A Single-center, Randomized, Interventional Controlled Study of NALIRIFOX Combined With PD-1 Sequential Radiotherapy Versus AG Combined With PD-1 Sequential Radiotherapy for First-line Treatment of Locally Advanced Pancreatic Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- mPFS
研究概览
简要总结
The purpose of the study is to evaluate the efficacy and safety of NALIRINOX combined with PD-1 synchronous sequential SBRT or AG combined with PD-1 synchronous sequential SBRT as first line systematical therapy in patients with ocally advanced pancreatic cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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 or cytologically confirmed pancreatic cancer;
- •ECOG performance no more than 2;
- •Radiographically assessed as locally advanced pancreatic cancer according to NCCN guidelines;
- •No previous anti-tumor therapy；
- •Able and willing to provide a written informed consent;
排除标准
- •Prior anti-tumor therapy of any kind;
- •Severe infection (>NCI CTC grade 2); 3.Patients with autoimmune disease or immune deficiency who are treated with immunosuppressive drugs; 4.Patients with bleeding tendency;
- •Pregnant or lactating women.
研究组 & 干预措施
NALIRINOX combined with PD-1 synchronous sequential SBRT
Nal-IRI+Oxaliplatin+5-FU +PD-1, these drugs are given on d1, d15, 28 days as one cycle, 6-8 cycles. SBRT is performed during the third cycle.
干预措施: nal-IRI+Oxaliplatin+5-FU/LV+PD-1 (Drug)
NALIRINOX combined with PD-1 synchronous sequential SBRT
Nal-IRI+Oxaliplatin+5-FU +PD-1, these drugs are given on d1, d15, 28 days as one cycle, 6-8 cycles. SBRT is performed during the third cycle.
干预措施: Gemcitabine + albumin-paclitaxel+PD-1 (Drug)
AG combined with PD-1 synchronous sequential SBRT
Gemcitabine + albumin-paclitaxel +PD-1, these drugs are given on d1, d8, 21 days as one cycle, 6-8 cycles. SBRT is performed during the third cycle.
干预措施: nal-IRI+Oxaliplatin+5-FU/LV+PD-1 (Drug)
AG combined with PD-1 synchronous sequential SBRT
Gemcitabine + albumin-paclitaxel +PD-1, these drugs are given on d1, d8, 21 days as one cycle, 6-8 cycles. SBRT is performed during the third cycle.
干预措施: Gemcitabine + albumin-paclitaxel+PD-1 (Drug)
结局指标
主要结局
mPFS
时间窗: Up to 12 months
Time from randomization to disease progression and/or death.
次要结局
- DCR(Up to 12 months)
- ORR(Up to 12 months)
- mOS(Up to 24 months)
研究者
Du Juan
chief physician choice
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School