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

Tianjin Medical University

Status: Enrolling

Conditions: Cholangiocarcinoma

Treatments: Drug: Lenvatinib; Drug: Toripalimab; Drug: GEMOX Regimen

Study type: Interventional

Funder types: Other

Identifiers

NCT05215665

GTIC

Details and patient eligibility

About

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

Enrollment: 146 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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146 participants in 2 patient groups

group 1

Experimental group

Description:

GEMOX+Lenvatinib+Toripalimab

Treatment:

Drug: GEMOX Regimen

Drug: Toripalimab

Drug: Lenvatinib

group 2

Experimental group

Description:

GEMOX+Toripalimab

Treatment:

Drug: GEMOX Regimen

Drug: Toripalimab