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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
38
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 used up to 6 cycles.SHR-1210 3mg/kg IV Q2W will be administered beyond chemotherapy until the disease progression or untolerable toxicity.
Jiangsu Province Hospital
Nanjing, Jiangsu, China
6-month Progression Free Survival (PFS) rate
the rate of 6-month progression free survival
Time frame: from the first drug administration up to 6 months
Incidence of Treatment-Emergent Adverse Events
Incidence of Treatment-Emergent Adverse Events, especially immune related adverse events
Time frame: from the first drug administration to within 90 days for the last SHR-1210 dose
Objective Response Rate (ORR)
the best Objective Response Rate
Time frame: from the first drug administration up to two years
Duration of response (DOR)
Duration of response
Time frame: from the first drug administration up to two years
Disease Control Rate (DCR)
the Rate of Disease Control
Time frame: from the first drug administration up to two years
12-month Overall survival (OS) rate
Overall Survival rate at 12 months
Time frame: from the first drug administration up to approximately 12 months
OS
Overall survival
Time frame: from the first drug administration up to 2 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.