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Anlotinib Combined With TACE in Hepatocellular Carcinoma Patients at High Risk of Post Surgery Recurrence (ALTER-H-004)

Primary Purpose

Hepatocellular Carcinoma, TACE, Anlotinib

Status
Active
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Anlotinib Hydrochloride
TACE
Sponsored by
First Affiliated Hospital Xi'an Jiaotong 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

Inclusion Criteria:

  • Patients participate in the study voluntarily and sign informed consent with good compliance.
  • After hepatectomy, satisfy any of the following recurrence factors was assessed:≥5 cm and < 10 cm of tumor diameter; tumor number≥3; tumor microvascular invasion grade M1; portal vein carcinoma thrombus resection(Ⅰ、Ⅱ).
  • Histological or cytological confirmation of hepatocellular carcinoma, or at least two imaging tests with hepatocellular carcinoma characteristics, or one imaging test with hepatocellular carcinoma characteristics and AFP > 400μg/L.
  • TACE treatment (cTACE only) was completed within 1-2 months after hepatectomy.
  • ≥ 18 and ≤ 75 years of age.
  • ECOG performance status of 0-1.
  • liver function child-Pugh class A or B (≤7 points).
  • Except for hepatectomy, no previous tumor-related treatment was received, and the remaining liver was assessed to have good liver function.

Exclusion Criteria:

  • Patients who have had or are currently complicated with other malignant tumors,or recurrent hepatocellular carcinoma (>10 mm)in baseline data or in TACE.
  • Patients with absolute contraindications to TACE.
  • Patients with HCV infection.
  • Urine protein ≥ ++，and 24-hour urinary protein excretion>1.0 g confirmed.
  • Pregnant or lactating women.
  • Patients with mental illness.

Sites / Locations

  • The First Hospital of Lanzhou University
  • Hanzhong Central Hospital
  • Tangdu Hospital of The Fourth Military Medical University
  • The First Affiliated Hospital of Xi'an Jiaotong University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Group A

Arm Description

Administration anlotinib and it should be continued until relapse of HCC or intolerable toxicity or patients withdrawal of consent.

Outcomes

Primary Outcome Measures

Disease free survival
The period from resection surgery to recurrence of HCC

Secondary Outcome Measures

1-year DFS Rate
One year ratio of DFS
Time to recurrence
The period from resection surgery to recurrence of HCC
Incidence of Treatment-Emergent Adverse Events Safety and Tolerability
Any adverse effects occur during the use of anlotinib

Full Information

First Posted
December 25, 2019
Last Updated
January 12, 2023
Sponsor
First Affiliated Hospital Xi'an Jiaotong University
Collaborators
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04213118
Brief Title
Anlotinib Combined With TACE in Hepatocellular Carcinoma Patients at High Risk of Post Surgery Recurrence
Acronym
ALTER-H-004
Official Title
An Open, Single Arm,Multicenter Clinical Trial of Anlotinib Combined With Transcatheter Arterial Chemoembolization for Adjuvant Therapy in Patients With High Risk of Recurrence After Resection of Advanced Hepatocellular Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 23, 2020 (Actual)
Primary Completion Date
February 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
First Affiliated Hospital Xi'an Jiaotong University
Collaborators
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

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
A single-arm, open-label clinical trial to assess the effects and safety of anlotinib hydrochloride combined with transcatheter arterial chemoembolization (TACE) in hepatocellular carcinoma(HCC) patients at high risk of post surgery recurrence.
Detailed Description
Hepatocellular carcinoma is one of the most common malignant tumors in the world with high incidence and mortality. Recurrence of HCC is still a great challenge and threat to the patients after resection surgery. Anlotinib is a new, orally administered tyrosine kinase inhibitor that targets vascular endothelial growth factor receptor (VEGFR), fibroblast growth factor receptor (FGFR), platelet-derived growth factor receptors (PDGFR), and c-kit. HCC patients who meet the eligibility criteria of this clinical trial will adopt postoperative TACE combined with anlotinib hydrochloride. At Day4 of TACE,anlotinib 12mg QD PO d1-14, 21 days per cycle until disease progresses or intolerant. Primary Efficacy Endpoint: Disease free survival (DFS);Secondary Efficacy Endpoints: 1-year DFS Rate and Time to recurrence (TTR)(According to RECIST Version 1.1).Safety will be evaluated by incidence, severity and outcomes of AEs and categorized by severity in accordance with the NCI CTC AE Version 4.0.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Description
Administration anlotinib and it should be continued until relapse of HCC or intolerable toxicity or patients withdrawal of consent.
Intervention Type
Drug
Intervention Name(s)
Anlotinib Hydrochloride
Intervention Description
Anlotinib 12mg QD PO d1-14, 21 days per cycle.
Intervention Type
Procedure
Intervention Name(s)
TACE
Intervention Description
TACE first, followed by anlotinib within day4（+/-1days）
Primary Outcome Measure Information:
Title
Disease free survival
Description
The period from resection surgery to recurrence of HCC
Time Frame
From randomization to recurrence of HCC or death (up to 1year)
Secondary Outcome Measure Information:
Title
1-year DFS Rate
Description
One year ratio of DFS
Time Frame
From randomization to recurrence of HCC or death (up to 1year)
Title
Time to recurrence
Description
The period from resection surgery to recurrence of HCC
Time Frame
From randomization to recurrence of HCC(up to 1year)
Title
Incidence of Treatment-Emergent Adverse Events Safety and Tolerability
Description
Any adverse effects occur during the use of anlotinib
Time Frame
Up to 30 day safety follow-up visit

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: Patients participate in the study voluntarily and sign informed consent with good compliance. After hepatectomy, satisfy any of the following recurrence factors was assessed:≥5 cm and < 10 cm of tumor diameter; tumor number≥3; tumor microvascular invasion grade M1; portal vein carcinoma thrombus resection(Ⅰ、Ⅱ). Histological or cytological confirmation of hepatocellular carcinoma, or at least two imaging tests with hepatocellular carcinoma characteristics, or one imaging test with hepatocellular carcinoma characteristics and AFP > 400μg/L. TACE treatment (cTACE only) was completed within 1-2 months after hepatectomy. ≥ 18 and ≤ 75 years of age. ECOG performance status of 0-1. liver function child-Pugh class A or B (≤7 points). Except for hepatectomy, no previous tumor-related treatment was received, and the remaining liver was assessed to have good liver function. Exclusion Criteria: Patients who have had or are currently complicated with other malignant tumors,or recurrent hepatocellular carcinoma (>10 mm)in baseline data or in TACE. Patients with absolute contraindications to TACE. Patients with HCV infection. Urine protein ≥ ++，and 24-hour urinary protein excretion>1.0 g confirmed. Pregnant or lactating women. Patients with mental illness.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zheng Wu, PhD
Organizational Affiliation
First Affiliated Hospital Xi'an Jiaotong University
Official's Role
Study Chair
Facility Information:
Facility Name
The First Hospital of Lanzhou University
City
Lanzhou
State/Province
Gansu
ZIP/Postal Code
730000
Country
China
Facility Name
Hanzhong Central Hospital
City
Hanzhong
State/Province
Shaanxi
ZIP/Postal Code
723000
Country
China
Facility Name
Tangdu Hospital of The Fourth Military Medical University
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710000
Country
China
Facility Name
The First Affiliated Hospital of Xi'an Jiaotong University
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710000
Country
China

12. IPD Sharing Statement

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Anlotinib Combined With TACE in Hepatocellular Carcinoma Patients at High Risk of Post Surgery Recurrence

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