北京替雷利珠单抗注射液（皮下注射）III期临床试验-一项在不可切除或转移性胃或胃食管结合部腺癌患者中对比替雷利珠单抗皮下注射联合化疗和静脉输注联合化疗的研究

登记号	CTR20253206	试验状态	进行中
申请人联系人	李越	首次公示信息日期	2025-08-13
申请人名称	广州百济神州生物制药有限公司

登记号	CTR20253206
相关登记号	暂无
药物名称	替雷利珠单抗注射液（皮下注射）
药物类型	生物制品
临床申请受理号	企业选择不公示
适应症	胃或胃食管结合部腺癌
试验专业题目	一项替雷利珠单抗皮下注射联合化疗对比静脉输注联合化疗作为局部晚期不可切除或转移性胃或胃食管结合部腺癌患者一线治疗的3期、多中心、随机、开放性临床研究
试验通俗题目	一项在不可切除或转移性胃或胃食管结合部腺癌患者中对比替雷利珠单抗皮下注射联合化疗和静脉输注联合化疗的研究
试验方案编号	BGB-A317-316	方案最新版本号	原始方案
版本日期:	2025-02-21	方案是否为联合用药	是

申请人名称	[["广州百济神州生物制药有限公司"]]
联系人姓名	李越	联系人座机	4008203-159	联系人手机号
联系人Email	ClinicalTrials@beigene.com	联系人邮政地址	北京市-北京市-北京市昌平区中关村生命科学园，科学院路30号	联系人邮编	102206

证明替雷利珠单抗皮下注射给药相较于静脉输注给药的药代动力学（PK）非劣效性

试验分类	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	[["患有经组织学证实的局部晚期不可切除或转移性胃/胃食管结合部腺癌。"],["既往未曾接受过针对局部晚期不可切除或转移性胃/胃食管结合部癌症的全身治疗。"],["基于研究者根据RECIST 1.1版进行的评估，有至少1个可测量或不可测量病灶。"],["患者必须能够提供肿瘤组织用于生物标志物评估。"],["ECOG体能状态评分≤ 1"],["器官功能良好"],["有生育能力的女性须愿意在研究期间以及在替雷利珠单抗末次给药后≥ 120天采取高效避孕措施，且在随机化前≤ 7天尿液或血清妊娠试验结果为阴性。"],["未绝育的男性须愿意在研究期间以及在替雷利珠单抗末次给药后≥ 120天采取高效避孕措施。"]]
排除标准	[["患有鳞状细胞或未分化的或其他组织学类型的胃癌"],["有活动性软脑膜疾病或未得到控制的脑转移。转移结果不明确或确认脑转移的患者如果在随机化之前≥ 4周一直没有症状、经影像学检查确定处于稳定状态，且无需皮质类固醇治疗，则可入组。"],["诊断为HER2阳性的胃或胃食管结合部腺癌"],["有活动性自身免疫性疾病或有自身免疫性疾病史且可能复发。"],["随机化前7天内出现控制不良的胸腔积液、心包积液或需要频繁引流（至少每周一次）和/或使用利尿剂的腹水（允许通过细胞学技术来确诊任何积液）。"]]

