Actively Recruiting
Study of Adebrelimab Plus Apatinib as Additional Treatment to Lower Recurrence Risk in Liver Cancer After Surgery
Led by Qilu Hospital of Shandong University · Updated on 2024-08-01
30
Participants Needed
1
Research Sites
26 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the combination of Adebrelimab and Apatinib as an additional treatment for people with hepatocellular carcinoma HCC who have a high risk of cancer returning after surgery. This Phase 2, single-center, open-label study focuses on assessing the safety and effectiveness of this treatment approach to improve survival and quality of life. The study includes a mid-term analysis at 6 months after enrolling 30 participants to review recurrence-free survival and overall survival rates. Participants will receive Adebrelimab at a dose of 1200 mg every 3 weeks combined with daily Apatinib 250 mg for the first 6 months or 8 treatment cycles. After this initial phase, Adebrelimab alone will be continued every 3 weeks for up to 2 years during the maintenance phase. The study follows a single-arm design without a placebo or comparison group. Throughout the study, participants will be monitored regularly for cancer recurrence and survival for up to 24 months, focusing on the recurrence-free survival rate as the primary outcome. Additional assessments include overall survival and time to recurrence over a 3-year period. Safety and liver function will be closely evaluated through clinical visits, laboratory tests, and imaging. Participants will be followed for up to three years to assess long-term outcomes and treatment effects.
CONDITIONS
Brief Title
Adjuvant Adebrelimab Plus Apatinib for Participants With HCC at High-risk of Recurrence After Curative Resection
Research Team
T
Tao Li, Dr
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