Study of Donafenib Combined With Envafolimab as Adjuvant Treatment for High-Risk Hepatocellular Carcinoma After Surgery

What this Trial Is About

Hepatocellular carcinoma HCC is a serious cancer with high rates of illness and death. Surgery is the main treatment, but the cancer often returns, especially in patients with a high risk of recurrence after surgery. Researchers are studying how to lower the chance of cancer returning and improve survival, as there is currently no standard treatment after surgery. This study evaluates the safety and effectiveness of combining two drugs, donafenib and envafolimab, for patients at high risk of recurrent HCC after surgery. Participants will receive donafenib orally at 100mg twice daily and envafolimab intravenously at 300mg every three weeks. Treatment cycles range from 6 to 12 months or 8 to 16 sessions, continuing until cancer recurrence, unacceptable side effects, death, withdrawal, or completion of 16 envafolimab cycles. This is a single-arm, multicenter study designed to assess this drug combination as an adjuvant therapy after surgery. During the study, participants will be monitored for recurrence-free survival over 24 months. Researchers will also track overall survival, the rate of survival and recurrence at two years, and any adverse events during this time. Patients will undergo imaging and laboratory tests to confirm no cancer recurrence before starting treatment and will be followed closely throughout to assess treatment effects and safety.

Adjuvant Treatment of Patients With High Risk of Recurrent Hepatocellular Carcinoma With Donafenib in Combination With Envafolimab