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

Tianjin Medical University

Status and phase: Enrolling; Phase 2

Conditions: Intrahepatic Cholangiocarcinoma

Treatments: Drug: Sintilimab; Drug: IBI305; Drug: GEMOX

Study type: Interventional

Funder types: Other

Identifiers

NCT05251662

SGBICC

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 3 patient groups

experimental group1

Experimental group

Description:

Sintilimab Combined With GEMOX + IBI305

Treatment:

Drug: GEMOX

Drug: Sintilimab

Drug: IBI305

experimental group2

Experimental group

Description:

Sintilimab Combined With GEMOX

Treatment:

Drug: GEMOX

Drug: Sintilimab

Comparator

Active Comparator group

Description:

GEMOX

Treatment:

Drug: GEMOX