JPRN-jRCTs031230630招募中2 期
Phase 2 study of mFOLFOX6 plus nivolumab for patients with untreated unresectable or recurrent Esophageal Cancer - FLONTALE
Kubota Yohei0 个研究点目标入组 33 人开始时间: 2024年2月14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
- 33
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 comfirmed squamous cell carcinoma or adenosquamous carcinoma of esophagus (including esophagogastric junction).
- •(2) Unresectable or recurrent esophageal cancer that is not eligible for curative treatment (surgery, radiotherapy, or chemoradiotherapy).
- •(3) No history of systemic chemotherapy as primary treatment for unresectable or recurrent esophageal cancer.
- •(4) Age>=18 years.
- •(5) ECOG Performance Status (PS) of 0-2.
- •(6) At least one measurable lesion based on RECIST Ver.1.1.
- •(7) Adequate organ function
排除标准
- •(1) Patients with esophageal adenocarcinoma.
- •(2) Presence of symptomatic central nervous system metastasis (e.g., brain metastasis or leptomeningeal dissemination).
- •(3) Histroy of major surgery or significant trauma within at least 14 days prior to registration.
- •(4) Histroy of previous treatment with immune checkpoint inhibitors.
- •(5) Active known concurrent cancer (synchronous multiple cancers or metachronous multiple cancers with a disease-free interval of less than 3 years, except for early cancers such as superficial esophageal cancer or head and neck superficial cancer where prognosis is not considered, and lesions equivalent to intramucosal carcinoma or mucosal carcinoma that is judged to be cured by local treatment are allowed).
研究者
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