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Recruiting NCT05444478

Microwave Ablation Simultaneously Combined With Lenavatinib for Recurrent Hepatocellular Carcinoma

No phase Interventional Hepatocellular Carcinoma Microwave Ablation Liver Cancer Lenvatinib

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Microwave ablation, Lenvatinib.
Who it may be relevant to
Registry conditions: Hepatocellular Carcinoma, Microwave Ablation, Liver Cancer, Lenvatinib. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Microwave Ablation Simultaneously Combined With Lenavatinib for Recurrent Hepatocellular Carcinoma: a Prospective Randomized Controlled Study

Overview

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.

Interventions

  • Procedure Microwave ablation
    only microwave ablation for tumor
  • Drug Lenvatinib
    lenvatinib (80 mg for body no more than 60kg，120 mg for body weight \>60 kg)

Primary outcome measures

  • Tumor-free survival rate at 36 months [Time frame: 36 months]
  • Over-all survival (OS) rate at 36 months [Time frame: 36 months]
Secondary outcome measures (2)
  • Adverse events [Time frame: 24 months]
  • Complication rate [Time frame: 36 months]

Eligibility criteria

Inclusion criteria

  • 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；

Exclusion criteria

  • 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;

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Hunan Provincial People's Hospital — Changsha

Identifiers

NCT: NCT05444478 · Liver Projiect 2

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