Adjuvant Chemotherapy for Biliary Tract Cancer After Curative Resection

  • STATUS
    Recruiting
  • End date
    Dec 31, 2023
  • participants needed
    460
  • sponsor
    Tianjin Medical University Cancer Institute and Hospital
Updated on 22 January 2021

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.

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.

Details
Condition Adenocarcinoma, Malignant Adenoma, Adenocarcinoma, Cholangiocarcinoma, Gallbladder Carcinoma, Gall Bladder Carcinoma, Malignant Adenoma
Treatment Capecitabine, Gemcitabine
Clinical Study IdentifierNCT03779035
SponsorTianjin Medical University Cancer Institute and Hospital
Last Modified on22 January 2021

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