RecruitingNot ApplicableNCT05444478

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

Sponsor

Sun Yat-sen University

Enrollment

274 participants

Start Date

Jul 1, 2022

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 75 Years

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；

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;

PROCEDUREMicrowave ablation

only microwave ablation for tumor

DRUGLenvatinib

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

Hunan Provincial People's Hospital

Changsha, Hunan, China

View Full Details on ClinicalTrials.gov

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NCT05444478