NCT05444478Recruiting
Microwave Ablation Simultaneously Combined With Lenavatinib for Recurrent Hepatocellular Carcinoma
Microwave Ablation Simultaneously Combined With Lenavatinib for Recurrent Hepatocellular Carcinoma: a Prospective Randomized Controlled Study
Source: ClinicalTrials.gov · Last updated 7 Nov 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This study intends to evaluate the efficacy and safety of microwave ablation combined lenvatinib simultaneously for recurrent HCC
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 274 (estimated)
- First submitted
- 29 Jun 2022
- Start date
- 1 Jul 2022
- Primary completion date
- 1 Jul 2025
- Lead sponsor
- Sun Yat-sen University
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT05444478
What you commit to
- Study type: Interventional
- Planned participants: 274
- From 1 Jul 2022 to the primary completion date, 1 Jul 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- receiving system therapy such as targeted therapy or immunotherapy;
- receiving local therapy such as ablation or TACE;
Other illness
- Accompanying with a history of other malignancies;
Lab values
- 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;
Other
- disagreeing to receive follow-up observation and participate the clinical study;
- Accompanying with macrovascular invasion such as portal vain tumor thrombus, hepatic vein tumor thrombus;
- with extrahepatic metastasis or lymph metastasis;
Who the study is looking for
- 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;
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hunan Provincial People's Hospital Coordinator of this site? Confirm its status | Changsha | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.