试验药

[["中文通用名:替雷利珠单抗 英文通用名:Tislelizumab 商品名称:百泽安","剂型:注射剂 规格:300mg(2mL)/支 用法用量:300mg，每个21天周期的第1天皮下注射 用药时程:第1周期和第2周期：皮下注射，等待60分钟后给予化疗第3周期及后续周期：皮下注射，等待30分钟后给予化疗"],["中文通用名:奥沙利铂 英文通用名:NA 商品名称:齐沙","剂型:注射液 规格:50mg/瓶 用法用量:奥沙利85mg/m2+亚叶酸持续给药超过2小时（第1天），随后5-FU，每2周重复一次 用药时程:奥沙利85mg/m2+亚叶酸持续给药超过2小时（第1天），随后5-FU，每2周重复一次"],["中文通用名:亚叶酸 英文通用名:NA 商品名称:注射用左亚叶酸钙","剂型:注射液 规格:25mg/支 用法用量:奥沙利85mg/m2+亚叶酸持续给药超过2小时（第1天），随后5-FU，每2周重复一次 用药时程:奥沙利85mg/m2+亚叶酸持续给药超过2小时（第1天），随后5-FU，每2周重复一次"],["中文通用名:卡培他滨 英文通用名:NA 商品名称:卓仑","剂型:片剂 规格:0.15g/片*10片/板*1板/袋*1袋/盒或0.5g/片*12片/板*1板/袋*1袋/盒 用法用量:卡培他滨1000mg/m2（联合奥沙利铂）连续14天口服给药，每日两次。 用药时程:卡培他滨1000mg/m2（联合奥沙利铂）连续14天口服给药，每日两次，每3周重复一次，在完成初始12~24周研究治疗后，患者将继续接受维持治疗，即替雷利珠单抗300mgSC给药加可选的氟尿嘧啶类（卡培他滨或5-FU，给药剂量基于当地治疗规范）。"],["中文通用名:顺铂 英文通用名:NA 商品名称:注射用顺铂","剂型:冻干型 规格:20mg/支 用法用量:顺铂80mg/m2（第1天），联合5-FU，第1天至第5天每天24小时持续IV输注，每3周重复一次 用药时程:顺铂80mg/m2（第1天），联合5-FU，第1天至第5天每天24小时持续IV输注，每3周重复一次"],["中文通用名:5-FU 英文通用名:NA 商品名称:扶伊恒","剂型:注射液 规格:10ml:0.25g 用法用量:联合奥沙利铂+亚叶酸使用时，5-FU（2400至2800mg/m2）持续IV输注超过24或48小时，每2周重复一次；联合顺铂使用时，5-FU800mg/m2，第1天至第5天每天24小时持续IV输注，每3周重复一次。 用药时程:在完成初始12~24周研究治疗后，患者将继续接受维持治疗，即替雷利珠单抗300mgSC给药加可选的氟尿嘧啶类（卡培他滨或5-FU，给药剂量基于当地治疗规范）。"]] 序号 名称 用法

对照药

[["中文通用名:替雷利珠单抗 英文通用名:Tislelizumab 商品名称:百泽安","剂型:注射剂 规格:100mg(10mL)/瓶 用法用量:200mg，每个21天周期的第1天静脉输注 用药时程:第1周期：输注时间不短于60分钟（等待60分钟后给予化疗）第2周期：输注时间不短于30分钟（等待60分钟后给予化疗）第3周期及后续周期：输注时间不短于30分钟（等待30分钟后给予化疗）"],["中文通用名:奥沙利铂 英文通用名:NA 商品名称:齐沙","剂型:注射液 规格:50mg/瓶 用法用量:奥沙利85mg/m2+亚叶酸持续给药超过2小时（第1天），随后5-FU，每2周重复一次 用药时程:奥沙利85mg/m2+亚叶酸持续给药超过2小时（第1天），随后5-FU，每2周重复一次"],["中文通用名:亚叶酸 英文通用名:NA 商品名称:注射用左亚叶酸钙","剂型:注射液 规格:25mg/支 用法用量:奥沙利85mg/m2+亚叶酸持续给药超过2小时（第1天），随后5-FU，每2周重复一次 用药时程:奥沙利85mg/m2+亚叶酸持续给药超过2小时（第1天），随后5-FU，每2周重复一次"],["中文通用名:卡培他滨 英文通用名:NA 商品名称:卓仑","剂型:片剂 规格:0.15g/片*10片/板*1板/袋*1袋/盒或0.5g/片*12片/板*1板/袋*1袋/盒 用法用量:卡培他滨1000mg/m2（联合奥沙利铂）连续14天口服给药，每日两次。 用药时程:卡培他滨1000mg/m2（联合奥沙利铂）连续14天口服给药，每日两次，每3周重复一次，在完成初始12~24周研究治疗后，患者将继续接受维持治疗，即替雷利珠单抗200mgIV给药加可选的氟尿嘧啶类（卡培他滨或5-FU，给药剂量基于当地治疗规范）。"],["中文通用名:顺铂 英文通用名:NA 商品名称:注射用顺铂","剂型:冻干型 规格:20mg/支 用法用量:顺铂80mg/m2（第1天），联合5-FU，第1天至第5天每天24小时持续IV输注，每3周重复一次 用药时程:顺铂80mg/m2（第1天），联合5-FU，第1天至第5天每天24小时持续IV输注，每3周重复一次"],["中文通用名:5-FU 英文通用名:NA 商品名称:扶伊恒","剂型:注射液 规格:10ml:0.25g 用法用量:联合奥沙利铂+亚叶酸使用时，5-FU（2400至2800mg/m2）持续IV输注超过24或48小时，每2周重复一次；联合顺铂使用时，5-FU800mg/m2，第1天至第5天每天24小时持续IV输注，每3周重复一次。 用药时程:在完成初始12~24周研究治疗后，患者将继续接受维持治疗，即替雷利珠单抗200mgIV给药加可选的氟尿嘧啶类（卡培他滨或5-FU，给药剂量基于当地治疗规范）。"]] 序号 名称 用法

