Sintilimab Combined With GEMOX ± IBI305 (Bevacizumab Biosimilar) Versus GEMOX in Advanced Intrahepatic Cholangiocarcinoma

• Status: Recruiting
• Trial end date: 2025-01-13
• Target enrollment: 0
• Participant gender: All

Summary

A randomized controlled, phase II clinical trial is designed to compare the safety and efficacy of Sintilimab combined with GEMOX ± IBI305 and GEMOX as first-line therapy in advanced intrahepatic cholangiocarcinoma.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tianjin Medical University Cancer Institute and Hospital
• Treatments: Bevacizumab

Criteria

Inclusion Criteria:

• Written informed consent should be signed before implementing any trial-related procedures

• Male or female, 18 years old ≤ age ≤ 75 years old

• Histopathologically or cytologically diagnosed as locally advanced intrahepatic cholangiocarcinoma

• No previous systemic treatment, More than 6 months after the end of postoperative adjuvant therapy was allowed

• Expected survival time > 3 months

• At least ≥ 1 measurable lesions per RECIST 1.1

• ECOG PS scores 0-2

• Sufficient organ and bone marrow function

• Urine or serum pregnancy test is negative

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.