A Single-arm, Single-center, Exploratory Study of Adebrelimab Combined With Chemotherapy for Neoadjuvant Therapy in Resectable Pancreatic Cancer
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- R0 removal rate
研究概览
简要总结
Clinical Study on the Safety and Efficacy of the efficacy and safety of Adebrelimab combined with chemotherapy for neoadjuvant treatment of resectable pancreatic cancer
详细描述
The goal of this clinical trial is to observe and evaluate the efficacy and safety of Adebrelimab combined with chemotherapy for neoadjuvant treatment of resectable pancreatic cancer.The main questions it aims to answer are:
To investigate the feasibility of immunotherapy combined with chemotherapy in the neoadjuvant therapy of pancreatic cancer.
To explore more effective neoadjuvant therapies for pancreatic cancer. Participants will receive 2 cycles of Adebrelimab in combination with albumin-bound paclitaxel and gemcitabine in the neoadjuvant phase, followed by surgery.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Adebrelimab combined with chemotherapy administration group
Adebrelimab is a humanized anti-PD-L1 monoclonal antibody independently developed by Hengrui Pharmaceutical. It can block the PD-1/PD-L1 pathway leading to tumor immune tolerance through specific binding of PD-L1 molecules, and reactivate the anti-tumor activity of the immune system, so as to achieve the purpose of tumor treatment.
干预措施: Adebrelimab (Drug)
Adebrelimab combined with chemotherapy administration group
Adebrelimab is a humanized anti-PD-L1 monoclonal antibody independently developed by Hengrui Pharmaceutical. It can block the PD-1/PD-L1 pathway leading to tumor immune tolerance through specific binding of PD-L1 molecules, and reactivate the anti-tumor activity of the immune system, so as to achieve the purpose of tumor treatment.
干预措施: albumin-bound paclitaxel (Drug)
Adebrelimab combined with chemotherapy administration group
Adebrelimab is a humanized anti-PD-L1 monoclonal antibody independently developed by Hengrui Pharmaceutical. It can block the PD-1/PD-L1 pathway leading to tumor immune tolerance through specific binding of PD-L1 molecules, and reactivate the anti-tumor activity of the immune system, so as to achieve the purpose of tumor treatment.
干预措施: Gemcitabine (Drug)
结局指标
主要结局
R0 removal rate
时间窗: one year
To observe and evaluate the efficacy and safety of adbelizumab combined with chemotherapy for neoadjuvant treatment of resectable pancreatic cancer
pCR rate
时间窗: one year
To observe and evaluate the efficacy and safety of adbelizumab combined with chemotherapy for neoadjuvant treatment of resectable pancreatic cancer
次要结局
未报告次要终点
研究者
Sizhen Wang
associate chief physician
Jinling Hospital, China