广州PF-08046047III期临床试验-一项比较Sigvotatug Vedotin与多西他赛治疗既往经治的非小细胞肺癌的研究（Be6A Lung-01）

登记号	CTR20244723	试验状态	进行中
申请人联系人	王辘轳	首次公示信息日期	2024-12-13
申请人名称	Seagen Inc./ 辉瑞投资有限公司/ BSP Pharmaceuticals S.p.A.

登记号	CTR20244723
相关登记号	暂无
药物名称	PF-08046047
药物类型	生物制品
临床申请受理号	JXSL2400182
适应症	非小细胞肺癌
试验专业题目	一项评价 Sigvotatug Vedotin 相比多西他赛治疗既往接受过治疗的非小细胞肺癌成人研究参与者的随机、III 期、开放性研究（Be6A Lung-01）
试验通俗题目	一项比较Sigvotatug Vedotin与多西他赛治疗既往经治的非小细胞肺癌的研究（Be6A Lung-01）
试验方案编号	C5751002	方案最新版本号	修正案 03
版本日期:	2024-08-05	方案是否为联合用药	否

申请人名称	[["Seagen Inc."],["辉瑞投资有限公司"],["BSP Pharmaceuticals S.p.A."]]
联系人姓名	王辘轳	联系人座机	021-22312421	联系人手机号
联系人Email	Steven.Wang@pfizer.com	联系人邮政地址	上海市-上海市-南京西路1168号中信泰富广场36层	联系人邮编	200041

主要目的:比较试验组(Sigvotatug Vedotin)和对照组(多西他赛)之间的OS;比较试验组和对照组之间经盲态独立中心审查委员会(BICR)评估的ORR.关键次要目的:比较试验组和对照组之间经BICR评估的PFS.其他次要目的:比较试验组和对照组之间经研究者评估的ORR;比较试验组和对照组之间经研究者评估的PFS;估计试验组和对照组之间的DOR;描述Sigvotatug Vedotin的安全性和耐受性特征;比较试验组和对照组之间生活质量(QoL),功能和肺癌症状缓解的变化;比较试验组和对照组之间QoL,功能和肺癌症状的至恶化时间(TTD).探索性目的:比较试验组和对照组之间的疾病控制率(DCR);估计试验组和对照组的至缓解时间;描述Sigvotatug Vedotin的PK;探索Sigvotatug Vedotin PK与选定的有效性,安全性和/或其他相关探索性终点(如适用)之间的关系;描述Sigvotatug Vedotin的免疫原性;比较试验组和对照组之间对患者报告结局(PRO)的影响;描述Sigvotatug Vedotin的药效学活性,应答和耐药标记物

