Sintilimab Combined With GEMOX ± IBI305 (Bevacizumab Biosimilar) Versus GEMOX in Advanced Intrahepatic Cholangiocarcinoma
- Conditions
- Intrahepatic Cholangiocarcinoma
- Interventions
- Registration Number
- NCT05251662
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 90
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description experimental group1 IBI305 Sintilimab Combined With GEMOX + IBI305 experimental group1 GEMOX Sintilimab Combined With GEMOX + IBI305 experimental group2 Sintilimab Sintilimab Combined With GEMOX experimental group2 GEMOX Sintilimab Combined With GEMOX Comparator GEMOX GEMOX experimental group1 Sintilimab Sintilimab Combined With GEMOX + IBI305
- Primary Outcome Measures
Name Time Method Overall response rate ( ORR) up to 90 days after last treatment administration Overall response rate ( ORR) is defined as proportion of participants who have a best response of CR or PR
- Secondary Outcome Measures
Name Time Method Disease Control Rate (DCR) up to 90 days after last treatment administration Disease Control Rate (DCR) is defined as proportion of participants who have a best response of CR、PR or SD
Overall survival (OS) up to 3 years the time period from the randomization of the participants to the death event due to any reason
Progression free survival (PFS) up to 3 years the time period from randomization of the participants to objective tumor progression or death
Adverse event up to 30 days after last treatment administration All grades of adverse events, all grades of treatment related adverse events, serious of adverse events
Trial Locations
- Locations (1)
Tianjin Medical University Cancer Institute & Hospital
🇨🇳Tianjin, Tianjin, China