Description:
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.
Title
- Brief Title: Anlotinib Combined With TACE in Hepatocellular Carcinoma Patients at High Risk of Post Surgery Recurrence
- 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
Clinical Trial IDs
- ORG STUDY ID:
KYLLSL-2019-185
- NCT ID:
NCT04213118
Conditions
- Hepatocellular Carcinoma
- TACE
- Anlotinib
Interventions
Drug | Synonyms | Arms |
---|
Anlotinib Hydrochloride | | Group A |
Purpose
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.
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.
Trial Arms
Name | Type | Description | Interventions |
---|
Group A | Experimental | Administration anlotinib and it should be continued until relapse of HCC or intolerable toxicity or patients withdrawal of consent. | |
Eligibility 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.
Maximum Eligible Age: | 75 Years |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Disease free survival |
Time Frame: | From randomization to recurrence of HCC or death (up to 1year) |
Safety Issue: | |
Description: | The period from resection surgery to recurrence of HCC |
Secondary Outcome Measures
Measure: | 1-year DFS Rate |
Time Frame: | From randomization to recurrence of HCC or death (up to 1year) |
Safety Issue: | |
Description: | One year ratio of DFS |
Measure: | Time to recurrence |
Time Frame: | From randomization to recurrence of HCC(up to 1year) |
Safety Issue: | |
Description: | The period from resection surgery to recurrence of HCC |
Measure: | Incidence of Treatment-Emergent Adverse Events Safety and Tolerability |
Time Frame: | Up to 30 day safety follow-up visit |
Safety Issue: | |
Description: | Any adverse effects occur during the use of anlotinib |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | First Affiliated Hospital Xi'an Jiaotong University |
Last Updated
April 14, 2020