Relenvatinib in the Tatment of Recurrence of Hepatocellular Carcinoma After Liver Transplantation (RRHCCLT)

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

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.

Study Overview

• Status: Unknown
• Conditions: Liver Transplantation; Hepatocellular Carcinoma
• Intervention / Treatment: Drug: relenvatinib

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 Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: relenvatinib; The enrolled patients are treated with lenvatinib (dose: body weight < 60 kg: 8 mg/day, body weight ≥ 60 kg 12 mg/day).	Drug: relenvatinib; The enrolled patients are treated with lenvatinib (dose: body weight < 60 kg: 8 mg/day, body weight ≥ 60 kg 12 mg/day).; Other Names: relenvatinib treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
3 years recurrence-free survival rate	Tumor recurrence within 3 years	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
1 year recurrence-free survival rate	Tumor recurrence within 1 year	1 year
5 years recurrence-free survival rate	Tumor recurrence within 5 years	5 years
1 year overall survival rate	overall survival with one year	1 year
3 years overall survival rate	overall survival with 35 years	3 years
5 years overall survival rate	overall survival with 5 years	5 years

Collaborators and Investigators

• Sponsor: RenJi Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2020
• Primary Completion (Anticipated): January 1, 2022
• Study Completion (Anticipated): November 1, 2022

Study Registration Dates

• First Submitted: January 19, 2020
• First Submitted That Met QC Criteria: January 19, 2020
• First Posted (Actual): January 23, 2020

Study Record Updates

• Last Update Posted (Actual): March 24, 2020
• Last Update Submitted That Met QC Criteria: March 21, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: liver transplantation; recurrent hepatocellular carcinoma; relenvatinib
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Disease Attributes; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms; Carcinoma; Carcinoma, Hepatocellular; Recurrence
• Other Study ID Numbers: Renji8790

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes