Back to resultsA Multicenter Study of Anlotinib in Hepatocellular Carcinoma (HCC) Patients at High Risk of Post Surgery Recurrence
Primary Purpose
Hepatocellular Carcinoma
Status
Terminated
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Anlotinib Hydrochloride
Sponsored by
About this trial
This is an interventional prevention trial for Hepatocellular Carcinoma
Eligibility Criteria
Inclusion Criteria:
- No allergic history of Anlotinib
- 18-75 years
- No history of severe arrhythmia or heart failure
- No history of severe ventilation dysfunction or severe pulmonary infection
- No acute or chronic renal failure, creatinine clearance > 40 mL/min
- Liver function is normal: child-pugh grade A or grade B (≤7 points), total bilirubin ≤ 3.0 mg/dL, albumin ≥ 28 g/L, AST, ALT, ALP≤ 5 times of the upper limit of normal value
- Blood test: the absolute neutrophil count ≥ 1.5×10^9 /L, Hb ≥ 8.5 g/L, PLT ≥ 75×10^9 /L (without blood transfusions and drug therapy 14 days before the screening)
- Blood coagulation function: INR≤2.3
- ECOG: 0-2
- Pathology: hepatocellular carcinoma
- Satisfy any of the following:
A. portal vein, hepatic vein or bile duct carcinoma thrombus B. microvascular invasion (MVI) grade II (> 5 MVI, or MVI occurs in the area more than 1 cm from the tumor) C. tumor number ≥ 3 D. preoperative rupture of tumor or tumor invasion adjacent organs
- Patients participate in the study voluntarily and sign informed consent
Exclusion Criteria:
- Pregnant or lactating women
- Patients who have had or are currently complicated with other malignant tumors
- Recurrent hepatocellular carcinoma
- Patients who participated in other clinical trials within 1 month
- Patients with mental illness
- Patients treated with targeted drugs, immunotherapy (such as PD1 antibody), FOLFOX systemic chemotherapy or huaier granules after surgery
- Urine protein ≥ ++，and 24-hour urinary protein excretion>1.0 g confirmed
Sites / Locations
- The First Affiliated Hospital of Medical School of Zhejiang University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Anlotinib
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
Adverse effect
Any adverse effects occur during the use of anlotinib
Overall survival
The survival rate in a year
Full Information
NCT ID
NCT03945799
First Posted
May 9, 2019
Last Updated
August 25, 2022
Sponsor
Zhejiang University
Collaborators
Shulan (Hangzhou) Hospital, West China Hospital, Huashan Hospital, Third Affiliated Hospital, Sun Yat-Sen University, The First Affiliated Hospital of Zhengzhou University, The First Hospital of Jilin University, Tianjin First Central Hospital, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT03945799
Brief Title
A Multicenter Study of Anlotinib in Hepatocellular Carcinoma (HCC) Patients at High Risk of Post Surgery Recurrence
Official Title
A Single Group, Open Label, Multi-center Clinical Study to Assess the Efficacy and Safety of Anlotinib in HCC Patients at High Risk of Post Surgery Recurrence.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Terminated
Why Stopped
The study has gotten preliminary results and stopped advanced.
Study Start Date
April 22, 2019 (Actual)
Primary Completion Date
June 25, 2022 (Actual)
Study Completion Date
June 25, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zhejiang University
Collaborators
Shulan (Hangzhou) Hospital, West China Hospital, Huashan Hospital, Third Affiliated Hospital, Sun Yat-Sen University, The First Affiliated Hospital of Zhengzhou University, The First Hospital of Jilin University, Tianjin First Central Hospital, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
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
To assess the primary effects and safety of Anlotinib in 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 be administrated Anlotinib 12mg QD PO d1-14, 21 days per cycle. The disease free survival (DFS), overall survival (OS) and any adverse effect during the 8 cycles of Anlotinib treatment will be evaluated in order to assess the primary effects and safety of Anlotinib in HCC patients at high risk of post surgery recurrence.
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
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Anlotinib
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, 8 cycles.
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
Adverse effect
Description
Any adverse effects occur during the use of anlotinib
Time Frame
Up to 1year
Title
Overall survival
Description
The survival rate in a year
Time Frame
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:
No allergic history of Anlotinib
18-75 years
No history of severe arrhythmia or heart failure
No history of severe ventilation dysfunction or severe pulmonary infection
No acute or chronic renal failure, creatinine clearance > 40 mL/min
Liver function is normal: child-pugh grade A or grade B (≤7 points), total bilirubin ≤ 3.0 mg/dL, albumin ≥ 28 g/L, AST, ALT, ALP≤ 5 times of the upper limit of normal value
Blood test: the absolute neutrophil count ≥ 1.5×10^9 /L, Hb ≥ 8.5 g/L, PLT ≥ 75×10^9 /L (without blood transfusions and drug therapy 14 days before the screening)
Blood coagulation function: INR≤2.3
ECOG: 0-2
Pathology: hepatocellular carcinoma
Satisfy any of the following:
A. portal vein, hepatic vein or bile duct carcinoma thrombus B. microvascular invasion (MVI) grade II (> 5 MVI, or MVI occurs in the area more than 1 cm from the tumor) C. tumor number ≥ 3 D. preoperative rupture of tumor or tumor invasion adjacent organs
Patients participate in the study voluntarily and sign informed consent
Exclusion Criteria:
Pregnant or lactating women
Patients who have had or are currently complicated with other malignant tumors
Recurrent hepatocellular carcinoma
Patients who participated in other clinical trials within 1 month
Patients with mental illness
Patients treated with targeted drugs, immunotherapy (such as PD1 antibody), FOLFOX systemic chemotherapy or huaier granules after surgery
Urine protein ≥ ++，and 24-hour urinary protein excretion>1.0 g confirmed
Facility Information:
Facility Name
The First Affiliated Hospital of Medical School of Zhejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
A Multicenter Study of Anlotinib in Hepatocellular Carcinoma (HCC) Patients at High Risk of Post Surgery Recurrence
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