GEMOX Combined With Targeted Therapy and Immunotherapy for Patients With Advanced Cholangiocarcinoma

Efficacy, Safety Evaluation and Biomarker Screening of GEMOX Combined With Targeted Therapy and Immunotherapy for Patients With Advanced Cholangiocarcinoma

The clinical trial is designed to evaluate the safety and efficacy of GEMOX combined with targeted therapy and immunotherapy for patients with advanced cholangiocarcinoma, and screen the potential biomarkers

Inclusion Criteria:

• Male or female, 18 years old ≤ age ≤ 70 years old
• ECOG PS scores 0-1
• Expected survival time > 12 weeks
• Advanced cholangiocarcinoma confirmed by histopathology and/or cytology, locally advanced (inoperable) or distant metastasis, and with at least one measurable lesion that has not been locally treated (per RECIST 1.1 criteria)
• Not received any previous systemic or local treatment for the tumor
• Sufficient organ and bone marrow function

Exclusion Criteria:

• Suffered from other malignant tumors in the past 5 years (except Radical basal cell carcinoma of the skin squamous carcinoma of the skin and/or radical resected carcinoma in situ)
• Ampullary tumor
• Received treatment from other clinical trials within 4 weeks before the first dose
• Received any anti-PD-1 antibody, anti-PD-L1/L2 antibody, anti-CTLA4 antibody, or other immunotherapy
• Suffered from severe cardiovascular disease within 12 months before enrollment, such as symptomatic coronary heart disease, congestive heart failure ≥ Grade II, uncontrolled arrhythmia, and myocardial infarction
• Uncontrollable pleural effusion, pericardial effusion or ascites
• Use steroids or other systemic immunosuppressive therapies 4 weeks before enrollment
• Allergic reactions to the drugs used in this study
• HIV antibody positive, active hepatitis B or C (HBV, HCV)
• Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation
• other conditions that the investigator deems inappropriate for enrollment