NCT06280508招募中2 期
A Prospective, Single-arm Exploratory Trail of Chemotherapy Combined With Adebrelimab and Apatinib as the Perioperative Treatment in Patients With Biliary Tract Cancer
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年3月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- 1-year EFS rate
研究概览
简要总结
This is a prospective, single-arm exploratory study to evaluate the efficacy and safety of chemotherapy combined with Adebrelimab and Apatinib as the perioperative treatment in Patients With Biliary Tract Cancer.
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
- •confirmed intrahepatic cholangiocarcinoma
- •with Resectable tumor lesion
- •no contraindications to surgery
- •with high risk of tumour recurrence
- •No prior systemic therapy for intrahepatic cholangiocarcinoma.
- •ECOG Performance Status of 0 or 1
- •Child-Pugh Class: Grade A
排除标准
- •History of gastrointestinal hemorrhage within 6 months prior to the start of study treatment or clear tendency of gastrointestinal hemorrhage
- •Abdominal fistula, gastrointestinal perforation or intraperitoneal abscess within 6 months prior to the start of study treatment
- •Known genetic or acquired hemorrhage or thrombotic tendency
- •Thrombosis or thromboembolic event within 6 months prior to the start of study treatment
- •Cardiac clinical symptom or disease that is not well controlled
- •Hypertension that can not be well controlled through antihypertensive drugs
研究组 & 干预措施
treatment arm
Experimental
干预措施: Adebrelimab, Apatinib, Gemcitabine, cisplatin (Drug)
结局指标
主要结局
1-year EFS rate
时间窗: Up to approximately 3 years
1-year event-free survival rate
次要结局
- R0 Resection rate(Up to approximately 3 years)
- EFS(Up to approximately 3 years)
- RFS(Up to approximately 3 years)
- OS(Up to approximately 3 years)
研究者
研究点 (1)
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