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

Phase 2

Active, not recruiting

• Conditions: Hepatocellular Carcinoma; TACE; Anlotinib
• Interventions: Drug: Anlotinib Hydrochloride; Procedure: TACE

• Registration Number: NCT04213118
• Lead Sponsor: First Affiliated Hospital Xi'an Jiaotong University

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.

Study Timeline

• Study First Submitted: 2019-12-25
• Study First Submitted QC: 2019-12-25
• Study First Posted: 2019-12-30
• Study Start: 2020-04-23
• Status Verified: 2022-11
• Last Update Submitted: 2023-01-12
• Last Update Posted: 2023-01-17
• Primary Completion: 2023-02
• Study Completion: 2023-09

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Group A	Anlotinib Hydrochloride	Administration anlotinib and it should be continued until relapse of HCC or intolerable toxicity or patients withdrawal of consent.
Group A	TACE	Administration anlotinib and it should be continued until relapse of HCC or intolerable toxicity or patients withdrawal of consent.

Primary Outcome Measures

Name	Time	Method
Disease free survival	From randomization to recurrence of HCC or death (up to 1year)	The period from resection surgery to recurrence of HCC

Secondary Outcome Measures

Name	Time	Method
1-year DFS Rate	From randomization to recurrence of HCC or death (up to 1year)	One year ratio of DFS
Time to recurrence	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	Up to 30 day safety follow-up visit	Any adverse effects occur during the use of anlotinib

Trial Locations

Locations (4)

The First Hospital of Lanzhou University; 🇨🇳 Lanzhou, Gansu, China

Tangdu Hospital of The Fourth Military Medical University; 🇨🇳 Xi'an, Shaanxi, China

Hanzhong Central Hospital; 🇨🇳 Hanzhong, Shaanxi, China

The First Affiliated Hospital of Xi'an Jiaotong University; 🇨🇳 Xi'an, Shaanxi, China