NCT05751343招募中2 期
Atezolizumab Plus Bevacizumab Plus Transarterial Chemoembolization and Hepatic Artery Infusion Chemotherapy for Unresectable Advanced Hepatocellular Carcinoma: a Single-arm Phase 2 Clinical Trial
Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2023年3月9日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Objective response rate
研究概览
简要总结
Atezolizumab and bevacizumab was approve for advanced unresectable hepatocellular carcinoma (aHCC). Whether the additional of transartial chemobolization and hepatic artery infusion chemotherapy will improve the response rate for those patients is still unknown. This phase 2 clinical trial aims to investigate the objective response rate for unresectable advanced hepatocellular carcinoma.
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
- •(a) patients were diagnozied with unresectable advanced-stage HCC,
- •(b) Child-Pugh A or B liver function;
- •(d) Eastern Cooperative Oncology Group (ECOG) performance status 0-1;
- •(e) adequate hematologic blood counts (white blood cell count >3ⅹ109/L, absolute neutrophil count >1.5ⅹ109/L, platelet count >10ⅹ109/L, hemoglobin concentration >85 g/L);
排除标准
- •(a) severe underlying cardiac, pulmonary, or renal diseases;
- •(b) history of a second primary malignant tumor;
- •(c) contraindication to either atezolizumab and bevacizumab.
研究组 & 干预措施
TACE-HAIC plus atezolizumab-bevacizumab
Experimental
transartery chemoembolization and hepatic artery infusion of FOLFOX, simultaneously followed by intravenous of 1200mg atezolizumab plus bevacizumab (15mg/kg)
干预措施: TACE-HACI, plus atezolizumab-bevacizumab (Drug)
结局指标
主要结局
Objective response rate
时间窗: 12 months
objective response rate based on RECIST 1.1
次要结局
- objective response rate based mRECIST(12 months)
- progress-free survival(12 months)
- overall survival(12 months)
- adverse event(12 months)
研究者
Yunfei Yuan
Professor
Sun Yat-sen University
研究点 (1)
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