The Immune Assessment of PD-1 Antibody Therapy in Tumor - A Case-Control Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 3,000
- 试验地点
- 1
- 主要终点
- Objective response rate
研究概览
简要总结
This retrospective study will leverage previous immune function monitoring results in conjunction with clinical case data at this medical center.
详细描述
The primary aim of this study is to evaluate the efficacy and safety of PD(L)-1 antibody therapy for malignant tumors in real-world settings. Treatment outcomes will be assessed according to RECIST V1.1 and iRECIST criteria, with safety graded according to CTCAE V5.0 standards. The study aims to enroll 3000 adult cancer patients treated at this center and analyze their prognosis outcomes based on previous treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
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
- •Age ≥18 years.
- •Pathologically confirmed malignant tumors.
- •Complete medical records.
- •Assessable immune function test data.
排除标准
- •Age <18 years.
- •No confirmed tumor pathology.
- •Untraceable medical records.
- •Non-assessable immune function tests.
研究组 & 干预措施
Experimental group
PD-1 inhibitor combined therapy, 200mg, iv, q3w, 1 year for adjuvant therapy or 2 years for advanced therapy
干预措施: PD-1 Inhibitors (Drug)
Control group
PD-1 inhibitor mono-therapy, 200mg, iv, q3w, 1 year for adjuvant therapy or 2 years for advanced therapy
干预措施: PD-1 Inhibitors (Drug)
结局指标
主要结局
Objective response rate
时间窗: 6 months
The objective response rate at 6 months
Adverse events
时间窗: 1 year
Number of participants who experienced immune-related adverse events at 1 year according to CTCAE 5.0
次要结局
- Overall survival(1 year)
研究者
Quanli Gao
Chief of Immunotherapy department
Henan Cancer Hospital