Hepatocellular CarcinomaNCT05444478
Microwave Ablation Simultaneously Combined With Lenavatinib for Recurrent Hepatocellular Carcinoma
A study testing Microwave ablation and Lenvatinib 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 microwave ablation combined lenvatinib simultaneously for recurrent HCC Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatocellular Carcinoma, Microwave Ablation, Liver Cancer
- What is being tested?
- Microwave ablation and Lenvatinib
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 274 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2022to 1 Jul 2027
- 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
- Primary HCC (BCLC 0-B), and the pathological results is hepatocellular carcinoma；
- recurrent HCC without any tumor related therapy；
- Tumor number ≤3；
- Tumor size ≤5cm;
- Good performance, KPS≥90；
- Age：18-75
- Child-Pugh A or B（score of the B level is no more than 7）
- Baseline laboratory examinations meet the Criteria： Leukocyte ≥3.0×109/L； Blood platelet ≥75×109/L； Hemoglobin ≥100g/L； ALT、AST ≤ 3 x limit of normal（ULN）； Serum creatinine ≤ 1.5 x ULN； Prothrombin time < ULN+4 s；INR < 1.5, Albumin ≥30g/L ； Total bilirubin ≤34mmol/L；
Who cannot join
- disagreeing to receive follow-up observation and participate the clinical study;
- Accompanying with a history of other malignancies;
- Accompanying with macrovascular invasion such as portal vain tumor thrombus, hepatic vein tumor thrombus;
- with extrahepatic metastasis or lymph metastasis;
- receiving system therapy such as targeted therapy or immunotherapy;
- receiving local therapy such as ablation or TACE;
- Any of the following occurred within 12 months of the study: myocardial infarction, severe / unstable angina, coronary artery bypass grafting, congestive heart failure, cerebrovascular accident (including transient ischemic attack), pulmonary embolism; ongoing arrhythmia by NCI-CTCA standard ≥ 2, prolonged QTc interval (450 ms for males, and> 470 ms for females;
- other serious acute, chronic physiological or mental disorders or abnormal laboratory examination may increase the risk of participation in study treatment or may interfere with the interpretation of study findings or whom the investigator considers not fit;
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
Hunan Provincial People's Hospital
Changsha, Hunan, 410011
Xiaohui Wang, MD
About this study
Official title: Microwave Ablation Simultaneously Combined With Lenavatinib for Recurrent Hepatocellular Carcinoma: a Prospective Randomized Controlled Study
This study intends to evaluate the efficacy and safety of microwave ablation combined lenvatinib simultaneously for recurrent HCC
Read the detailed description
Microwave ablation (MWA) is available as the major curative treatments for early-stage recurrent HCC. Lenvatinib was non-inferior to sorafenib in overall survival in untreated advanced hepatocellular carcinoma. No study has evaluated MWA simultaneously combined Lenvatinib for recurrent HCC. There needs further investigation to explore the efficacy and safety of the combination treatment. Thus, the investigators carried out this randomized, multicenter, prospective trial study to find out it.
- Being tested
- Microwave ablation, Lenvatinib
- Medical subject headings
- Carcinoma, Hepatocellular, Liver Neoplasms, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microwave ablationProcedure or surgery
only microwave ablation for tumor
LenvatinibDrug
lenvatinib (80 mg for body no more than 60kg，120 mg for body weight >60 kg)
| Study group | Role | What they receive |
|---|---|---|
| Microwave ablation | Experimental | Patients only accepted microwave ablation Receives: Procedure: Microwave ablation |
| Microwave ablation plus lenvatinib | Experimental | Patients accepted microwave ablation plus lenvatinib Receives: Procedure: Microwave ablation; Drug: Lenvatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor-free survival rate at 36 months
Progression was defined as progressive disease after microwave ablation by independent radiologic review according to mRECIST or death from any cause
Measured: 36 months
Over-all survival (OS) rate at 36 months
OS is the length of time from the date of microwave ablation until death from any cause.
Measured: 36 months
Secondary outcomes (2)
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: 24 months
Complication rate
Complication was defined as the a disease or sythrome caused by the therapy
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 posted6 Jul 2022
- Study start1 Jul 2022
- Primary completion1 Jul 2025 (estimated)
- Study completion1 Jul 2027 (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
- 274 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhou Qunfang, Sun Yat-sen University
- Investigators
- Xianhai Mao, Professor, Study director, Hunan Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05444478
- Sponsor's protocol ID
- Liver Projiect 2
- Status last verified
- Nov 2023
- First submitted
- 29 Jun 2022
- Last updated
- 7 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microwave Ablation Simultaneously Combined With Lenavatinib for Recurrent Hepatocellular Carcinoma: a Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05444478
- Acronym / sponsor ID
- Liver Projiect 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 274 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 6 Jul 2022 (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 microwave ablation combined lenvatinib simultaneously for recurrent HCC
Detailed description
Microwave ablation (MWA) is available as the major curative treatments for early-stage recurrent HCC. Lenvatinib was non-inferior to sorafenib in overall survival in untreated advanced hepatocellular carcinoma. No study has evaluated MWA simultaneously combined Lenvatinib for recurrent HCC. There needs further investigation to explore the efficacy and safety of the combination treatment. Thus, the investigators carried out this randomized, multicenter, prospective 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 |
|---|---|---|
| Microwave ablation | Experimental | Procedure: Microwave ablationPatients only accepted microwave ablation |
| Microwave ablation plus lenvatinib | Experimental | Procedure: Microwave ablation, Drug: LenvatinibPatients accepted microwave ablation plus lenvatinib |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Primary HCC (BCLC 0-B), and the pathological results is hepatocellular carcinoma；
- recurrent HCC without any tumor related therapy；
- Tumor number ≤3；
- Tumor size ≤5cm;
- Good performance, KPS≥90；
Key exclusion criteria (8 listed)
- disagreeing to receive follow-up observation and participate the clinical study;
- Accompanying with a history of other malignancies;
- Accompanying with macrovascular invasion such as portal vain tumor thrombus, hepatic vein tumor thrombus;
- with extrahepatic metastasis or lymph metastasis;
- receiving system therapy such as targeted therapy or immunotherapy;
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 |
|---|---|---|
| Microwave ablationonly microwave ablation for tumor | Procedure or surgery | Microwave ablation, Microwave ablation plus lenvatinib |
| Lenvatiniblenvatinib (80 mg for body no more than 60kg，120 mg for body weight >60 kg) | Drug | Microwave ablation plus lenvatinib |
Primary outcome
Tumor-free survival rate at 36 months
Time frame: 36 months
Progression was defined as progressive disease after microwave ablation by independent radiologic review according to mRECIST or death from any cause
Over-all survival (OS) rate at 36 months
Time frame: 36 months
OS is the length of time from the date of microwave ablation until death from any cause.
2 secondary outcomes
Adverse events
Time frame: 24 months
Complication rate
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 7 Nov 2023.
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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.
Xianhai Mao, Professor study director
Hunan Provincial People's 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 Microwave ablation and Lenvatinib 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 8 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 7 Nov 2023. 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 Qunfnag 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 at 36 months (time frame: 36 months). The study lists 2 primary outcomes in all. 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 7 Nov 2023.