Microwave ablation combined with lenvatinib for recurrent liver cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Hunan Provincial People's Hospital
  Changsha, Hunan, China Recruiting

Study contacts

• Study coordinator: Qunfnag Zhou, MD
• Email: zhouqun988509@163.com
• Phone: 86 19868000115

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Using donafenib after thermal ablation for recurrent liver cancer

  This study is testing if adding a low dose of donafenib after thermal ablation can help people with early recurrent liver cancer do better than just having the ablation alone.

  Recruiting Sun Yat-sen University · Beijing, None Selected · NCT06609876

• BGB-B2033 vs Sorafenib or Lenvatinib for advanced liver cancer

  This study tests whether the investigational drug BGB-B2033 can help people with advanced hepatocellular carcinoma when given after prior PD-1/PD-L1 therapy, compared with the standard medicines sorafenib or lenvatinib.

  Recruiting at 2 sites Phase 3 BeOne Medicines · South Brisbane, Queensland and 1 other locations · NCT07836530

• Tracking immune and genomic changes in liver cancer during immunotherapy

  This study will test whether blood and tumor biomarkers can predict how people with advanced hepatocellular carcinoma respond to immunotherapy.

  Recruiting Asan Medical Center · Seoul, Song-pa · NCT07186010

• Using contrast-enhanced ultrasound to check Y-90 radioembolization response in liver cancer

  This will test whether contrast-enhanced ultrasound (CEUS) can show treatment response to Y‑90 radioembolization in people with newly diagnosed hepatocellular carcinoma who are scheduled for TARE.

  Recruiting Phase 2 Thomas Jefferson University · Philadelphia, Pennsylvania · NCT07145801

• Assessing blood biomarkers and MRI for liver cancer patients undergoing radiation therapy

  This study is testing if using special MRI scans and blood tests can help doctors keep track of liver health in patients with liver cancer who are getting radiation therapy.

  Recruiting Montefiore Medical Center · The Bronx, New York · NCT06899152

• Combining TACE and surgery for large liver tumors

  This study is testing if a treatment called TACE before surgery can help people with large liver tumors do better after surgery and have fewer chances of the cancer coming back.

  Recruiting Sun Yat-sen University · Beijing, Beijing Municipality · NCT06898398

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.