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The Impact on Recurrence Risk of Adjuvant Lenvatinib for Patients With Hepatocellular Carcinoma And Microvascular Invasion (MVI) After Hepatectomy : A Random, Controlled, Stage III Clinical Trial.

Primary Purpose

Hepatocellular Carcinoma

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Lenvatinib
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma

Eligibility Criteria

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

No

Criteria:

Inclusion Criteria:

older than 18 years old and younger than 75 years; ECOG PS<3; proven hepatocellular carcinoma with MVI according pathological examination; not previous treated for tumor; tumor was removed in operation; no recurrence occurence at 4 to 7 weeks after surgery; the lab test could meet: neutrophil count≥1.5×109/L; hemoglobin≥80g/L; platelet count≥60×109/L; serum albumin≥28g/L; total bilirubin<3-times upper limit of normal; ALT<5-times upper limit of normal; AST<5-times upper limit of normal; serum creatine<1.5-times upper limit of normal; PT≤upper limit of normal plus 6 seconds; INR≤2.3; sign up consent; unrolled by other clinical trials about hepatocellular carcinoma.

Exclusion Criteria:

cannot tolerate lenvatinib; CNS or bone metastasis exits; known history of other malignancy; be allergic to related drugs; underwent organ transplantation before; be treated before (interferon included); known history of HIV infection; known history of drug or alcohol abuse; have GI hemorreage or cardiac/brain vascular events within 30 days; pregnancy;

Sites / Locations

  • SUN YAT-SEN University Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

treatment group

control group

Arm Description

adjuvant lenvatinib

no intervention

Outcomes

Primary Outcome Measures

RFS
recurrence-free survival

Secondary Outcome Measures

OS
overall survival
recurrence rate
recurrence rate

Full Information

First Posted
August 10, 2019
Last Updated
August 10, 2019
Sponsor
Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT04053972
Brief Title
The Impact on Recurrence Risk of Adjuvant Lenvatinib for Patients With Hepatocellular Carcinoma And Microvascular Invasion (MVI) After Hepatectomy : A Random, Controlled, Stage III Clinical Trial.
Official Title
The Impact on Recurrence Risk of Adjuvant Lenvatinib for Patients With Hepatocellular Carcinoma And Microvascular Invasion (MVI) After Hepatectomy : A Random, Controlled, Stage III Clinical Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 31, 2018 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To compare The Impact on Recurrence Risk of Adjuvant Lenvatinib for Patients With Hepatocellular Carcinoma And Microvascular Invasion (MVI) After Hepatectomy.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
377 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
treatment group
Arm Type
Experimental
Arm Description
adjuvant lenvatinib
Arm Title
control group
Arm Type
No Intervention
Arm Description
no intervention
Intervention Type
Drug
Intervention Name(s)
Lenvatinib
Intervention Description
oral lenvatinib after hepatectomy
Primary Outcome Measure Information:
Title
RFS
Description
recurrence-free survival
Time Frame
From date of randomization until the date of recurrence, assessed up to 60 months
Secondary Outcome Measure Information:
Title
OS
Description
overall survival
Time Frame
From date of randomization until the date of death from any cause, assessed up to 60 months
Title
recurrence rate
Description
recurrence rate
Time Frame
1 year, 2 year, 3 year, 5 year after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
No Criteria: Inclusion Criteria: older than 18 years old and younger than 75 years; ECOG PS<3; proven hepatocellular carcinoma with MVI according pathological examination; not previous treated for tumor; tumor was removed in operation; no recurrence occurence at 4 to 7 weeks after surgery; the lab test could meet: neutrophil count≥1.5×109/L; hemoglobin≥80g/L; platelet count≥60×109/L; serum albumin≥28g/L; total bilirubin<3-times upper limit of normal; ALT<5-times upper limit of normal; AST<5-times upper limit of normal; serum creatine<1.5-times upper limit of normal; PT≤upper limit of normal plus 6 seconds; INR≤2.3; sign up consent; unrolled by other clinical trials about hepatocellular carcinoma. Exclusion Criteria: cannot tolerate lenvatinib; CNS or bone metastasis exits; known history of other malignancy; be allergic to related drugs; underwent organ transplantation before; be treated before (interferon included); known history of HIV infection; known history of drug or alcohol abuse; have GI hemorreage or cardiac/brain vascular events within 30 days; pregnancy;
Facility Information:
Facility Name
SUN YAT-SEN University Cancer Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rong-Ping Guo, M.D.
Phone
00862087342266
Email
guorp@sysucc.org.cn
First Name & Middle Initial & Last Name & Degree
Wei Wei, Ph.D. M.D.
Phone
00862087343790
Email
weiwei@sysucc.org.cn

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

The Impact on Recurrence Risk of Adjuvant Lenvatinib for Patients With Hepatocellular Carcinoma And Microvascular Invasion (MVI) After Hepatectomy : A Random, Controlled, Stage III Clinical Trial.

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