A Study of the Efficacy and Safety of Chemotherapy Combined With Toripalimab in Advanced Biliary Tract Cancer

Summary

1. Target population: patients with advanced biliary tract cancer (including gallbladder carcinoma, intrahepatic and extrahepatic cholangiocarcinoma) . 2. Primary objective: progression free survival (PFS)/ overall survival (OS) of first-line chemotherapy plus PD-1 antibody (Toripalimab) in patients with advanced biliary tract cancer. Secondary objectives: 1. objective response rate (ORR) of first-line chemotherapy plus PD-1 antibody (Toripalimab) 2. safety of first-line chemotherapy plus PD-1 antibody (Toripalimab) 3.Trial design: This is a monocenter, single arm, phase II study to evaluate the efficacy and safety of first-line chemotherapy plus PD-1 antibody (Toripalimab) in patients with advanced advanced biliary tract cancer. 4.Treatment plan: Patients will be given treatment as below once recruited: PD-1 antibody Toripalimab（240mg, iv, q3w），combined with GS regimen(gemcitabine 1000mg／m2 ，d1,d8 + S1 40-60mg bid\*14d，Q21d). The treatment will be continued until emerging of disease progression or intolerable adverse effects (The upper time limit for treatment is 2 years). 5.Number of subjects: 40 patients. Number of centers: 1 sites ( Fudan University Affiliated Zhongshan Hospital).

Timeline

Start

2018-12-17

Primary completion

2021-12-01

Completion

2022-03-30

Drugs

Indications