RecruitingNot ApplicableNCT05215665

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

Sponsor

Tianjin Medical University Cancer Institute and Hospital

Enrollment

146 participants

Start Date

Jan 15, 2022

Study Type

INTERVENTIONAL

Conditions

Cholangiocarcinoma

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

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria6

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 Criteria11

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