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

Phase 3

• Conditions: Hepatocellular Carcinoma; Liver Transplantation
• Interventions: Drug: relenvatinib

• Registration Number: NCT04237740
• Lead Sponsor: RenJi Hospital

Brief 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.

Detailed Description

The research is an open, one-arm, single-center study. 40 patients with recurrence of hepatocellular carcinoma after liver transplantation are included according to the criteria of admission. The enrolled patients are treated with lenvatinib (dose: body weight \< 60 kg: 8 mg/day, body weight ≥ 60 kg 12 mg/day). The baseline data of patients are collected before allocation. Serum and imaging examination are checked regularly every month to monitor the recurrence of hepatocellular carcinoma and the side effects of lenvatinib. The efficacy and safety of lenvatinib in the treatment of recurrence of hepatocellular carcinoma are observed, and the clinicopathological factors affecting the efficacy of lenvatinib are analyzed. When side effects of lenvatinib occur, the dosage can be reduced according to the patients' condition until discontinuation. When tumor advances, a multidisciplinary team will draw up specific treatment plans according to the patients' condition.

Study Timeline

• Study First Submitted: 2020-01-19
• Study First Submitted QC: 2020-01-19
• Study First Posted: 2020-01-23
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-21
• Last Update Posted: 2020-03-24
• Study Start: 2020-05-01
• Primary Completion: 2022-01-01
• Study Completion: 2022-11-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
relenvatinib	relenvatinib	The enrolled patients are treated with lenvatinib (dose: body weight \< 60 kg: 8 mg/day, body weight ≥ 60 kg 12 mg/day).

Primary Outcome Measures

Name	Time	Method
3 years recurrence-free survival rate	3 years	Tumor recurrence within 3 years

Secondary Outcome Measures

Name	Time	Method
1 year recurrence-free survival rate	1 year	Tumor recurrence within 1 year
5 years recurrence-free survival rate	5 years	Tumor recurrence within 5 years
1 year overall survival rate	1 year	overall survival with one year
3 years overall survival rate	3 years	overall survival with 35 years
5 years overall survival rate	5 years	overall survival with 5 years