Brief Title
GEMOX Combined With Targeted Therapy and Immunotherapy for Patients With Advanced Cholangiocarcinoma
Official Title
Efficacy, Safety Evaluation and Biomarker Screening of GEMOX Combined With Targeted Therapy and Immunotherapy for Patients With Advanced Cholangiocarcinoma
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
Study Type
Interventional
Primary Outcome
Overall response rate (ORR)
Secondary Outcome
Disease Control Rate (DCR)
Condition
Cholangiocarcinoma
Intervention
GEMOX Regimen
Study Arms / Comparison Groups
group 1
Description: Lenvatinib+Toripalimab
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
120
Start Date
January 15, 2022
Completion Date
January 15, 2026
Primary Completion Date
January 15, 2024
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 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
Gender
All
Ages
18 Years - 70 Years
Accepts Healthy Volunteers
No
Contacts
, +86 22-27468682, [email protected]
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT05215665
Organization ID
GTIC
Responsible Party
Sponsor
Study Sponsor
Tianjin Medical University Cancer Institute and Hospital
Study Sponsor
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Verification Date
January 2022