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Alkylating agents

Durvalumab + Chemotherapy for Bile Duct Cancer

Phase 2

Recruiting

Led By Hop S Tran Cao

Research Sponsored by National Cancer Institute (NCI)

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 from randomization to death, assessed up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a combination of durvalumab, a monoclonal antibody, with standard chemotherapy drugs (gemcitabine and cisplatin) before surgery for patients with high-risk liver

Who is the study for?

This trial is for patients with a specific liver cancer called intrahepatic cholangiocarcinoma that can be surgically removed. They must have measurable disease, no prior treatments for this cancer, and be fit for surgery. The tumor should be larger than 5 cm or there may be regional lymph node metastases or vascular invasion.

What is being tested?

The study tests the combination of durvalumab (a monoclonal antibody) with standard chemotherapy drugs gemcitabine and cisplatin before surgery in high risk liver cancer patients to see if it reduces the tumor size more effectively than current methods.

What are the potential side effects?

Durvalumab might cause immune-related reactions, fatigue, skin rash, while gemcitabine and cisplatin can lead to nausea, kidney damage, low blood cell counts increasing infection risk.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from randomization to death, assessed up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from randomization to death, assessed up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization to death, assessed up to 2 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Proportion of patients who complete 4 cycles of neoadjuvant therapy followed by surgical resection

Secondary study objectives

Incidence of adverse events

Major pathologic response (MPR) rate

Overall survival (OS)

+5 more

Other study objectives

Changes in circulating immune phenotypic profiles in the neoadjuvant phase

Circulating tumor deoxyribonucleic acid-based minimal residual disease correlated with pathological response and RFS

Measures of body composition and fatty liver from imaging

+2 more

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: Treatment (durvalumab, gemcitabine, cisplatin)Experimental Treatment8 Interventions

Patients receive durvalumab IV over 60 minutes on day 1 with gemcitabine IV over 30 minutes and cisplatin IV over 60 minutes on days 1 and 8 for 4 cycles and then undergo surgical resection on study. Following surgery, patients may continue the durvalumab, gemcitabine and cisplatin regimen for up to 4 additional cycles. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo CT scans and/or MRI scans and blood sample collection throughout study, as well as tissue biopsies during screening and on study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Biospecimen Collection

2004

Completed Phase 3

~2020

Durvalumab

2017

Completed Phase 2

~3750