A Single-center, Single-arm Study of Avatrombopag for Patients With Hepatocellular Carcinoma and Thrombocytopenia Who Intend to Undergo Transarterial Chemoembolization and/or Hepatic Arterial Infusion Chemotherapy
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Proportion of patients with PLT >75×10^9/L or doubling from baseline
研究概览
简要总结
This study is conducted to evaluate the efficacy of avatrombopag for thrombocytopenia in patients with hepatocellular carcinoma (HCC) who intend to undergo transarterial chemoembolization (TACE) and/or hepatic arterial infusion chemotherapy (HAIC).
详细描述
This is a single-center, prospective study to evaluate the efficacy of avatrombopag for thrombocytopenia in HCC patients who intend to undergo TACE and/or HAIC.
30 HCC patients with thrombocytopenia will be enrolled in this study. Avatrombopag (platelet count [PLT] <40×10^9/L, 60mg P.O. QD; PLT of 40-75×10^9/L, 40mg P.O. QD) will be administered to the patients and last 5-10 days. When the PLT reaches ≥100×10^9/L, the treatment will be discontinued.
The primary end point of this study is the proportion of patients with PLT >75×10^9/L or doubling from baseline. The secondary endpoints are the proportion of patients with PLT >75×10^9/L, the proportion of patients with PLT doubling from baseline, the increace in PLT, the proportion of patients who successfully receive TACE/HAIC, .adverse events.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HCC with diagnosis confirmed pathologically or clinically
- •Patients who need to receive TACE and/or HAIC, or have plans to undergo another treatment (3-6 weeks after the previous treatment)
- •Child Pugh class A or B
- •ECOG PS 0-2
- •PLT ≤ 75×10^9/L (10 days before interventional therapy)
排除标准
- •Thrombocytopenia caused by hematological diseases, non chemotherapy related thrombocytopenia (excluding liver cirrhosis with hypersplenism)
- •PLT <30×10^9/L
- •History of hepatic encephalopathy, refractory ascites, or hepatorenal syndrome
- •History of arterial or venous thrombosis within 6 months
- •Uncontrolled severe infections
- •Pregnant or breastfeeding female patients
- •Immune deficiencies, such as autoimmune diseases, HIV infected individuals, etc
- •Anticoagulation or antiplatelet therapy witch cannot be suspended during the treatment period: heparin, warfarin, rivaroxaban, dipyridamole, non-steroidal anti-inflammatory drugs, aspirin, verapamil, Ticlopidine, clopidogrel, glycoprotein IIb/IIIa antagonists, erythropoietin, etc;
- •Administration of blood products within 7 days prior to the baseline visit (excluding albumin infusion)
- •Allergy to avatrombopag or any of its formulations
- •History (such as gastrointestinal bleeding within 3 months, high risk of thrombosis, such as portal vein main flow velocity<10cm/s) which may affect the safety of the patients or their ability to complete the study
研究组 & 干预措施
Avatrombopag
Patients receive avatrombopag treatment 5-10 days.
干预措施: Avatrombopag (Drug)
结局指标
主要结局
Proportion of patients with PLT >75×10^9/L or doubling from baseline
时间窗: 1 year
The proportion of patients with PLT \>75×10\^9/L or doubling from baseline
次要结局
- Proportion of patients with PLT doubling from baseline(1 year)
- Increace in PLT(1 year)
- Proportion of patients who successfully receive TACE/HAIC(1 year)
- Proportion of patients with PLT >75×10^9/L(1 year)
- Adverse events (AEs)(1 year)