Prospective Observational Study on Prediction of Response to First-line Immunotherapy in Patients With Biliary Tract Tumors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Identifying predictive biomarkers of immunotherapy response
研究概览
简要总结
A prospective, observational study to explore multidimensional biomarkers for predicting the efficacy of immunotherapy In biliary tract tumors
详细描述
Patient with unresectable advanced or metastatic biliary tract tumors will be enrolled and plan to receive PD-1/PD-L1 inhibitors combined with chemotherapy as first-line treatment. To explore the biomarkers, tumor tissues, acquired from puncture biopsies at baseline, will be collected and investigated by genomic panel sequencing , transcriptome sequencing, and mIHC. Meanwhile, baseline peripheral blood and feces were also collected for detection of plasma proteins, genomes, and metagenomes. Finally, the investigators will analysis and explore predictive biomarkers of immunotherapy in biliary tract tumors.
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
- •Over 18 years old;
- •Imaging evaluation indicates unresectable advanced or metastatic biliary tract tumors (including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder carcinoma);
- •Confirmed as adenocarcinoma by histology;
- •Has not received systemic therapy in the past (patients who have not progressed within six months after the completion of neoadjuvant therapy or adjuvant therapy can be enrolled);
- •At least one measurable lesion according to RECIST 1.1 standard;
- •Plan to receive PD-1/PD-L1 inhibitors combined with chemotherapy as first-line treatment;
- •Sign informed consent, has good compliance and can cooperate with follow-up.
排除标准
- •Suffering from other active malignant tumors within 5 years or simultaneously; Unable to collect baseline plasma or tissue samples.
结局指标
主要结局
Identifying predictive biomarkers of immunotherapy response
时间窗: 1 year
ldentifying predictive biomarkers of immunotherapy response by detecting differences in genome and transcriptome sequencing between responder and non-responder patients
次要结局
未报告次要终点
研究者
Ying Jieer
Principal Investigator
Zhejiang Cancer Hospital