A Study of the Efficacy and Safety of Chemotherapy Combined With Toripalimab in Advanced Biliary Tract Cancer
Status:
Recruiting
Trial end date:
2024-06-30
Target enrollment:
Participant gender:
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).