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

NCT ID: NCT03945799

Last Updated: 2022-08-31

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-22
• Study Completion Date: 2022-06-25

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.

Conditions

Hepatocellular Carcinoma

Study Design

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

Study Groups

Anlotinib

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, 8 cycles.

Interventions

Anlotinib Hydrochloride

Anlotinib: 12mg QD PO d1-14, 21 days per cycle, 8 cycles.

Intervention Type: DRUG

Eligibility Criteria

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

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

Sponsors

Shulan (Hangzhou) Hospital

OTHER

Sponsor Role: collaborator

West China Hospital

OTHER

Sponsor Role: collaborator

Huashan Hospital

OTHER

Sponsor Role: collaborator

Third Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role: collaborator

The First Affiliated Hospital of Zhengzhou University

OTHER

Sponsor Role: collaborator

The First Hospital of Jilin University

OTHER

Sponsor Role: collaborator

Tianjin First Central Hospital

OTHER

Sponsor Role: collaborator

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role: collaborator

Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Xiao Xu

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The First Affiliated Hospital of Medical School of Zhejiang University

Hangzhou, Zhejiang, China

Countries

China

Other Identifiers

KY2019-AHR-ZJU

Identifier Type: -

Identifier Source: org_study_id