癌研連線CancerLink
已完成 NCT04540211

一项 Atezolizumab 加 Tiragolumab 联合 Paclitaxel 及 Cisplatin 相比 Paclitaxel 及 Cisplatin 作为第一线治疗用于不可切除局部晚期、不可切除复发性或转移性食管癌参与者的研究

食管癌Phase IIIIII 期IV 期PD-L1

本研究旨在评估 atezolizumab 加 tiragolumab 联合 paclitaxel 及 cisplatin (PC) 相比 atezolizumab 匹配安慰剂加 tiragolumab 匹配安慰剂加 PC 作为第一线治疗，用于不可切除局部晚期、不可切除复发性或转移性食管癌 (EC) 参与者的疗效与安全性。

适应症：Esophageal Cancer

入组条件

纳入标准

  • 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

排除标准

  • 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

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。