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.
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
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Anlotinib 12mg QD PO d1-14, 21 days per cycle.
TACE first, followed by anlotinib within day4(+/-1days)
The First Hospital of Lanzhou University
Lanzhou, Gansu, China
Hanzhong Central Hospital
Hanzhong, Shaanxi, China
Tangdu Hospital of The Fourth Military Medical University
Xi'an, Shaanxi, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China
Disease free survival
The period from resection surgery to recurrence of HCC
Time frame: From randomization to recurrence of HCC or death (up to 1year)
1-year DFS Rate
One year ratio of DFS
Time frame: From randomization to recurrence of HCC or death (up to 1year)
Time to recurrence
The period from resection surgery to recurrence of HCC
Time frame: From randomization to recurrence of HCC(up to 1year)
Incidence of Treatment-Emergent Adverse Events Safety and Tolerability
Any adverse effects occur during the use of anlotinib
Time frame: Up to 30 day safety follow-up visit
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