Microwave ablation combined with lenvatinib for recurrent liver cancer

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

This study is testing whether combining microwave ablation with the drug lenvatinib can help people with recurrent liver cancer feel better and live longer.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 274 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Sun Yat-sen University (Academic / other)
• Drugs / interventions: immunotherapy, lenvatinib
• Locations: 1 site (Changsha, Hunan)
• Trial ID: NCT05444478 on ClinicalTrials.gov

What this trial studies

This study evaluates the efficacy and safety of combining microwave ablation with lenvatinib for patients with recurrent hepatocellular carcinoma (HCC). Microwave ablation is a curative treatment for early-stage recurrent HCC, while lenvatinib has shown promise in improving overall survival in advanced HCC. This randomized, multicenter, prospective trial aims to explore the potential benefits of this combination therapy, which has not been previously studied. The trial will assess patient outcomes and safety profiles associated with this innovative treatment approach.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18-75 with recurrent HCC, limited tumor burden, and good performance status.

Not a fit: Patients with macrovascular invasion, extrahepatic metastasis, or those who have received prior systemic or local therapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this combination therapy could provide a new effective treatment option for patients with recurrent hepatocellular carcinoma.

How similar studies have performed: While microwave ablation and lenvatinib have been studied separately, this specific combination approach is novel and has not been previously tested.

Eligibility criteria

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;

Where this trial is running

Changsha, Hunan

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

Study contacts

• Study coordinator: Qunfnag Zhou, MD

Conditions Hepatocellular Carcinoma; Microwave Ablation; Liver Cancer; Lenvatinib; Recurrent Tumor