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

NCT04237740 | Unknown Phase 3 DMC FDA Drug

• 1 other identifier: Renji8790
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hepatocellular Carcinoma; Liver Transplantation

Keywords

recurrent hepatocellular carcinoma; liver transplantation; relenvatinib

Outcome Measures

Primary Outcomes (1)

• 3 years recurrence-free survival rate

  Tumor recurrence within 3 years

  3 years

Secondary Outcomes (5)

• 1 year recurrence-free survival rate

  1 year

• 5 years recurrence-free survival rate

  5 years

• 1 year overall survival rate

  1 year

• 3 years overall survival rate

  3 years

• 5 years overall survival rate

  5 years

Study Arms (1)

relenvatinib

EXPERIMENTAL

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

Drug: relenvatinib

Interventions

relenvatinib DRUG

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

Also known as: relenvatinib treatment

relenvatinib

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• aged 18 to 75.
• ECOG physical condition was 0-2 points.
• Child-Pugh A grade of liver function.
• Targeted therapy is acceptable within 1-2 months after liver transplantation.
• Immunosuppressive regimen consists of calcineurin inhibitor, mycophenolate mofetil and sirolimus.
• No history of surgical resection of liver tumors and targeted drug therapy before liver transplantation.
• Good liver, kidney and bone marrow function: or PT within 6 seconds over normal upper limit.
• For fertile female patients, the serum/urine pregnancy test should be negative within 7 days before treatment.
• All male and female participants must take reliable contraceptive measures during the trial and within four weeks after the end of the trial.
• The participants have the capability of oral medication. 13.The participants must sign the consent form.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• RenJi Hospital: lead

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• qiang xia, doctor

  RenJi Hospital

  STUDY CHAIR

Central Study Contacts

qiang Xia, doctor

CONTACT

+8613661889035; xiaqiang1966@126.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The cases are from patients with recurrent hepatocellular carcinoma who underwent liver transplantation in the liver surgery department of Shanghai Renji Hospital. The enrolled patients are treated with lenvatinib (dose: body weight \< 60 kg: 8 mg/day, body weight ≥ 60 kg 12 mg/day).

Study Record Dates

• First Submitted: January 19, 2020
• First Posted: January 23, 2020
• Study Start: May 1, 2020
• Primary Completion: January 1, 2022
• Study Completion: November 1, 2022
• Last Updated: March 24, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share