EUCTR2019-001555-40-DE进行中（未招募）1 期
A Randomized, Double-blind, Placebo-controlled, Phase III Study of Neoadjuvant-Adjuvant Durvalumab and FLOT Chemotherapy Followed by Adjuvant Durvalumab or Placebo in Patients with Resectable Gastric and Gastroesophageal Cancer (GC/GEJC) (MATTERHORN) - MATTERHOR
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 900
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Patients with histologically documented gastric or gastroesophageal junction adenocarcinoma with resectable disease (Stage II or higher per AJCC 8th edition).
- •Patients must have undergo radical surgery.
- •No prior anti-cancer therapy for the current malignancy.
- •World Health Organization (WHO)/ECOG PS of 0 or 1 at enrollment
- •Adequate organ and marrow function
- •Availability of tumor sample prior to study entry
- •Must have a life expectancy of at least 24 weeks
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 450
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 450
排除标准
- •Patients with peritoneal dissemination or distant metastasis
- •Patients with adenosquamous cell carcinoma, squamous cell carcinoma, or GI stromal tumor
- •History of allogeneic organ transplantation.
- •Contra-indication to any of the study drugs
- •Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab.
研究者
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