An Open, Single Arm,Multicenter Clinical Trial of Anlotinib Combined With Transcatheter Arterial Chemoembolization for Adjuvant Therapy in Patients With High Risk of Recurrence After Resection of Advanced Hepatocellular Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 30
- 试验地点
- 4
- 主要终点
- Disease free survival
研究概览
简要总结
A single-arm, open-label clinical trial to assess the effects and safety of anlotinib hydrochloride combined with transcatheter arterial chemoembolization (TACE) in hepatocellular carcinoma(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 adopt postoperative TACE combined with anlotinib hydrochloride. At Day4 of TACE,anlotinib 12mg QD PO d1-14, 21 days per cycle until disease progresses or intolerant.
Primary Efficacy Endpoint: Disease free survival (DFS);Secondary Efficacy Endpoints: 1-year DFS Rate and Time to recurrence (TTR)(According to RECIST Version 1.1).Safety will be evaluated by incidence, severity and outcomes of AEs and categorized by severity in accordance with the NCI CTC AE Version 4.0.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Patients participate in the study voluntarily and sign informed consent with good compliance.
- •After hepatectomy, satisfy any of the following recurrence factors was assessed:≥5 cm and < 10 cm of tumor diameter; tumor number≥3; tumor microvascular invasion grade M1; portal vein carcinoma thrombus resection(Ⅰ、Ⅱ).
- •Histological or cytological confirmation of hepatocellular carcinoma, or at least two imaging tests with hepatocellular carcinoma characteristics, or one imaging test with hepatocellular carcinoma characteristics and AFP > 400μg/L.
- •TACE treatment (cTACE only) was completed within 1-2 months after hepatectomy.
- •≥ 18 and ≤ 75 years of age.
- •ECOG performance status of 0-
- •liver function child-Pugh class A or B (≤7 points).
- •Except for hepatectomy, no previous tumor-related treatment was received, and the remaining liver was assessed to have good liver function.
排除标准
- •Patients who have had or are currently complicated with other malignant tumors,or recurrent hepatocellular carcinoma (>10 mm)in baseline data or in TACE.
- •Patients with absolute contraindications to TACE.
- •Patients with HCV infection.
- •Urine protein ≥ ++，and 24-hour urinary protein excretion>1.0 g confirmed.
- •Pregnant or lactating women.
- •Patients with mental illness.
研究组 & 干预措施
Group A
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)
Group A
Administration anlotinib and it should be continued until relapse of HCC or intolerable toxicity or patients withdrawal of consent.
干预措施: TACE (Procedure)
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
- 1-year DFS Rate(From randomization to recurrence of HCC or death (up to 1year))
- Time to recurrence(From randomization to recurrence of HCC(up to 1year))
- Incidence of Treatment-Emergent Adverse Events Safety and Tolerability(Up to 30 day safety follow-up visit)