Clinical trial NCT03945799: A Multicenter Study of Anlotinib in Hepatocellular Carcinoma (HCC) Patients at High Risk of Post Surgery Recurrence
Official title: 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.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Hepatocellular Carcinoma
Lead sponsor: Zhejiang University
Sponsor class: OTHER
Collaborators: name: Shulan (Hangzhou) Hospital
name: West China Hospital
name: Huashan Hospital
name: Third Affiliated Hospital, Sun Yat-Sen University
name: The First Affiliated Hospital of Zhengzhou University
name: The First Hospital of Jilin University
name: Tianjin First Central Hospital
name: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
First posted: 2019-05-10
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Disease free survival
timeFrame: From randomization to recurrence of HCC or death (up to 1year)
Secondary outcomes:
measure: Adverse effect
timeFrame: Up to 1year
measure: Overall survival
timeFrame: 1 year
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The First Affiliated Hospital of Medical School of Zhejiang University
state: Zhejiang
Study officials:
References: