Adjuvant Chemotherapy for Biliary Tract Cancer After Curative Resection

Phase 3

• Conditions: Cholangiocarcinoma; Gall Bladder Carcinoma
• Interventions: Drug: Gemcitabine; Drug: Capecitabine

• Registration Number: NCT03779035
• Lead Sponsor: Tianjin Medical University Cancer Institute and Hospital

Brief Summary

This prospective, open-Label, comparative, randomized, controlled phase III trial was designed to compare the clinical performance of gemcitabine with capecitabine vs. capecitabine alone for patients with biliary tract cancer (BTC) after curative resection.

Detailed Description

Currently, complete surgical resection represents the only potentially curative treatment option for cholangiocarcinoma (CCA, including intrahepatic, hilar and distal CCA) and gallbladder carcinoma (GBCA). Because of high rates of disease recurrence and poor survival rates following surgical resection, postoperative treatment have been considered to improve patient survival after resection of BTC. The systematic review showed a beneficial impact of adjuvant treatment in BTC, particularly in patients with involved lymph nodes or resection margins and distal or hilar CCA. However, in regard of the paucity of randomized data, current guidelines recommend inclusion in clinical trials.

Previously, the data of the BILCAP trial showed an improvement in median overall survival for capecitabine compared to observation alone for BTC, indicating capecitabine as the new standard postoperative treatment after curative resection of BTC.

Previous phase II studies for advanced BTC showed superiority of the combination gemcitabine/ capecitabine regimen vs. the capecitabine monotherapy, the median OS was 12.7-14 vs. 7.9 months.

Based on these data, this AdBTC trial will was designed to compare the clinical performance of gemcitabine with capecitabine vs. capecitabine alone for patients with biliary tract cancer (BTC) after curative resection, aiming for superiority of the combination regimen vs. the oral monotherapy. This will be based on the BILCAP protocol, applying the similar dosing, assessments and dose modifications.

The primary endpoint is DFS and secondary endpoints include recurrence free survival, OS, safety and tolerability of adjuvant CTx, quality of life, and patterns of disease recurrence.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Status Verified: 2018-12
• Study First Submitted: 2018-12-12
• Study Start: 2018-12-15
• Study First Submitted QC: 2018-12-17
• Last Update Submitted: 2018-12-17
• Study First Posted: 2018-12-19
• Last Update Posted: 2018-12-19
• Primary Completion: 2020-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 460

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gemcitabine plus Capecitabine	Capecitabine	Gemcitabine (1000 mg per square meter) on days 1 and 8 Capecitabine (1250 mg per square meter) twice a day on days 1-14. Treatment repeats every 3 weeks for 8 courses in the absence of disease progression or unacceptable toxicity.
Gemcitabine plus Capecitabine	Gemcitabine	Gemcitabine (1000 mg per square meter) on days 1 and 8 Capecitabine (1250 mg per square meter) twice a day on days 1-14. Treatment repeats every 3 weeks for 8 courses in the absence of disease progression or unacceptable toxicity.
Capecitabine	Capecitabine	Capecitabine (1250 mg per square meter) twice a day on days 1-14. Treatment repeats every 3 weeks for 8 courses in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measures

Name	Time	Method
Disease free survival (DFS) rate	at 24 months	DFS

Secondary Outcome Measures

Name	Time	Method
The rate of patients with hepatic or locoregional recurrence	24 months
Disease free survival (DFS) rate	at 60 months	DFS
Overall survival (OS) rate	at 60 months	OS

Trial Locations

Locations (1)

Tianjin Medical University Cancer Insititute and Hospital; 🇨🇳 Tianjin, Tianjin, China