Phase 3 Study of Anlotinib Hydrochloride Capsules and Penpulimab Injection as Adjuvant Treatment After Surgery or Ablation in Patients With Hepatocellular Carcinoma at High Risk of Recurrence

What this Trial Is About

Researchers are evaluating the effectiveness of combining anlotinib hydrochloride capsules with penpulimab injection as an additional treatment after radical surgery or ablation for patients with hepatocellular carcinoma HCC who are at high risk of cancer returning. This Phase 3 randomized, double-blind, placebo-controlled study aims to compare this combination therapy to a placebo to assess recurrence-free survival RFS over a period of up to three years. Participants receive either the anlotinib capsules plus penpulimab injection or matching placebos in 21-day treatment cycles. The study groups include an experimental arm receiving both active drugs and a control arm receiving placebo capsules and injections. This approach helps researchers understand how well the combination works in preventing cancer recurrence after initial treatment. Throughout the study, participants will have their health monitored regularly, including assessments of recurrence-free survival, time to cancer recurrence, time to spread outside the liver or vascular invasion, overall survival, and response rate after any recurrence. These evaluations will occur from the start of the study and continue for up to three years to track long-term outcomes and safety.

Anlotinib Hydrochloride Capsules Combined With Penpulimab Injection for the Treatment of Hepatocellular Carcinoma at High Risk of Recurrence.