Donafenib as Adjuvant Therapy Following Ablation for Recurrent HCC

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

This study intends to evaluate the efficacy and safety of low-dose adjuvant donafenib after thermal ablation for early recurrent HCC within Milan criteria.

Thermal ablation is available as the major curative treatments for early-stage recurrent HCC. Donafenib was inferior to sorafenib in overall survival in untreated advanced hepatocellular carcinoma. No study has evaluated low-dose donafenib as adjuvant therapy after thermal ablation. There needs further investigation to explore the efficacy and safety of the combination treatment. Thus, the investigators carried out this prospective, randomized, open-label, phase II trial study to find out it.

Inclusion Criteria:

1. were aged 18-75 years;
2. had recurrent HCC (RHCC) diagnosed by imaging studies, the first or the second RHCC;
3. RHCC met the Milan criteria, namely single RHCC lesion less than 5 cm in diameter or no more than 3 tumors (each ≤3 cm in diameter);
4. the early RHCC (recurrent time <1 year)
5. patients were unwilling to undergo repeat hepatectomy or liver transplantation;
6. had well-preserved liver function, i.e., Child-Pugh class A or B, and prolonged prothrombin time≤5 s;
7. patients had an Eastern Cooperative Oncology Group performance status score ≤1.
8. Ability to understand the protocol and to agree to and sign a written informed consent document.

Exclusion Criteria:

1. were under 18 years or over 75 years of age;
2. primary HCC;
3. recurrent HCC beyond Milan criteria;
4. RHCC with metastasis or macrovascular tumor thrombus