NCT07665697尚未招募不适用
Analysis of Efficacy and Outcomes of Immunotherapy for Malignant Tumors: A Prospective Non-interventional Clinical Study
Sichuan University1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2026年6月30日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 500
- 试验地点
- 1
研究概览
简要总结
The population receiving immunotherapy is heterogeneous. Multiple factors, including combination treatment modalities, influence the immune response, and survival outcomes also vary among individuals receiving immunotherapy. The aim of this study is to develop and validate a clinical prediction model that can predict survival outcomes of immunotherapy for malignant tumors, and to assess the calibration and discrimination of this model in a prospective independent cohort.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years;
- •Histologically or cytologically confirmed malignant tumor;
- •Planned to receive immune checkpoint inhibitor (e.g., PD-1/PD-L1 inhibitor)-based therapy (monotherapy or in combination with chemotherapy/targeted therapy/radiotherapy, etc.);
- •At least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST 1.1);
- •Adequate organ function (with reference to laboratory tests such as complete blood count, liver and kidney function tests);
- •Voluntary participation in this study, signed informed consent, and willingness to comply with follow-up.
排除标准
- •Active autoimmune disease requiring systemic immunosuppressive therapy (physiological doses of glucocorticoid replacement therapy or inhaled steroids are permitted);
- •Active, uncontrolled severe infection, or known human immunodeficiency virus (HIV) infection;
- •Pregnant or breastfeeding women;
- •Any unstable systemic disease (including but not limited to severe cardiac, hepatic, or renal insufficiency).
研究者
You Lu
MD. PhD
Sichuan University
研究点 (1)
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