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

Hepatocellular Carcinoma Clinical Trial

— ALTER-H-004  

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 Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04213118
• Other study ID #: KYLLSL-2019-185
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: April 23, 2020
• Est. completion date: September 2023

Study information

• Verified date: November 2022
• Source: First Affiliated Hospital Xi'an Jiaotong University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: September 2023
• Est. primary completion date: February 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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(???).

• 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.

Related Conditions & MeSH terms

• Anlotinib
• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma
• Recurrence
• TACE

Intervention

Drug:
• Anlotinib Hydrochloride
Anlotinib 12mg QD PO d1-14, 21 days per cycle.

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

Locations

Country	Name	City	State
China	Hanzhong Central Hospital	Hanzhong	Shaanxi
China	The First Hospital of Lanzhou University	Lanzhou	Gansu
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

Sponsors (2)

Lead Sponsor	Collaborator
First Affiliated Hospital Xi'an Jiaotong University	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease free survival	The period from resection surgery to recurrence of HCC	From randomization to recurrence of HCC or death (up to 1year)
Secondary	1-year DFS Rate	One year ratio of DFS	From randomization to recurrence of HCC or death (up to 1year)
Secondary	Time to recurrence	The period from resection surgery to recurrence of HCC	From randomization to recurrence of HCC(up to 1year)
Secondary	Incidence of Treatment-Emergent Adverse Events Safety and Tolerability	Any adverse effects occur during the use of anlotinib	Up to 30 day safety follow-up visit