GP Chemotherapy in Combination With Tislelizumab and Ociperlimab as First-line Treatment in Advanced BTC

• Status: Not yet recruiting
• Trial end date: 2024-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fudan University

Criteria

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 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