Phase II Study of HAIC with Donafenib and Sintilimab Compared to Surgery in Patients with Resectable Hepatocellular Carcinoma at High Risk of Recurrence

What this Trial Is About

Researchers are evaluating the safety and effectiveness of treatments given around the time of surgery for patients with resectable hepatocellular carcinoma HCC who have a high risk of cancer returning. This phase II study compares three approaches chemotherapy with hepatic arterial infusion combined with the drugs donafenib and sintilimab, donafenib and sintilimab without chemotherapy, and direct surgery without preoperative drug treatment. The goal is to find the best way to reduce recurrence and improve outcomes in these patients. Patients are randomly assigned to one of three groups. Group A receives two cycles of chemotherapy via hepatic arterial infusion every three weeks, along with donafenib and sintilimab, followed by surgery and then continuation of donafenib and sintilimab for six cycles. Group B receives donafenib and sintilimab without chemotherapy before surgery, then continues both drugs for six cycles after surgery. Group C undergoes direct surgery followed by six cycles of donafenib and sintilimab. Doses of donafenib may be adjusted based on the patients condition, and sintilimab is given every three weeks intravenously. During the study, participants will be monitored regularly through scans and other assessments to measure outcomes such as one-year recurrence-free survival rate, tumor response, and overall survival up to three years. Researchers will also track safety and side effects throughout the trial. The total study participation may last up to several years to assess long-term benefits and risks. Participants will have scheduled visits to evaluate their health, treatment response, and any adverse events.

HAIC Combined with Donafenib and Sintilimab As Perioperative Treatment for Resectable Hepatocellular Carcinoma Patients At High Risk of Recurrence