试验分类	安全性和有效性	试验分期	III期	设计类型	平行分组
随机化	随机化	盲法	开放	试验范围	国际多中心试验

年龄	18岁(最小年龄)至 无上限 (最大年龄)
性别	男+女
健康受试者	无
入选标准	[["年龄≥18 岁，签署知情同意时为法定成人，且大于等于地区要求规定的法定成人年龄。"],["根据美国癌症联合委员会（AJCC）分期手册第 8.0 版和国际癌症控制联盟（UICC）分期系统（第 8 版），经组织学或细胞学确诊为局部晚期且不可切 除（IIIB、IIIC 期）或转移性（IV 期：M1a、M1b 或 M1c）NSCLC。"],["研究参与者必须患有非鳞状组织学 NSCLC：n排除鳞状或以鳞状组织学为主的肿瘤。n排除包含小细胞成分的肿瘤。"],["允许入组携带已知 AGA（例如，EGFR 突变、ALK 易位）的 NSCLC 研究参与者。"],["研究参与者必须接受过以下既往治疗，并且在接受最近的既往治疗期间出现疾病进展或治疗之后复发：n未携带已知 AGA 的研究参与者必须满足以下条件之一：n接受过治疗转移性或复发性疾病的铂类药物联合治疗和 PD-（L）1 单克隆抗体治疗（与铂类药物化疗同期或序贯进行），除非存在禁忌。n 在辅助、新辅助或放化疗治疗背景下接受铂类药物化疗末次给药后6 个月内发生疾病进展，并且在治疗过程中的任何时间接受了 PD-（L）1 单克隆抗体治疗。n携带已知 AGA（例如，EGFR 突变、ALK 易位或其他相关可靶向突变） 的研究参与者必须满足以下条件：n必须接受过至少 1 种相关 AGA 靶向治疗，并且研究者认为额外的AGA 靶向治疗不符合研究参与者的最佳利益。n接受过治疗转移性或复发性疾病的铂类药物联合治疗，或在辅助、 新辅助或放化疗治疗背景下接受铂类药物化疗末次给药后 6 个月内 发生疾病进展。n可能接受过最多一种 PD-（L）1 单克隆抗体（与铂类药物化疗同时 给药或序贯给药）。"],["研究者根据 RECIST v1.1 确定病灶可测量。"],["ECOG体能状态评分为0或1。"],["根据研究干预开始（第 1 周期第 1 天）前 7 天内获得的以下基线实验室标准， 确定器官功能良好：n血液学：tn中性粒细胞绝对计数≥1500/μLn血小板计数≥100,000/μLn血红蛋白≥9 g/dL 或≥5.6 mmol/Ln肝脏t：n血清胆红素≤1.5x 正常值上限（ULN）n丙氨酸氨基转移酶（ALT）、天门冬氨酸氨基转移酶（AST）和碱性磷酸酶：如果碱性磷酸酶>2.5xULN，则AST和ALT必须≤1.5xULN；如果碱性磷酸酶≤2.5xULN，则AST和ALT必须<2.5xULNn肾脏：tn估计肾小球滤过率（eGFR）≥45 mL/min/1.73 m2（使用肾病饮食调整（MDRD）研究公式（如适用）计算）n注：该表包括治疗所需的实验室检查值的资格定义；实验室检查值要求应根据当地法规和特定化疗给药指南进行调整。"],["符合以下条件的有生育能力的女性研究参与者（定义见第 10.4 节）：n第 1 周期第 1 天前 72 小时内，血清妊娠试验（最低灵敏度为 25 mIU/mL 或等效的 β 人绒毛膜促性腺激素[βhCG]定量检测方法）结果必须为阴性。 具有假阳性结果并有文件证明其未怀孕的研究参与者有资格参加研究。n必须同意在研究期间和研究干预末次给药后至少 2 个月内不怀孕。n必须同意从签署知情同意书开始持续至研究干预末次给药后至少 2 个月 内不哺乳且不捐献卵子。n如果性生活活跃可能导致妊娠，必须从签署知情同意书开始始终使用至 少 2 种可接受的节育（避孕）方法，其中至少 1 种必须高度有效（定义见第 10.4 节），持续至研究干预末次给药后至少 2 个月。"],["符合以下条件的可能使女性怀孕的男性研究参与者（定义见第 10.4 节）：n必须同意从签署知情同意书开始持续至研究干预末次给药后至少4个月内不捐献精子。n如果与有生育能力的女性性生活活跃，可能导致妊娠，则必须从签署知 情同意书开始始终使用至少2种可接受的节育（避孕）方法，其中至少1种必须高度有效（定义见第 10.4 节），持续至研究干预末次给药后至少4个月。n如果与处于妊娠期或哺乳期的女性性生活活跃，则必须从签署知情同意 书开始始终使用避孕套（定义见第 10.4 节），持续至研究干预末次给药后至少4个月。"],["能够提供以下任何肿瘤组织，用于生物标志物分析：n存档样本（最好在签署知情同意书前 2 年内采集）（详见实验室手册）或n来自肿瘤病灶的新鲜组织（如果医学上可行）。n对于不能按照上述要求提供存档肿瘤组织或新鲜肿瘤组织的研究参与者入组事宜，必须与申办方的医学监查员讨论。"],["研究参与者或研究参与者的法定授权代表必须提供书面知情同意书。"]]
排除标准	[["研究者认为预期寿命<3 个月。"],["已知对紫杉烷、多西他赛或 Sigvotatug Vedotin 药物制剂中包含的任何辅料过敏/发生超敏反应/不耐受或禁忌。"],["第 1 周期第 1 天前 6 个月内记录到有脑血管事件（卒中或短暂性脑缺血发作）、 不稳定型心绞痛、心肌梗死或符合纽约心脏病学会 III-IV 级的心脏症状史。"],["第 1 周期第 1 天前 3 年内有其他恶性肿瘤史，或有既往诊断恶性肿瘤的任何残 留病灶证据。转移或死亡风险可忽略不计的恶性肿瘤（例如，5 年 OS≥90%） 除外，如经过充分治疗的宫颈原位癌、非黑色素瘤皮肤癌、局限性前列腺癌、导管原位癌或 I 期子宫癌。"],["患有以下任何呼吸系统疾病的研究参与者：n1.非感染性 ILD 或非感染性肺部炎症的证据：n既往确诊且需要全身性类固醇治疗，或n目前确诊并接受治疗，或n筛选时放射影像学显示疑似。n2.已知 DLCO（经血红蛋白校正）<50%预测值n3.与基础恶性肿瘤无关的任何≥3 级肺部疾病，包括但不限于：n第 1 周期第 1 天前 3 个月内发生肺栓塞；n第 1 周期第 1 天前 30 天内需要全身性皮质类固醇或低剂量吸入性皮 质类固醇/长效 β-2 受体激动剂控制不佳的重度哮喘；n需要辅助供氧或全身性皮质类固醇治疗的重度慢性阻塞性肺疾病；n筛选时存在显著肺实质受累的任何自身免疫性或炎症性疾病（即类 风湿关节炎、舍格伦综合征、结节病等）。"],["第 1 周期第 1 天前 21 天内进行过大手术（定义为需要住院治疗至少 48 小时的手术），或第 1 周期第 1 天前 7 天内进行过小手术。在开始研究干预之前，研 究参与者必须已从毒性或手术并发症中充分恢复。必须从研究中排除计划在治疗期间进行大手术的研究参与者。"],["第 1 周期第 1 天前 30 天内接种过活疫苗。"],["根据 NCI CTCAE v5.0，判定既存≥2 级周围神经病变。"],["未受控制的糖尿病，定义为 HbA1c≥8.0%或 HbA1c 介于 7%至<8.0%之间，伴 有无法另行解释的相关糖尿病症状（多尿或烦渴）。"],["既往治疗：n既往在局部晚期、不可切除/难治性或转移性疾病阶段接受过抗微管类药 物（紫杉烷、长春花碱类或 MMAE）治疗。n？允许既往曾在根治性治疗背景（包括辅助、新辅助或放化疗）下接 受过抗微管类药物治疗。n既往在局部晚期、不可切除/难治性或转移性疾病阶段接受过超过 1 线的 细胞毒药物化疗。n？允许既往曾在根治性治疗背景下接受过细胞毒药物化疗。n从末次放疗给药至第 1 周期第 1 天必须至少间隔 14 天。研究参与者必须 已从所有放疗相关毒性中恢复，否则将无法参与试验。在与申办方的医 学监查员或其指定人员讨论后，允许在第 1 周期第 1 天前 14 天内进行姑息性放疗。n第 1 周期第 1 天前 6 个月内对肺实质的既往放射治疗>30 戈瑞（Gy）。n第 1 周期第 1 天前 21 天内接受过任何全身性抗癌治疗（标准或试验性治疗）。n将排除发生与既往治疗相关的≥2 级持续性毒性（脱发除外）的研究参与者。"],["有感染既往史或现病史，包括：n随机化时正在接受全身性抗菌治疗活动性感染（病毒、细菌或真菌感 染）。允许进行常规抗菌预防治疗。n已知人类免疫缺陷病毒（HIV）血清反应阳性，接受稳定抗逆转录病毒治疗（ART）方案后 HIV 感染得到控制的研究参与者除外。研究者应确 保 ART 不会与研究用药或伴随用药发生实质性相互作用。n乙型肝炎表面抗原表达阳性。n活动性丙型肝炎感染（聚合酶链反应[PCR]阳性）。如果在完成抗病毒治 疗后 12 周记录到持续病毒学应答，则允许接受丙型肝炎感染治疗的研究 参与者参加研究。n注：如果当地卫生监管机构强制要求，需进行 HIV 或乙型肝炎和丙型肝炎检测。"],["与既往 PD-L（1）抑制剂治疗相关的持续性免疫介导的 AEn患有充分控制且稳定的≤2 级内分泌疾病的研究参与者可入组研究。n患有≥3 级活动性免疫治疗相关内分泌疾病的研究参与者无资格参加研究。n患有持续性免疫治疗相关的心肌炎、结肠炎或葡萄膜炎的研究参与者无 资格参加研究。n发生其他免疫治疗相关 AE 且需要高剂量类固醇（>20 mg/天泼尼松或等 效药物）治疗的研究参与者无资格参加研究。"],["活动性中枢神经系统（CNS）病变（包括软脑膜转移）的患者无资格参加研究。接受过根治性治疗（手术和/或放疗）的脑部转移研究参与者如果符合以下标准，则有资格参加研究：n治疗开始前，CNS 转移已在临床上保持稳定至少 4 周，基线扫描提示无 新发的或扩大的转移证据。n研究参与者接受稳定剂量≤10 mg/天泼尼松或等效药物治疗，至少持续 2周（如果需要类固醇治疗）。n筛选访视前>1 个月内接受过皮质类固醇治疗，除非按照第 6.8.2 节中的规 定允许其作为伴随治疗。允许使用剂量稳定的抗惊厥药治疗。n在根治性放疗和/或手术后≥21 天，CNS 无临床和放射影像学疾病进展证据。"],["目前正在接受其他试验药物治疗。"],["患有其他严重基础疾病，研究者认为会损害研究参与者接受或耐受计划治疗和随访的能力。"],["直接参与研究实施的研究中心工作人员及其家人、以其他方式受研究者监管的研究中心工作人员，以及直接参与本研究实施的申办方和申办方代表员工及其家人。"]]

