Thermal Ablation Combined With Low-dose Donafinib for Early Recurrent Hepatocellular Carcinoma: a Multicenter Prospective Study

What this Trial Is About

Researchers are evaluating the safety and effectiveness of low-dose donafenib as an additional treatment after thermal ablation for patients with early recurrent hepatocellular carcinoma (HCC) within the Milan criteria. This trial aims to address the need for further study of this combination treatment since donafenib alone was less effective than sorafenib in advanced HCC, and no prior research has tested low-dose donafenib following ablation. The study is a prospective, randomized, open-label phase II trial. Participants will receive either thermal ablation alone (using microwave or radiofrequency ablation) or thermal ablation combined with low-dose donafenib (100 mg twice daily). The study compares these two groups to explore the benefits and safety of adding donafenib after ablation. Thermal ablation is the main curative treatment, and donafenib is being assessed as an adjuvant therapy. During the study, participants will be monitored for tumor-free survival over 24 months as the primary outcome. Secondary outcomes include overall survival and adverse events tracked over 36 months. Researchers will conduct regular evaluations to measure these outcomes and monitor safety. The study starts in October 2024 and runs until October 2028, involving multiple centers under the sponsorship of Sun Yat-sen University.

Donafenib as Adjuvant Therapy Following Ablation for Recurrent HCC