NCT01985958已完成不适用
A Pilot Study to Evaluate Radiotherapy-Induced Ant-Tumor Immunity in Metastatic Carcinoma of the Pancreas
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Number of Participants With Adverse Events
研究概览
简要总结
Primary Objective: To estimate the rate at which radiotherapy to the primary or a metastatic lesion produces an immune response in patients with metastatic carcinoma of the pancreas.
Secondary Objectives: To characterize the kinetics of an immune response induced by radiotherapy. To characterize the dependency of the immune response on prior exposure to chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
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
- •Histological or cytological diagnosis of pancreatic carcinoma
- •Patients ≥ 18 years of age
- •Eastern Cooperative Oncology Group (ECOG) performance status 0,1,or 2
- •Patients must have distant metastatic disease (stage 4)
- •Satisfactory organ and bone marrow function as defined by: Absolute neutrophil count> 1,000/uL, Platelets > 75,000uL Hemoglobin > 9 Bilirubin ≤ 2.0x the institutional normal upper limit unless secondary to bile duct obstruction by tumor,
- •Creatinine ≤ 1.5x the institutional normal upper limit
- •Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 5x the institutional normal upper limit.
- •A clinical recommendation for radiotherapy to the primary or a metastatic lesion had been made.
- •Must be able to provide informed consent.
排除标准
- •No prior radiation to the area planned for radiotherapy
- •Active invasive cancer other than pancreatic adenocarcinoma. Non-melanoma skin cancer, superficial cervical or bladder cancer and prostate cancer with PSA level < 1.0 are not excluded.
- •Known HIV, HCV and/or HBV positive (by patient report/medical record)
- •Patients with ongoing or active infection
- •Planned concurrent treatment with systemic high dose corticosteroids.
- •Received an anticancer treatment (systemic therapy or radiation therapy)within 21 days prior to enrollment.
- •Immunotherapy (e.g. monoclonal antibodies)within 21 days prior to enrollment.
- •Immunosuppressive therapies (e.g. steroids, cyclosporine) are not permitted.
结局指标
主要结局
Number of Participants With Adverse Events
时间窗: One Year
次要结局
未报告次要终点
研究者
研究点 (2)
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