Using donafenib after thermal ablation for recurrent liver cancer
Official title: Thermal Ablation Combined With Low-dose Donafinib for Early Recurrent Hepatocellular Carcinoma: a Multicenter Prospective Study
Run by Sun Yat-sen University · NCT06609876 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 108 (estimated) |
| Sponsor | Sun Yat-sen University Academic / other |
| Locations | 1 site (Beijing, None Selected) |
| Status | Recruiting |
| Started | October 1, 2024 |
| Main results expected | October 1, 2026 |
| Study ends | October 1, 2028 |
| Registry record updated | December 3, 2024 |
| Trial ID | NCT06609876 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18-75 with early recurrent HCC meeting specific criteria and who are not candidates for repeat surgery.
✕Probably not a fit
Patients with primary HCC, those beyond Milan criteria, or with significant liver dysfunction may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
Chinese PLA General hospital
Beijing, None Selected, China Recruiting
Study contacts
- Study coordinator: Qunfang Zhou, MD
- Email: zhouqun988509@163.com
- Phone: 86 19868000115
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.