Clinical Study of Irinotecan,Oxaliplatin, and S1 in Patients With Advanced Pancreatic Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- The overall survival in this population of patients.
研究概览
简要总结
To identify the efficiency of Irinotecan, Oxaliplatin, and S1 in patients with previously untreated local regional or metastatic pancreatic cancer.
详细描述
This research study is a Phase 2 clinical trial. It will test the efficiency and safety of an investigational drug f Irinotecan,Oxaliplatin, and S1, with the goal of determining the OS of advanced pancreatic adenocarcinoma..
Subjects must have a newly diagnosed stage 4 untreated metastatic pancreatic ductal cancer and meet all inclusion/exclusion criteria.
Treatment consists of treatment with Irinotecan 165mg/m2, Oxaliplatin 85mg/m2 on day 1, and S1 40mg orally on day 1-14, every 21 days each cycle. Treatment will be administered until untolerable toxicities or progression or subject death, or either the subject or sponsor discontinues the study.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Cytologically- or histologically-confirmed pancreatic adenocarcinoma or poorly differentiated pancreatic carcinoma that is metastatic to distant sites.
- •Other histologies such as neuroendocrine and acinar cell carcinoma are excluded.
- •No prior chemotherapy for locally advanced or metastatic pancreatic cancer.
- •Patients are eligible if they received adjuvant treatment after surgical resection
- •Participants are required to have measurable disease (RECIST v1.1), defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as > 20 mm with conventional techniques or as > 10 mm with spiral CT scan. See section 11 for the evaluation of measurable disease.
- •Participants enrolled must have disease that is accessible for tumor biopsies and must agree to a pre-treatment tumor biopsy.
- •Age ≥ 18 years. Because no dosing or adverse event data are currently available in participants <18 years of age, children are excluded from this study but will be eligible for future pediatric trials.
- •ECOG performance status ≤2 (see Appendix A)
- •Patients must have completed any major surgery or open biopsy ≥4 weeks from start of treatment.
- •Participants must have adequate organ and marrow function as defined below:
- •Absolute neutrophil count ≥1,500/mcL
- •Platelets ≥100,000/mcL
- •Total bilirubin ≤1.5 × institutional upper limit of normal
- •AST(SGOT)/ALT(SGPT) ≤2.5 × institutional upper limit of normal
- •Creatinine ≤1.5 × institutional upper limit of normal OR
- •Creatinine clearance ≥60 mL/min/1.73 m2 for participants with creatinine levels above 1.5 × upper limit of normal.
- •Negative serum pregnancy test for women of childbearing potential.
- •Ability to understand and the willingness to sign a written informed consent document
排除标准
- •• Prior chemotherapy or any other investigational agents for the treatment of locally advanced or metastatic pancreatic cancer
- •Concurrent use of any other anti-cancer therapy, including chemotherapy, targeted therapy, immunotherapy, or biological agents.
- •Participants with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. Screening for brain metastases with head imaging is not required.
- •History of allergic reactions attributed to compounds of similar chemical or biologic composition to above drugs or other agents used in study.
- •History of prior or current synchronous malignancy, except:
- •o Malignancy that was treated with curative intent and for which there has been no known active disease for >3 years prior to enrollment
- •Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, NYHA class III/IV congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
研究组 & 干预措施
experimental arm
Treatment consists of treatment with Irinotecan 165mg/m2, Oxaliplatin 85mg/m2 on day 1, and S1 40mg orally on day 1-14, every 21 days each cycle. Treatment will be administered until untolerable toxicities or progression or subject death, or either the subject or sponsor discontinues the study.
干预措施: Irinotecan,Oxaliplatin, and S1 (Drug)
结局指标
主要结局
The overall survival in this population of patients.
时间窗: Time Frame: 2 years
The overall survival of the enrolled patients from start the combination treatment of Irinotecan, Oxaliplatin, and S1.
次要结局
- The progression free survival in this population of patients.(Time Frame: 2 years)
- The toxicities in this population patients(Time Frame: 2 years)
- The response rate in this population of patients.(Time Frame: 2 years)