Actively Recruiting
Microwave Ablation Simultaneously Combined With Lenavatinib for Recurrent Hepatocellular Carcinoma: a Prospective Randomized Controlled Study
Led by Sun Yat-sen University · Updated on 2023-11-07
274
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of combining microwave ablation with lenvatinib for treating recurrent hepatocellular carcinoma (HCC), a common type of liver cancer. Microwave ablation is already used as a main treatment for early-stage recurrent HCC, while lenvatinib has shown similar overall survival results compared to sorafenib in advanced liver cancer. This trial aims to explore the benefits and risks of using both treatments together for recurrent HCC, which has not been studied before. Participants will be randomly assigned to one of two groups: one group will receive microwave ablation alone, and the other will receive microwave ablation combined with lenvatinib. Lenvatinib doses depend on body weight, with 80 mg for participants weighing 60 kg or less and 120 mg for those weighing more than 60 kg. The study is prospective, randomized, and conducted at multiple centers to assess these treatment approaches. During the study, researchers will monitor participants for tumor-free survival and overall survival rates at 36 months. They will also track adverse events over 24 months and complication rates over 36 months. Participants will undergo regular assessments including laboratory tests and clinical evaluations to ensure safety and measure treatment effects. The total study duration involves follow-up visits up to three years to gather comprehensive outcome data.
CONDITIONS
Brief Title
Microwave Ablation Simultaneously Combined With Lenavatinib for Recurrent Hepatocellular Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Primary hepatocellular carcinoma (BCLC 0-B) confirmed by pathology
- Recurrent HCC without any prior tumor-related therapy
- Tumor number is 3 or fewer
- Tumor size is 5 cm or smaller
- Good performance status with Karnofsky Performance Score of 90 or higher
- Age between 18 and 75 years
- Child-Pugh liver function class A or B (score no more than 7 for B)
- Baseline lab tests meeting specific criteria: leukocytes ≥3.0x10^9/L; platelets ≥75x10^9/L; hemoglobin ≥100 g/L; ALT and AST ≤3 times upper limit of normal; serum creatinine ≤1.5 times upper limit of normal; prothrombin time < upper limit + 4 seconds; INR < 1.5; albumin ≥30 g/L; total bilirubin ≤34 mmol/L
You will not qualify if you...
- Refusal to participate or undergo follow-up
- History of other cancers
- Macrovascular invasion such as portal vein or hepatic vein tumor thrombus
- Presence of extrahepatic or lymph node metastasis
- Receiving systemic therapies like targeted therapy or immunotherapy
- Receiving local therapies such as ablation or TACE
- Recent (within 12 months) severe cardiovascular or cerebrovascular events, arrhythmia grade 2 or higher, or prolonged QTc interval
- Other serious acute or chronic medical or mental disorders or abnormal labs that increase risk or interfere with study participation as judged by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 36 months
Participants receive microwave ablation alone or microwave ablation combined with lenvatinib as part of the trial treatment.
Visits occur as needed for treatment administration and monitoring during the treatment period
Duration - Up to 36 months
Participants are monitored for tumor-free survival, overall survival, adverse events, and complication rates after treatment.
Periodic visits for up to 36 months post-treatment
Trial Site Locations
Total: 1 location
1
Hunan Provincial People's Hospital
Changsha, Hunan, China, 410011
Actively Recruiting
Research Team
Q
Qunfnag Zhou, MD
X
Xiaohui Wang, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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