NCT05444478 Microwave Ablation Simultaneously Combined With Lenavatinib for Recurrent Hepatocellular Carcinoma
| NCT ID | NCT05444478 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Sun Yat-sen University |
| Condition | Hepatocellular Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 274 participants |
| Start Date | 2022-07-01 |
| Primary Completion | 2025-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 274 participants in total. It began in 2022-07-01 with a primary completion date of 2025-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study intends to evaluate the efficacy and safety of microwave ablation combined lenvatinib simultaneously for recurrent HCC
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;
Contact & Investigator
Xianhai Mao, Professor
STUDY DIRECTOR
Hunan Provincial People's Hospital
Frequently Asked Questions
Who can join the NCT05444478 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Hepatocellular Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05444478 currently recruiting?
Yes, NCT05444478 is actively recruiting participants. Contact the research team at zhouqun988509@163.com for enrollment information.
Where is the NCT05444478 trial being conducted?
This trial is being conducted at Changsha, China.
Who is sponsoring the NCT05444478 clinical trial?
NCT05444478 is sponsored by Sun Yat-sen University. The principal investigator is Xianhai Mao, Professor at Hunan Provincial People's Hospital. The trial plans to enroll 274 participants.
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