Clinical trial · Interventional
Relenvatinib in the Tatment of Recurrence of Hepatocellular Carcinoma After Liver Transplantation
Evaluation of the Efficacy and Safety of Relenvatinib in the Tatment of Recurrence of Hepatocellular Carcinoma After Liver Transplantation: a One-arm, Open-label Study
NCT04237740CI-TRIAL-00044187RRHCCLTunknownPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- 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 aim of this study is to evaluate the efficacy and safety of lenvatinib in the treatment of recurrence of hepatocellular carcinoma after liver transplantation.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Liver Transplantation | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| relenvatinib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- relenvatinib
- description
- The enrolled patients are treated with lenvatinib (dose: body weight \< 60 kg: 8 mg/day, body weight ≥ 60 kg 12 mg/day).
- interventionNames
- Drug: relenvatinib
Primary outcomes (1)
- measure
- 3 years recurrence-free survival rate
- timeFrame
- 3 years
- description
- Tumor recurrence within 3 years
Secondary outcomes (5)
- measure
- 1 year recurrence-free survival rate
- timeFrame
- 1 year
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients are with recurrence of hepatocellular carcinoma after liver transplantation who are unfit for or reject the treatment of hepatectomy, retransplantation, local therapy (radiofrequency ablation, interventional therapy, radiotherapy) and chemotherapy. 2. aged 18 to 75. 3. ECOG physical condition was 0-2 points. 4. Child-Pugh A grade of liver function. 5. Targeted therapy is acceptable within 1-2 months after liver transplantation. 6. Immunosuppressive regimen consists of calcineurin inhibitor, mycophenolate mofetil and sirolimus. 7. No history of surgical resection of liver tumors and targeted drug therapy before liver transplantation. 8. Good liver, kidney and bone marrow function: or PT within 6 seconds over normal upper limit. 9. For fertile female patients, the serum/urine pregnancy test should be negative within 7 days before treatment. 10. All male and female participants must take reliable contraceptive measures during the trial and within four weeks after the end of the trial. 12.The participants have the capability of oral medication. 13.The participants must sign the consent form. Exclusion Criteria: 1. Patients are with other malignant tumors simultaneously. 2. Patients are anaphylaxis to the inactive ingredients of lenvatinib or drugs. 3. Pregnant or lactating women (Female participants need pregnancy test within 7 days before treatment). 4. 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. 5. History of HIV infection. 6. Severe clinical active infections 7. Epilepsy patients requires medication (e.g. steroids or antiepileptic drugs). 8. Patients with kidney diseases requires renal dialysis. 9. Drug abuse, medical symptoms, mental illness or social status that may interfere with participants'participation in research or evaluation of research results. 10. Patients who could not swallow oral drugs, such as those with severe upper gastrointestinal obstruction and need gastric tube feeding.
References
Publications (0)
Data not yet available
No reference posted for this study.