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The Efficacy and Safety of Nab-paclitaxel Plus S-1 in First-line Treatment of Advanced Biliary Tract Adenocarcinoma

Biliary Tract Cancer Clinical Trial

Official title:
Phase II Study of Nab-paclitaxel Plus S-1 in First-line Treatment of Advanced Biliary Tract Adenocarcinoma

Clinical Trial Summary

Advanced biliary tract adenocarcinoma has a poor prognosis with limited therapeutic options. Nab-paclitaxel plus S-1 chemotherapy will be given to untreated patients with advanced biliary tract adenocarcinoma for the first-line treatment.

Clinical Trial Description

Gemcitabine/Nab-paclitaxel has become a standard therapy in advanced pancreatic cancer. Given the morphologic and histologic similarities between pancreatic cancer and biliary tract adenocarcinoma, nab-Paclitaxel may be a promising regimen, and S-1 has been approved for biliary tract cancer in Japan. Untreated patients with advanced biliary tract adenocarcinoma will receive Nab-paclitaxel 120 mg/m2 (D1, D8, q3w) and S-1 (40mg BID for body surface area<1.25 m2; 50mg BID for body surface area of 1.25-1.5 m2; and 60mg BID for body surface area>1.5 m2; D1-14, q3w) as the first-line treatment. The investigators will investigate the efficacy and safety of the combination treatment, and expect to provide a more effective treatment plan for patients with advanced biliary tract cancer in China.The primary endpoint is objective response rate(ORR), and the secondary endpoints are progression-free survival(PFS), overall survival(OS) and the safety. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03830606
Study type Interventional
Source Chinese Academy of Medical Sciences
Contact
Status Completed
Phase Phase 2
Start date March 23, 2016
Completion date September 1, 2019
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