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

Anlotinib Combined With TACE in Hepatocellular Carcinoma Patients at High Risk of Post Surgery Recurrence: Conditions:   Hepatocellular Carcinoma;   TACE;   Anlotinib Interventions:   Drug: Anlotinib Hydrochloride;   Procedure: TACE Sponsors:   First Affiliated Hospital Xi'an Jiaotong University;   Chia Tai Tianqing Pharmaceutical Group Co., Ltd. Not yet recruiting (Source: ClinicalTrials.gov)




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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.



ClinicalTrials.gov Identifier: NCT04213118

Recruitment Status  : Not yet recruiting

First Posted  : December 30, 2019

Last Update Posted  : December 30, 2019

See Contacts and Locations

Sponsor:

First Affiliated Hospital Xi'an Jiaotong University

Collaborator:

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Information provided by (Responsible Party):

First Affiliated Hospital Xi'an Jiaotong University



Study DetailsTabular ViewNo Results PostedDisclaimerHow to Read a Study Record

Study Description

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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.





Study Design

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Study Type  : Interventional  (Clinical Trial)

Estimated Enrollment  : 48 participants

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  : December 2019

Estimated Primary Completion Date  : December 2020

Estimated Study Completion Date  : June 2022

Arms and Interventions

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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）







Outcome Measures

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Primary Outcome Measures  :

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

One year ratio of DFS



Time to recurrence [ Time Frame: From randomization to recurrence of HCC(up to 1year) ]

The period from resection surgery to recurrence of HCC



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





Eligibility Criteria

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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.





Ages Eligible for Study:  18 Years to 75 Years   (Adult, Older Adult)

Sexes Eligible for Study:  All

Accepts Healthy Volunteers:  No

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.

Contacts and Locations

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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 ClinicalTrials.gov identifier (NCT number): NCT04213118





Contacts

Contact: Zheng Wu, PhD 0086-13609195898 wuzheng@126.com

Contact: Zheng Wang, PhD 0086-15902993665 wangzheng0923@126.com



Locations

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 Not yet 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.

Investigators

Study Chair: Zheng Wu, PhD First Affiliated Hospital Xi'an Jiaotong University

More Information

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Responsible Party: First Affiliated Hospital Xi'an Jiaotong University

ClinicalTrials.gov Identifier: NCT04213118     History of Changes

Other Study ID Numbers: KYLLSL-2019-185

First Posted: December 30, 2019    Key Record Dates

Last Update Posted: December 30, 2019

Last Verified: December 2019

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

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

Additional relevant MeSH terms:

Carcinoma

Carcinoma, Hepatocellular

Recurrence

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms

Adenocarcinoma

Liver Neoplasms

Digestive System Neoplasms

Neoplasms by Site

Digestive System Diseases

Liver Diseases

Disease Attributes

Pathologic Processes





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