NCT04227041Unknown1 期
Single-arm, Prospective, Open-label, Exploratory Study of Pyrotinib Combined With Capecitabine for Metastatic HER-2 Positive Colorectal Cancer Patients After at Least Second-line Standard Treatment
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Maximally Tolerated Dose (MTD)
研究概览
简要总结
To evaluate the efficacy and safety of pyrotinib combined with capecitabine in patients with metastatic her-2 positive colorectal cancer after standard treatment.
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 should be histologically diagnosed with metastatic CRC and after receiving at least two standard treatment regimens；
- •Patients with HER2 positive；
- •Metastatic colorectal cancer (stage Ⅳ, T1-4N0-2M1)；
- •Life expectancy is at least 6 months
- •ECOG score 0-1；
- •The functional level of the major organs must meet the following requirements (no blood transfusion within 2 weeks prior to screening, no use of leukocytes or platelets)：
排除标准
- •The histopathological type is mucinous adenocarcinoma or ovarian implant metastasis；
- •Patients who have previously been treated with anti-Her2-targeted drugs；
- •Patients with surgical opportunity or potential for surgical treatment；
- •Patients with a high risk of bleeding or perforation due to a tumor that has apparently invaded adjacent organs (including large vessels) of the colorectal lesion or who have developed fistulas；
- •Patients with any severe and/or uncontrolled disease;
- •Patients with any or present brain metastases；
- •Women who were pregnant or breast-feeding.
研究组 & 干预措施
HER2 positive metastatic colorectal cancer
Experimental
干预措施: Pyrotinib in combination with capecitabine (Drug)
结局指标
主要结局
Maximally Tolerated Dose (MTD)
时间窗: up to 36 months
Evaluation of tumor burden based on RECIST criteria.
Progression-free survival (PFS)
时间窗: up to 36 months
Evaluation of tumor burden based on RECIST criteria.
次要结局
- Duration Of Response (DOR)(up to 36 months)
- Disease Control Rate (DCR)(up to 36 months)
- Incidence of Treatment-Emergent Adverse Events [Safety](up to 36 months)
- Objective Response Rate (ORR)(up to 36 months)
研究者
Nailong Yang
Principal Investigator
The Affiliated Hospital of Qingdao University
研究点 (1)
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