试验药	[["中文通用名:PF-08046047 英文通用名:SigvotatugVedotin 商品名称:NA","剂型:输注用浓缩粉 规格:40mg/瓶，4瓶/盒 用法用量:在28天周期的第1天和第15天（±3天）以1.8mg/kg调整后理想体重的剂量静脉输注30分钟 用药时程:研究干预给药将持续至出现疾病进展、因AE而停药、撤回知情同意、妊娠、研究者决定让研究参与者退出、研究参与者主动决定退出（非AE）、申办方终止研究、其他原因（非AE）或研究结束。"]] 序号 名称 用法
对照药	[["中文通用名:多西他赛 英文通用名:Docetaxel 商品名称:多西他赛注射液","剂型:输注用浓缩液 规格:80mg/4mL西林瓶包装，1瓶/盒 用法用量:在每个21天周期第1天（±3天）（每3周一次）以75mg/m2的剂量静脉输注1小时 用药时程:研究干预给药将持续至出现疾病进展、因AE而停药、撤回知情同意、妊娠、研究者决定让研究参与者退出、研究参与者主动决定退出（非AE）、申办方终止研究、其他原因（非AE）或研究结束。"]] 序号 名称 用法

主要终点指标及评价时间

[["OS","在约观察到 407 起 OS 事件时进行最终 OS 分析","有效性指标+安全性指标"],["BICR使用实体瘤疗效评价标准第1.1版（RECIST v1.1）评估的确认ORR","1年","有效性指标"]] 序号 指标 评价时间 终点指标选择

次要终点指标及评价时间

[["BICR使用RECIST v1.1评估的PFS","1年","有效性指标"],["研究者使用RECIST v1.1评估的确认 ORR","1年","有效性指标"],["研究者使用RECIST v1.1评估的PFS","1年","有效性指标"],["BICR使用RECIST v1.1评估的DORn研究者使用RECIST v1.1评估的DOR","1年","有效性指标"],["AE的类型、发生率、严重程度、严重性和相关性","1年","安全性指标"],["采用EORTC QLQ-C30评估的总体健康状态/QoL综合评分的平均评分和较基线的变化","1年","安全性指标"],["采用EORTC QLQ-C30评估的躯体功能和角色功能的平均评分和较基线的变化","1年","安全性指标"],["采用EORTC QLQ-LC13评估的呼吸困难、咳嗽和胸痛评分的 平均评分和较基线的变化","1年","安全性指标"],["采用EORTC QLQ-C30评估的总体健康状态/QoL综合评分的TTD;采用C30评估的躯体和角色功能评分的TTD;采用LC13评估的呼吸困难、咳嗽和胸痛评分的TTD","1年","安全性指标"]] 序号 指标 评价时间 终点指标选择

1	姓名	吴一龙	学位	医学博士	职称	主任医师
	电话	020-83827812-21190	Email	syylwu@live.cn	邮政地址	广东省-广州市-越秀区中山二路106号
	邮编	510080	单位名称	广东省人民医院

