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.
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Disease free survival
研究概览
简要总结
To assess the primary effects and safety of Anlotinib in HCC patients at high risk of post surgery recurrence.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Anlotinib
Administration Anlotinib and it should be continued until relapse of HCC or intolerable toxicity or patients withdrawal of consent.
干预措施: Anlotinib Hydrochloride (Drug)
结局指标
主要结局
Disease free survival
时间窗: From randomization to recurrence of HCC or death (up to 1year)
The period from resection surgery to recurrence of HCC
次要结局
- Overall survival(1 year)
- Adverse effect(Up to 1year)
研究者
Xiao Xu
Clinical Professor
Zhejiang University