jRCT2011230016招募中不适用
A Phase 3, Open-Label, Randomized Study of Perioperative Dostarlimab Monotherapy versus Standard of Care in Participants with Untreated T4N0 or Stage III dMMR/MSI-H Resectable Colon Cancer
GlaxoSmithKline K.K.0 个研究点目标入组 50 人开始时间: 2023年12月4日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •Has untreated pathologically confirmed colon adenocarcinoma
- •Has resectable colon adenocarcinoma defined as clinically T4N0 or Stage III
- •Has radiologically evaluable disease
- •Has a tumor demonstrating the presence of either dMMR status or MSI-H
排除标准
- •Has distant metastatic disease.
- •Has received prior medical therapy (chemotherapy, immunotherapy, biologic, or targeted therapy), radiation therapy or surgery for management of colon cancer
- •Has a tumor that, in the investigator's judgment is causing symptomatic bowel obstruction or otherwise requires urgent/emergent surgery
- •Has undergone any major surgical procedure, open biopsy, or experienced significant traumatic injury within 28 days prior to enrollment
- •Has any history of interstitial lung disease or pneumonitis
- •Has cirrhosis or current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal/gastric varices, or persistent jaundice
- •Has a history of allogenic stem cell transplantation or organ transplantation
- •Is receiving any other anticancer or experimental therapy. No other experimental therapies (including but not limited to chemotherapy, radiation, hormonal treatment, antibody therapy, immunotherapy, gene therapy, vaccine therapy, or other experimental drugs) of any kind are permitted while the participant is receiving study intervention
- •Is pregnant, breastfeeding, or expecting to conceive children within the projected duration of the study
- •Has a history of severe allergic and/or anaphylactic reactions to chimeric, human or humanized antibodies, fusion proteins, or known allergies to dostarlimab, or its excipients, or any components of FOLFOX or CAPEOX
结局指标
主要结局
-
Event-free Survival (EFS) Assessed by Blinded Independent Central Review (BICR)
次要结局
未报告次要终点
研究者
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