Microwave Ablation Simultaneously Combined With Lenavatinib for Recurrent Hepatocellular Carcinoma
Primary Purpose
Hepatocellular Carcinoma, Microwave Ablation, Liver Cancer
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Microwave ablation
Lenvatinib
Sponsored by
About this trial
This is an interventional treatment trial for Hepatocellular Carcinoma
Eligibility Criteria
Inclusion Criteria:
- Primary HCC (BCLC 0-B), and the pathological results is hepatocellular carcinoma;
- recurrent HCC without any tumor related therapy;
- Tumor number ≤3;
- Tumor size ≤5cm;
- Good performance, KPS≥90;
- Age:18-75
- Child-Pugh A or B(score of the B level is no more than 7)
- 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:
- disagreeing to receive follow-up observation and participate the clinical study;
- Accompanying with a history of other malignancies;
- Accompanying with macrovascular invasion such as portal vain tumor thrombus, hepatic vein tumor thrombus;
- with extrahepatic metastasis or lymph metastasis;
- receiving system therapy such as targeted therapy or immunotherapy;
- receiving local therapy such as ablation or TACE;
- 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;
- 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;
Sites / Locations
- Hunan Provincial People's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Microwave ablation
Microwave ablation plus lenvatinib
Arm Description
Patients only accepted microwave ablation
Patients accepted microwave ablation plus lenvatinib
Outcomes
Primary Outcome Measures
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
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.
Secondary Outcome Measures
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.
Complication rate
Complication was defined as the a disease or sythrome caused by the therapy
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05444478
Brief Title
Microwave Ablation Simultaneously Combined With Lenavatinib for Recurrent Hepatocellular Carcinoma
Official Title
Microwave Ablation Simultaneously Combined With Lenavatinib for Recurrent Hepatocellular Carcinoma: a Prospective Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2022 (Actual)
Primary Completion Date
July 1, 2025 (Anticipated)
Study Completion Date
July 1, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma, Microwave Ablation, Liver Cancer, Lenvatinib, Recurrent Tumor
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
274 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Microwave ablation
Arm Type
Experimental
Arm Description
Patients only accepted microwave ablation
Arm Title
Microwave ablation plus lenvatinib
Arm Type
Experimental
Arm Description
Patients accepted microwave ablation plus lenvatinib
Intervention Type
Procedure
Intervention Name(s)
Microwave ablation
Intervention Description
only microwave ablation for tumor
Intervention Type
Drug
Intervention Name(s)
Lenvatinib
Intervention Description
lenvatinib (80 mg for body no more than 60kg,120 mg for body weight >60 kg)
Primary Outcome Measure Information:
Title
Tumor-free survival rate at 36 months
Description
Progression was defined as progressive disease after microwave ablation by independent radiologic review according to mRECIST or death from any cause
Time Frame
36 months
Title
Over-all survival (OS) rate at 36 months
Description
OS is the length of time from the date of microwave ablation until death from any cause.
Time Frame
36 months
Secondary Outcome Measure Information:
Title
Adverse events
Description
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.
Time Frame
24 months
Title
Complication rate
Description
Complication was defined as the a disease or sythrome caused by the therapy
Time Frame
36 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Primary HCC (BCLC 0-B), and the pathological results is hepatocellular carcinoma;
recurrent HCC without any tumor related therapy;
Tumor number ≤3;
Tumor size ≤5cm;
Good performance, KPS≥90;
Age:18-75
Child-Pugh A or B(score of the B level is no more than 7)
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:
disagreeing to receive follow-up observation and participate the clinical study;
Accompanying with a history of other malignancies;
Accompanying with macrovascular invasion such as portal vain tumor thrombus, hepatic vein tumor thrombus;
with extrahepatic metastasis or lymph metastasis;
receiving system therapy such as targeted therapy or immunotherapy;
receiving local therapy such as ablation or TACE;
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;
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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qunfnag Zhou, MD
Phone
86 19868000115
Email
zhouqun988509@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaohui Wang, MD
Phone
8615692436948
Email
xiaohuiwang21@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xianhai Mao, Professor
Organizational Affiliation
Hunan Provincial People's Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Hunan Provincial People's Hospital
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410011
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaohui Wang, MD
12. IPD Sharing Statement
Learn more about this trial
Microwave Ablation Simultaneously Combined With Lenavatinib for Recurrent Hepatocellular Carcinoma
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