JPRN-jRCT2051220179招募中3 期
A Randomized, Open-Label, Multicenter Phase 3 Trial of Domvanalimab, Zimberelimab, and Chemotherapy Versus Nivolumab and Chemotherapy in Participants with Previously Untreated Locally Advanced Unresectable or Metastatic Gastric, Gastroesophageal Junction, and Esophageal Adenocarcinoma - STAR-221
asermoaddeli Ali0 个研究点目标入组 970 人开始时间: 2023年4月10日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 970
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. Age >= 18 years at the time of signing the informed consent.
- •2. Capable of giving signed informed consent which is in compliance with the requirements and restrictions listed in the informed consent form (ICF) and in protocol.
- •3. Histologically confirmed diagnosis of locally advanced unresectable or metastatic gastric, GEJ, or esophageal adenocarcinoma.
- •4. Eastern Cooperative Oncology Group (ECOG) Performance Score of 0-1.
- •5. At least one measurable target lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
排除标准
- •1. Underlying medical or psychiatric conditions that, in the investigator's or sponsor's opinion, will make the administration of study-specified therapy hazardous, including but not limited to:
- •- Interstitial lung disease, including history of interstitial lung disease or non-infectious pneumonitis. Active viral, bacterial, or fungal infections requiring parenteral treatment within 14 days of randomization.
- •- Clinically significant cardiovascular disease, such as New York Heart Association Class II or greater cardiac disease or cerebrovascular accident within 3 months prior to randomization, unstable angina, or new onset angina within 3 months prior to randomization, myocardial infarction within 6 months prior to randomization, or unstable arrhythmia within 3 months prior to randomization.
- •- History of prior solid-organ transplantation, including allogenic bone marrow transplantation.
- •- Dementia, psychiatric, or substance abuse disorders that would interfere with satisfying the requirements of the trial.
- •2. Known human epidermal growth factor receptor 2 (HER-2) positive tumor.
- •3. Known untreated, symptomatic, or actively progressing central nervous system (CNS) (brain) metastases. Participants with leptomeningeal metastases are excluded from enrollment.
- •4. Received prior systemic treatment for locally advanced unresectable or metastatic gastric, GEJ, or esophageal adenocarcinoma.
- •5. Disease progression within 6 months of neoadjuvant or adjuvant chemotherapy.
研究者
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