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Alkylating agents

Pembrolizumab + Chemotherapy for Bile Duct Cancer

Phase 2
Recruiting
Led By Hop Tran Cao, MD
Research Sponsored by M.D. Anderson Cancer 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 up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial will compare adding a drug to standard chemotherapy to standard chemotherapy alone to see if it improves cholangiocarcinoma treatment.

Who is the study for?
Adults diagnosed with intrahepatic cholangiocarcinoma that can potentially be removed by surgery. They should not have had previous systemic therapy for this cancer, no other active cancers or serious illnesses, and must agree to use contraception. HIV-positive patients on effective treatment can join.
What is being tested?
The trial is testing if adding pembrolizumab (an immunotherapy drug) to the usual chemotherapy drugs gemcitabine and cisplatin before and after surgery can improve outcomes in bile duct cancer compared to just surgery and chemotherapy.
What are the potential side effects?
Pembrolizumab may cause immune system-related side effects, including inflammation of organs, fatigue, skin reactions, flu-like symptoms, hormonal changes. Gemcitabine and Cisplatin might cause nausea, kidney damage, low blood cell counts leading to increased infection risk.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

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: Pembrolizumab with Gemcitabine and CisplatinExperimental Treatment3 Interventions
Participants will receive 4 cycles (21 days each) of the combined chemotherapy before and after your scheduled surgery. During the 9 months of chemotherapy treatment, participants will have clinic visits every 3 weeks or so. During the 2-4 year follow-up period, participants will come to the clinic every 3 months or so
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 3
~3130
Gemcitabine
2017
Completed Phase 3
~1920
Cisplatin
2013
Completed Phase 3
~3120

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
3,073 Previous Clinical Trials
1,803,303 Total Patients Enrolled
14 Trials studying Cholangiocarcinoma
3,987 Patients Enrolled for Cholangiocarcinoma
Hop Tran Cao, MDPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
36 Total Patients Enrolled

Media Library

Cisplatin (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT05967182 — Phase 2
Cholangiocarcinoma Research Study Groups: Pembrolizumab with Gemcitabine and Cisplatin
Cholangiocarcinoma Clinical Trial 2023: Cisplatin Highlights & Side Effects. Trial Name: NCT05967182 — Phase 2
Cisplatin (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05967182 — Phase 2
~16 spots leftby Jul 2027