Nimotuzumab Plus Adjuvant Chemotherapy vs Adjuvant Chemotherapy Alone for Resectable Pancreatic Cancer: a Propensity Score Matching Analysis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 主要终点
- overall survival (OS）
研究概览
简要总结
This trial is a retrospective, observational study, patients who underwent surgical resection of the pancreas for non-metastatic pancreatic cancer between 2016 and 2022 were selected and divided into two groups according to with (study arm) or without (control arm) nimotuzumab. The primary efficacy endpoint was overall survival (OS).
详细描述
This trial is a retrospective, observational study based on real-world data obtained from the Health Information System (HIS) of Ruijin Hospital, Shanghai Jiao Tong University School of Medicine. Patients who underwent surgical resection of the pancreas for non-metastatic pancreatic cancer between 2016 and 2022 were selected and divided into two groups according to with (study arm) or without (control arm) nimotuzumab. The primary efficacy endpoint was overall survival (OS).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
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
- •Age≥18 years old, gender is not limited;
- •Confirmed by histopathological or cytological diagnosis of pancreatic cancer;
- •Underwent surgical resection of the pancreas for non-metastatic pancreatic cancer (including resectable/borderline resectable pancreatic cancer, or locally advanced pancreatic cancer);
- •Received Nimotuzumab plus adjuvant chemotherapy or adjuvant chemotherapy alone after surgery.
排除标准
- •Patients with other primary malignancies other than pancreatic cancer;
- •Evidence of recurrence or distant metastasis before surgery
- •Received immunotherapy drugs (such as PD-1 inhibitors, etc.) used during adjuvant therapy, or proprietary Chinese medicines with anti-tumor indications, or hyperthermia, targeted therapy drugs other than nimotuzumab;
- •Key information is missing (e.g., primary endpoint data were not available).
研究组 & 干预措施
study arm
Nimotuzumab plus adjuvant chemotherapy
干预措施: Nimotuzumab (Drug)
结局指标
主要结局
overall survival (OS）
时间窗: approximately 84 months
The primary endpoint is overall survival (OS), defined as the time from the start of surgery to the date of death due to any cause.
次要结局
- disease-free survival (DFS)(approximately 84 months)
- locoregional recurrence-free survival (LRRFS)(approximately 84 months)