[["广东省人民医院","吴一龙","中国","广东省","广州市"],["广东省人民医院","汪斌超","中国","广东省","广州市"],["浙江省台州医院","吕冬青","中国","浙江省","台州市"],["安徽医科大学第一附属医院","杜瀛瀛","中国","安徽省","合肥市"],["吉林省肿瘤医院","程颖","中国","吉林省","长春市"],["山西白求恩医院（山西医学科学院）","张俊萍","中国","山西省","太原市"],["河南省肿瘤医院","王启鸣","中国","河南省","郑州市"],["浙江大学医学院附属邵逸夫医院","方勇","中国","浙江省","杭州市"],["南昌大学第一附属医院","左玮","中国","江西省","南昌市"],["湖南省肿瘤医院","邬麟","中国","湖南省","长沙市"],["四川大学华西医院","李潞","中国","四川省","成都市"],["广西医科大学附属肿瘤医院/广西壮族自治区肿瘤医院","于起涛","中国","广西壮族自治区","南宁市"],["广西医科大学附属肿瘤医院/广西壮族自治区肿瘤医院","谭莉萍","中国","广西壮族自治区","南宁市"],["山东第一医科大学附属肿瘤医院（山东省肿瘤防治研究院、山东省肿瘤医院）","邢力刚","中国","山东省","济南市"],["南京医科大学第一附属医院","束永前","中国","江苏省","南京市"],["临沂市肿瘤医院","石建华","中国","山东省","临沂市"],["首都医科大学附属北京胸科医院","刘喆","中国","北京市","北京市"],["西安交通大学第一附属医院","姚煜","中国","陕西省","西安市"],["华中科技大学同济医学院附属协和医院","董晓荣","中国","湖北省","武汉市"],["河南科技大学第一附属医院","张治业","中国","河南省","洛阳市"],["北京大学肿瘤医院","方健","中国","北京市","北京市"],["中国医科大学附属第一医院","赵明芳","中国","辽宁省","沈阳市"],["天津市肿瘤医院（天津医科大学肿瘤医院）","黄鼎智","中国","天津市","天津市"],["江门市中心医院","林大任","中国","广东省","江门市"],["四川省肿瘤医院","李娟","中国","四川省","成都市"],["重庆大学附属肿瘤医院","王春梅","中国","重庆市","重庆市"],["复旦大学附属肿瘤医院","王佳蕾","中国","上海市","上海市"],["福建省肿瘤医院","黄章洲","中国","福建省","福州市"],["浙江省肿瘤医院","范云","中国","浙江省","杭州市"],["佛山市第一人民医院","冯卫能","中国","广东省","佛山市"],["内蒙古自治区人民医院","李文新","中国","内蒙古自治区","呼和浩特市"],["浙江大学医学院附属第一医院","周建英","中国","浙江省","杭州市"],["University of California San Francisco | HDFCCC - Hematopoietic Malignancies","Cheng, Michael L.","美国","CALIFORNIA","San Francisco"],["Summit Health","Gurubhagavatula, Sarada","美国","NEW JERSEY","Florham"],["Oregon Health and Science University.","Huang, Ted","美国","OREGON","Portland"],["Comprehensive Cancer Centers of Nevada","Kingsley, Edwin C.","美国","NEVADA","Las Vegas"],["The University of Texas Health Science Center at Tyler on behalf of UT","Droder, Robert M","美国","TEXAS","Tyler"],["Alaska Oncology and Hematology, LLC","Liu, Steven Y","美国","ALASKA","Anchorage"],["NYU Langone Hospital","Schneider, Jeffrey Gary","美国","NEW YORK","Mineola"],["American Oncology Network Vista Oncology Division","Ye, Joseph Z.","美国","WASHINGTON","Olympia"],["UCLA Department of Medicine - Hematology & Oncology","Lisberg, Aaron","美国","CALIFORNIA","Santa Monica"],["University Of Texas Southwestern Medical Center","Dowell, Jonathan","美国","TEXAS","Dallas"],["University Hospitals Cleveland Medical Center","Santos Bruno, Debora","美国","OHIO","Cleveland"],["Miami Cancer Institute at Baptist Health, Inc.","Ahluwalia, Manmeet Singh","美国","FLORIDA","Miami"],["Hattiesburg Clinic Hematology/Oncology.","Hrom, John S.","美国","MISSISSIPPI","Hattiesburg"],["Medical College of Wisconsin (Milwaukee)","Thompson, Jonathan","美国","WISCONSIN","Milwaukee"],["St. Joseph Hospital Orange","Byun, Timothy E.","美国","CALIFORNIA","Orange"],["Cleveland Clinic","Pennell, Nathan Adam","美国","OHIO","Cleveland"],["Beth Israel Deaconess Medical Center","Rangachari, Deepa","美国","MASSACHUSETTS","Boston"],["Sansum Clinic","Bank, Eric","美国","CALIFORNIA","Santa Barbara"],["Willamette Valley Cancer Institute and Research Center","Wang, Bo","美国","OREGON","Eugene"],["New Mexico Cancer Center","Mapalo, Martha","美国","NEW MEXICO","Albuquerque"],["Minnesota Oncology Hematology, P.A","Eric, Lander","美国","MINNESOTA","Minneapolis"],["Texas Oncology","Uyeki, James V.H.","美国","TX","Austin"],["Northwest Cancer Centers, P.C.","Van Ho, Anthony","美国","WASHINGTON","Vancouver"],["New York Oncology Hematology PC","Evangelist, Makenzi C.","美国","NEW YORK","Albany"],["Oncology and Hematology Associates of Southwest Virginia","Goldschmidt, Jerome H.","美国","VIRGINIA","Blacksburg"],["Rocky Mountain Cancer Centers - Aurora","Jotte, Robert M","美国","COLORADO","Lone Tree"],["Alliance Cancer Specialists, PC","Potz, Joseph Louis","美国","PENNSYLVANIA","Horsham"],["Illinois Cancer Care.","Hakimian, David","美国","ILLINOIS","Niles"],["Cancer Care Centers of Brevard, Inc.","kancharla, Venkat pavan","美国","FLORIDA","Palm Bay"],["Texas Oncology","Khandelwal, Pankaj","美国","TEXAS","Odessa"],["Allina Health Cancer Institute - Abbott Northwestern Hospital","Fares, Charlene","美国","MINNESOTA","Saint Paul"],["Maryland Oncology Hematology P.A.","Bridges, Benjamin Buckner","美国","MARYLAND","Annapolis"],["Texas Oncology","Levin, Pavel A","美国","TEXAS","Webster"],["Cleveland Clinic Fairview Hospital","Pennell, Nathan Adam","美国","OHIO","Cleveland"],["Cleveland Clinic Hillcrest Hospital","Pennell, Nathan Adam","美国","OHIO","Cleveland"],["Providence Medical Foundation","Park, David J.","美国","CALIFORNIA","Fullerton"],["Comprehensive Blood and Cancer Center TRIO","Patel, Ravi Kumar","美国","CALIFORNIA","Bakersfield"],["Cancer Center of Kansas","Dakhil, Shaker R.","美国","KANSAS","Wichita"],["Saint Luke's Cancer Institute, LLC","Bansal, Dhruv","美国","MISSOURI","Kansas City"],["Cancer and Blood Specialty Clinic","Phan, Vu Quang","美国","CALIFORNIA","Los