NCT06327269 Innovative Diagnosis and Therapy in LDLT Patients With High-risk Hepatocellular Carcinoma
| NCT ID | NCT06327269 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Chang Gung Memorial Hospital |
| Condition | High Risk of Recurrence |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2021-04-01 |
| Primary Completion | 2024-12 |
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.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 40 participants in total. It began in 2021-04-01 with a primary completion date of 2024-12.
⚠ 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
The challenge of LDLT to HCC is that tumors with a high risk of recurrence have a high rate of recurrence after liver transplantation, and there is no appropriate treatment to prevent HCC recurrence after transplantation in these patients. Using the advance proton therapy or yttrium 90 as a more aggressive down-staging therapy may contribute to change tumor behavior. It can be used to get a better treatment response and tumor necrosis before LDLT. As a result, it will improve recurrence-free survival and overall survival rate, especially in high-risk groups. In addition, lenvatinib is approved for using in patients with advanced liver cancer because its overall survival rate is not less than sorafenib in clinical trials. A new generation of targeted therapies will be applied to adjuvant therapy after LDLT.
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 (RFA、PEI 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06327269 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying High Risk of Recurrence. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06327269 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06327269 currently recruiting?
Yes, NCT06327269 is actively recruiting participants. Contact the research team at chihchelin@cgmh.org.tw for enrollment information.
Where is the NCT06327269 trial being conducted?
This trial is being conducted at Kaohsiung City, Taiwan.
Who is sponsoring the NCT06327269 clinical trial?
NCT06327269 is sponsored by Chang Gung Memorial Hospital. The trial plans to enroll 40 participants.