Status:
UNKNOWN
Sintilimab Combined With GEMOX ± IBI305 (Bevacizumab Biosimilar) Versus GEMOX in Advanced Intrahepatic Cholangiocarcinoma
Lead Sponsor:
Tianjin Medical University Cancer Institute and Hospital
Conditions:
Intrahepatic Cholangiocarcinoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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 chol...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 13 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 13 2025
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT05251662
Start Date
January 13 2022
End Date
January 13 2025
Last Update
February 23 2022
Active Locations (1)
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1
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China, 300060