Alamitos"],["Oncology Hematology Care","Waterhouse, David","美国","OHIO","Cincinnati"],["Southcoast Health","Seng, Sonia","美国","MASSACHUSETTS","Fairhaven"],["University of Nebraska Medical Center.","Abughanimeh, Omar","美国","NEBRASKA","Omaha"],["Boston Medical Center","Tapan, Umit","美国","MASSACHUSETTS","Boston"],["Arizona Oncology Associates","Hamarneh, Iyad S.","美国","ARIZONA","Prescott"],["University of Massachusetts Medical School","Walsh, William V.","美国","MA","Worcester"],["Cancer Specialists of North Florida","Lourdes, Laura Shamini","美国","FLORIDA","Jacksonville"],["Northwest Medical Specialties, PLLC","Zhang, Li","美国","WASHINGTON","Tacoma"],["Ottawa Hospital Cancer Centre","Moore, Sara M","加拿大","ONTARIO","Ottawa"],["Tom Baker Cancer Centre","Navani, Vishal","加拿大","ALBERTA","Calgary"],["McGill University Department of Oncology/McGill University Health Centre","Saleh, Ramy","加拿大","QUEBEC","Montreal"],["Centre Hospitalier de l'Universite de Montreal","Blais, Normand","加拿大","QUEBEC","Montreal"],["Sunnybrook Health Sciences Centre","Menjak, Ines B","加拿大","ONTARIO","Toronto"],["University of Alberta / Cross Cancer Institute","Fenton, David","加拿大","ALBERTA","Edmonton"],["William Osler Health Sciences","Cheema, Parneet","加拿大","ONTARIO","East Brampton"],["CISSS de la Monteregie-Centre","Daaboul, Nathalie","加拿大","QUEBEC","Greenfield Park"],["Princess Margaret Hospital","Leighl, Natasha Basant","加拿大","ONTARIO","Toronto"],["Metropolitan Hospital","Linardou, Helena","希腊","NA","Athens"],["Alexandra General Hospital of Athens.","ZAGOURI, FLORA","希腊","NA","Athens"],["General University Hospital of Patras","Koutras, Angelos","希腊","NA","Patras"],["INTERBALKAN MEDICAL CENTER","Emmanouilides, Christos","希腊","OTHER","Pilea"],["Theagenio Cancer Hospital.","Papakotoulas, Pavlos","希腊","NA","Thessaloniki"],["Henry Dunant Hospital Center","Mountzios, Giannis","希腊","OTHER","Athens"],["Metropolitan General Hospital.","Katsaounis, Panagiotis","希腊","NA","Cholargos"],["Bioclinic Thessaloniki","Boukovinas, Ioannis","希腊","NA","THESSALONIKI"],["Athens Medical Center","Ramfidis, Vasileios","希腊","NA","Maroussi-Athens"],["St. Luke s Hospital","Korantzis, Ippokratis","希腊","NA","Thessaloniki"],["University Hospital of Larissa","Kotsakis, Athanasios","希腊","THESSALIA","Larissa"],["Athens Medical Group Psychiko Hospital","Karamouzis, Michalis","希腊","ATHENS","Psychiko"],["Leids Universitair Medisch Centrum (LUMC)","Smit, Egbert F","荷兰","NA","Leiden"],["Maastricht UMC","Hendriks, Lizza Elisabeth Lucia","荷兰","NA","Maastricht"],["Erasmus Medisch Centrum Daniel Den Hoed","Aerts, Joachim G.","荷兰","NA","Rotterdam"],["Martini Ziekenhuis","Van Putten, J.W.G.","荷兰","NA","Groningen"],["St. Antonius Hospital","Kastelijn, Elisabeth Lisanne","荷兰","NA","Utrecht"],["Jessa Ziekenhuis VZW","Cuppens, Kristof","比利时","NA","Hasselt"],["Algemeen Ziekenhuis Klina","Demey, Wim","比利时","NA","Brasschaat"],["University Hospital Ghent","Vermaelen, Karim Y.","比利时","NA","Ghent"],["Universitair Ziekenhuis Antwerpen","Wener, Reinier","比利时","NA","Edegem"],["CHU de Liege","Lecocq, Marie","比利时","NA","Liege"],["Centre Hospitalier Universitaire de Rennes, Hopital Pontchaillou","Le Guen, Yannick","法国","NA","Rennes Cedex 9"],["IGR Gustave Roussy","Planchard, David","法国","NA","Villejuif"],["CHRU de Lille","Cortot, Alexis","法国","NA","Lille"],["Hopital Nord - Batiment Mistral","Greillier, Laurent","法国","NA","Marseille"],["Hopital Sainte Musse","Audigier-Valette, Clarisse","法国","NA","Toulon"],["CHU Bordeaux Hopital Haut-Leveque","Veillon, Remi","法国","NA","Pessac"],["Institut de Cancerologie Strasbourg Europe","Schott, Roland","法国","NA","Strasbourg"],["CHU de Besancon - Hopital Jean Minjoz","Westeel, Virginie","法国","NA","Besancon"],["Hopital Cochin","Wislez, Marie Alice Veronique","法国","NA","Paris"],["CHU Toulouse Hopital Larrey","Mazieres, Julien","法国","NA","Toulouse"],["CCGM","Becht, Catherine","法国","NA","Montpellier"],["Centre Hospitalier Intercommunal Creteil - CHI Creteil","Chouaid, Christos","法国","NA","Creteil"],["CH de Cornouaille","Andre, Michel","法国","NA","Quimper"],["Hopital Bichat-Claude Bernard - APHP","Zalcman, Gerard","法国","NA","Paris"],["Centre Hospitalier de Cholet","Guillemois, Sylvere","法国","NA","Cholet"],["Hospices Civils de Lyon - Hopital Lyon Sud","Couraud, Sebastien","法国","NA","Pierre-Benite"],["Hospital Universitari Vall d'Hebron","Felip Font, Enriqueta","西班牙","NA","Barcelona"],["lnstitut Catala D'oncologia (ICO) Badalona - Hospital Universitari Germans Trias I Pujol","Carcereny, Enric","西班牙","NA","Barcelona"],["Fundación Instituto Valenciano de Oncología (FIVO)","Sandiego Contreras, SERGIO","西班牙","VALENCIA","Valencia"],["Hospital Clinico Universitario Lozano Blesa de Zaragoza","Isla Casado, Dolores","西班牙","NA","Zaragoza"],["Hospital