New treatment approach for liver transplant patients with high-risk liver cancer
Innovative Diagnosis and Therapy in LDLT Patients With High-risk Hepatocellular Carcinoma
This study is testing a new treatment using advanced radiation and a targeted therapy for liver cancer patients at high risk of their cancer coming back after a liver transplant to see if it helps them do better.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Chang Gung Memorial Hospital Academic / other |
| Drugs / interventions | lenvatinib |
| Locations | 1 site (Kaohsiung City) |
| Trial ID | NCT06327269 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of advanced proton therapy or yttrium 90 as a down-staging treatment for patients with hepatocellular carcinoma (HCC) who are at high risk of recurrence after living donor liver transplantation (LDLT). The study aims to improve tumor response and necrosis prior to transplantation, potentially enhancing recurrence-free and overall survival rates. Additionally, lenvatinib, a targeted therapy, will be administered post-transplant to further improve outcomes. The trial focuses on patients with specific high-risk criteria, including positive PET scans and poorly differentiated tumors.
Who should consider this trial
Good fit: Ideal candidates include patients with hepatocellular carcinoma who meet high-risk criteria and are scheduled for living donor liver transplantation.
Not a fit: Patients with a life expectancy of less than three months or those with other concurrent malignancies may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the risk of cancer recurrence in liver transplant patients.
How similar studies have performed: While there is ongoing research in this area, the specific combination of therapies being tested in this trial represents a novel approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Kaohsiung City
- Department of Surgery — Kaohsiung City, Taiwan (Recruiting)
Study contacts
- Study coordinator: Chih-Che Lin, Ph.D
- Email: chihchelin@cgmh.org.tw
- Phone: +88677317123
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.