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Chemotherapy
Chemo + Immuno + Radiation Therapy for Bile Duct Cancer
Phase 2
Recruiting
Led By Andrea Bullock, MD, MPH
Research Sponsored by Beth Israel Deaconess Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up enrollment to end of treatment and up to 52 weeks thereafter
Awards & highlights
Study Summary
This trial will study a combination of chemo, immuno, and radiation therapies for bile duct cancer that's inoperable.
Who is the study for?
Adults with advanced bile duct cancer that can't be surgically removed may join this trial. They must understand and agree to the study's terms, have a certain level of physical fitness (ECOG ≤1), weigh over 30 kg, and have proper liver, kidney, and bone marrow function. People with active hepatitis or HIV are excluded unless meeting specific conditions. Those who've had recent immunotherapy or certain infections, or are pregnant/breastfeeding cannot participate.Check my eligibility
What is being tested?
The trial is testing a combination therapy for bile duct cancer involving Y-90 radiation beads, Durvalumab immunotherapy, and Gemcitabine plus Cisplatin chemotherapy. It aims to see if this mix can effectively treat patients whose cancer has not been removed by surgery.See study design
What are the potential side effects?
Possible side effects include reactions from the immune system due to Durvalumab like inflammation in various organs; typical chemo side effects such as nausea, fatigue from Gemcitabine/Cisplatin; and localized damage to healthy tissue near where Y-90 radiation beads are used.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ enrollment to end of treatment and up to 52 weeks thereafter
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~enrollment to end of treatment and up to 52 weeks thereafter
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of Grade 3 or Higher Treatment-Related Toxicity
Median Progression Free Survival (PFS)
Secondary outcome measures
Disease Control Rate (DCR)
Median Overall Survival (OS)
Objective Response Rate (ORR)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Gemcitabine + Cisplatin + Durvalumab + Yttrium-90 Selective Internal Radiation TherapyExperimental Treatment4 Interventions
Participants will receive:
Cycle 1:
Day 1 of 21 Day cycle: Pre-determined dose(s) of Gemcitabine and Cisplatin (Chemotherapy) plus Durvalumab (immunotherapy).
Day 8 of 21 Day cycle: Pre-determined dose(s) of Gemcitabine and Cisplatin (Chemotherapy)
Week 2 or 3 of 21 Day Cycle: One time treatment of Y-90 radiation.
Cycles 2-8:
Day 1 of 21 Day cycle: Pre-determined dose(s) of Gemcitabine and Cisplatin (Chemotherapy) plus Durvalumab (immunotherapy).
Day 8 of 21 Day cycle: Pre-determined dose(s) of Gemcitabine and Cisplatin (Chemotherapy)
Cycles 9+:
Day 1 of 21 Day Cycle: Durvalumab (immunotherapy) maintenance
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gemcitabine
2017
Completed Phase 3
~2070
Cisplatin
2013
Completed Phase 3
~1940
Durvalumab
2017
Completed Phase 2
~3870
Find a Location
Who is running the clinical trial?
Beth Israel Deaconess Medical CenterLead Sponsor
837 Previous Clinical Trials
13,010,242 Total Patients Enrolled
AstraZenecaIndustry Sponsor
4,272 Previous Clinical Trials
288,612,645 Total Patients Enrolled
1 Trials studying Intrahepatic Cholangiocarcinoma
50 Patients Enrolled for Intrahepatic Cholangiocarcinoma
Sirtex MedicalIndustry Sponsor
28 Previous Clinical Trials
4,240 Total Patients Enrolled
1 Trials studying Intrahepatic Cholangiocarcinoma
89 Patients Enrolled for Intrahepatic Cholangiocarcinoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have an active hepatitis B or C infection.I have HIV, HBV, or HCV that is not being treated.I do not have any active, uncontrolled infections.I have not had major surgery in the last 4 weeks.I have had a heart problem in the last 6 months.I have severe lung disease with ongoing low oxygen levels.I do not have any unmanaged ongoing illnesses.I've had chemotherapy or radiotherapy for bile duct cancer within the last 6 months.My disease can be removed with surgery.I can carry out all my self-care but not work activities.My doctor has advised against Y-90 SIRT treatment for me.I do not have an active infection, including tuberculosis.My blood counts meet the required levels for treatment.My liver cancer is confirmed by lab tests.I haven't taken immunosuppressive drugs in the last 14 days.I have been treated with drugs that target the immune system.I am 18 years old or older.I have Hepatitis B but am on treatment to control it.I had Hepatitis C but am cured, confirmed by a test 12 weeks after treatment.My liver functions are within the required limits.I have HIV, am on HAART, and my viral load has been undetectable for 6 months.My kidney function is good, with creatinine levels low or clearance high.My cancer is a type that started in the liver bile ducts and can't be removed by surgery.
Research Study Groups:
This trial has the following groups:- Group 1: Gemcitabine + Cisplatin + Durvalumab + Yttrium-90 Selective Internal Radiation Therapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are new participants allowed to join this experiment?
"As per the information hosted on clinicaltrials.gov, this trial is not presently seeking volunteers, despite being posted on December 1st of 2022 and last updated 9 days later. Nonetheless, there are over 200 other studies actively recruiting candidates for participation at this time."
Answered by AI
What perils have been associated with the concurrent administration of Gemcitabine, Cisplatin, Durvalumab and Yttrium-90 Selective Internal Radiation Therapy?
"Based on the available evidence, Power has assigned Gemcitabine + Cisplatin + Durvalumab + Yttrium-90 Selective Internal Radiation Therapy a safety rating of 2. This is because Phase 2 trials have not yet demonstrated efficacy, but there are some data points in favor of its security profile."
Answered by AI
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