An Open Label Phase 2 Trial to Evaluate the Safety, Tolerability, and Efficacy of Low Dose G-FLIP in Combination With Mitomycin C in Patients With Stage IV Pancreatic Cancer Who Have Failed First-Line Treatment
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Response Rate
研究概览
简要总结
The study focuses on advanced metastatic pancreatic cancer, testing a combination of low-dose anti-cancer drugs (G-FLIP: Gemcitabine, Fluorouracil, Leucovorin, Irinotecan, and Oxaliplatin) with the addition of Mitomycin C. The aim is to find a safer and more effective therapy for this devastating disease.
详细描述
Objective
Evaluate the safety, tolerability, and efficacy of G-FLIP combined with Mitomycin C for advanced pancreatic cancer.
Design: Open-label study with 60 evaluable subjects. Treatments: G-FLIP administered every 2 weeks, with Mitomycin administered every 4 weeks.
Efficacy Assessments: Based on response criteria (Complete Response, Partial Response, Stable Disease, Progressive Disease), Response Rate, Progression-Free-Survival, Overall Survival, and 12-Month Survival Rate.
Safety Assessments: Include physical exams, symptom evaluation, vital signs, ECOG performance status, clinical pathology, urinalysis, and Quality of Life assessments.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed metastatic (Stage IV) pancreatic adenocarcinoma.
- •Failed first-line chemotherapy.
- •ECOG performance status of 0-
- •Expected survival of more than 3 months.
- •Adequate organ function as indicated by lab values.
- •Age 18 or older.
- •Signed informed consent.
排除标准
- •• Known brain metastases.
- •Significant cardiovascular or other uncontrolled diseases.
- •Pregnant or breastfeeding women
研究组 & 干预措施
G-GLIP plus Mitomycin C
G-FLIP: Gemcitabine, Fluorouracil, Leucovorin, Irinotecan, and Oxaliplatin every 2 weeks plus Mitomycin C every 4 weeks
干预措施: G-GLIP plus Mitomycin C (Drug)
结局指标
主要结局
Response Rate
时间窗: Baseline, 3 months, 6 months, 1 year, and then annually up to 5 years.
This measure assesses the rate of disease progression or worsening, as determined by changes in tumor size and appearance on radiological scans. The evaluation is conducted using the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines, which provide a standardized method for measuring tumor size and categorizing response to treatment."
Overall Survival
时间窗: Baseline, 3 months, 6 months, 1 year, and then annually up to 5 years.
This measure assesses the duration of time from the start of the study until death from any cause.
次要结局
未报告次要终点