)

Prior to surgery these patients will be given a ICG dose of 0.05 mg IV.

Indocyanine green: Low dose or standard dose ICG will be administered by the anesthesiologist as guided by the study coordinator at the beginning of the case, at two points during the operation (1- prior to the dissection of the biliary tract and 2- upon completion of the dissection and establishment of the critical view of safety).

PINPOINT Endoscopic Fluorescence: The PINPOINT Endoscopic Fluorescence Imaging System (Stryker Corporation, Kalamazoo, Michigan) will be used. This device enables the surgeon to simultaneously see real-time, high-definition visible-range and NIR fluorescence videos and to superimpose them. It is currently approved by the FDA for intraoperative near-infrared fluorescence imaging.

Oxaliplatin

Panitumumab

Panitumumab 6mg/kg on days 1 and 15 of every cycle (28 days); Gemcitabine 1000mg/m2 on days 1 and 15 of every cycle (28 days); Oxaliplatin 85mg/m2 on days 1 and 15 of every cycle (28 days)

oxaliplatin

gemcitabine

Aram Hezel, MD

The purpose of this study is to determine disease response of GEMOX-Panitumumab (GEMOX-P) in KRAS/ BRAF wild-type, Stage IV, biliary tract and gallbladder cancer patients who have previously not received chemotherapy. This study will also examine the potential toxicities, progression-free and overall survival in this population.

Gemcitabine, Oxaliplatin and Panitumumab in Kras/B-raf Wild-Type Biliary Track and Gallbladder Cancer

Phase II Study of Gemcitabine, Oxaliplatin in Combination With Panitumumab in Kras/B-raf Wild-Type Unresectable or Metastatic Biliary Track and Gallbladder Cancer

Tumor measurement - same imaging modality used in pre-treatment evaluation - include radiological examination of all areas with affected disease. For pretreatment and at the end of cycle 2 CT scans (chest/abdomen/pelvis) will be used. For all subsequent cycles, CT of chest/abdomen/pelvis will be used every 8 weeks.

Progression-free survival was defined as the time from study enrollment to date of cancer progression or death, whichever occurred first. Progression was assessed using CT scans and the Response Evaluation Criteria In Solid Tumors criteria. Progression is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

Any adverse event continuing after the study completion and considered potentially related to study treatment will be followed until resolution, stabilization or initiation of treatment that confounds the ability to assess the event

Amgen

University of Rochester

Professor

Panitumumab 6mg/kg on days 1 and 15 of every cycle (28 days); Gemcitabine 1000mg/m2 on days 1 and 15 of every cycle (28 days); Oxaliplatin 85mg/m2 on days 1 and 15 of every cycle (28 days)

Panitumumab: Day 1 and 15 = 6 mg/kg IV

oxaliplatin: Days 1 and 15 = 85mg/m2 IV

gemcitabine: Days 1 and 15 = 1000 mg/m2 IV

ECOG describes a patient's level of functioning in terms of their ability to care for themself, daily activity, and physical ability. It ranges from 0-5 with higher numbers indicating reduced ability to care for themself.

Eastern Cooperative Oncology Group (ECOG) Performance status

locally advanced

metastatic

Extent of disease

intrahepatic cholangiocarcinoma

gallbladder

extrahepatic cholantiocarcinoma

primary tumor site

lymph nodes

lung

bone

omentum/peritoneal

adrenal

pelvic soft tissue

metastases

Aram F Hezel

complete response

partial response

stable disease

progressive disease

The Number of Participants With Response to GEMOX-Panitumumab (GEMOX-P) in Chemotherapy naïve KRAS/ BRAF Wild Type Stage IV Biliary Tract Cancer Using the Response Evaluation Criteria In Solid Tumors (RECIST) Criteria.

Median Progression Free Survival

Median Overall Survival

The Number of Participants Who Experience an Adverse Event

Calculi

Gallstones

Cholelithiasis

Cholecystolithiasis

Pathological Conditions, Anatomical

Participants who meet the criteria of biliary stone enrollment and are willing to join in this study will be applied to the custom-made endoscope system for biliary disease diagnosis.

Participants who meet the criteria of biliary neoplasm enrollment and are willing to join in this study will be applied to the custom-made endoscope system for biliary disease diagnosis.

The NCKU-scope-01 is a custom-made endoscope system for this study and it will be applied to help biliary disorders diagnosis

NCKU-scope-01 (a custom-made biliary endoscope system)

A disposable endoscopy system (NCKU-scope-01) was developed for the evaluation of bile duct stone or neoplasm. This system consists of a camera, light sources, a working channel, and a water injection channel. The endoscope could be inserted into the common bile duct via the working channel of a commercial duodenoscope. This study aims to test the feasibility and safety of this system. The efficacy of stone and neoplasm diagnosis will also be analyzed.

Clinical Evaluation of a Custom-made and Disposable Endoscope System for Biliary Tract

To test the device's feasibility. About Likert scale, it range from 1 to 5 (1 is worse and 5 is better).

The ability for residual stones diagnosis after initial ERCP stone extraction, compared with standard x-ray imaging)

The ability for differential diagnosis of benign or malignant stricture. The specific features include increased vascularity, irregular mucosa/nodularity, luminal narrowing, tumor vessel, mucosal lesion.

National Cheng-Kung University Hospital

Associate Professor

Liver Neoplasms

Liver Diseases

Hematinics

Bevacizumab

Liver Extracts

Angiogenesis Inhibitors

Growth Inhibitors

10 mg/kg by vein every 14 days +/- 2 days, starting on day 1.

