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Spots Global Cancer Trial Database for SHR-1210 in Combination With GEMOX in Patients With Advanced BTC

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Trial Identification

Brief Title: SHR-1210 in Combination With GEMOX in Patients With Advanced BTC

Official Title: A Single-arm, Open-label and Exploratory Clinical Study of PD-1 Monoclonal Antibody SHR-1210 in Combination With GEMOX (Gemcitabine Combined Oxaliplatin) in Patients With Advanced Biliary Tract Cancer

Study ID: NCT03486678

Interventions

SHR-1210+GEMOX

Study Description

Brief 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.

Detailed Description:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Jiangsu Province Hospital, Nanjing, Jiangsu, China

Contact Details

Name: Yongqian Shu, PhD

Affiliation: JANGSU PROVINCE HOSPITAL

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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