SHR-1210 in Combination With GEMOX in Patients With Advanced BTC
Status:
Completed
Trial end date:
2020-11-30
Target enrollment:
Participant gender:
Summary
This is a single-arm, open-label and exploratory clinical study of PD-1 monoclonal antibody
SHR-1210 combined with GEMOX regimen (gemcitabine combined oxaliplatin) in the treatment of
advanced biliary malignancies.
In oder to observe and evaluate the efficacy and safety of PD-1 antibody SHR-1210 combined
with GEMOX in the treatment of patients with advanced biliary malignant tumor (BTC),subjects
with pathological confirmed biliary cancer, including intrahepatic bile duct carcinoma,
extrahepatic bile duct carcinoma, and gallbladder carcinoma will be enrolled.
28 days as a treatment cycle, SHR-1210 3mg/kg and Gemcitabine 800 mg/m2 will be administered
IV Q2W (D1 and D15 of a treatment cycle),and Oxaliplatin 85mg/m2 will be administered IV Q2W
(D2 and D16 of a treatment cycle). PD-1 antibody combined chemotherapy will be used up to 6
cycles.SHR-1210 3mg/kg IV Q2W will be administered beyond 6 cycles chemotherapy until disease
progression or un-tolerable toxicity.
Phase:
Phase 2
Details
Lead Sponsor:
The First Affiliated Hospital with Nanjing Medical University