NCT04401709

Gemcitabine+ Capecitabine Vs Capecitabine in Curatively Resected Biliary Tract Cancer

A Randomized, Multi-center Phase III Trial of Adjuvant Chemotherapy With Gemcitabine and Capecitabine Compared to Capecitabine Alone in Curatively Resected Biliary Tract Cancer

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 490 (estimated)
• Sponsor: Samsung Medical Center · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial is an open-label, multicenter, phase 3 clinical trial to study the efficacy and safety of adjuvant gemcitabine + capecitabine combination treatment in patients with resectable biliary tract cancer according to imaging studies after surgery. All the patients must complete a consent forms before participating in the clinical trial, and the estimated enrollment period is 36 months after IRB approval. Drug Dose and Schedule: * Cohort 1: Gemcitabine/Capecitabine, every 4 weeks, total 6 cycles gemcitabine1,000 mg/m2 over 30 min D1, D8, D15 capecitabine 1660 mg/m2, D1-21 * Cohort 2: Capecitabine, everu 3 weeks, total 8 cycles capecitabine 2,500 mg/m2 D1-14

Detailed description

1. Study Background \& Rationale:adjuvant capecitabine monotherapy following surgery is regarded as standard treatment after phase 3 BILCAP trial, we need further phase 3 clinical trials to evaluate efficacy of doublet combination adjuvant chemotherapy for Biliary Track Cancer after surgery. Since Korea has much higher incidence rate of Biliary Track Cancer compared to western countries, Korea is considered to be a region that can lead large-scale Biliary Track Cancer clinical trials. In this background, we intend to conduct a randomized phase 3 study to compare adjuvant gemcitabine+cisplatin combination therapy with camecitabine monotherapy following curative intent surgical resection in patients with Biliary Track Cancer . 2. Primary Objective: * Disease-free survival at 24 months (2-year DFS) 3. Primary Hypothesis: Adjuvant gemcitabine and capecitabine combination treatment confers diseae free survival benefit over capecitabine monotherapy after curative intent surgical resection of biliary tract cancer 4. Study Design: This clinical trial is an open-label, multicenter, phase 3 clinical trial to study the efficacy and safety of adjuvant gemcitabine + capecitabine combination treatment in patients with resectable biliary tract cancer according to imaging studies after surgery. All the patients must complete a consent forms before participating in the clinical trial, and the estimated enrollment period is 36 months after IRB approval.

Conditions

• Biliary Tract Cancer

Interventions

Type	Name	Description
DRUG	Gemcitabine/Capecitabine	gemcitabine 1,000 mg / m2 IV on day 1, 8, and 15 of each cycle Capecitabine 1,660mg / m2 PO twice daily 1 \~ 21 days for 4 weeks
DRUG	Capecitabine	total 8 cycles Capecitabine 1,250 mg / m2 PO twice daily 1 \~ 14 days for 3 weeks

Timeline

• Start date: 2021-04-01
• Primary completion: 2025-03-30
• Completion: 2025-03-30
• First posted: 2020-05-26
• Last updated: 2022-06-15

Locations

1 site across 1 country: South Korea