General Universitario Gregorio Maranon","Alvarez Alvarez, Rosa Maria","西班牙","MADRID","Madrid"],["Hospital Universitari i Politecnic La Fe de Valencia","Juan Vidal, Oscar","西班牙","NA","Valencia"],["Hospital Universitario 12 de Octubre","Paz-Ares Rodriguez, Luis","西班牙","MADRID","Madrid"],["Complejo Hospitalario Universitario La Coruna","Garcia Campelo, Maria Rosario","西班牙","NA","A Coruna"],["Hospital Universitario Son Espases","Marse Fabregat, Raquel","西班牙","ISLAS BALEARES","Palma"],["Hospital Quironsalud Malaga","Cobo-Dols, Manuel","西班牙","NA","Malaga"],["Consorcio Hospitalario Provincial de Castellon","Rondan, Maria Arnal","西班牙","NA","Castello de la Plana"],["Hospital Clinic de Barcelona","Reguart Aransay, Noemi","西班牙","CATALUNYA [CATALUNA]","Barcelona"],["Hospital General Universitario Alicante","Massuti Sureda, Bartomeu","西班牙","ALICANTE","Alicante"],["HOSPITAL CLINICO SAN CARLOS","Gonzalez Larriba, Jose Luis","西班牙","MADRID","Madrid"],["Hospital Juan Ramon Jimenez","Sanchez Escudero, Laura","西班牙","NA","Huelva"],["Farkasgyepui Tudogyogyintezet","Kiraly, Zsolt","匈牙利","NA","Farkasgyepu"],["National Koranyi Institute of Pulmonology","Fulop, Andrea","匈牙利","NA","Budapest"],["Bacs-Kiskun Varmegyei Oktatokorhaz","Horvath, Zsolt","匈牙利","NA","Kecskemet"],["Tolna Megyei Balassa Janos Korhaz","Al-Farhat, Yousuf","匈牙利","NA","Szekszard"],["Centro di Riferimento Oncologico Di Aviano","Bearz, Alessandra","意大利","PORDENONE","Aviano"],["Istituto Nazionale Tumori Regina Elena","Cappuzzo, Federico","意大利","ROME","Roma"],["Policlinico Universitario Agostino Gemelli","Bria, Emilio","意大利","LAZIO","Roma"],["Azienda Ospedaliera Spedali Civili di brescia","Grisanti, Salvatore","意大利","PROVINCE OF BRESCIA","Brescia"],["Azienda Ospedaliera Universitaria San Martino","Genova, Carlo","意大利","LIGURIA","Genova"],["Fondazione IRCCS San Gerardo dei Tintori.","Cortinovis, Diego Luigi","意大利","LOMBARDY","Monza (MB)"],["Ospedale San Raffaele","Bulotta, Alessandra","意大利","LOMBARDY","Milano"],["A.O.U Policlinico G. Rodolico S. Marco","SOTO PARRA, HECTOR JOSE'","意大利","SICILY","Catania"],["Azienda Ospedaliero Universitaria di parma","Tiseo, Marcello","意大利","OTHER","Parma"],["Azienda Ospedaliera di Rilievo Nazionale Sant'Anna e San Sebastiano","Orditura, Michele","意大利","CAMPANIA","Caserta"],["Fondazione IRCCS Istituto Nazionale Dei Tumori","Proto, Claudia","意大利","LOMBARDY","Milano"],["A.O.U. - Ospedali Riuniti di Ancona","Berardi, Rossana","意大利","ANCONA","Torrette"],["IRCCS Istituto Romagnolo per lo Studio dei Tumori Dino Amadori- IRST S.r.l","Delmonte, Angelo","意大利","EMILIA-ROMAGNA","Meldola"],["Centrul de Oncologie Sf Nectarie","Schenker, Michael P.","罗马尼亚","NA","Craiova"],["Institutul Oncologic Prof. Dr. I. Chiricuta Cluj-Napoca","Muntean, Alina-Simona","罗马尼亚","NA","Cluj-Napoca"],["SC Policlinica CCBR SRL","Alexandru, Aurelia","罗马尼亚","NA","Bucuresti"],["Clinica Medicala Integra Lotus Med SRL","Gales, Laurentia Nicoleta","罗马尼亚","NA","Bucuresti"],["Spitalul de Oncologie Monza SRL","Iordan, Ingrid Adriana","罗马尼亚","NA","Bucuresti"],["Medisprof Cancer Center","Udrea, Anghel Adrian","罗马尼亚","NA","Cluj-Napoca"],["Ovidius Clinical Hospital S.R.L","Mazilu, Laura","罗马尼亚","NA","Constanta"],["Oncocenter-Oncologie Clinica SRL","Scheusan, Roxana Ioana","罗马尼亚","NA","Timisoara"],["Universitatsspital Basel","Schmitt, Andreas Michael","瑞士","NA","Basel"],["University Hospital Lausanne CHUV","Bouchaab, Hasna","瑞士","NA","Lausanne"],["Inselspital","Schmid, Sabine","瑞士","NA","Bern"],["Kantonsspital Graubunden","Mark, Michael","瑞士","NA","Chur"],["Universitatsspital Zurich","Bankel, Lorenz","瑞士","NA","Zurich"],["Nemocnice AGEL Ostrava Vitkovice a.s.,","Roubec, Jaromir","捷克共和国","NA","Ostrava"],["Onkologicka klinika VFN","Zemanova, Milada","捷克共和国","NA","Praha 2"],["Fakultni nemocnice Olomouc, Onkologicka klinika","Melichar, Bohuslav","捷克共和国","NA","Olomouc"],["AKH - Medizinische Universitat Wien","Kiesewetter-Wiederkehr, Barbara","奥地利","NA","Vienna"],["LKH- Universitat Klinikum Graz","absenger, Gudrun","奥地利","NA","Graz"],["The Royal Marsden NHS Foundation Trust (RM).","Minchom, Anna","英国","NA","London"],["The Beatson West of Scotland Cancer Centre","Steele, Nicola Louise","英国","NA","Glasgow"],["Christie Hospital NHS Foundation Trust","Hughes, Sarah Anne","英国","NA","Manchester"],["Barts Health NHS Trust Saint Bartholomews Hospital","Januszewski, Adam","英国","NA","London"],["Royal Marsden Hospital Sutton","Minchom, Anna","英国","NA","Sutton"],["The Newcastle upon Tyne Hospitals NHS Foundation Trust","Greystoke, Alastair","英国","NA","Newcastle Upon Tyne"],["University Hospitals of Leicester NHS Trust","Chauhan, Meera","英国","NA","Leicester"],["Sarah Cannon Research Institute UK","Joshi, Kroopa","英国","NA","London"],["Leeds