主要终点指标及评价时间

[["模型预测的稳态血清谷浓度（Ctrough）","85天","有效性指标"],["模型预测的第1周期首次给药后0时至21天的血清浓度-时间曲线下面积（AUC0-21d）","21天","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

[["基于研究者根据实体瘤疗效评价标（RECIST）1.1版评估的结果确定的总缓解率（ORR）","最长两年","有效性指标"],["基于研究者根据实体瘤疗效评价标（RECIST）1.1版评估的结果确定的无进展生存期（PFS）","最长两年","有效性指标"],["基于研究者根据实体瘤疗效评价标（RECIST）1.1版评估的结果确定的缓解持续时间（DOR）","最长两年","有效性指标"],["基于研究者根据实体瘤疗效评价标（RECIST）1.1版评估的结果确定的疾病控制率（DCR）","最长两年","有效性指标"],["基于研究者根据实体瘤疗效评价标（RECIST）1.1版评估的结果确定的总生存期（OS","最长两年","有效性指标"],["不良事件（AE）和严重不良事件（SAE）按类型、频率、严重程度（美国国家癌症研究所不良事件通用术语标准[NCI-CTCAE] 5.0版）、发生时间、严重性以及与研究治疗的关系进行描述","最长两年","安全性指标"],["模型预测的第1周期Ctrough","21天","有效性指标"],["实测第1周期Ctrough","21天","有效性指标"],["实测第1周期AUC","21天","有效性指标"],["模型预测的稳态AUC（AUCss）","85天","有效性指标"],["SC或IV给药后出现替雷利珠单抗抗药抗体（ADA）的患者百分比","最长两年","有效性指标"]] 序号 指标 评价时间 终点指标选择

1	姓名	周爱萍	学位	博士	职称	主任医师
	电话	136 9116 1998	Email	zhouap1825@126.com	邮政地址	北京市-北京市-朝阳区潘家园南里17号
	邮编	100021	单位名称	中国医学科学院肿瘤医院

