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Gemcitabine plus cisplatin for Cholangiocarcinoma

Phase 2
Waitlist Available
Led By Baek-Yeol Ryoo, MD
Research Sponsored by Asan 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 4 years
Awards & highlights
All Individual Drugs Already Approved
Approved for 10 Other Conditions
No Placebo-Only Group

Summary

There is no proven adjuvant treatment after curative surgical resection in patients with cholangiocarcinoma, although previous meta-analysis suggested potential survival benefit of adjuvant chemotherapy or radiotherapy in patients with lymph node-positive resected cholangiocarcinoma. Despite of lack of level 1 evidence and no data which regimen is optimal, adjuvant chemotherapy is widely used in daily practice setting. Based on this background, the investigators designed the randomized phase 2 trial comparing capecitabine and gemcitabine plus cisplatin in patients with resected lymph node-positive extrahepatic cholangiocarcinoma.

Eligible Conditions
  • Cholangiocarcinoma
  • Bile Duct Cancer
  • Biliary Tract Cancer
  • Adjuvant Chemotherapy
  • Capecitabine
  • Gemcitabine
  • Cisplatin

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 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
2-year disease-free survival
Secondary study objectives
Disease-free survival
Overall survival
Toxicities (Adverse events related with chemotherapy)

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Gemcitabine plus cisplatinExperimental Treatment1 Intervention
Adjuvant Gemcitabine plus Cisplatin
Group II: CapecitabineActive Control1 Intervention
Adjuvant Capecitabine
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cisplatin
FDA approved

Find a Location

Who is running the clinical trial?

Asan Medical CenterLead Sponsor
663 Previous Clinical Trials
210,629 Total Patients Enrolled
4 Trials studying Cholangiocarcinoma
296 Patients Enrolled for Cholangiocarcinoma
Bundang CHA HospitalOTHER
39 Previous Clinical Trials
7,306 Total Patients Enrolled
Seoul St. Mary's HospitalOTHER
120 Previous Clinical Trials
870,781 Total Patients Enrolled
~12 spots leftby Dec 2025
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