Teaching Hospitals Trust","Jain, Pooja","英国","NA","Leeds"],["Vestre Viken Health Trust - Drammen Hospital","Brustugun, Odd Terje","挪威","NA","Drammen"],["Oslo University Hospital","Moksnes Bjaanaes, Maria","挪威","NA","Oslo"],["Kreftklinikken, St.Olavs hospital","Henning Gronberg, Bjorn","挪威","NA","Trondheim"],["Institute of Genetics and Immunology GENIM LCC","Chmielewska, Izabela","波兰","NA","Lublin"],["Medical University of Gdansk","Skrzypski, Marcin","波兰","OTHER","GdaDsk"],["Med-Polonia Sp. z.o.o.","Ramlau, Rodryg","波兰","NA","Poznan"],["Specjalistyczny Szpital Onkologiczny NU-MED sp. z o.o.","Chmielowska, Ewa","波兰","MAZOWIECKIE","Tomaszow"],["Instytut MSF Sp. z.o.o.","Kalinka, Ewa","波兰","NA","Lodz"],["Krankenhaus Martha-Maria Halle-Dolau GmbH","Schuette, Wolfgang","德国","OTHER","Halle"],["Universitatsklinkik Frankfurt","Sebastian, Martin","德国","NA","Frankfurt"],["Klinikum Esslingen GmbH","Faehling, Martin","德国","NA","Esslingen"],["Klinikum Kassel GmbH","Wolf, Martin","德国","NA","Kassel"],["Universitatsklinikum Heidelberg","Bozorgmehr, Farastuk","德国","NA","Heidelberg"],["Asklepios Klinik Gauting GmbH","Reinmuth, Niels","德国","NA","Gauting"],["Universitatsklinikum Schleswig-Holstein, Campus Lubeck","Bohnet, Sabine","德国","NA","Lubeck"],["Johanniter Krankenhaus Bonn","Ko, Yon-Dschun","德国","NA","Bonn"],["LungenClinic Grosshansdorf","Reck, Martin","德国","NA","Grosshansdorf"],["Lungenklinik Hemer","Schulmann, Karsten","德国","NA","Hemer"],["Universitaetsklinikum Muenster","Evers, Georg","德国","NA","Munster"],["Preparaciones Oncologicas, S.C","Gonzalez Trujillo, Jose Luis","墨西哥","NA","Leon"],["Centro Potosino de Investigacion Medica S.C.","Mendoza Oliva, Dolores Leticia","墨西哥","NA","San Luis Potosi"],["Hospital Civil Fray Antonio Alcalde","Vazquez Limon, Juan Carlos","墨西哥","NA","Guadalajara"],["Hospital Médica Tec 100","Feregrino Arreola, Juan Pablo","墨西哥","NA","Santiago de Querétar"],["Oncare","Cancel Trevino, Luis Antonio","墨西哥","NA","Monterrey"],["I CAN ONCOLOGY CENTER S.A. de C.V.","Medina Soto, Francisco Alejo","墨西哥","NA","Monterrey"],["Health Pharma Professional Research S.A. de C.V.","Ruiz Garcia, Abraham","墨西哥","NA","CDMX"],["Cryptex Investigacion Clinica S.C.","Motola Kuba, Daniel","墨西哥","NA","Distrito Federal"],["Accelerium Clinical Research","Martinez Lira, Jose Luis","墨西哥","NA","Monterrey"],["Centro de Investigacion Clinica de Oaxaca","Bautista Aragon, Yolanda Lizbeth","墨西哥","NA","Oaxaca de juarez"],["Consultorio del Dr. Joaquin Gabriel Reinoso Toledo","Reinoso-Toledo, Joaquin G.","墨西哥","NA","Monterrey"],["Instituto Alexander Fleming","Martin, Claudio","阿根廷","NA","Ciudad Autonoma Buenos Aires"],["Instituto de Oncologia de Rosario","Fein, Luis Enrique","阿根廷","NA","Rosario"],["Hospital Provincial Del Centenario","Ostoich, Sandra","阿根廷","NA","Rosario"],["Sanatorio Parque","Martinengo, Gaston Lucas","阿根廷","NA","Rosario"],["Centro Oncologico de Excelencia","Puig, Juan Manuel","阿根廷","NA","San Juan"],["CEMAIC - Centro Medico Privado","Salinas, Jorge Emilio","阿根廷","NA","Cordoba"],["Instituto de Investigaciones Clinicas de Mar del Plata","Casarini, Ignacio Alfredo","阿根廷","NA","Mar del Plata"],["Sanatorio Allende - Cerro","castagneris, nicolas","阿根廷","NA","Cordoba"],["Hospital General de Agudos Cecilia Grierson","Goy, Dante Pascual","阿根廷","NA","Caba"],["Hospital Italiano de Buenos Aires","Ferreira, Yamila","阿根廷","NA","Ciudad Autonoma de Buenos Aires"],["Fundacao Doutor Amaral Carvalho.","Beato, Patricia Medeiros Milhomem","巴西","NA","Jau"],["Centro de Oncologia da Bahia","de Cerqueira Mathias, Clarissa Maria","巴西","NA","Salvador"],["Hospital Mae de Deus","Azambuja, Alan Arrieira","巴西","NA","Porto Alegre"],["Sao Lucas Hospital of PUCRS","Barrios, Carlos Henrique Escosteguy","巴西","NA","Porto Alegre"],["Oncosite - Centro de Pesquisa Clinica e Oncologia","Franke, Fabio Andre","巴西","NA","Ijui"],["Centro Regional Integrado de Oncologia.","Cronemberger Costa e Silva, Eduardo Henrique","巴西","NA","Fortaleza"],["CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia.","Sette, Claudia Vaz de Melo","巴西","NA","Santo Andre"],["Hospital de Cancer de Barretos - Fundacao Pio XII","Baston Silva, Carlos","巴西","NA","Barretos"],["COT - Centro Oncologico do Triangulo Ltda.","Barbosa, Fernando Maciel","巴西","NA","Uberlandia"],["Grupo Oncoclinicas","De Marchi, Pedro Rafael Martins","巴西","NA","Rio de Janeiro"],["CeCim Biocinetic.","Gomez, Erik Leonardo","智利","NA","Santiago"],["Centro de Investigaciones Clinicas Vina del Mar","Perrot Rosenberg, llan Daniel","智利","NA","Vina Del Mar"],["Centro de Investigacion Clinica Bradford Hill","Rojas, Carlos Ignacio","智利","NA","Santiago"],["BIOCENTER Centro Clínico de Investigación","Rodriguez De Vasquez, Esther","智利","NA","Concepción"],["James Lind Centro De