← Back to Search

Alkylating agents

Treatment (durvalumab, gemcitabine, cisplatin) for Intrahepatic Cholangiocarcinoma

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 surgery, and from surgery to recurrence of icca

Awards & highlights

Study 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.Check my eligibility

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.See study design

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 ~ after 2 and 4 cycles of neoadjuvant therapy (cycle length=21 days)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~after 2 and 4 cycles of neoadjuvant therapy (cycle length=21 days)

This trial's timeline: 3 weeks for screening, Varies for treatment, and after 2 and 4 cycles of neoadjuvant therapy (cycle length=21 days) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

Incidence of adverse events

Major pathologic response (MPR) rate

Overall survival (OS)

+5 more

Other outcome measures

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

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 2

~1700

Durvalumab

2017

Completed Phase 2

~3870

Resection

2021

Completed Phase 2

~410

Cisplatin

2013

Completed Phase 3

~1940

Biopsy

2014

Completed Phase 4

~1090

Computed Tomography

2017

Completed Phase 2

~2720

Gemcitabine

2017

Completed Phase 3

~2070

Magnetic Resonance Imaging

2017

Completed Phase 3

~1190

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,669 Previous Clinical Trials

40,926,294 Total Patients Enrolled

3 Trials studying Intrahepatic Cholangiocarcinoma

1,130 Patients Enrolled for Intrahepatic Cholangiocarcinoma

Hop S Tran CaoPrincipal InvestigatorUniversity of Texas MD Anderson Cancer Center LAO

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the overall patient enrollment count for this particular research investigation?

"Yes, data from clinicaltrials.gov confirms that recruitment is ongoing for this study. The trial was first listed on 11/26/2024 and last revised on 3/16/2024. It aims to enroll 27 participants at a single site."

Answered by AI

Are there any available slots for patients to participate in this clinical trial?

"Yes, information on clinicaltrials.gov confirms the ongoing recruitment of participants for this trial. The initial posting date was 11/26/2024 and the most recent update occurred on 3/16/2024. The study aims to recruit 27 patients from a single site."

Answered by AI

What is the safety profile of the therapy consisting of durvalumab, gemcitabine, and cisplatin in individuals undergoing treatment?

"Based on the trial phase, with some safety data available but lacking efficacy evidence, Treatment (durvalumab, gemcitabine, cisplatin) is rated as a 2 for safety by our team at Power."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Durvalumab With Gemcitabine and Cisplatin for the Treatment of High Risk Resectable Liver Cancer Before Surgery

2024. "Durvalumab With Gemcitabine and Cisplatin for the Treatment of High Risk Resectable Liver Cancer Before Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06050252.

All > Liver Cancer