Last updated: September 22, 2023
Sponsor: Beijing 302 Hospital
Overall Status: Active - Recruiting
Phase
2
Condition
Digestive System Neoplasms
Liver Cancer
Primary Biliary Cholangitis
Treatment
Tislelizumab plus tyrosine kinase inhibitor
Clinical Study ID
NCT06059885
ChiECRCT20210555
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Eligible patients are ≥18 years, diagnosed with HCC confirmed by histopathology orcytology, with no prior targeted or immune checkpoint therapy for HCC, and haveundergone curative ablation with no residual lesions according to imaging orpathological assessment. Patients are at high risk of recurrence meeting one of thefollowing criteria: solitary tumor >2cm but ≤5cm, or multiple tumors ≤4tumors and all≤5cm; poor tumordifferentiation; macrovascular invasion of the portal vein(Vp1/Vp2) ; the absence orinfiltration of a tumor capsule ; AFP≥32ng/ml; HBV DNA ≥105IU/ml; history of recurrenceafter curative treatment; family history of tumors.
Exclusion
Exclusion Criteria: Concurrent with other primary malignant tumors; severe coagulation dysfunction or severethrombocytopenic purpura; There is serious infection or organ failure; have previouslyreceived targeted drugs or other PD-1 antibody therapy;
Study Design
Total Participants: 60
Treatment Group(s): 1
Primary Treatment: Tislelizumab plus tyrosine kinase inhibitor
Phase: 2
Study Start date:
December 22, 2021
Estimated Completion Date:
December 20, 2025
Connect with a study center
302 Hospital
Beijing, Beijing 100039
ChinaActive - Recruiting
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