Ireland
--:--IST
Recruiting Not applicable

Microwave Ablation Simultaneously Combined With Lenavatinib for Recurrent Hepatocellular Carcinoma

NCT05444478 · tracked via the Priya Life Science China tracker
Phase
Not applicable
Started
2022-07-01
Last updated
2023-11-07

Condition(s) studied

Hepatocellular CarcinomaMicrowave AblationLiver CancerLenvatinibRecurrent Tumor

Investigational drug(s) / intervention(s)

Microwave ablationLenvatinib →

Microwave ablation: only microwave ablation for tumor

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

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
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;

Primary outcome measure(s)

  • 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
  • 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.

Trial sites (1)

FacilityCityRegionStatus
Hunan Provincial People's Hospital Changsha Hunan Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05444478 on ClinicalTrials.gov ↗ ← All trials in China