NCT06609876Recruiting
Donafenib as Adjuvant Therapy Following Ablation for Recurrent HCC
Thermal Ablation Combined With Low-dose Donafinib for Early Recurrent Hepatocellular Carcinoma: a Multicenter Prospective Study
Source: ClinicalTrials.gov · Last updated 3 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This study intends to evaluate the efficacy and safety of low-dose adjuvant donafenib after thermal ablation for early recurrent HCC within Milan criteria.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 108 (estimated)
- First submitted
- 20 Sept 2024
- Start date
- 1 Oct 2024
- Primary completion date
- 1 Oct 2026
- Lead sponsor
- Sun Yat-sen University
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT06609876
What you commit to
- Study type: Interventional
- Planned participants: 108
- From 1 Oct 2024 to the primary completion date, 1 Oct 2026
- 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.
Age
- were under 18 years or over 75 years of age;
Other
- primary HCC;
- recurrent HCC beyond Milan criteria;
- RHCC with metastasis or macrovascular tumor thrombus
Who the study is looking for
- were aged 18-75 years;
- had recurrent HCC (RHCC) diagnosed by imaging studies, the first or the second RHCC;
- 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);
- the early RHCC (recurrent time \<1 year)
- patients were unwilling to undergo repeat hepatectomy or liver transplantation;
- had well-preserved liver function, i.e., Child-Pugh class A or B, and prolonged prothrombin time≤5 s;
- patients had an Eastern Cooperative Oncology Group performance status score ≤1.
- Ability to understand the protocol and to agree to and sign a written informed consent document.
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 |
|---|---|---|---|
| Chinese PLA General Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.