NCT05593419招募中不适用
Selecting Patients Who May Benefit From Immunotherapy by Tissue-based Biomarkers
Peking University1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2022年10月31日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- TIIC signature
研究概览
简要总结
We have established a machine learning model based on effective TIIC signature which could select GC patients who may benefit from immunotherapy.
The current study aims to enroll 300 GC patients as a validation cohort to vertify the accuracy of TIIC signature in predicting immunotherapy efficacy
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Having signed informed consent
- •Age:18-80 years old
- •Histologically confirmed gastric adenocarcinoma
- •Unresectable recurrent or metastatic gastric cancer
- •Previous neo-adjuvant or adjuvant treatment for gastric cancer, if applicable, more than 6 months
- •Measurable disease according to the RECIST criteria
- •Karnofsky performance status ≥70
- •Life expectancy of ≥3 month
- •No prior radiotherapy except radiotherapy at non-target lesion of the study more than 4 weeks
- •ALT and AST<2.5 times ULN (≤5 times ULN in patients with liver metastases)
- •Serum albumin level ≥3.0g/dL
- •Serum AKP < 2.5 times ULN
- •Serum creatinine <ULN, and CCr < 60ml/min
- •Bilirubin level < 1.5 ULN
- •WBC>3,000/mm3, absolute neutrophil count ≥2000/mm3, platelet>100,000/mm3, Hb>9g/dl
排除标准
- •Previous systemic therapy for metastatic gastric cancer
- •Surgery (excluding diagnostic biopsy) within 4 weeks prior to study entry Contraindications of nuclear magnetic resonance image such as fitment of cardiac pacemaker , nerve stimulator, or aneurysm clip, and metallic foreign body in eye ball and so on.
- •Allergic constitution or allergic history to protium biologic product or any investigating agents.
- •Severe heart disease or such history as recorded congestive heart failure, uncontrolled cardiac arrhythmia, angina pectoris needing medication, cardiac valve disease, severe abnormal ECG findings, cardiac infarction , or retractable hypertension.
- •Pregnancy or lactation period
- •Other previous malignancy within 5 year, except non-melanoma skin cancer
- •Legal incapacity
结局指标
主要结局
TIIC signature
时间窗: Treatment baseline
Density and spatial proximity of 4 kinds of immune cells involved in TIIC signature infiltrate in tumor at treatment baseline will be recorded.
次要结局
未报告次要终点
研究者
Shen Lin
Professor
Peking University
研究点 (1)
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