Establishment of a Predictive Model for Immunotherapy Response in Pancreatic Cancer
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Objective Best Tumor Response
研究概览
简要总结
This project aims to establish a single-center, prospective, observational clinical cohort for pancreatic cancer immunotherapy. It plans to enroll 100 patients with advanced pancreatic cancer, collecting tumor tissue sections, plasma, serum, and fecal samples. Through multi-omics analysis including proteomics, metabolomics, and microbiomics, the project will develop predictive models for immunotherapy response.
详细描述
Primary Objective: Establish a cohort for immunotherapy combined with chemotherapy in advanced pancreatic cancer, ultimately developing predictive models for immunotherapy response based on proteomics, metabolomics, and microbiome data.
Secondary Objectives: Map the clinical and genomic/metabolomic/microbiome profiles of patients with advanced pancreatic ductal adenocarcinoma, evaluate the therapeutic efficacy of immunotherapy combined with chemotherapy, and explore potential biomarkers for predicting immunotherapy response.
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 or older;
- •Histologically or cytologically confirmed locally advanced or metastatic pancreatic ductal adenocarcinoma that is unresectable;
- •No prior systemic anticancer therapy;
- •At least one measurable lesion confirmed according to RECIST 1.1 criteria;
- •Receiving first-line treatment with an immunotherapy combined with chemotherapy regimen;
- •Signed informed consent.
排除标准
- •Active malignancy other than pancreatic cancer within the past 5 years or concurrently;
- •Prior receipt of immunotherapy or anti-angiogenic therapy.
结局指标
主要结局
Objective Best Tumor Response
时间窗: 12 months
Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria.
Overall Survival
时间窗: 60 months
Overall survival is the duration from diagnosis to death. For patients who are alive, overall survival is censored at the last contact.
次要结局
- Progression-free Survival(36 months)
研究者
Ying Jieer
Principal Investigator
Zhejiang Cancer Hospital