[["中国医学科学院肿瘤医院","周爱萍","中国","北京市","北京市"],["郑州大学第一附属医院","王峰","中国","河南省","郑州市"],["河南省肿瘤医院","赵燕","中国","河南省","郑州市"],["南京医科大学附属鼓楼医院","刘芹","中国","江苏省","南京市"],["安徽医科大学第二附属医院","张明军","中国","安徽省","合肥市"],["厦门大学附属第一医院","蔡铭泉","中国","福建省","厦门市"],["安阳市肿瘤医院","夏金","中国","河南省","安阳市"],["温州医科大学附属第一医院","李文峰","中国","浙江省","温州市"],["赣州市人民医院","彭卫卫","中国","江西省","赣州市"],["天津医科大学附属肿瘤医院","邓婷","中国","天津市","天津市"],["中国医科大学附属第一医院","曲晶磊","中国","辽宁省","沈阳市"],["山东省肿瘤医院","刘波","中国","山东省","济南市"],["山西省肿瘤医院","杨文慧","中国","山西省","太原市"],["济宁医学院附属医院","韩磊","中国","山东省","济宁市"],["长治市人民医院","赵军","中国","山西省","长治市"],["CITY OF HOPE NATIONAL MEDICAL CENTER","CASTILLO, DANI","United States","California","Duarte"],["COMPREHENSIVE CANCER CENTERS OF NEVADA","BRAITEH, FADI","United States","Nevada","Las Vegas"],["NORTHWESTERN UNIVERSITY","KALYAN, APARNA","United States","Illinois","Chicago"],["MD ANDERSON CANCER CENTER","AJANI, JAFFER","United States","Texas","Houston"],["SUMMIT MEDICAL GROUP","KOVTUN, JEANETTE","United States","New Jersey","Florham Park"],["SCOTT AND WHITE MEMORIAL HOSPITAL","WONG, LUCAS","United States","Texas","Temple"],["CANCER & BLOOD SPECIALTY CLINIC","ABDULLA, NIHAL","United States","California","Los Alamitos"],["UNIVERSITY OF KANSAS MEDICAL CENTER RESEARCH INSTITUTE","AL-RAJABI, RAED","United States","Kansas","Kansas City"],["HUNTERDON HEMATOLOGY ONCOLOGY","SHAH, MEGHA","United States","New Jersey","Flemington"],["NORTHWEST MEDICAL SPECIALTIES","CHAVES, JORGE","United States","Washington","Tacoma"],["UNIVERSITY OF COLORADO HEALTH – MEMORIAL HOSPITAL","HOYER, ROBERT","United States","Colorado","Springs"],["PAN AMERICAN ONCOLOGY TRIALS, LLC","AROCHO, KARINA","United States","Puerto Rico","Rio Piedras"],["NEBRASKA HEMATOLOGY ONCOLOGY","MOSALPURIA, KAILASH","United States","Nebraska","Lincoln"],["HOPE AND HEALING CANCER SERVICES","GUNDALA, SRILATA","United States","Illinois","Hinsdale"],["BIORESEARCH PARTNERS HOLDING- HIALEAH HOSPITAL","RANGEL, LUIS","United States","Florida","Hialeah"],["IRONWOOD CANCER & RESEARCH CENTERS","MANTRIPRAGADA, KALYAN","United States","Arizona","Chandler"],["ORLANDO HEALTH UFHEALTH CANCER CENTER","SHAMEEM, RAJI","United States","Florida","Orlando"],["NEW ENGLAND CANCER SPECIALISTS","DUGAN, MATTHEW","United States","Maine","Westbrook"],["OREGON ONCOLOGY SPECIALISTS","STROTHER, JOHN","United States","Oregon","Salem"],["VANDERBILT UNIVERSITY","GIBSON, MICHAEL","United States","Tennessee","Nashville"],["HOPITAL CLAUDE HURIEZ - CHU LILLE","PLOQUIN, ANNE","France","Lille","Lille"],["CHRU DE BREST - HOPITAL CAVALE BLANCHE","METGES, JEAN-PHILIPPE","France","Brest","Brest"],["INSTITUT SAINTE CATHERINE","MINEUR, LAURENT","France","AVIGNON","AVIGNON"],["HOSPITAL UNIVERSITARIO MIGUEL SERVET","PAZO CID, ROBERTO","Spain","Zaragoza","Zaragoza"],["HOSPITAL CLINIC DE BARCELONA","SAURI NADAL, TAMARA","Spain","Barcelona","Barcelona"],["HOSPITAL CLINICO UNIVERSITARIO DE VALENCIA","FLEITAS