Hepatocellular CarcinomaNCT06609876
Donafenib as Adjuvant Therapy Following Ablation for Recurrent HCC
A study testing Thermal ablation and Donafenib in people with Hepatocellular Carcinoma and Microwave Ablation, run by Sun Yat-sen University at 1 site in China.
Trial summary
This study intends to evaluate the efficacy and safety of low-dose adjuvant donafenib after thermal ablation for early recurrent HCC within Milan criteria. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatocellular Carcinoma, Microwave Ablation, Donafenib
- What is being tested?
- Thermal ablation and Donafenib
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2024to 1 Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- were under 18 years or over 75 years of age;
- primary HCC;
- recurrent HCC beyond Milan criteria;
- RHCC with metastasis or macrovascular tumor thrombus
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Chinese PLA General hospital
Beijing, None Selected, 100853
Qunfang Zhou, zhouqun988509@163.com
Feng Duan, 8613910984586, duanfeng@vip.sina.com
About this study
Official title: Thermal Ablation Combined With Low-dose Donafinib for Early Recurrent Hepatocellular Carcinoma: a Multicenter Prospective Study
This study intends to evaluate the efficacy and safety of low-dose adjuvant donafenib after thermal ablation for early recurrent HCC within Milan criteria.
Read the detailed description
Thermal ablation is available as the major curative treatments for early-stage recurrent HCC. Donafenib was inferior to sorafenib in overall survival in untreated advanced hepatocellular carcinoma. No study has evaluated low-dose donafenib as adjuvant therapy after thermal ablation. There needs further investigation to explore the efficacy and safety of the combination treatment. Thus, the investigators carried out this prospective, randomized, open-label, phase II trial study to find out it.
- Being tested
- Thermal ablation, Donafenib
- Medical subject headings
- Carcinoma, Hepatocellular, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thermal ablationProcedure or surgery
Thermal ablation of tumors
DonafenibDrug
Donafenib ( 100 mg，bid)
| Study group | Role | What they receive |
|---|---|---|
| Thermal ablation | Experimental | Patients only accepted thermal ablation (microwave ablation,radiofrequency ablation) Receives: Procedure: Thermal ablation |
| Microwave ablation plus Donafenib | Experimental | Patients accepted thermal ablation (microwave ablation,radiofrequency ablation) plus Donafenib (100mg, bid) Receives: Procedure: Thermal ablation; Drug: Donafenib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor-free survival rate
Progression was defined as progressive disease after thermal ablation by independent radiologic review according to mRECIST or death from any cause
Measured: 24 months
Secondary outcomes (2)
Overall survival (OS)
OS is the length of time from the date of ablation until death from any cause.
Measured: 36 months
Adverse events
Safety will be evaluated according to the NCI CTCAE Version 4.03. All observations pertinent to the safety of the study medication will be recorded on the CRF and included in the final report.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2024
- Study start1 Oct 2024
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese PLA General Hospital
- Responsible party
- Principal investigator, Zhou Qunfang, Sun Yat-sen University
- Investigators
- Feng Duan, Professor, Study director, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06609876
- Sponsor's protocol ID
- Liver Projiect1
- Status last verified
- Dec 2024
- First submitted
- 20 Sep 2024
- Last updated
- 3 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thermal Ablation Combined With Low-dose Donafinib for Early Recurrent Hepatocellular Carcinoma: a Multicenter Prospective Study
- ClinicalTrials.gov ID
- NCT06609876
- Acronym / sponsor ID
- Liver Projiect1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- Chinese PLA General Hospital
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Oct 2028 (estimated)
- First posted
- 24 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study intends to evaluate the efficacy and safety of low-dose adjuvant donafenib after thermal ablation for early recurrent HCC within Milan criteria.
Detailed description
Thermal ablation is available as the major curative treatments for early-stage recurrent HCC. Donafenib was inferior to sorafenib in overall survival in untreated advanced hepatocellular carcinoma. No study has evaluated low-dose donafenib as adjuvant therapy after thermal ablation. There needs further investigation to explore the efficacy and safety of the combination treatment. Thus, the investigators carried out this prospective, randomized, open-label, phase II trial study to find out it.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thermal ablation | Experimental | Procedure: Thermal ablationPatients only accepted thermal ablation (microwave ablation,radiofrequency ablation) |
| Microwave ablation plus Donafenib | Experimental | Procedure: Thermal ablation, Drug: DonafenibPatients accepted thermal ablation (microwave ablation,radiofrequency ablation) plus Donafenib (100mg, bid) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (4 listed)
- were under 18 years or over 75 years of age;
- primary HCC;
- recurrent HCC beyond Milan criteria;
- RHCC with metastasis or macrovascular tumor thrombus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thermal ablationThermal ablation of tumors | Procedure or surgery | Microwave ablation plus Donafenib, Thermal ablation |
| DonafenibDonafenib ( 100 mg，bid) | Drug | Microwave ablation plus Donafenib |
Primary outcome
Tumor-free survival rate
Time frame: 24 months
Progression was defined as progressive disease after thermal ablation by independent radiologic review according to mRECIST or death from any cause
2 secondary outcomes
Overall survival (OS)
Time frame: 36 months
Adverse events
Time frame: 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Feng Duan, Professor study director
Chinese PLA General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thermal ablation and Donafenib in people with Hepatocellular Carcinoma and Microwave Ablation, run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qunfang Zhou, MD (86 19868000115, zhouqun988509@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor-free survival rate (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2024.