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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04213118
Recruitment Status : Recruiting
First Posted : December 30, 2019
Last Update Posted : April 14, 2020
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Information provided by (Responsible Party):
First Affiliated Hospital Xi'an Jiaotong University

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.

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma TACE Anlotinib Drug: Anlotinib Hydrochloride Procedure: TACE 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 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : April 13, 2020
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : June 2022

Arm Intervention/treatment
Experimental: Group A
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.

Procedure: TACE
TACE first, followed by anlotinib within day4(+/-1days)

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. 1-year DFS Rate [ Time Frame: From randomization to recurrence of HCC or death (up to 1year) ]
    One year ratio of DFS

  2. Time to recurrence [ Time Frame: From randomization to recurrence of HCC(up to 1year) ]
    The period from resection surgery to recurrence of HCC

  3. Incidence of Treatment-Emergent Adverse Events Safety and Tolerability [ Time Frame: Up to 30 day safety follow-up visit ]
    Any adverse effects occur during the use of anlotinib

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04213118

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Contact: Zheng Wu, PhD 0086-13609195898
Contact: Zheng Wang, PhD 0086-15902993665

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China, Gansu
The First Hospital of Lanzhou University Not yet recruiting
Lanzhou, Gansu, China, 730000
Contact: Lei Zhang, PhD         
China, Shaanxi
Tangdu Hospital of The Fourth Military Medical University Not yet recruiting
Xi'an, Shaanxi, China, 710000
Contact: Xilin Du, PhD         
The First Affiliated Hospital of Xi'an Jiaotong University Recruiting
Xi'an, Shaanxi, China, 710000
Contact: Zheng Wu, PhD         
Sponsors and Collaborators
First Affiliated Hospital Xi'an Jiaotong University
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
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Study Chair: Zheng Wu, PhD First Affiliated Hospital Xi'an Jiaotong University
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Responsible Party: First Affiliated Hospital Xi'an Jiaotong University Identifier: NCT04213118    
Other Study ID Numbers: KYLLSL-2019-185
First Posted: December 30, 2019    Key Record Dates
Last Update Posted: April 14, 2020
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Disease Attributes
Pathologic Processes