Last updated: February 22, 2022
Sponsor: Tianjin Medical University Cancer Institute and Hospital
Overall Status: Active - Recruiting
Phase
2
Condition
Biliary Tract Cancer
Abdominal Cancer
Digestive System Neoplasms
Treatment
N/AClinical Study ID
NCT05251662
SGBICC
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Written informed consent should be signed before implementing any trial-relatedprocedures
- Male or female, 18 years old ≤ age ≤ 75 years old
- Histopathologically or cytologically diagnosed as locally advanced intrahepaticcholangiocarcinoma
- No previous systemic treatment, More than 6 months after the end of postoperativeadjuvant 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
Exclusion Criteria:
- Suffered from other malignant tumors in the past 5 years (except Radical basal cellcarcinoma of the skin squamous carcinoma of the skin and/or radical resected carcinomain 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 otherimmunotherapy
- Suffered from severe cardiovascular disease within 12 months before enrollment, suchas 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 stemcell transplantation
- other conditions that the investigator deems inappropriate for enrollment.
Study Design
Total Participants: 90
Study Start date:
January 13, 2022
Estimated Completion Date:
January 13, 2025
Connect with a study center
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin 300060
ChinaActive - Recruiting

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