KANONNIKOFF, TANIA","Spain","VALèNCIA","VALèNCIA"],["HOSPITAL UNIVERSITARIO DE NAVARRA","ALSINA MAQUEDA, MARIA","Spain","Pamplona","Pamplona"],["A.O.U. PISANA, STABILIMENTO DI SANTA CHIARA","FORNARO, LORENZO","Italy","Pisa","Pisa"],["OSPEDALE POLICLINICO SAN MARTINO-IRCCS PER L ONCOLOGIA, DIVISIONE EMATOLOGIA CENTRO TRAPIANTI DI MID","PESSINO, ANNAMARIA","Italy","Genova","Genova"],["ISTITUTO CLINICO HUMANITAS","SANTORO, ARMANDO","Italy","Rozzano","Rozzano"],["FONDAZIONE IRCCS ISTITUTO NAZIONALE DEI TUMORI","PIETRANTONIO, FILIPPO","Italy","Milano","Milano"],["KRANKENHAUS DER BARMHERZIGEN SCHWESTERN LINZ","DOLESCHAL, BERNHARD","Austria","Linz","Linz"],["MEDICAL UNIVERISTY VIENNA","ILHAN-MUTLU, AYSEGüL","Austria","Wien","Wien"],["CAMBRIDGE UNIVERSITY HOSPITALS NHS FOUNDATION TRUST","PURUSHOTHAMAN, KIRAN","United Kingdom","Cambridge","Cambridge"],["CLATTERBRIDGE CANCER CENTRE","ALCHAWAF, ALIA","United Kingdom","Wirral","Wirral"],["BELFAST CITY HOSPITAL","TURKINGTON, RICHARD","United Kingdom","Belfast","Belfast"],["NINEWELLS HOSPITAL AND MEDICAL SCHOOL","PETTY, RUSSELL","United Kingdom","Dundee","Dundee"],["PRATIA MCM KRAKóW","DROSIK-KWASNIEWSKA, ANNA","Poland","KRAKóW","KRAKóW"],["KLINIKA ONKOLOGII SPZOZ OPOLSKIE CENTRUM ONKOLOGII","RADECKA, BARBARA","Poland","OPOLE","OPOLE"],["NARODOWY INSTYTUT ONKOLOGII IM. MARII SK？ODOWSKIEJ-CURIE – HEMATOLOGY UNIT","WYRWICZ, LUCJAN","Poland","WARSZAWA","WARSZAWA"],["HEALTH PHARMA PROFESSIONAL RESEARCH S.A. DE C.V","VALENZUELA, ANA","Mexico","Ciudad de Mexico","Ciudad de Mexico"],["CENTRO DE INVESTIGACION CLINICA DE OAXACA","CASTRO ALONSO, FRANCISCO JAVIER","Mexico","Oaxaca De Juárez","Oaxaca De Juárez"],["MEDICAL CARE AND RESEARCH S.A DE C.V","BALANCáN ZAPATA, PAOLA MARIANELA","Mexico","Merida","Merida"],["HOSPITAL ALEMAN","CASTILLO, JAVIER","Argentina","CABA","CABA"],["HOSPITAL DE GASTROENTEROLOGIA CARLOS BONORINO UDAONDO","MENDEZ, GUILLERMO","Argentina","Ciudad Autónoma Buenos Aires","Ciudad Autónoma Buenos Aires"],["FUNDACION CORI PARA LA INVESTIGACION Y PREVENCION DEL CANCER","KAEN, DIEGO LUCAS","Argentina","La Rioja","La Rioja"],["INCA - INSTITUTO NACIONAL DE C？NCER","DUTRA, JAMILLE","Brazil","Rio De Janeiro","Rio De Janeiro"],["HOSPITAL DE AMOR BARRETOS","DIAS COSTA, LETICIA","Brazil","Barretos","Barretos"],["ICESP - INSTITUTO DO C？NCER DO ESTADO DE S？O PAULO OCTAVIO FRIAS DE OLIVEIRA","MOTTA VENCHIARUTTI MONIZ, CAMILA","Brazil","S？o Paulo","S？o Paulo"],["HOSPITAL S？O LUCAS DA PUCRS","SPILLARI VIOLA, LUCIANA","Brazil","Porto Alegre","Porto Alegre"],["FUNDA？？O FACULDADE REGIONAL DE MEDICINA DE S？O JOSé DO RIO PRETO","ABDALLA, KATHIA","Brazil","S？o José Do Rio Preto","S？o José Do Rio Preto"],["INSTITUTO D’OR DE PESQUISA E ENSINO - S？O PAULO","GEHM HOFF, PAULO MARCELO","Brazil","S？o Paulo","S？