Status:
UNKNOWN
Tislelizumab Plus TKI as Adjuvant Therapy Versus Active Surveillance in Patients With HCC
Lead Sponsor:
Beijing 302 Hospital
Conditions:
Liver Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Background: Ablation is important radical treatment in hepatocellular carcinoma (HCC). However, the 5-year recurrence rate of HCC after ablation is up to 80%. Early and late recurrences are more likel...
Eligibility Criteria
Inclusion
- Eligible patients are ≥18 years, diagnosed with HCC confirmed by histopathology or cytology, with no prior targeted or immune checkpoint therapy for HCC, and have undergone curative ablation with no residual lesions according to imaging or pathological assessment. Patients are at high risk of recurrence meeting one of the following criteria:
- solitary tumor \>2cm but ≤5cm, or multiple tumors ≤4tumors and all≤5cm； poor tumor differentiation； macrovascular invasion of the portal vein(Vp1/Vp2) ； the absence or infiltration of a tumor capsule ； AFP≥32ng/ml； HBV DNA ≥105IU/ml； history of recurrence after curative treatment； family history of tumors.
Exclusion
- Concurrent with other primary malignant tumors; severe coagulation dysfunction or severe thrombocytopenic purpura; There is serious infection or organ failure; have previously received targeted drugs or other PD-1 antibody therapy;
Key Trial Info
Start Date :
December 22 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 20 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06059885
Start Date
December 22 2021
End Date
December 20 2025
Last Update
September 29 2023
Active Locations (1)
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1
302 Hospital
Beijing, Beijing Municipality, China, 100039