Relenvatinib in the Tatment of Recurrence of Hepatocellular Carcinoma After Liver Transplantation

• Status: Not yet recruiting
• Trial end date: 2022-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: RenJi Hospital
• Treatments: Lenvatinib

Criteria

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.