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Recruiting NCT05215665

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

Trial Parameters

Condition Cholangiocarcinoma
Sponsor Tianjin Medical University Cancer Institute and Hospital
Study Type INTERVENTIONAL
Phase N/A
Enrollment 146
Sex ALL
Min Age 18 Years
Max Age 70 Years
Start Date 2022-01-15
Completion 2024-05-15
Interventions
GEMOX RegimenLenvatinibToripalimab

Brief Summary

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

Eligibility Criteria

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 dis

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