JPRN-jRCTs031220572招募中2 期
Phase 2 study of CapeOX plus nivolumab for patients with gastric cancer with early relapse after adjuvant S-1 or S-1 plus docetaxel - JACCRO GC-11 (FirSTAR Trial)
Arai Hiroyuki0 个研究点目标入组 92 人开始时间: 2023年1月17日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 92
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1) Histologically confirmed adenocarcinoma (papillary adenocarcinoma, tumular adenocarcinoma, poorly differentiated adenocarcinoma), signet-ring cell carcinoma, mucinous adenocarcinoma, hepatoid adenocarcinoma, or carcinoma with lymphoid stroma of stomach or esophagogastric junction
- •2) Radiologically diagnosed recurrence during or < 6 months after completion of adjuvant chemotherapy (S-1 or S-1 plus docetaxel administered more than 12 weeks) for R0 resected pStage II or pStage III cases
- •3) Age > 18 years
- •4) ECOG performance status of 0-1
- •5) HER2 negative
- •6) Presence of measurable lesions according to RECIST ver.1.1
- •7) Adequate oral intake
- •8) Adequate organ functions
排除标准
- •1) Prior treatment with immune checkpoint inhibitors
- •2) Refractory to pre-operative chemotherapy or chemoradiotherapy including platinum compounds
- •3) Multiple cancers
- •4) Active autoimmune diseases
- •5) Grade > 2 peripheral sensory and/or motor neuropathy
- •6) Symptomatic brain metastasis
- •7) Interstitial pneumonia or pulmonary fibrosis
研究者
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