Cholangiocarcinoma Clinical Trial
Official title:
Adjuvant Chemotherapy With Gemcitabine and Capecitabine Compared to Capecitabine for Biliary Tract Cancer After Curative Resection
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.
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.
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