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

Primary Purpose

Hepatocellular Carcinoma, Liver Transplantation

Status

Unknown status

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

relenvatinib

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring recurrent hepatocellular carcinoma, liver transplantation, relenvatinib

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

12.The participants have the capability of oral medication. 13.The participants must sign the consent form.

Exclusion Criteria:

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.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

relenvatinib

Arm Description

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

Outcomes

Primary Outcome Measures

3 years recurrence-free survival rate

Tumor recurrence within 3 years

Secondary Outcome Measures

1 year recurrence-free survival rate

Tumor recurrence within 1 year

5 years recurrence-free survival rate

Tumor recurrence within 5 years

1 year overall survival rate

overall survival with one year

3 years overall survival rate

overall survival with 35 years

5 years overall survival rate

overall survival with 5 years

Full Information

NCT ID

NCT04237740

First Posted

January 19, 2020

Last Updated

March 21, 2020

Sponsor

RenJi Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04237740

Brief Title

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

Acronym

RRHCCLT

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2020

Overall Recruitment Status

Unknown status

Study Start Date

May 1, 2020 (Anticipated)

Primary Completion Date

January 1, 2022 (Anticipated)

Study Completion Date

November 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

RenJi Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatocellular Carcinoma, Liver Transplantation

Keywords

recurrent hepatocellular carcinoma, liver transplantation, relenvatinib

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Model Description

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).

Masking

None (Open Label)

Allocation

N/A

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

relenvatinib

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

relenvatinib

Other Intervention Name(s)

relenvatinib treatment

Intervention Description

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

Primary Outcome Measure Information:

Title

3 years recurrence-free survival rate

Description

Tumor recurrence within 3 years

Time Frame

3 years

Secondary Outcome Measure Information:

Title

1 year recurrence-free survival rate

Description

Tumor recurrence within 1 year

Time Frame

1 year

Title

5 years recurrence-free survival rate

Description

Tumor recurrence within 5 years

Time Frame

5 years

Title

1 year overall survival rate

Description

overall survival with one year

Time Frame

1 year

Title

3 years overall survival rate

Description

overall survival with 35 years

Time Frame

3 years

Title

5 years overall survival rate

Description

overall survival with 5 years

Time Frame

5 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. 12.The participants have the capability of oral medication. 13.The participants must sign the consent form. Exclusion Criteria: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

qiang Xia, doctor

Phone

+8613661889035

xiaqiang1966@126.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

qiang xia, doctor

Organizational Affiliation

RenJi Hospital

Official's Role

Study Chair

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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