Donafenib, Hepatocellular Carcinoma, Microwave Ablation, Recurrent Tumor
Conditions
Brief summary
This study intends to evaluate the efficacy and safety of low-dose adjuvant donafenib after thermal ablation for early recurrent HCC within Milan criteria.
Detailed description
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.
Interventions
PROCEDUREThermal ablation
Thermal ablation of tumors
DRUGDonafenib
Donafenib ( 100 mg，bid)
Sponsors
Chinese PLA General Hospital
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tumor-free survival rate | 24 months | Progression was defined as progressive disease after thermal ablation by independent radiologic review according to mRECIST or death from any cause |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival (OS) | 36 months | OS is the length of time from the date of ablation until death from any cause. |
| Adverse events | 36 months | Safety will be evaluated according to the NCI CTCAE Version 4.03. All observations pertinent to the safety of the study medication will be recorded on the CRF and included in the final report. |
Countries
China
Contacts
Primary ContactQunfang Zhou, MD
Backup ContactFeng Duan, Professor
Outcome results
None listed