Microwave Ablation Simultaneously Combined With Lenavatinib for Recurrent Hepatocellular Carcinoma

NCT ID: NCT05444478

Last Updated: 2023-11-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 274 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-01
• Study Completion Date: 2027-07-01

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Microwave ablation

Patients only accepted microwave ablation

Group Type: EXPERIMENTAL

Microwave ablation

Intervention Type: PROCEDURE

only microwave ablation for tumor

Microwave ablation plus lenvatinib

Patients accepted microwave ablation plus lenvatinib

Group Type: EXPERIMENTAL

Microwave ablation

Intervention Type: PROCEDURE

only microwave ablation for tumor

Lenvatinib

Intervention Type: DRUG

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

Interventions

Microwave ablation

only microwave ablation for tumor

Intervention Type: PROCEDURE

Lenvatinib

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

Intervention Type: DRUG

Eligibility Criteria

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Zhou Qunfang

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xianhai Mao, Professor

Role: STUDY_DIRECTOR

Hunan Provincial People's Hospital

Locations

Hunan Provincial People's Hospital

Changsha, Hunan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Qunfnag Zhou, MD

Role: CONTACT

zhouqun988509@163.com

86 19868000115

Xiaohui Wang, MD

Role: CONTACT

xiaohuiwang21@163.com

8615692436948

Facility Contacts

Xiaohui Wang, MD

Role: primary

Other Identifiers

Liver Projiect 2

Identifier Type: -

Identifier Source: org_study_id