癌研連線CancerLink
已完成 NCT05568095

一项新联合治疗方案 Domvanalimab 与 Zimberelimab 加上化疗，用于无法手术切除且已扩散至身体其他部位的上消化道癌症患者的临床试验

胃癌食管癌Phase IIIIII 期IV 期EGFR

这项随机第三期开放标签研究将比较 T 细胞免疫球蛋白及免疫受体酪氨酸抑制基序（ITIM）结构域（TIGIT）单克隆抗体 domvanalimab、抗程序性细胞死亡蛋白 1（PD-1）单克隆抗体 zimberelimab 与多药化疗，对比抗 PD-1 单克隆抗体 nivolumab 与多药化疗，在局部晚期不可切除的上消化道癌症患者第一线治疗中的疗效。

适应症：Advanced Upper Gastrointestinal Tract Adenocarcinoma

入组条件

纳入标准

  • 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.
  • Histologically confirmed diagnosis of locally advanced unresectable or metastatic gastric, GEJ, or esophageal adenocarcinoma.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
  • At least one measurable target lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

排除标准

  • 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.
  • Known human epidermal growth factor receptor 2 (HER-2) positive tumor.
  • Known untreated, symptomatic, or actively progressing central nervous system (CNS) (brain) metastases. Participants with leptomeningeal metastases are excluded from enrollment.
  • Received prior systemic treatment for locally advanced unresectable or metastatic gastric, GEJ, or esophageal adenocarcinoma.
  • Disease progression within 6 months of completion of neoadjuvant or adjuvant therapy.

入组条件维持 ClinicalTrials.gov 原始英文登记资料，实际入组资格以研究团队的正式评估与受试者知情同意书为准。资料来源：ClinicalTrials.gov，每两周自动更新，最后同步：2026年10月8日。