Microwave Ablation Simultaneously Combined With Lenavatinib for Recurrent Hepatocellular Carcinoma

Not Applicable

Recruiting

• Conditions: Hepatocellular Carcinoma; Microwave Ablation; Liver Cancer; Lenvatinib; Recurrent Tumor
• Interventions: Procedure: Microwave ablation; Drug: Lenvatinib

• Registration Number: NCT05444478
• Lead Sponsor: Sun Yat-sen University

Brief Summary

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 Timeline

• Study First Submitted: 2022-06-29
• Study First Submitted QC: 2022-06-29
• Study Start: 2022-07-01
• Study First Posted: 2022-07-06
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-05
• Last Update Posted: 2023-11-07
• Primary Completion: 2025-07-01
• Study Completion: 2027-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 274

Inclusion Criteria

1. Primary HCC (BCLC 0-B), and the pathological results is hepatocellular carcinoma；
2. recurrent HCC without any tumor related therapy；
3. Tumor number ≤3；
4. Tumor size ≤5cm;
5. Good performance, KPS≥90；
6. Age：18-75
7. Child-Pugh A or B（score of the B level is no more than 7）
8. 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

1. disagreeing to receive follow-up observation and participate the clinical study;
2. Accompanying with a history of other malignancies;
3. Accompanying with macrovascular invasion such as portal vain tumor thrombus, hepatic vein tumor thrombus;
4. with extrahepatic metastasis or lymph metastasis;
5. receiving system therapy such as targeted therapy or immunotherapy;
6. receiving local therapy such as ablation or TACE;
7. 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;
8. 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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Microwave ablation	Microwave ablation	Patients only accepted microwave ablation
Microwave ablation plus lenvatinib	Microwave ablation	Patients accepted microwave ablation plus lenvatinib
Microwave ablation plus lenvatinib	Lenvatinib	Patients accepted microwave ablation plus lenvatinib

Primary Outcome Measures

Name	Time	Method
Tumor-free survival rate at 36 months	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	36 months	OS is the length of time from the date of microwave ablation until death from any cause.

Secondary Outcome Measures

Name	Time	Method
Complication rate	36 months	Complication was defined as the a disease or sythrome caused by the therapy
Adverse events	24 months	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.

Trial Locations

Locations (1)

Hunan Provincial People's Hospital; 🇨🇳 Changsha, Hunan, China