NCT06669078尚未招募2 期
A Prospective, Open, Randomized Controlled, Multicenter, Exploratory Clinical Study of NALIRIFOX Combined With PD-1 Sequential Radiotherapy Versus NALIRIFOX for Conversion Therapy for Locally Advanced Pancreatic Cancer
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School0 个研究点目标入组 120 人开始时间: 2024年10月30日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 主要终点
- 1 year OS rate
研究概览
简要总结
The purpose of the prospective, open, randomized controlled, multicenter, exploratory clinical study is to evaluate efficacy and safety of NALIRIFOX Combined With PD-1 Sequential Radiotherapy Versus NALIRIFOX for Conversion Therapy for Locally 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confi rmed pancreatic cancer;
- •ECOG performance no more than 1;
- •Radiographically assessed as locally advanced pancreatic cancer according ;
- •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;
- •Known to be symptomatic central nervous system metastasis and/or cancerous meningitis.
- •Patients with autoimmune disease or immune deficiency who are treated with immuno-suppressive drugs;
- •Patients with bleeding tendency;
- •Pregnant or lactating women.
研究组 & 干预措施
NALIRINOX combined with PD-1 synchronous sequential SBRT group
Experimental
Nal-IRI+Oxaliplatin+5- FU +PD-1, these drugs are given on d1, d15, 28 days as one cycle, SBRT is performed during the third and fourth cycle.
干预措施: Nal-lRl+Oxaliplain+5- FU +PD 1 (Drug)
NALIRIFOX group
Experimental
Nal-IRI+Oxaliplatin+5- FU, these drugs are given on d1, d15, 28 days as one cycle.
干预措施: Nal-lRl+Oxaliplain+5- FU (Drug)
结局指标
主要结局
1 year OS rate
时间窗: Up to 12 months]
Proportion of patients alive from randomization to 1 year
次要结局
- R0/R1 rate(Up to 6 months)
- The rate of mPR(Up to 6 months)
- OS(Up to 24 months)
- ORR(Up to 6 months)
- PFS(Up to 12 months)
- Surgical resection rate(Up to 6 months)
- The incidence of grade 3 or higher AE and serious adverse event(SAE) [Safety](From the first treatment to 28 days after the last treatment, about 6 months)
研究者
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