癌研連線CancerLink
已完成 NCT04540211

一項 Atezolizumab 加 Tiragolumab 聯合 Paclitaxel 及 Cisplatin 相比 Paclitaxel 及 Cisplatin 作為第一線治療用於不可切除局部晚期、不可切除復發性或轉移性食道癌參與者的研究

食道癌Phase IIIIII 期IV 期PD-L1

本研究旨在評估 atezolizumab 加 tiragolumab 聯合 paclitaxel 及 cisplatin (PC) 相比 atezolizumab 匹配安慰劑加 tiragolumab 匹配安慰劑加 PC 作為第一線治療，用於不可切除局部晚期、不可切除復發性或轉移性食道癌 (EC) 參與者的療效與安全性。

適應症：Esophageal Cancer

收案條件

納入條件

  • Histologically confirmed EC
  • Unresectable locally advanced, unresectable recurrent, or metastatic disease
  • Measurable disease per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  • Adequate hematologic and end-organ function
  • Female participants must be willing to avoid pregnancy and refrain from donating eggs during the treatment period and for 90 days after the final dose
  • Male participants with partners of childbearing potential must commit to the use of two methods of contraception and must not donate sperm for the study duration and 90 days after the final dose

排除條件

  • Palliative radiation treatment for EC within 4 weeks prior to initiation of study treatment
  • Evidence of complete esophageal obstruction not amenable to treatment
  • Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
  • Uncontrolled tumor-related pain, uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
  • Active or history of autoimmune disease or immune deficiency or leptomeningeal disease
  • History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis
  • Malignancies other than EC within 2 years prior to screening with a negligible risk of metastasis or death adequately treated with expected curative outcome
  • Severe infection within 4 weeks prior to initiation of study treatment or any active infection that, in the opinion of the investigator, could impact patient safety
  • Positive test result for human immunodeficiency virus (HIV)
  • Active hepatitis B or hepatitis C
  • Prior treatment with CD137 agonists or immune checkpoint blockade therapies, anti-CTLA-4, anti-TIGIT, anti-PD-1, and anti-PD-L1 therapeutic antibodies
  • Treatment with any investigational therapy prior to initiation of study treatment
  • Poor peripheral venous access
  • Prior allogeneic stem cell or solid organ transplantation
  • Concurrent participation in another therapeutic clinical trial

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。