Clinical trial · Interventional
Innovative Diagnosis and Therapy in LDLT Patients With High-risk Hepatocellular Carcinoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| High Risk of Recurrence | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lenvatinib 10 mg | Drug | Lenvatinib | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- A new generation of targeted therapies and adjuvant therapy after LDLT.
- description
- The proton therapy or yttrium 90 as a more aggressive down-staging therapy may contribute to change tumor behavior. Lenvatinib is applied to adjuvant therapy after LDLT.
- interventionNames
- Drug: Lenvatinib 10 mg
- type
- ACTIVE_COMPARATOR
- label
- prolong the recurrence-free survival to high risk of HCC after LDLT
- description
- Lenvatinib which is applied to adjuvant therapy after LDLT may prolong the recurrence-free survival
- interventionNames
- Drug: Lenvatinib 10 mg
Primary outcomes (1)
- measure
- Recurrence-free survival with adjuvant therapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (1)
- RESULTHan B, Ding H, Zhao S, Zhang Y, Wang J, Zhang Y, Gu J. Potential Role of Adjuvant Lenvatinib in Improving Disease-Free Survival for Patients With High-Risk Hepatitis B Virus-Related Hepatocellular Carcinoma Following Liver Transplantation: A Retrospective, Case Control Study. Front Oncol. 2020 Dec 7;10:562103. doi: 10.3389/fonc.2020.562103. eCollection 2020. PMID 33365268