癌研連線CancerLink
已完成 NCT05568095

一項新聯合治療方案 Domvanalimab 與 Zimberelimab 加上化療，用於無法手術切除且已擴散至身體其他部位的上消化道癌症患者的臨床試驗

胃癌食道癌Phase IIIIII 期IV 期EGFR

這項隨機第三期開放標籤研究將比較 T 細胞免疫球蛋白及免疫受體酪氨酸抑制基序（ITIM）結構域（TIGIT）單克隆抗體 domvanalimab、抗程序性細胞死亡蛋白 1（PD-1）單克隆抗體 zimberelimab 與多藥化療，對比抗 PD-1 單克隆抗體 nivolumab 與多藥化療，在局部晚期不可切除的上消化道癌症患者第一線治療中的療效。

適應症：Advanced Upper Gastrointestinal Tract Adenocarcinoma

收案條件

納入條件

  • 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.

排除條件

  • 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.

收案條件維持 ClinicalTrials.gov 原始英文登錄資料，實際收案資格以研究團隊的正式評估與受試者同意書為準。資料來源：ClinicalTrials.gov，每兩週自動更新，最後同步：2026年10月8日。