Using donafenib after thermal ablation for recurrent liver cancer
Thermal Ablation Combined With Low-dose Donafinib for Early Recurrent Hepatocellular Carcinoma: a Multicenter Prospective Study
This study is testing if adding a low dose of donafenib after thermal ablation can help people with early recurrent liver cancer do better than just having the ablation alone.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 108 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Sun Yat-sen University Academic / other |
| Locations | 1 site (Beijing, None Selected) |
| Trial ID | NCT06609876 on ClinicalTrials.gov |
What this trial studies
This study evaluates the efficacy and safety of low-dose donafenib as an adjuvant therapy following thermal ablation in patients with early recurrent hepatocellular carcinoma (HCC) that meets the Milan criteria. The trial is prospective, randomized, and open-label, focusing on patients who have undergone thermal ablation for their first or second recurrence of HCC. The goal is to determine whether this combination treatment can improve outcomes compared to thermal ablation alone.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 with early recurrent HCC meeting specific criteria and who are not candidates for repeat surgery.
Not a fit: Patients with primary HCC, those beyond Milan criteria, or with significant liver dysfunction may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could enhance survival rates and improve quality of life for patients with recurrent HCC.
How similar studies have performed: While donafenib has been studied in advanced HCC, this specific approach as adjuvant therapy after thermal ablation is novel and has not been previously tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Beijing, None Selected
- Chinese PLA General hospital — Beijing, None Selected, China (Recruiting)
Study contacts
- Study coordinator: Qunfang Zhou, MD
- Email: zhouqun988509@163.com
- Phone: 86 19868000115
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.