Proton Radiation Therapy

Sunil Krishnan, MD

Primary Objectives:

1. To evaluate the safety of the treatment of patients with technically or medically inoperable hepatocellular carcinoma and cholangiocarcinoma with proton therapy and concurrent bevacizumab biotherapy.
2. To identify the maximum tolerated dose (MTD) using this combination.

Secondary Objectives:

1. To evaluate local control rate within the radiation field, hepatic control rate outside the treatment field, time to radiographic progression and 2 year survival rate.
2. To analyze dose-volume characteristics that influence the development of radiation induced liver disease (RILD) and GI bleeds that may occur.
3. To assess quality of life during and after chemoradiation therapy.

Proton beams are designed to deliver a high dose of radiation to the abnormal tissues while sparing surrounding normal tissues. Bevacizumab is a biotherapy that is designed to prevent or slow down the growth of cancer cells by blocking the growth of blood vessels.

Before you can start treatment on this study, you will have "screening tests." These tests will help the doctor decide if you are eligible to take part in this study. You will have a complete physical exam. Blood (about 2 tablespoons) and urine will be collected for routine tests. You will have chest x-rays and a computed tomography (CT) scan of your abdomen (stomach area) and pelvis. Women who are able to have a children must have a negative urine pregnancy test.

You will then have a radiation treatment planning session called a simulation. You will get a CT scan of your abdomen, and marks will be placed on your skin to help guide the radiation treatments when you return for the actual treatments. At around the same time, you will receive your first dose of bevacizumab through a needle in your vein. The infusion will at first last 90 minutes. If there are no allergic reactions, fevers, or chills, the infusion will be shortened to 60 minutes and then 30 minutes for later infusions. Your second dose of bevacizumab will be given with the start of radiation therapy treatments. Your final dose of bevacizumab will be given 2 weeks later. You will receive radiation therapy once a day, for 5 days in a row (Monday-Friday) for 4 weeks (total of 20 treatments).

During this study, you will have physical exams weekly during treatment, 1 month after the last proton beam therapy visit and then every 3 months thereafter. Every week, while receiving proton beam therapy, blood (about 2 teaspoons) will be drawn to check for any side effects. You will be asked about any side effects you may be experiencing.

You may remain on study for as long as you are benefitting. You will be taken off study if the disease gets worse or intolerable side effects occur.

After participation in this study is over, you will have follow-up evaluation every 3 months for 2 years. During these visits, you will have a physical exam. You will have CT scans. Blood (about 2 teaspoons) will be drawn for routine tests.

This is an investigational study. Bevacizumab is FDA approved and commercially available for the treatment of metastatic colon cancer. The use of bevacizumab with proton beam therapy is investigational. Up to 30 patients will take part in this study. All will be enrolled at M. D. Anderson.

Proton Therapy and Bevacizumab for Primary Liver Tumors

Phase I Study of Proton Radiotherapy and Bevacizumab for Primary Liver Tumors

Genentech, Inc.

M.D. Anderson Cancer Center

Evolution® Biliary Stent - Uncovered

Christopher Lawrence

The Evolution® Biliary Stent System Clinical Study is a clinical trial on a commercially available device to gather physician experience with the Cook Evolution® Biliary Stent System for the palliation of cancer in the biliary tree. Patients will be treated as per usual medical practices.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Durvalumab and SNDX-6532 Following Chemo or Radio-Embolization for Patients With Intrahepatic Cholangiocarcinoma	NCT04301778	Unresectable In...	Durvalumab SNDX-6352	18 Years -	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Gemcitabine and Cisplatin for Gallbladder and Biliary Tract Cancer	NCT00123825	Gallbladder Can... Biliary Tract C...	Gemcitabine Cisplatin	18 Years -	Dana-Farber Cancer Institute
Low Dose ICG for Biliary Tract and Tumor Imaging	NCT04942665	Cholecystitis Hepatocellular ... Liver Metastase...	Indocyanine gre... PINPOINT Endosc...	18 Years - 80 Years	University of Florida
Gemcitabine, Oxaliplatin and Panitumumab in Kras/B-raf Wild-Type Biliary Track and Gallbladder Cancer	NCT01308840	Biliary Tract C... Gallbladder Can...	Panitumumab oxaliplatin gemcitabine	18 Years - 100 Years	University of Rochester
Clinical Evaluation of a Custom-made and Disposable Endoscope System for Biliary Tract	NCT04456218	Biliary Tract Neoplasms Stone - Biliary	NCKU-scope-01 (...	20 Years -	National Cheng-Kung University Hospital
Gemcitabine and Cisplatin for Gallbladder and Biliary Tract Cancer	NCT00123825	Gallbladder Can... Biliary Tract C...	Gemcitabine Cisplatin	18 Years -	Dana-Farber Cancer Institute
Proton Therapy and Bevacizumab for Primary Liver Tumors	NCT00426829	Liver Cancer Hepatocellular ... Cholangiocarcin...	Bevacizumab Proton Radiatio...	-	M.D. Anderson Cancer Center
Gemcitabine, Oxaliplatin and Panitumumab in Kras/B-raf Wild-Type Biliary Track and Gallbladder Cancer	NCT01308840	Biliary Tract C... Gallbladder Can...	Panitumumab oxaliplatin gemcitabine	18 Years - 100 Years	University of Rochester
Evolution® Biliary Stent System Clinical Study	NCT01962168	Biliary Tract N... Neoplasms Gastrointestina... Digestive Syste... Biliary Tract Stents	Evolution® Bili...	18 Years -	Cook Group Incorporated
Proton Therapy and Bevacizumab for Primary Liver Tumors	NCT00426829	Liver Cancer Hepatocellular ... Cholangiocarcin...	Bevacizumab Proton Radiatio...	-	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for biliary tract