Clinical trial NCT04213118: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Hepatocellular Carcinoma
TACE
Anlotinib
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
Collaborators: name: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
First posted: 2019-12-30
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

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.

Primary outcomes:
measure: Disease free survival
timeFrame: From randomization to recurrence of HCC or death (up to 1year)
Secondary outcomes:
measure: 1-year DFS Rate
timeFrame: From randomization to recurrence of HCC or death (up to 1year)
measure: Time to recurrence
timeFrame: From randomization to recurrence of HCC(up to 1year)
measure: Incidence of Treatment-Emergent Adverse Events Safety and Tolerability
timeFrame: Up to 30 day safety follow-up visit
Other outcomes:
Locations:
city: Lanzhou
country: China
facility: The First Hospital of Lanzhou University
state: Gansu
city: Hanzhong
country: China
facility: Hanzhong Central Hospital
state: Shaanxi
city: Xi'an
country: China
facility: Tangdu Hospital of The Fourth Military Medical University
state: Shaanxi
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Jiaotong University
state: Shaanxi
Study officials:
affiliation: First Affiliated Hospital Xi'an Jiaotong University
name: Zheng Wu, PhD
role: STUDY_CHAIR
References: