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Atezolizumab 加替拉戈单抗联合紫杉醇和顺铂与紫杉醇和顺铂一线治疗不可切除的局部晚期、不可切除的复发性或转移性食管癌患者的研究 (SKYSCRAPER-08)

2026年8月4日 更新者：Hoffmann-La Roche

一项 Atezolizumab 加 Tiragolumab 联合紫杉醇和顺铂与紫杉醇和顺铂一线治疗不可切除的局部晚期、不可切除的复发性或转移性食管鳞状细胞癌患者的 III 期、随机、双盲、安慰剂对照研究

本研究的目的是评估 atezolizumab 加 tiragolumab 联合紫杉醇和顺铂 (PC) 与 atezolizumab 匹配安慰剂加 tiragolumab 匹配安慰剂加 PC 作为不可切除局部晚期、不可切除复发性复发参与者一线治疗的疗效和安全性, 或转移性食管癌 (EC)。 在诱导阶段，参与者将以 1:1 的比例随机接受以下治疗方案之一：

A 组：Atezolizumab 加 Tiragolumab 和 PC B 组：Atezolizumab 安慰剂加 Tiragolumab 安慰剂和 PC 在诱导阶段后，参与者将继续使用 atezolizumab 加 tiragolumab（A 组）或 atezolizumab 匹配安慰剂加 tiragolumab 匹配安慰剂（B 组）进行维持治疗。

研究概览

地位

地位

指示当前招聘状态或扩展访问状态。
完全的

条件

条件

正在研究的疾病、紊乱、综合征、疾病或损伤。在 ClinicalTrials.gov 上，条件还可能包括其他与健康相关的问题，例如寿命、生活质量和健康风险。

干预/治疗

干预/治疗

作为临床研究重点的过程或行动。干预措施包括药物、医疗设备、程序、疫苗和其他处于研究阶段或已经可用的产品。干预措施还可以包括非侵入性方法，例如教育或调整饮食和锻炼。

研究类型

研究类型

描述临床研究的性质。研究类型包括介入性研究（也称为临床试验）、观察性研究（包括患者登记）和扩展访问。
介入性

注册 (实际的)

注册

临床研究的参与者人数。 “预期”入组人数是研究人员进行研究所需的目标参与者人数。
461

阶段

阶段

根据美国食品和药物管理局 (FDA) 制定的定义，研究药物或生物制品的临床试验阶段。阶段基于研究的目标、参与者的数量和其他特征。有五个阶段：早期第 1 阶段（以前列为第 0 阶段）、第 1 阶段、第 2 阶段、第 3 阶段和第 4 阶段。不适用用于描述没有 FDA 定义的阶段的试验，包括设备试验或行为干预。
  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 中国
      • Anhui、中国、230001
        • Anhui Provincial Hospital
      • Anyang、中国、455000
        • Anyang Tumor Hosptial
      • Beijing、中国
        • Beijing Luhe Hospital Capital Medical University
      • Changchun、中国、130021
        • The First Hospital of Jilin University
      • Changchun、中国、132013
        • Jilin cancer hospital
      • Changsha、中国、410013
        • Hunan Cancer Hospital
      • Chengde、中国、067020
        • Affiliated Hospital of Chengde Medical University
      • Chengdu、中国、610041
        • West China Hospital, Sichuan University
      • Chengdu、中国、610041
        • Sichuan Provincial Cancer Hospital
      • Chongqing、中国、404000
        • Chongqing Sanxia Central Hospital
      • Foshan、中国、510000
        • The First People's Hospital of Foshan
      • Fuzhou、中国、350014
        • Fujian Cancer Hospital
      • Fuzhou、中国
        • Fujian Provincial Hospital
      • Guangdong Province Guangzhou City、中国、510515
        • Southern medical university Nanfang hospital
      • Hangzhou、中国、310022
        • Zhejiang Cancer Hospital
      • Harbin、中国、150081
        • Harbin Medical University Cancer Hospital
      • Hefei、中国、230601
        • The Second Affiliated Hospital of Anhui Medical University
      • Hefei、中国、12345
        • Anhui Province Cancer Hospital
      • Huai'an、中国
        • Huai'an first people's hospital
      • Huai'an、中国
        • The Second People's Hospital of Huai'an
      • Jining、中国
        • Affiliated Hopsital of Jining Medical University
      • Lanzhou、中国、730000
        • Gansu Province People Hospital
      • Lianyungang、中国、222002
        • The First People's Hospital of Lian Yun Gang
      • Linyi、中国、276034
        • Linyishi Cancer Hospital
      • Luoyang、中国、471003
        • The First Affiliated Hospital to Henan University of Science and Technology
      • Nanjing、中国、211100
        • Jiangsu Cancer Hospital
      • Nanjing、中国、210029
        • Jiangsu Province Hospital of Chinese Medicine
      • Nantong、中国、226361
        • Nan Tong Tumor Hospital
      • Shanghai、中国、200000
        • Shanghai Chest Hospital
      • Shanghai、中国、200032
        • Zhongshan Hospital Fudan University
      • Shanghai、中国、200120
        • Fudan University Shanghai Cancer Center
      • Shantou、中国、515041
        • Cancer Hospital of Shantou University Medical College
      • Shengyang、中国、110042
        • Liaoning Provincial Cancer Hospital
      • Suining、中国、629000
        • Suining Central Hospital
      • Tianjin、中国、300060
        • Tianjin Cancer Hospital
      • Weifang、中国
        • Weifang People's Hospital
      • Wuhan、中国、430079
        • Hubei Cancer Hospital
      • Wuhan、中国、430022
        • Wuhan Union Hospital Tongji Medical College, Huazhong University of Science and Technology
      • Wuxi、中国、214122
        • Affiliated Hospital of Jiangnan University(Wuxi Fourth People's Hospital )
      • Xi'an、中国、710061
        • First Affiliated Hospital of Medical College of Xi'an Jiaotong University
      • Xi'an、中国、710038
        • The Second Affiliated Hospital of The Fourth Military Medical University (Tangdu Hospital)
      • Xiamen、中国、361003
        • The First Affiliated Hospital of Xiamen University
      • Xiamen、中国、361004
        • Zhongshan Hospital Xiamen University
      • Xiangyang、中国
        • Xiangyang Central Hospital
      • Xinxiang、中国
        • The First Affiliated Hospital of Xinxiang Medical University
      • Xuzhou、中国
        • Xuzhou Central Hospital
      • Yangzhou、中国、225001
        • Northern Jangsu People's Hospital
      • Zhengzhou、中国、450008
        • Henan Cancer Hospital
      • Zhengzhou、中国、450052
        • The First Affiliated Hospital of Zhengzhou University
  • 台湾
      • Kaohisung、台湾
        • Chang Gung Medical Foundation - Kaohsiung
      • Tainan、台湾、00704
        • National Cheng Kung University Hospital
      • Taipei、台湾、112201
        • Taipei Veterans General Hospital
      • Zhongzheng Dist.、台湾、10048
        • National Taiwan University Hospital
  • 泰国
      • Bangkok、泰国、10700
        • Siriraj Hospital
      • Bangkok、泰国、10400
        • Rajavithi Hospital
      • Bangkok、泰国、10330
        • Chulalongkorn Hospital
      • Bangkok、泰国、10400
        • Ramathibodi Hospital
      • Songkhla、泰国、90110
        • Songklanagarind Hospital
  • 韩国
      • Daegu、韩国、41404
        • Kyungpook National University Chilgok Hospital
      • Goyang-si、韩国、10408
        • National Cancer Center
      • Seongnam-si、韩国、13605
        • Seoul National University Bundang Hospital
      • Seoul、韩国、05505
        • Asan Medical Center
      • Seoul、韩国、06351
        • Samsung Medical Center
      • Seoul、韩国、03722
        • Severance Hospital, Yonsei University Health System
      • Seoul、韩国、08308
        • Korea University Guro Hospital
  • 香港
      • Hong Kong、香港
        • Queen Mary Hospital
      • Shatin、香港
        • Prince of Wales Hosp

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

资格标准

想要参加临床研究的人必须满足的关键要求或他们必须具备的特征。资格标准包括纳入标准（一个人参与研究所必需的）和排除标准（阻止一个人参与）。资格标准的类型包括一项研究是否接受健康志愿者、是否有年龄或年龄组要求，或是否受性别限制。

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

描述

关键纳入标准：

  • 组织学证实的 EC
  • 不可切除的局部晚期、不可切除的复发或转移性疾病
  • 符合实体瘤反应评估标准 1.1 版 (RECIST v1.1) 的可测量疾病
  • 东部肿瘤合作组 (ECOG) 绩效状态为 0 或 1
  • 足够的血液学和终末器官功能
  • 女性参与者必须愿意避免怀孕，并在治疗期间和最后一次给药后 90 天内不捐卵
  • 有育龄伴侣的男性参与者必须承诺使用两种避孕方法，并且在研究期间和最后一次给药后 90 天内不得捐献精子

关键排除标准：

  • 研究治疗开始前 4 周内对 EC 进行姑息性放射治疗
  • 不适合治疗的完全食管阻塞的证据
  • 有症状、未经治疗或积极进展的中枢神经系统 (CNS) 转移
  • 不受控制的肿瘤相关疼痛、不受控制的胸腔积液、心包积液或需要反复引流的腹水
  • 自身免疫性疾病或免疫缺陷或软脑膜疾病的活动或病史
  • 特发性肺纤维化、机化性肺炎、药物性肺炎或特发性肺炎的病史，或活动性肺炎的证据
  • 筛查前 2 年内除 EC 以外的恶性肿瘤，转移或死亡风险可忽略不计，并经充分治疗达到预期治愈结果
  • 研究治疗开始前 4 周内发生严重感染或研究者认为可能影响患者安全的任何活动性感染
  • 人类免疫缺陷病毒 (HIV) 阳性检测结果
  • 活动性乙型肝炎或丙型肝炎
  • 既往接受过 CD137 激动剂或免疫检查点阻断疗法、抗 CTLA-4、抗 TIGIT、抗 PD-1 和抗 PD-L1 治疗性抗体的治疗
  • 在开始研究治疗之前接受任何研究治疗
  • 外周静脉通路不良
  • 先前的同种异体干细胞或实体器官移植
  • 同时参与另一项治疗性临床试验

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：四人间

武器和干预

参与者组/臂

参与者组/臂

根据试验方案，接受特定干预/治疗或不接受干预的临床试验参与者组或亚组。
干预/治疗

干预/治疗

作为临床研究重点的过程或行动。干预措施包括药物、医疗设备、程序、疫苗和其他处于研究阶段或已经可用的产品。干预措施还可以包括非侵入性方法，例如教育或调整饮食和锻炼。
实验性的：阿特朱单抗 + 替拉戈单抗 + PC
在研究期间，参与者将在每个 21 天周期的第 1 天接受 atezolizumab 和 tiragolumab，然后在每个 21 天周期的第 1 天接受紫杉醇和顺铂，直到在诱导治疗阶段出现疾病进展、失去临床益处或不可接受的毒性。
药品：阿替珠单抗
在每个 21 天周期的第 1 天，每 3 周 (Q3W) 通过静脉内 (IV) 输注 1200 毫克 (mg) 的固定剂量的阿替利珠单抗。
其他名称：
  • 技术中心
药品：替拉戈单抗
在每个 21 天周期的第 1 天，每 Q3W 通过 IV 输注固定剂量的 Tiragolumab 600 mg。
其他名称：
  • MTIG7192A
药品：紫杉醇
紫杉醇 175 mg/m^2 在每个 21 天周期的第 1 天通过静脉输注给药，共 6 个周期。
药品：顺铂
顺铂 60-80 mg/m^2 在每个 21 天周期的第 1 天通过静脉输注给药，共 6 个周期。
安慰剂比较：安慰剂 + PC
在研究期间，参与者将在每个 21 天周期的第 1 天接受 atezolizumab 匹配安慰剂和 tiragolumab 匹配安慰剂，然后在每个 21 天周期的第 1 天接受紫杉醇和顺铂，直到疾病进展、失去临床益处或不可接受的毒性。诱导治疗阶段。
药品：紫杉醇
紫杉醇 175 mg/m^2 在每个 21 天周期的第 1 天通过静脉输注给药，共 6 个周期。
药品：顺铂
顺铂 60-80 mg/m^2 在每个 21 天周期的第 1 天通过静脉输注给药，共 6 个周期。
药品：Atezolizumab 匹配安慰剂
Atezolizumab 匹配安慰剂通过静脉输注给药，每 21 天周期的第 1 天 Q3W。
药品：替拉戈单抗匹配安慰剂
Tiragolumab 匹配安慰剂通过 IV 输注给药，Q3W 在每个 21 天周期的第 1 天。

研究衡量的是什么？

主要结果指标

主要结果指标

在临床研究的方案中，对于评估干预/治疗的效果最重要的计划结果测量。大多数临床研究有一项主要结果指标，但有些研究有不止一项。
结果测量
措施说明
大体时间
Independent Review Facility (IRF)-Assessed Progression-free Survival (PFS)
大体时间：From randomization to the first occurrence of PD or death from any cause, whichever occurred first (up to approximately 19 months)
PFS was defined as the time from randomization to the first occurrence of progressive disease (PD) or death from any cause (whichever occurred first), as determined by an IRF according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1). PD was defined as at least a 20% increase in the sum of diameters (SOD) of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline). Additionally, the SOD must also demonstrate an absolute increase of ≥ 5 millimeters (mm) or unequivocal progression of existing non-target lesions. Kaplan-Meier (KM) method was used to estimate median PFS.
From randomization to the first occurrence of PD or death from any cause, whichever occurred first (up to approximately 19 months)
Overall Survival (OS)
大体时间：From randomization to death from any cause (up to approximately 27.5 months)
OS was defined as the time from randomization to death from any cause. K-M method was used to estimate median OS.
From randomization to death from any cause (up to approximately 27.5 months)

次要结果测量

次要结果测量

在临床研究的方案中，计划的结果测量值在评估干预效果时不如主要结果测量值重要，但仍然值得关注。大多数临床研究有不止一项次要结果指标。
结果测量
措施说明
大体时间
Investigator-assessed PFS
大体时间：From randomization to the first occurrence of PD or death from any cause, whichever occurs first (up to approximately 19 months)
PFS was defined as the time from randomization to the first occurrence of PD or death from any cause (whichever occurred first), as determined by the investigator according to RECIST v1.1. PD was defined at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline). Additionally, the SOD must also demonstrate an absolute increase of ≥ 5 mm or unequivocal progression of existing non-target lesions. K-M method was used to estimate median PFS.
From randomization to the first occurrence of PD or death from any cause, whichever occurs first (up to approximately 19 months)
IRF-assessed Confirmed Objective Response Rate (ORR)
大体时间：Up to approximately 19 months
IRF-assessed confirmed ORR was defined as the percentage of participants with an objective response (OR), characterized by a complete response (CR) or partial response (PR) on 2 consecutive occasions ≥ 4 weeks apart, as determined by an IRF according to RECIST v1.1. CR was defined as disappearance of all target lesions. & normalization of tumor marker level. Additionally, any pathological lymph nodes (whether target or non-target) must have a reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR.
Up to approximately 19 months
Investigator-assessed Confirmed ORR
大体时间：Up to approximately 19 months
Investigator-assessed confirmed ORR was defined as the percentage of participants with an OR, characterized by a CR or a PR on 2 consecutive occasions ≥ 4 weeks apart, as determined by the investigator according to RECIST v1.1. CR was defined as disappearance of all target lesions. & normalization of tumor marker level. Additionally, any pathological lymph nodes (whether target or non-target) must have a reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR.
Up to approximately 19 months
IRF-assessed Duration of Objective Response (DOR)
大体时间：From the first occurrence of a of a confirmed OR to PD or death from any cause, whichever occurred first (up to approximately 19 months)
DOR was defined as the time from the first occurrence of a confirmed OR to PD or death from any cause (whichever occurred first), as determined by an IRF according to RECIST v1.1. OR was defined as either a CR or a PR on 2 consecutive occasions ≥ 4 weeks apart. CR was defined as disappearance of all target lesions. & normalization of tumor marker level. Additionally, any pathological lymph nodes (whether target or non-target) must have a reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD on study (including baseline). Additionally, the SOD must also demonstrate an absolute increase of ≥ 5 mm or unequivocal progression of existing non-target lesions. K-M method was used to estimate median DOR.
From the first occurrence of a of a confirmed OR to PD or death from any cause, whichever occurred first (up to approximately 19 months)
Investigator-assessed DOR
大体时间：From the first occurrence of a of a confirmed OR to PD or death from any cause, whichever occurred first (up to approximately 19 months)
DOR was defined as the time from the first occurrence of a confirmed OR to PD or death from any cause (whichever occurred first), as determined by an IRF according to RECIST v1.1. OR was defined as either a CR or a PR on 2 consecutive occasions ≥ 4 weeks apart. CR was defined as disappearance of all target lesions. & normalization of tumor marker level. Additionally, any pathological lymph nodes (whether target or non-target) must have a reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD on study (including baseline). Additionally, the SOD must also demonstrate an absolute increase of ≥ 5 mm or unequivocal progression of existing non-target lesions. K-M method was used to estimate median DOR.
From the first occurrence of a of a confirmed OR to PD or death from any cause, whichever occurred first (up to approximately 19 months)
Time to Confirmed Deterioration (TTCD) in Participant-reported Physical Functioning, as Measured by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30)
大体时间：Up to approximately 27 months
Clinically meaningful changes in physical functioning as measured by the EORTC QLQ-C30. EORTC QLQ-C30 is a self-reported measure, consisting of 30 questions that assess 5 aspects of participants functioning (physical, emotional, role, cognitive and social), 3 symptom scales (fatigue, nausea and vomiting, and pain), global health status/quality of life (GHS/QoL), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea and financial difficulties) within the previous week. Physical functioning was scored on a 4-point scale: 1=Not at all, 2=A little, 3=Quite a bit, 4=Very much. Scores were linearly transformed to a range of 0 to 100, with higher scores (i.e. closer to 100) reflecting better functioning. Participants were considered "Worsened" if their baseline score decreased by ≥10 points. K-M method was used to estimate median TTCD.
Up to approximately 27 months
TTCD in Participant-reported Role Functioning (RF), as Measured by EORTC QLQ-C30
大体时间：Up to approximately 27 months
Clinically meaningful changes in role functioning as measured by the EORTC QLQ-C30. EORTC QLQ-C30 is a self-reported measure, consisting of 30 questions that assess 5 aspects of participants functioning (physical, emotional, role, cognitive and social), 3 symptom scales (fatigue, nausea and vomiting, and pain), GHS/QoL, and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea and financial difficulties) within the previous week. Role functioning was scored on a 4-point scale: 1=Not at all, 2=A little, 3=Quite a bit, 4=Very much. Scores were linearly transformed to a range of 0 to 100, with higher scores (i.e. closer to 100) reflecting better functioning. Participants were considered "Worsened" if their baseline score decreased by ≥10 points. K-M method was used to estimate median TTCD.
Up to approximately 27 months
TTCD in Participant-Reported GHS/QoL, as Measured by EORTC QLQ-C30
大体时间：Up to approximately 27 months
Clinically meaningful changes in GHS/QoL as measured by the EORTC QLQ-C30. EORTC QLQ-C30 is a self-reported measure, consisting of 30 questions that assess 5 aspects of participants functioning (physical, emotional, role, cognitive and social), 3 symptom scales (fatigue, nausea and vomiting, and pain), GHS/QoL, and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea and financial difficulties) within the previous week. GHS and QoL items were scored on a 7-point scale, with scores ranging from 1=Very poor to 7=Excellent. Scores were linearly transformed to a range of 0 to 100, with higher scores (i.e. closer to 100) reflecting better GHS/QoL. Participants were considered "Worsened" if their baseline score decreased by ≥10 points. K-M method was used to estimate median TTCD.
Up to approximately 27 months
TTCD in Participant-reported Dysphagia, as Measured by European Organisation for Research and Treatment of Cancer Quality-of-life Esophageal Cancer, Module 18 Questionnaire (EORTC QLQ-OES18)
大体时间：Up to approximately 27 months
Clinically meaningful changes in dysphagia as measured by the EORTC QLQ-OES18. EORTC QLQ-OES18 is a modular supplement to the EORTC QLQ-C30 questionnaire for use in participants with esophageal cancer. EORTC QLQ-OES18 consists of 4 multiple-item scale (dysphagia, eating, reflux, and pain) and 6 single items (trouble swallowing saliva, choked when swallowing, dry mouth, trouble with taste, trouble with coughing, and trouble talking) with a recall period of the previous week. Each symptom item was scored on a 4-point scale: 1=Not at all, 2=A little, 3=Quite a bit, 4=Very much. Scores were linearly transformed to a range of 0 to 100, with higher transformed scores (i.e. closer to 100) reflecting worse symptoms. Participants were considered "Worsened" if their baseline score increased by ≥ 10 points. K-M method was used to estimate median TTCD.
Up to approximately 27 months
Number of Participants With Adverse Events (AEs)
大体时间：Up to approximately 49.6 months
An AE was any untoward medical occurrence in a participant administered a pharmaceutical product, and which does not necessarily have a causal relationship with the treatment. An AE was therefore any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product.
Up to approximately 49.6 months
Number of Participants With Cytokine-release Syndrome (CRS), With Severity Determined by the American Society for Transplantation and Cell Therapy (ASTCT) Consensus Grading Scale
大体时间：Up to approximately 49.6 months
CRS was defined as supraphysiologic response following administration of any immune therapy that results in activation/engagement of endogenous or infused T cells and/or other immune effector cells. Symptoms may be progressive, including fever at onset, and may also include hypotension, capillary leak (hypoxia), and end-organ dysfunction. Severity of CRS was determined per ASTCT Consensus Grading Criteria, which categorizes CRS into 5 grades: Grade 1: fever (≥38◦Celsius), with/without constitutional symptoms, in absence of hypotension & hypoxia; Grade 2: fever with hypotension not requiring vasopressors and/or hypoxia requiring low-flow oxygen; Grade 3: fever with hypotension requiring one vasopressor, with/without vasopressin, and/or hypoxia requiring high-flow oxygen; Grade 4: fever accompanied by hypotension requiring multiple vasopressors (excluding vasopressin) and/or hypoxia requiring positive-pressure ventilation; Grade 5: death due to CRS.
Up to approximately 49.6 months
Minimum Serum Concentration (Cmin) of Tiragolumab
大体时间：Pre-dose on Day 1 of Cycles 2, 3, 4, 8, 12, and 16 (1 Cycle=21 days)
Pre-dose on Day 1 of Cycles 2, 3, 4, 8, 12, and 16 (1 Cycle=21 days)
Maximum Serum Concentration (Cmax) of Tiragolumab
大体时间：30 minutes post-dose on Day 1 of Cycle 1 (1 Cycle=21 days)
30 minutes post-dose on Day 1 of Cycle 1 (1 Cycle=21 days)
Cmin of Atezolizumab
大体时间：Pre-dose on Day 1 of Cycles 2, 3, 4, 8, 12, and 16 (1 Cycle=21 days)
Pre-dose on Day 1 of Cycles 2, 3, 4, 8, 12, and 16 (1 Cycle=21 days)
Cmax of Atezolizumab
大体时间：30 minutes post-dose on Day 1 of Cycle 1 (1 Cycle=21 days)
30 minutes post-dose on Day 1 of Cycle 1 (1 Cycle=21 days)
Number of Participants With Anti-drug Antibodies (ADAs) to Tiragolumab
大体时间：Up to approximately 27.5 months
Participants were considered to be ADA positive if they were ADA negative at baseline but developed an ADA response following tiragolumab administration (treatment-induced ADA response), or if they were ADA positive at baseline and the titer of one or more post-baseline samples was greater than the titer of the baseline sample by a scientifically reasonable margin such as at least 0.60 titer unit (t.u.) greater than the baseline titer result (treatment-enhanced ADA response). Participants with a positive post-baseline sample have been reported here.
Up to approximately 27.5 months
Number of Participants With ADAs to Atezolizumab
大体时间：Up to approximately 27.5 months
Participants were considered to be ADA positive if they were ADA negative at baseline but developed an ADA response following atezolizumab administration (treatment-induced ADA response), or if they were ADA positive at baseline and the titer of one or more post-baseline samples was greater than the titer of the baseline sample by a scientifically reasonable margin such as at least 0.60 t.u. greater than the baseline titer result (treatment-enhanced ADA response). Participants with a positive post-baseline sample have been reported here.
Up to approximately 27.5 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

