Microwave Ablation Simultaneously Combined With Lenavatinib for Recurrent Hepatocellular Carcinoma

Sun Yat-sen University

Status: Enrolling

Conditions: Microwave Ablation; Hepatocellular Carcinoma; Recurrent Tumor; Lenvatinib; Liver Cancer

Treatments: Drug: Lenvatinib; Procedure: Microwave ablation

Study type: Interventional

Funder types: Other

Identifiers

NCT05444478

Liver Projiect 2

Details and patient eligibility

About

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

Full 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.

Enrollment: 274 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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274 participants in 2 patient groups

Microwave ablation

Experimental group

Description:

Patients only accepted microwave ablation

Treatment:

Procedure: Microwave ablation

Microwave ablation plus lenvatinib

Experimental group

Description:

Patients accepted microwave ablation plus lenvatinib

Treatment:

Drug: Lenvatinib

Procedure: Microwave ablation