A Prospective, Exploratory Study Evaluating the Effectiveness of Treatment Regimens for Locally Advanced/Metastatic Non-resectable Pancreatic Neuroendocrine Tumor (PNET) Guided by in Vitro Drug Sensitivity Testing of Tumor Organoids
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Objective Response Rate
研究概览
简要总结
The purpose of this study is to explore whether chemotherapy and targeted-therapy regimens guided by organoid drug sensitivity test can improve the outcomes of non-resectable locally advanced and metastatic Pancreatic neuroendocrine tumors. At the same time, this study will evaluate the successful stablishment rate of organoid from biopsy tissue , and explore the concordance between drug sensitivity test results and patients' treatment response
详细描述
Twenty non-resectable locally advanced and metastatic pancreatic neuroendocrine Tumor(p-NET) patients who should receive palliative treatment will be enrolled in this study. Baseline information of the enrolled patients including medical history, physical examination records and clinical examination records will be collected. Tumor material of those patients will be obtained from Pancreatic endoscopic biopsies or surgical resection. Patient-derived organoids (PDOs) will be established and cultured from p-NET tumor specimens. PDOs will then be treated with drugs of the chemotherapeutic and targeted therapeutic regimens for p-NET. Organoid size and growth will be monitored before and after the treatment, and dose-response curves will be generated. As for the assessment of clinical outcomes of patients, treatment responses will be assessed by biomedical imaging according to the Response Evaluation Criteria in Solid Tumors (RECIST1.1). Consistency between treatment responses in PDO models and clinical outcomes of patients will be assessed by correlation analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 and ≤ 75 years old.
- •Histologically or cytologically confirmed locally advanced/metastatic Pancreatic Neuroendocrine Tumor
- •Surgery was considered impossible or can not receive the radical purpose.
- •Able to provide fresh tumor tissue specimens for organoid culture, including: tumor biopsy tissues, tumor surgical specimens, etcy.
- •Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0-
- •Expected survival time≥ six months.
- •Patient have been informed and consented, compliance and geographic proximity to ensure adequate follow-up
排除标准
- •Other malignancies in the past 5 years, excluding cured basal cell carcinoma of the skin.
- •History of severe cardiovascular events and myocardial Infarction within twelve months before the study.
- •Patients with psychiatric disorders or with psychotropic substance abuse and inability to abstain.
- •Pregnant or breastfeeding women.
- •According to researcher's consideration, patients with other serious systemic diseases or other conditions that are not suitable for participation.
结局指标
主要结局
Objective Response Rate
时间窗: 1-2 years
Percentage of patient's measurable disease who have achieved either complete response (CR) or partial response (PR) according to RECIST 1.1.
次要结局
- The successful establishment rate of organoids(1-2 years)
- Concordance between drug sensitivity test results and patients' treatment response(1-2 years)
- Overall survival time(2 years)
- Progressive free survival(1-2 years)
研究者
JIABIN JIN
Associate Chief Physician, Pancreatic Disease Center
Ruijin Hospital