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Study of TACE Combined With Lenvatinib to Prevent Postoperative Recurrence in Patients With MVI Positive HCC

Primary Purpose

Hepatocellular Carcinoma, Lenvatinib

Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Lenvatinib
TACE
Sponsored by
Second Affiliated Hospital, School of Medicine, Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring TACE, Hepatocellular Carcinoma, MVI, Prognosis, Lenvatinib

Eligibility Criteria

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

Inclusion Criteria:

  • Radical hepatocellular carcinoma was treated 4 weeks (±1 week) ago, and the pathological diagnosis was HCC after surgery, and MVI was positive
  • Child-Pugh score ≤9 points (Child-Pugh A-B), PS score 0-2 points, BCLC stage A-B
  • The main portal vein is not completely obstructed, or although it is completely obstructed, the compensatory collateral branches of the portal vein are abundant or the portal vein blood flow can be restored by implanting the portal vein stent
  • With sufficient organ and bone marrow function, the laboratory test values within 7 days before enrollment meet the requirements
  • Physical fitness score ECOG 0～2
  • Expected survival> 3 months
  • No other systemic malignancies
  • Female subjects of childbearing age or male subjects whose sexual partners are females of childbearing age must take effective contraceptive measures throughout the treatment period and 6 months after the treatment period
  • Subjects have informed consent, understand and are willing to cooperate with the trial protocol, and sign relevant documents

Exclusion Criteria:

  • Histology includes fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma, etc.
  • Severe liver dysfunction (Child-Pugh C), including jaundice, hepatic encephalopathy, refractory ascites, hepatorenal syndrome, or a history of liver transplantation
  • The main portal vein is completely blocked, and the formation of collateral vessels is small

Sites / Locations

  • Weilin WangRecruiting
  • The Second Affiliated Hospital, Zhejiang University School of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

control group

Intervention group

Arm Description

patients receive transcatheter arterial chemoembolization (TACE) only.

patients receive transcatheter arterial chemoembolization (TACE) and lenvatinib 8mg per day.

Outcomes

Primary Outcome Measures

Incidence of adverse events
To evaluate the safety of TACE combined with lenvatinib treatment in preventing postoperative recurrence in patients with MVI-positive HCC
Changes in tumor volume
To evaluate the effectiveness of TACE combined with lenvatinib treatment in preventing postoperative recurrence in patients with MVI-positive HCC
Recurrence-free survival (RFS) evaluation
To evaluate the recurrence-free survival of patients with MVI-positive HCC after TACE combined with lenvatinib treatment

Secondary Outcome Measures

Disease recurrence time evaluation
To evaluate the tumor recurrence time of patients with MVI-positive HCC after TACE combined with lenvatinib treatment
Overall survival ( OS) evaluation
Overall survival time as assessed by IRC

Full Information

First Posted
January 18, 2021
Last Updated
February 2, 2023
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
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1. Study Identification

Unique Protocol Identification Number
NCT04911959
Brief Title
Study of TACE Combined With Lenvatinib to Prevent Postoperative Recurrence in Patients With MVI Positive HCC
Official Title
Study on the Safety and Effectiveness of Transcatheter Arterial Chemoembolization (TACE) Combined With Lenvatinib to Prevent Postoperative Recurrence in Patients With Microvascular Invasion (MVI) Positive Hepatocellular Carcinoma (HCC)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2022 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
single-center clinical trial studies have verified the safety and effectiveness of transcatheter arterial chemoembolization (TACE) combined with lenvatinib in preventing postoperative recurrence of microvascular invasion (MVI) positive HCC patients. Explore a new clinical first-line treatment plan for patients with liver cancer microvascular invasion after surgery.
Detailed Description
Focusing on the current status of clinical treatment of microvascular invasion (MVI) positive postoperative hepatocellular carcinoma (HCC) , single-center clinical trial studies have verified the safety and effectiveness of transcatheter arterial chemoembolization (TACE) combined with lenvatinib in preventing postoperative recurrence of MVI-positive HCC patients. Explore a new clinical first-line treatment plan for patients with liver cancer microvascular invasion after surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma, Lenvatinib
Keywords
TACE, Hepatocellular Carcinoma, MVI, Prognosis, Lenvatinib