赞助

发起研究并有权和控制研究的组织或个人。
Hoffmann-La Roche

调查人员

调查人员

参与临床研究的研究人员。相关术语包括中心首席研究员、中心副研究员、研究主席、研究主管和研究首席研究员。
  • 研究主任：Clinical Trials、Hoffmann-La Roche

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

学习开始

第一位参与者参加临床研究的实际日期。 “预期”研究开始日期是研究人员认为将成为研究开始日期的日期。
2020年10月30日

初级完成 (实际的)

初级完成

临床研究的最后一名参与者接受检查或接受干预以收集主要结果测量的最终数据的日期。临床研究是否根据方案结束或被终止不影响该日期。对于具有多个不同完成日期的主要结果测量的临床研究，该术语是指完成所有主要结果测量的数据收集的日期。 “预期”主要完成日期是研究人员认为将成为研究主要完成日期的日期。
2023年2月13日

研究完成 (实际的)

研究完成

临床研究中最后一位参与者接受检查或接受干预/治疗以收集主要结局指标、次要结局指标和不良事件（即最后一位参与者的最后一次就诊）的最终数据的日期。 “预期”研究完成日期是研究人员认为将成为研究完成日期的日期。
2025年8月28日

研究注册日期

首次提交

首次提交

研究发起人或研究者首次向 ClinicalTrials.gov 提交研究记录的日期。在首次提交日期和记录在 ClinicalTrials.gov 上的可用性（首次发布日期）之间通常会有几天的延迟。
2020年9月3日

首先提交符合 QC 标准的

首先提交符合 QC 标准的

研究发起人或研究者首次提交符合国家医学图书馆 (NLM) 质量控制 (QC) 审查标准的研究记录的日期。在满足 NLM 的 QC 审查标准之前，发起人或研究者可能需要修改和提交研究记录一次或多次。申办者或研究者有责任确保研究记录符合 NLM QC 审查标准。
2020年9月3日

首次发布 (实际的)

首次发布

在国家医学图书馆 (NLM) 质量控制 (QC) 审查结束后，研究记录首次在 ClinicalTrials.gov 上可用的日期。研究发起人或研究者提交研究记录的日期与首次发布日期之间通常会有几天的延迟。
2020年9月7日

研究记录更新

最后更新发布 (实际的)

最后更新发布

在 ClinicalTrials.gov 上提供研究记录更改的最近日期。研究发起人或研究者向 ClinicalTrials.gov 提交变更的时间（最后更新提交日期）和最后更新发布日期之间可能会有延迟。
2026年8月27日

上次提交的符合 QC 标准的更新

上次提交的符合 QC 标准的更新

研究发起人或研究者提交符合国家医学图书馆 (NLM) 质量控制 (QC) 审查标准的研究记录更改的最近日期。申办者或研究者有责任确保研究记录符合 NLM QC 审查标准。
2026年8月4日

最后验证

最后验证

研究发起人或研究者确认 ClinicalTrials.gov 上的临床研究信息准确且最新的最近日期。如果一项研究的招募状态为招募；尚未招聘；或活跃，未在过去 2 年内确认招募，该研究的招募状态显示为未知。
2026年8月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

其他研究编号

由研究的发起人、资助者或其他人分配给临床研究的标识符或 ID 号，而不是 NCT 号。这些编号可能包括来自其他试验登记处的唯一标识符和美国国立卫生研究院的资助编号。
  • YO42138

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

合格的研究人员可以通过临床研究数据请求平台 (www.vivli.org) 请求访问个体患者水平的数据。 有关罗氏合格研究标准的更多详细信息，请参见此处 (https://vivli.org/ourmember/roche/)。 有关罗氏临床信息共享全球政策的更多详细信息以及如何请求访问相关临床研究文件，请参见此处 (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm)。

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

是的

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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