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出境医 / 临床实验 / A Multicenter Study of Anlotinib in Hepatocellular Carcinoma (HCC) Patients at High Risk of Post Surgery Recurrence

A Multicenter Study of Anlotinib in Hepatocellular Carcinoma (HCC) Patients at High Risk of Post Surgery Recurrence

Study Description
Brief Summary:
To assess the primary effects and safety of Anlotinib in HCC patients at high risk of post surgery recurrence.

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Drug: Anlotinib Hydrochloride Phase 1 Phase 2

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.
Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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.
Actual Study Start Date : April 22, 2019
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2024
Arms and Interventions
Arm Intervention/treatment
Experimental: Anlotinib
Administration Anlotinib and it should be continued until relapse of HCC or intolerable toxicity or patients withdrawal of consent.
 Drug: Anlotinib Hydrochloride
Anlotinib: 12mg QD PO d1-14, 21 days per cycle, 8 cycles.
Outcome Measures
Primary Outcome Measures :
  1. Disease free survival [ Time Frame: From randomization to recurrence of HCC or death (up to 1year) ]
    The period from resection surgery to recurrence of HCC


Secondary Outcome Measures :
  1. Adverse effect [ Time Frame: Up to 1year ]
    Any adverse effects occur during the use of anlotinib

  2. Overall survival [ Time Frame: 1 year ]
    The survival rate in a year


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Contacts
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Contact: Jiangguo Wang, PhD (+86)15967123327 21118059@zju.edu.cn

Locations
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China, Zhejiang
The First Affiliated Hospital of Medical School of Zhejiang University Recruiting
Hangzhou, Zhejiang, China, 310003
Contact: Jiangguo Wang, PhD    (+86)15967123327      
Sponsors and Collaborators
Zhejiang University
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
Tracking Information
First Submitted Date  ICMJE May 9, 2019
First Posted Date  ICMJE May 10, 2019
Last Update Posted Date May 10, 2019
Actual Study Start Date  ICMJE April 22, 2019
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 9, 2019) 		Disease free survival [ Time Frame: From randomization to recurrence of HCC or death (up to 1year) ]
The period from resection surgery to recurrence of HCC
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 9, 2019)
  • Adverse effect [ Time Frame: Up to 1year ]
    Any adverse effects occur during the use of anlotinib
  • Overall survival [ Time Frame: 1 year ]
    The survival rate in a year
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Multicenter Study of Anlotinib in Hepatocellular Carcinoma (HCC) Patients at High Risk of Post Surgery Recurrence
Official Title  ICMJE 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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Hepatocellular Carcinoma
Intervention  ICMJE Drug: Anlotinib Hydrochloride
Anlotinib: 12mg QD PO d1-14, 21 days per cycle, 8 cycles.
Study Arms  ICMJE Experimental: Anlotinib
Administration Anlotinib and it should be continued until relapse of HCC or intolerable toxicity or patients withdrawal of consent.
Intervention: Drug: Anlotinib Hydrochloride
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 9, 2019) 		60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2024
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jiangguo Wang, PhD (+86)15967123327 21118059@zju.edu.cn
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03945799
Other Study ID Numbers  ICMJE KY2019-AHR-ZJU
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Responsible Party Xiao Xu, Zhejiang University
Study Sponsor  ICMJE Zhejiang University
Collaborators  ICMJE
  • 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
Investigators  ICMJE Not Provided
PRS Account Zhejiang University
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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