Microwave Ablation Simultaneously Combined With Lenavatinib for Recurrent Hepatocellular Carcinoma

Recruiting now · Not applicable

Conditions studied: Hepatocellular Carcinoma, Microwave Ablation, Liver Cancer, Lenvatinib, Recurrent Tumor

In brief

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

Key facts

Study ID

NCT05444478

Run by

Sun Yat-sen University

People needed

274

Starts

2022-07-01

Expected to finish

2027-07-01

Last updated by the study team

2023-11-07

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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；

You may not qualify if…

• 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;

Where it is running

• Hunan Provincial People's Hospital — Changsha, Hunan, China (enrolling)

Full record on ClinicalTrials.gov

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