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Microwave Ablation Simultaneously Combined With Lenavatinib for Recurrent Hepatocellular Carcinoma

ConditionsHepatocellular CarcinomaMicrowave AblationLiver CancerLenvatinibRecurrent Tumor
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSun Yat-sen University

About this trial

This study intends to evaluate the efficacy and safety of microwave ablation combined lenvatinib simultaneously for recurrent HCC

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Microwave ablation

    Procedure/Surgery

    only microwave ablation for tumor

  • Lenvatinib

    Drug

    lenvatinib (80 mg for body no more than 60kg，120 mg for body weight \>60 kg)

Treatment groups

274 Participants
are divided into 2 treatment groups
Group A: Microwave ablationExperimental treatment 1 intervention
Group B: Microwave ablation plus lenvatinibExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
36 months
2

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.

Time frame
36 months

Secondary outcomes

1

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.

Time frame
24 months
2

Complication rate

Complication was defined as the a disease or sythrome caused by the therapy

Time frame
36 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sun Yat-sen University

Lead sponsor

Source ClinicalTrials.gov
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