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

NCT ID: NCT04213118

Last Updated: 2023-01-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-04-23
• Study Completion Date: 2023-09-30

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.

Conditions

Hepatocellular Carcinoma; TACE; Anlotinib

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group A

Administration anlotinib and it should be continued until relapse of HCC or intolerable toxicity or patients withdrawal of consent.

Group Type: EXPERIMENTAL

Anlotinib Hydrochloride

Intervention Type: DRUG

Anlotinib 12mg QD PO d1-14, 21 days per cycle.

TACE

Intervention Type: PROCEDURE

TACE first, followed by anlotinib within day4（+/-1days）

Interventions

Anlotinib Hydrochloride

Anlotinib 12mg QD PO d1-14, 21 days per cycle.

Intervention Type: DRUG

TACE

TACE first, followed by anlotinib within day4（+/-1days）

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

First Affiliated Hospital Xi'an Jiaotong University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zheng Wu, PhD

Role: STUDY_CHAIR

First Affiliated Hospital Xi'an Jiaotong University

Locations

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

Countries

China

Other Identifiers

KYLLSL-2019-185

Identifier Type: -

Identifier Source: org_study_id