A Multicenter Study of Anlotinib in Hepatocellular Carcinoma (HCC) Patients at High Risk of Post Surgery Recurrence

Phase 1

Terminated

• Conditions: Hepatocellular Carcinoma
• Interventions: Drug: Anlotinib Hydrochloride

• Registration Number: NCT03945799
• Lead Sponsor: Zhejiang University

Brief Summary

To assess the primary effects and safety of Anlotinib in 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 be administrated Anlotinib 12mg QD PO d1-14, 21 days per cycle. The disease free survival (DFS), overall survival (OS) and any adverse effect during the 8 cycles of Anlotinib treatment will be evaluated in order to assess the primary effects and safety of Anlotinib in HCC patients at high risk of post surgery recurrence.

Study Timeline

• Study Start: 2019-04-22
• Study First Submitted: 2019-05-09
• Study First Submitted QC: 2019-05-09
• Study First Posted: 2019-05-10
• Primary Completion: 2022-06-25
• Study Completion: 2022-06-25
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-25
• Last Update Posted: 2022-08-31

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

• No allergic history of Anlotinib
• 18-75 years
• No history of severe arrhythmia or heart failure
• No history of severe ventilation dysfunction or severe pulmonary infection
• No acute or chronic renal failure, creatinine clearance > 40 mL/min
• Liver function is normal: child-pugh grade A or grade B (≤7 points), total bilirubin ≤ 3.0 mg/dL, albumin ≥ 28 g/L, AST, ALT, ALP≤ 5 times of the upper limit of normal value
• Blood test: the absolute neutrophil count ≥ 1.5×10^9 /L, Hb ≥ 8.5 g/L, PLT ≥ 75×10^9 /L (without blood transfusions and drug therapy 14 days before the screening)
• Blood coagulation function: INR≤2.3
• ECOG: 0-2
• Pathology: hepatocellular carcinoma
• Satisfy any of the following:

A. portal vein, hepatic vein or bile duct carcinoma thrombus B. microvascular invasion (MVI) grade II (> 5 MVI, or MVI occurs in the area more than 1 cm from the tumor) C. tumor number ≥ 3 D. preoperative rupture of tumor or tumor invasion adjacent organs

• Patients participate in the study voluntarily and sign informed consent

Exclusion Criteria

• Pregnant or lactating women
• Patients who have had or are currently complicated with other malignant tumors
• Recurrent hepatocellular carcinoma
• Patients who participated in other clinical trials within 1 month
• Patients with mental illness
• Patients treated with targeted drugs, immunotherapy (such as PD1 antibody), FOLFOX systemic chemotherapy or huaier granules after surgery
• Urine protein ≥ ++，and 24-hour urinary protein excretion>1.0 g confirmed

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Anlotinib	Anlotinib Hydrochloride	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
Overall survival	1 year	The survival rate in a year
Adverse effect	Up to 1year	Any adverse effects occur during the use of anlotinib

Trial Locations

Locations (1)

The First Affiliated Hospital of Medical School of Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China