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

A Single Group, Open Label, Multi-center Clinical Study to Assess the Efficacy and Safety of Anlotinib in HCC Patients at High Risk of Post Surgery Recurrence.

To assess the primary effects and safety of Anlotinib in HCC patients at high risk of post surgery recurrence.

Study Overview

• Status: Terminated
• Conditions: Hepatocellular Carcinoma
• Intervention / Treatment: Drug: Anlotinib Hydrochloride

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 Type: Interventional
• Enrollment (Actual): 28
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310003
      • The First Affiliated Hospital of Medical School of Zhejiang University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Anlotinib; Administration Anlotinib and it should be continued until relapse of HCC or intolerable toxicity or patients withdrawal of consent.	Drug: Anlotinib Hydrochloride; Anlotinib: 12mg QD PO d1-14, 21 days per cycle, 8 cycles.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease free survival	The period from resection surgery to recurrence of HCC	From randomization to recurrence of HCC or death (up to 1year)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	The survival rate in a year	1 year
Adverse effect	Any adverse effects occur during the use of anlotinib	Up to 1year

Collaborators and Investigators

• Sponsor: Zhejiang University
• Collaborators: Huashan Hospital; West China Hospital; The First Affiliated Hospital of Zhengzhou University; The First Hospital of Jilin University; Third Affiliated Hospital, Sun Yat-Sen University; Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine; Tianjin First Central Hospital; Shulan (Hangzhou) Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 22, 2019
• Primary Completion (Actual): June 25, 2022
• Study Completion (Actual): June 25, 2022

Study Registration Dates

• First Submitted: May 9, 2019
• First Submitted That Met QC Criteria: May 9, 2019
• First Posted (Actual): May 10, 2019

Study Record Updates

• Last Update Posted (Actual): August 31, 2022
• Last Update Submitted That Met QC Criteria: August 25, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Disease Attributes; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms; Carcinoma; Carcinoma, Hepatocellular; Recurrence
• Other Study ID Numbers: KY2019-AHR-ZJU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No