Using donafenib after surgery for liver cancer
Official title: Efficacy and Safety of Donafenib as Adjuvant Therapy for Postoperative Patients With High-Risk Recurrent Hepatocellular Carcinoma: A Multicenter, Randomized Controlled Study
Run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · NCT06581315 · Data updated 2026-11-12
This study is testing if the drug donafenib can help prevent liver cancer from coming back in patients who have just had surgery to remove their tumors.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 204 (estimated) |
| Sponsor | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Guangzhou, Guangdong) |
| Status | Recruiting |
| Started | August 28, 2024 |
| Main results expected | August 30, 2027 |
| Study ends | August 30, 2032 |
| Registry record updated | September 3, 2024 |
| Trial ID | NCT06581315 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are patients who have recently undergone surgery for hepatocellular carcinoma and are classified as high risk for recurrence.
✕Probably not a fit
Patients with recurrent hepatocellular carcinoma or those who have received prior anti-tumor therapies 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 donafenib as an adjuvant therapy for patients who have undergone radical resection of hepatocellular carcinoma and are at high risk for recurrence. It is a multicenter, randomized controlled trial that aims to determine if donafenib can improve outcomes in these postoperative patients. Participants must have no evidence of recurrence or metastasis at least four weeks after surgery and meet specific eligibility criteria related to their health status and tumor characteristics.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the risk of recurrence in patients with hepatocellular carcinoma after surgery.
How similar studies have gone: Other studies have shown promise in using targeted therapies like donafenib for liver cancer, suggesting potential for success in this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participants underwent radical resection of hepatocellular carcinoma 4 weeks before randomization * High Risk of recurrence as assessed by tumor characteristics * Without any anti-tumor therapy before surgery, except preoperative TACE therapy, traditional Chinese medicine therapy and interferon therapy * Child-Pugh Class A statu * ECOG Performance Status of 0 or 1 * CT/MR confirmed no recurrence or metastasis at ≥4 weeks after surgery * Expected survival time of no less than 3 months Exclusion Criteria: * Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC * Evidence of residual or a history of spontaneous tumor rupture * Recurrent HCC * Prior received Liver transplantation * Prior anti tumor therapy for treatment of HCC (including sorafenib or any other molecular therapy, anti-PD-1 antibody and other immunotherapies, FOLFOX systemic chemotherapy) is excluded * AFP does not return to normal 4 weeks after operation
Where it's running
-
Sun Yat-sen Memorial Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China Recruiting
Study contacts
- Principal investigator: Changzhen Shang, MD — Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Study coordinator: Changzhen Shang, MD
- Email: shchzh2@mail.sysu.edu.cn
- Phone: +86-20-3407 0701
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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.