Microwave Ablation Simultaneously Combined With Lenavatinib for Recurrent Hepatocellular Carcinoma

Sponsor
Sun Yat-sen University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05444478
Collaborator
(none)
274
1
2
60
4.6

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
274 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Microwave Ablation Simultaneously Combined With Lenavatinib for Recurrent Hepatocellular Carcinoma: a Prospective Randomized Controlled Study
Actual Study Start Date :
Jul 1, 2022
Anticipated Primary Completion Date :
Jul 1, 2025
Anticipated Study Completion Date :
Jul 1, 2027

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

  1. 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

  2. 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

  1. 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.

  2. Complication rate [36 months]

    Complication was defined as the a disease or sythrome caused by the therapy

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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;

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hunan Provincial People's Hospital Changsha Hunan China 410011

Sponsors and Collaborators

  • Sun Yat-sen University

Investigators

  • Study Director: Xianhai Mao, Professor, Hunan Provincial People's Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Zhou Qunfang, Clinical Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT05444478
Other Study ID Numbers:
  • Liver Projiect 2
First Posted:
Jul 6, 2022
Last Update Posted:
Jul 12, 2022
Last Verified:
Jun 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 12, 2022