NCT05385809招募中不适用
A Retrospective Study of Sintilimab Combined With Chemotherapy in Conversion Therapy of Unresectable Locally Advanced or Stage IV Gastric Cancer/Gastroesophageal Junction Carcinoma
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Surgical conversion rate
研究概览
简要总结
This study was an observational, non-interventional, multicenter retrospective study to evaluate the feasibility and safety of sintilimab combined with chemotherapy (SOX or PS) in the clinical practice of unresectable locally advanced or stage IV gastric cancer/gastroesophageal junction carcinoma.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Ages: 18-75 Years (concluding 18 and 75 Years)
- •Pathologically confirmed gastric/gastroesophageal junction adenocarcinoma
- •Unresectable, locally advanced or limited distant metastasis of IV gastric cancer(AJCC 8th)
- •Meets only ≤2 of the following conditions: highly locally advanced (T4b), or extensive or bulcky lymph nodes; Para-aortic lymph node metastasis(mainly 16A2/B1 region); limited liver metastasis(H1); limited Peritoneal metastasis(CY1, P1), with or without ovarian metastasis(Kukernburg tumor);
- •Untreated(e.g. radiotherapy, chemotherapy, target therapy, immunotherapy, et al.)
- •At least 1 measurable lesion by RECIST v1.1 criteria
- •ECOG PS: 0-2
- •Received sintilimab combined with chemotherapy(SOX or PS) at least 1 cycle
排除标准
- •Known Her2 positive
- •Patients with incomplete data or other factors affecting the judgment of efficacy and safety
结局指标
主要结局
Surgical conversion rate
时间窗: two years
次要结局
- Overall response rate ( ORR)(two years)
- adverse event (AEs)(two years)
- R0 resection rate(two years)
- Major pathological response (MPR)(two years)
研究者
Xiangdong Cheng
MD
Zhejiang Cancer Hospital
研究点 (1)
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