← Back to Search

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

No Placebo-Only Group

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.

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.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and enrollment to end of treatment and up to 52 weeks thereafter for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of Grade 3 or Higher Treatment-Related Toxicity

Median Progression Free Survival (PFS)

Secondary study objectives

Disease Control Rate (DCR)

Median Overall Survival (OS)

Objective Response Rate (ORR)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~1920

Cisplatin

2013

Completed Phase 3

~3120