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

Zhejiang University

Status and phase

Terminated

Phase 2

Phase 1

Conditions

Hepatocellular Carcinoma

Treatments

Drug: Anlotinib Hydrochloride

Study type

Interventional

Funder types

Other

Identifiers

NCT03945799

KY2019-AHR-ZJU

Details and patient eligibility

About

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

Full 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.

Enrollment

28 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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