Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:02 PM
Ignite Modification Date:
2025-12-24 @ 11:02 PM
NCT ID:
NCT06327269
Eligibility Criteria:
Inclusion Criteria
* Targeted therapy is acceptable within 1-2 months after liver transplantation.
* Immunosuppressive regimen consists of calcineurin inhibitor, mycophenolate mofetil and sirolimus.
* All male and female participants must take reliable contraceptive measures during the trial and within four weeks after the end of the trial.
* The definition of high-risk patients:
* The PET scan is positive before LDLT;
* Tumors beyond USCF criteria
* Poorly-differentiated tumor;
* The patients who has poor AFP response (\<15%)or AFP\>400 ng/ml after LRT after conventional LRT (RFAćPEI or TACE)
Exclusion Criteria
* Life expectancy is less than 3 months
* Patients are with other malignant tumors simultaneously.
* Patients are anaphylaxis to the inactive ingredients of lenvatinib or drugs.
* Pregnant or lactating women (Female participants need pregnancy test within 7 days before treatment).
* Preoperative history of severe cardiovascular disease: congestive heart failure \> NYHA grade 2; active coronary heart disease (myocardial infarction occurred within 6 months before entry into the study); severe arrhythmia requiring antiarrhythmic treatment (allowable use of beta-blockers or digoxin); uncontrolled hypertension.
* History of HIV infection.
* Severe clinical active infections (\> NCI-CTCAE version 3.0).
* Epilepsy patients requires medication (e.g. steroids or antiepileptic drugs).
* Patients with kidney diseases requires renal dialysis.
* Drug abuse, medical symptoms, mental illness or social status that may interfere with participants' participation in research or evaluation of research results.
* Patients who could not swallow oral drugs, such as those with severe upper gastrointestinal obstruction and need gastric tube feeding.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT06327269
Study Brief:
Protocol Section:
NCT06327269