Gemcitabine and Oxaliplatin With or Without KN035 for Biliary Tract Cancer: a Randomised, Open-label, Parallel-group, Multicenter Phase III Study

KN035-CN-005

This is a randomized, open-label, parallel-group multi-center study of Phase 3 study to assess the efficacy and safety of KN035 compared to standard of care (SOC) Gemcitabine-based chemotherapies in the treatment of participants with previously untreated locally advanced or metastatic biliary tract cancer. The primary hypothesis of this study is that participants will have a longer overall Survival (OS) when treated with combined therapy than SOC.

2018-04-16

2024-07-15

2024-07-30

Recruiting

Early phase I

480

Inclusion Criteria: * Eighteen years and older; * Histological or cytological diagnosis of unresectable or metastatic gallbladder cancer or cholangiocarcinoma; * Previously untreated with systemic therapy; Subjects who developed recurrent disease \>6 months after a sort of adjuvant, neoadjuvant chemotherapy could also be eligible. * Liver function Child-Pugh A or B; * Performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status; * Life expectancy of at least 12 weeks; * At least one measurable lesion per RECIST 1.1; * Adequate organ function Exclusion Criteria: * Specific anti-tumor treatment prior to 4 weeks; * more than 50% liver metastasis ; * Patient with other serious diseases or clinical conditions, including but not limited to uncontrolled active infection etc; * History of severe hypersensitivity reaction to any monoclonal antibody or chemistry; * Women who are pregnant or in the period of lactation; * Patients with an active, known or suspected autoimmune disease. Patients are permitted to enrol if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement;

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 480, 'type': 'ESTIMATED'}}

2024-05-07