NCT05350917尚未招募2 期
A Single-arm, Prospective, Open-label Clinical Study of Tislelizumab Combined With DisitamabVedotin and Pyrotinib Maleate in HER2-positive or Mutated Advanced Colorectal Cancer Who Failed Standard Therapy
The First Affiliated Hospital of Zhengzhou University0 个研究点目标入组 20 人开始时间: 2022年6月20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
- 尚未招募
- 发起方
- 入组人数
- 20
- 主要终点
- Objective Response Rate (ORR)
研究概览
简要总结
This study will explore the efficacy and safety of tislelizumab (PD1 inhibitor) combined with DisitamabVedotin (ADC) and pyrotinib maleate (TKI) in the treatment of HER2-positive or mutated advanced colorectal cancer who have failed standard therapy .
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
- 未提供
排除标准
- •Patients who have not received first-line standard therapy;
- •Previous antitumor therapy or radiation therapy for any other malignant tumor;
- •concurrently receiving anti-tumor therapy in other clinical trials, including endocrine therapy, bisphosphonate therapy, and immunotherapy;
- •Has undergone major surgical procedures not related to colorectal cancer within 4 weeks prior to enrollment, or the patient has not fully recovered from such surgical procedures;
- •Serious heart disease or discomfort, including but not limited to the following:
- •Diagnosed history of heart failure or systolic dysfunction (LVEF < 50%)
- •High-risk uncontrolled arrhythmias, such as atrial tachycardia, resting heart rate >100 bpm, significant ventricular arrhythmia (eg, ventricular tachycardia), or higher-grade AV block (ie, Mobitz II second-degree AV block or third-degree AV block)
- •Angina pectoris requiring antianginal drug treatment
- •Clinically significant heart valve disease
- •ECG showing transmural myocardial infarction
- •Poorly controlled hypertension (systolic blood pressure > 180 mmHg and/or diastolic blood pressure > 100 mmHg)
- •Inability to swallow, bowel obstruction, or other factors that interfere with drug taking and absorption;
- •Known history of allergy to the drug components of this regimen; history of immunodeficiency, including HIV positive test, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation;
- •Pregnant or lactating female patients, female patients of childbearing potential with a positive baseline pregnancy test, or patients of childbearing age who are unwilling to take effective contraceptive measures throughout the trial period and within 7 months after the last study drug;
- •have serious comorbidities or other comorbidities that would interfere with planned treatment, orAny other conditions for which the patient was deemed unsuitable for participation in this study by the investigator.
研究组 & 干预措施
Tislelizumab Combined With DisitamabVedotin and Pyrotinib Maleate
Experimental
One arm study
干预措施: Tislelizumab (Drug)
结局指标
主要结局
Objective Response Rate (ORR)
时间窗: Up to 24 months
It is defined as the number of subjects with the best response effect as complete remission (CR) or partial remission (PR) during the period from the start of the subjects receiving the treatment regimen of this study to the progression of the subjects' disease in the total number of subjects in the analysis data set. percentage of the population（%）.
次要结局
- Disease Control Rate (DCR)(Up to 24 months)
- Progression Free Survival (PFS)(Up to 24 months)
- Overall survival (OS)(Up to 24 months)
- Drug-Related Safety Indicators(Up to 24 months)
- Study on the mechanism of drug resistance after progression(Up to 24 months)
研究者
Hong Zong
Department of Oncology, The First Affiliated Hospital of Zhengzhou University
The First Affiliated Hospital of Zhengzhou University
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