A Multicentre, Open-label, Randomised, Controlled Study of Molecularly Precision Target Therapy Based on Tumor Molecular Profiling With FORFIRINOX in Advanced or Recurrent Extrahepatic Cholangiocarcinoma and Gallbladder Carcinoma

NCT03768375 Phase 2 UNKNOWN

The purpose of this study is to evaluate the feasibility, efficacy and safety of target therapy according to genomic and proteomic profiling combined with FORFIRINOX in advanced or recurrent extrahepatic cholangiocarcinoma and gallbladder carcinoma.

Details

Lead sponsor	Shanghai Jiao Tong University School of Medicine
Phase	Phase 2
Status	UNKNOWN
Enrolment	150
Start date	2016-11
Completion	2021-12-30

Conditions

• Cholangiocarcinoma of the Extrahepatic Bile Duct
• Gallbladder Cancer

Interventions

• conventional chemotherapy(FORFIRINOX) combined with target agents
• conventional chemotherapy(FORFIRINOX)

Primary outcomes

• Progression Free Survival — up to 1 year
  From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 year. The progression is defined consistent with Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria for solid tumors.

Countries

China