Investigacion Del Cancer","Yanez Ruiz, Eduardo","智利","NA","Temuco"],["CDIEM – Centro de Investigación y Especialidades Medicas","Munoz, Ricardo Silva","智利","NA","Huechuraba"],["Calvary Mater Newcastle","Mallesara, Girish","澳大利亚","NA","Waratah"],["Border Medical Oncology","Underhill, Craig Richard","澳大利亚","NEW SOUTH WALES","Albury"],["Frankston Hospital","Potasz, Nicole","澳大利亚","NA","Frankston"],["The Alfred Hospital","Moore, Maggie A.","澳大利亚","VICTORIA","Melbourne"],["St John of God Hospital Murdoch","Feeney, Kynan Tadao","澳大利亚","WESTERN AUSTRALIA","Murdoch"],["Royal Hobart Hospital","Black, Allison","澳大利亚","TASMANIA","Hobart"],["GenesisCare Kingswood","Karikios, Deme John","澳大利亚","NEW SOUTH WALES","Kingswood"],["Princess Alexandra Hospital","O'Byrne, Kenneth","澳大利亚","QUEENSLAND","Woolloongabba"],["Aichi Cancer Center","Shimizu, Junichi","日本","AICHI","Nagoya-shi"],["National Cancer Center Hospital","Horinouchi, Hidehito","日本","TOKYO","Chuo-ku"],["Kindai University Hospital","Tanizaki, Junko","日本","OSAKA","Osakasayama"],["Osaka International Cancer Institute","Tamiya, Motohiro","日本","OTHER","Osaka"],["NHO Shikoku Cancer Center","KOZUKI, TOSHIYUKI","日本","EHIME","Matsuyama-shi"],["Gunma Prefectural Cancer Center","Masubuchi, Ken","日本","TOKYO","Ota-shi"],["Shizuoka Cancer Center","Kobayashi, Haruki","日本","OTHER","Sunto-Gun"],["Kurume University Hospital","Tokito, Takaaki","日本","FUKUOKA","Kurume"],["Osaka Medical and Pharmaceutical University Hospital","Fujisaka, Yasuhito","日本","OSAKA","Takatsuki-shi"],["Nippon Medical School Hospital","Kasahara, Kazuo","日本","TOKYO","Bunkyo-ku"],["Kanazawa University Hospital","Tambo, Yuichi","日本","ISHIKAWA","Kanazawa-shi"],["Niigata Cancer Center Hospital","Tanaka, Hiroshi","日本","NIIGATA","Niigata-shi"],["Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital","Hosomi, Yukio","日本","TOKYO","Bunkyo-ku"],["National Cancer Center Hospital East","Izumi, Hiroki","日本","CHIBA","Kashiwa"],["Kobe City Hospital Organization Kobe City Medical Center General Hospital","Sato, Yuki","日本","TOKYO","Kobe-shi"],["Kansai Medical University Hospital","Kurata, Takayasu","日本","OSAKA","Hirakata-shi"],["Kanagawa Cancer Center","Saito, Haruhiro","日本","KANAGAWA","Yokohama"],["The Cancer Institute Hospital of JFCR","Ariyasu, Ryo","日本","TOKYO","koto-ku"],["Seoul National University Bundang Hospital","Kim, Se Hyun","韩国","NA","Seongnam-si"],["Severance Hospital, Yonsei University Health System.","Lim, Sun Min","韩国","NA","Seoul"],["Ajou University Hospital.","Lee, Hyun Woo","韩国","OTHER","Suwon-si"],["St. Vincent's Hospital, The Catholic University of Korea.","Shim, Byoung Yong","韩国","OTHER","Suwon-si"],["Jeonbuk National University Hospital","Song, Eun-kee","韩国","NA","Jeonju-si"],["CHA Bundang Medical Center","Kim, Joo-Hang","韩国","OTHER","Seongnam"],["Asan Medical Center.","Kim, Sang-We","韩国","OTHER","Seoul"],["Korea University Anam Hospital","Choi, Yoon Ji","韩国","OTHER","Seoul"],["Chungbuk National University Hospital.","Lee, Ki Hyeong","韩国","OTHER","Cheongju-si"],["Kaohsiung Medical University Hospital.","Hung, Jen-Yu","中国台湾","OTHER","Kaohsiung"],["National Taiwan University Hospital Yunlin Branch","Chen, Chung-Yu","中国台湾","OTHER","Douliou City"],["Taipei Veterans General Hospital","Luo, Yung-Hung","中国台湾","OTHER","Taipei City"],["Changhua Christian Hospital","Lin, Sheng-Hao","中国台湾","NA","Changhua"],["E-Da Hospital","Wei, Yu-Feng","中国台湾","OTHER","Kaohsiung"],["Adana City Hospital.","Cil, Timucin","土耳其","OTHER","Adana"],["Ankara University Medical Faculty","Cay Senler, Filiz","土耳其","NA","Ankara"],["Goztepe Prof. Dr. Suleyman Yalcin City Hospital.","Gumus, Mahmut","土耳其","OTHER","Istanbul"],["Necmettin Erbakan University Meram Medical Faculty - Oncology","Artac, Mehmet","土耳其","OTHER","Konya"],["Medipol Mega Hospital - Medical Oncology","Bilici, Ahmet","土耳其","OTHER","Istanbul"],["Ondokuz May1s University of Medicine","Yilmaz, Bahiddin","土耳其","NA","Samsun"],["Istanbul University Cerrahpasa Medical Faculty.","Ozguroglu, Mustafa","土耳其","OTHER","Istanbul"],["Tel Aviv Sourasky Medical Center","Merimsky, Ofer","以色列","OTHER","Tel Aviv"],["Meir Medical Center","Gottfried, Maya","以色列","OTHER","Kfar Saba"],["Kaplan Medical Center","Evron, Ella","以色列","HAMERKAZ","Rehovt"],["Shaare Zedek Medical Center","Peled, Nir","以色列","NA","Jerusalem"],["Rabin Medical Center.","Moskovitz, Mor","以色列","OTHER","Petach Tikva"]]

序号	机构名称	主要研究者	国家	省（州）	城市

[["广东省人民医院伦理审查委员会","同意","2024-10-12"],["广东省人民医院伦理审查委员会","同意","2024-11-01"]]

序号	名称	审查结论	批准日期/备案日期

进行中（尚未招募）

目标入组人数	国内: 100 ； 国际: 600 ；
已入组人数	国内: 登记人暂未填写该信息； 国际: 236 ；
实际入组总人数	国内: 登记人暂未填写该信息； 国际: 登记人暂未填写该信息；

第一例受试者签署知情同意书日期	国内：登记人暂未填写该信息；     国际：2024-02-21；
第一例受试者入组日期	国内：登记人暂未填写该信息；     国际：2024-03-06；
试验完成日期	国内：登记人暂未填写该信息；     国际：登记人暂未填写该信息；