Microwave Ablation Simultaneously Combined With Lenavatinib for Recurrent Hepatocellular Carcinoma

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

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

Study Overview

• Status: Recruiting
• Conditions: Hepatocellular Carcinoma; Liver Cancer; Recurrent Tumor; Microwave Ablation; Lenvatinib
• Intervention / Treatment: Procedure: Microwave ablation; Drug: Lenvatinib

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 Type: Interventional
• Enrollment (Estimated): 274
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xiaohui Wang, MD; Phone Number: 8615692436948; Email: xiaohuiwang21@163.com
• Study Contact Backup: Name: Qunfnag Zhou, MD; Phone Number: 86 19868000115; Email: zhouqun988509@163.com

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China, 410011
      • Recruiting
      • Hunan Provincial People's Hospital
      • Contact: Xiaohui Wang, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Microwave ablation; Patients only accepted microwave ablation	Procedure: Microwave ablation; only microwave ablation for tumor
Experimental: Microwave ablation plus lenvatinib; Patients accepted microwave ablation plus lenvatinib	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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	36 months
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.	36 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	24 months
Complication rate	Complication was defined as the a disease or sythrome caused by the therapy	36 months

Collaborators and Investigators

• Sponsor: Sun Yat-sen University
• Investigators: Study Director: Xianhai Mao, Professor, Hunan Provincial People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2022
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: June 29, 2022
• First Submitted That Met QC Criteria: June 29, 2022
• First Posted (Actual): July 6, 2022

Study Record Updates

• Last Update Posted (Actual): November 7, 2023
• Last Update Submitted That Met QC Criteria: November 5, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Disease Attributes; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms; Carcinoma; Carcinoma, Hepatocellular; Recurrence; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Lenvatinib
• Other Study ID Numbers: Liver Projiect 2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No