o Paulo"],["HOSPITAL SANTA RITA DE CASSIA - AFECC","DE MELO BARRETO, ERIKA","Brazil","Vitória","Vitória"],["HOSPITAL BRASILIA","DOS SANTOS FERNANDES, GUSTAVO","Brazil","Brasilia","Brasilia"],["CECAP","RAMOS, BRUNO RAFAEL","Brazil","Blumenau","Blumenau"],["IMIP","RAMERI, CARLA","Brazil","Recife","Recife"],["HOSPITAL UNIVERSIARIO ONOFRE LOPES","DE MENDON？A REGO, JULIANA FLORINDA","Brazil","Natal","Natal"],["SAITAMA CANCER CENTER","TAKAHASHI, NAOKI","Japan","Saitama","Kitaadachi-gun"],["OSAKA MEDICAL AND PHARMACEUTICAL UNIVERSITY HOSPITAL","YAMAGUCHI, TOSHIFUMI","Japan","Osaka","Takatsuki-shi"],["JAPAN COMMUNITY HEALTH CARE ORGANIZATION KYUSHU HOSPITAL","SHINOHARA, YUDAI","Japan","Fukuoka","Kitakyushu"],["TOCHIGI CANCER CENTER","MATSUSHITA, HISAYUKI","Japan","Tochigi","Utsunomiya-Shi"],["HAMAMATSU UNIVERSITY SCHOOL OF MEDICINE, UNIVERSITY HOSPITAL","TAKEUCHI, HIROYA","Japan","Shizuoka","Hamamatsu-shi"],["MATSUYAMA RED CROSS HOSPITAL","SHIRAISHI, TAKESHI","Japan","Ehime","Matsuyama-shi"],["NHO HOKKAIDO CANCER CENTER","SAGAWA, TAMOTSU","Japan","Hokkaido","Sapporo-Shi"],["INSTITUTE OF SCIENCE TOKYO HOSPITAL","HAMAMOTO, YASUO","Japan","Tokyo","Tokyo"],["OSAKA ROSAI HOSPITAL","AKAMARU, YUSUKE","Japan","Osaka","Sakai-Shi"],["TOKYO METROPOLITAN BOKUTOH HOSPITAL","FURUMOTO, YOHEI","Japan","Tokyo","Sumida-Ku"],["SEVERANCE HOSPITAL YONSEI UNIVERSITY HEALTH SYSTEM","RHA, SUN YOUNG","Korea","Seoul Teugbyeolsi","Seodaemun-Gu"],["SEOUL NATIONAL UNIVERSITY HOSPITAL","OH, DO-YOUN","Korea","Seoul Teugbyeolsi","Seoul"],["SEOUL NATIONAL UNIVERSITY BUNDANG HOSPITAL","LEE, KEUN-WOOK","Korea","Gyeonggi-do","Bundang-Gu, Seongnam-Si"],["ASAN MEDICAL CENTER","RYU, MIN-HEE","Korea","Seoul Teugbyeolsi","Songpa-Gu"],["SAMSUNG MEDICAL CENTER","LEE, JEEYUN","Korea","Seoul Teugbyeolsi","Gangnam-Gu"],["KYUNGPOOK NATIONAL UNIVERSITY CHILGOK HOSPITAL","KIM, JONG GWANG","Korea","Gyeongsangbukdo","Buk-Gu"],["ACIBADEM ADANA HOSPITAL","DISEL, UMUT","Turkey","Kuruk？prü","Kuruk？prü"],["DR. ABDURRAHMAN YURTASLAN ANKARA ONCOLOGY TRAINING AND RESEARCH HOSPITAL","KARACIN, CENGIZ","Turkey","Ankara","Ankara"],["MEDICAL PARK SEYHAN HOSPITAL","BE？EN, ALI AYBERK","Turkey","Adana","Adana"],["MEDICAL PARK FLORYA HOSPITAL","CICIN, IRFAN","Turkey","Sefak？y","Sefak？y"],["FAKULTNI NEMOCNICE HRADEC KRALOVE","VOSMIK, MILAN","Czech Republic","Hradec Králové","Hradec Králové"],["FAKULTNI NEMOCNICE OLOMOUC","MELICHAR, BOHUSLAV","Czech Republic","Olomouc","Olomouc"],["VSEOBECNA FAKULTNI NEMOCNICE V PRAZE","VOCKA, MICHAL","Czech Republic","Praha","Praha"],["MASARYKUV ONKOLOGICKY USTAV","LORDICK OBERMANNOVA, RADKA","Czech Republic","BRNO","BRNO"]]

序号	机构名称	主要研究者	国家	省（州）	城市

[["郑州大学第一附属医院临床试验伦理委员会","同意","2025-06-19"],["中国医学科学院肿瘤医院伦理委员会","同意","2025-07-11"]]

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: 112 ； 国际: 351 ；
已入组人数	国内: 登记人暂未填写该信息； 国际: 登记人暂未填写该信息；
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：登记人暂未填写该信息；
第一例受试者入组日期	国内：登记人暂未填写该信息；     国际：登记人暂未填写该信息；
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；