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

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

Detailed Description
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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.

Official Title
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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.

Conditions
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Hepatocellular Carcinoma

Intervention / Treatment
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* Drug: Anlotinib Hydrochloride


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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 |
| --- | --- | --- |
| Adverse effect | Any adverse effects occur during the use of anlotinib | Up to 1year | 
| Overall survival | The survival rate in a year | 1 year |