A Study to Evaluate GP Chemotherapy in Combination With Tislelizumab and Ociperlimab as First-line Treatment in Participants With Unresectable Advanced Biliary Tract Carcinoma (BTC)

ZSAB-TOP

This is an open label, multi-center, phaseⅡstudy to evaluate the efficacy and safety of GP (Gemcitabine/Cisplatin) in combination with Tislelizumab and Ociperlimab as first-line treatment in participants with unresectable advanced Biliary Tract Carcinoma (BTC).

2021-02-01

2023-01-18

2024-12-01

Active (not recruiting)

Early phase I

45

Inclusion Criteria: * • Subjects with a histopathological or cytologically diagnosis of BTC * The participants must be required to sign an informed consent * At least one measurable lesion (RECIST 1.1) * No previous systematic treatment for BTC * Child-Pugh Score, Class A * ECOG performance status 0 or 1 * Adequate organ function * Life expectancy of at least 3 months Exclusion Criteria: * • Diagnosis of mixed ampullary, hepatocellular, and cholangiocarcinoma * Known history of a serious allergy to any monoclonal antibody * Known central nervous system metastases and/or leptomeningeal disease prior to treatment * Portal hypertension with esophageal or gastric varices within 6 months prior to initiation of treatment * Any bleeding or thrombotic disorder within 6 months prior to initiation of treatment * Any active malignancy prior to the start of treatment * Active or history of autoimmune disease * Other acute or chronic conditions, psychiatric disorders, or laboratory abnormalities that may increase the risk of study participation * Pregnant or lactating women

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 45, 'type': 'ESTIMATED'}}

2023-08-15