New treatment approach for liver transplant patients with high-risk liver cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Department of Surgery
  Kaohsiung City, Taiwan Recruiting

Study contacts

• Study coordinator: Chih-Che Lin, Ph.D
• Email: chihchelin@cgmh.org.tw
• Phone: +88677317123

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Neoadjuvant TACE plus atezolizumab and bevacizumab for resectable high-risk liver cancer

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• AK104 plus TACE with surgery for resectable high‑risk liver cancer (real‑world cohort)

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• Neoadjuvant iparomlimab and tuvonralimab before surgery for resectable hepatocellular carcinoma

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  Recruiting Phase 2 Tongji Hospital · Wuhan, Hubei · NCT06954116

• Chemotherapy with Adebrelimab and Apatinib for Biliary Tract Cancer Treatment

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  Recruiting Phase 2 Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Guangzhou, China/Guangdong · NCT06280508

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.