NCT06581315Recruiting
Postoperative Adjuvant Therapy of Donafenib for Hepatocellular Carcinoma
Efficacy and Safety of Donafenib as Adjuvant Therapy for Postoperative Patients With High-Risk Recurrent Hepatocellular Carcinoma: A Multicenter, Randomized Controlled Study
Source: ClinicalTrials.gov · Last updated 3 Sept 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This study aims to evaluate the efficacy and safety of donafenib as adjuvant therapy for postoperative patients with high-risk recurrent Hepatocellular Carcinoma. This is a multicenter, randomized controlled study.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 204 (estimated)
- First submitted
- 30 Aug 2024
- Start date
- 28 Aug 2024
- Primary completion date
- 30 Aug 2027
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT06581315
What you commit to
- Study type: Interventional
- Planned participants: 204
- From 28 Aug 2024 to the primary completion date, 30 Aug 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Evidence of residual or a history of spontaneous tumor rupture
Other
- Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
- Recurrent HCC
- AFP does not return to normal 4 weeks after operation
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sun Yat Sen Memorial Hospital of Sun Yat sen University Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.