Microwave Ablation Simultaneously Combined With Lenavatinib for Recurrent Hepatocellular Carcinoma

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05444478
• Other study ID #: Liver Projiect 2
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2022
• Est. completion date: July 1, 2027

Study information

• Verified date: November 2023
• Source: Sun Yat-sen University
• Contact: Qunfnag Zhou, MD
• Phone: 86 19868000115
• Email: zhouqun988509[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 274
• Est. completion date: July 1, 2027
• Est. primary completion date: July 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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;

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma
• Lenvatinib
• Liver Cancer
• Microwave Ablation
• Recurrence
• Recurrent Tumor

Intervention

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)

Locations

Country	Name	City	State
China	Hunan Provincial People's Hospital	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	Complication rate	Complication was defined as the a disease or sythrome caused by the therapy	36 months