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
control group
Arm Type
Active Comparator
Arm Description
patients receive transcatheter arterial chemoembolization (TACE) only.
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
patients receive transcatheter arterial chemoembolization (TACE) and lenvatinib 8mg per day.
Intervention Type
Drug
Intervention Name(s)
Lenvatinib
Intervention Description
Lenvatinib is taken orally.
Intervention Type
Procedure
Intervention Name(s)
TACE
Other Intervention Name(s)
Transcatheter Arterial Chemoembolization
Intervention Description
TACE treatment once.
Primary Outcome Measure Information:
Title
Incidence of adverse events
Description
To evaluate the safety of TACE combined with lenvatinib treatment in preventing postoperative recurrence in patients with MVI-positive HCC
Time Frame
Up to 8 weeks
Title
Changes in tumor volume
Description
To evaluate the effectiveness of TACE combined with lenvatinib treatment in preventing postoperative recurrence in patients with MVI-positive HCC
Time Frame
Up to 8 weeks
Title
Recurrence-free survival (RFS) evaluation
Description
To evaluate the recurrence-free survival of patients with MVI-positive HCC after TACE combined with lenvatinib treatment
Time Frame
Through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
Disease recurrence time evaluation
Description
To evaluate the tumor recurrence time of patients with MVI-positive HCC after TACE combined with lenvatinib treatment
Time Frame
Through study completion, an average of 1 year
Title
Overall survival ( OS) evaluation
Description
Overall survival time as assessed by IRC
Time Frame
Through study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Radical hepatocellular carcinoma was treated 4 weeks (±1 week) ago, and the pathological diagnosis was HCC after surgery, and MVI was positive Child-Pugh score ≤9 points (Child-Pugh A-B), PS score 0-2 points, BCLC stage A-B The main portal vein is not completely obstructed, or although it is completely obstructed, the compensatory collateral branches of the portal vein are abundant or the portal vein blood flow can be restored by implanting the portal vein stent With sufficient organ and bone marrow function, the laboratory test values within 7 days before enrollment meet the requirements Physical fitness score ECOG 0～2 Expected survival> 3 months No other systemic malignancies Female subjects of childbearing age or male subjects whose sexual partners are females of childbearing age must take effective contraceptive measures throughout the treatment period and 6 months after the treatment period Subjects have informed consent, understand and are willing to cooperate with the trial protocol, and sign relevant documents Exclusion Criteria: Histology includes fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma, etc. Severe liver dysfunction (Child-Pugh C), including jaundice, hepatic encephalopathy, refractory ascites, hepatorenal syndrome, or a history of liver transplantation The main portal vein is completely blocked, and the formation of collateral vessels is small
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Weilin Wang
Phone
+8657187783820
Email
wam@zju.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Yuan Ding
Phone
+8618858101960
Email
dingyuan@zju.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhongquan Sun
Organizational Affiliation
Second Affiliated Hospital, School of Medicine, Zhejiang University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Weilin Wang
City
Hangzhou
State/Province
None Selected
ZIP/Postal Code
310009
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weilin Wang, M.D.
Phone
+86 0571 87783820
Email
wam@zju.edu.cn
Facility Name
The Second Affiliated Hospital, Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310009
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuan Ding, M.D.
Phone
+86 18858101960
Email
dingyuan@zju.edu
First Name & Middle Initial & Last Name & Degree
Weilin Wang, M.D.
Phone
+86 0571 87783820
Email
wam@zju.edu.cn

12. IPD Sharing Statement

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Study of TACE Combined With Lenvatinib to Prevent Postoperative Recurrence in Patients With MVI Positive HCC

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