Anlotinib Combined With TACE in Hepatocellular Carcinoma Patients at High Risk of Post Surgery Recurrence (ALTER-H-004)
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|ClinicalTrials.gov Identifier: NCT04213118|
Recruitment Status : Recruiting
First Posted : December 30, 2019
Last Update Posted : April 14, 2020
|Condition or disease||Intervention/treatment||Phase|
|Hepatocellular Carcinoma TACE Anlotinib||Drug: Anlotinib Hydrochloride Procedure: TACE||Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||48 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
TACE first, followed by anlotinib within day4（+/-1days）
- 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
- 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
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
|Contact: Zheng Wu, PhDemail@example.com|
|Contact: Zheng Wang, PhDfirstname.lastname@example.org|
|The First Hospital of Lanzhou University||Not yet recruiting|
|Lanzhou, Gansu, China, 730000|
|Contact: Lei Zhang, PhD|
|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|
|Study Chair:||Zheng Wu, PhD||First Affiliated Hospital Xi'an Jiaotong University|