登记号
CTR20160510
相关登记号
曾用名
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
完全切除的IB-IIIA期非小细胞肺癌患者
试验通俗题目
Atezolizumab 对比最佳支持治疗作为非小细胞肺癌患者辅助治疗的试验
试验专业题目
一项比较顺铂为基础辅助化疗后ATEZOLIZUMAB与最佳支持治疗在非小细胞肺癌患者中的疗效和安全性的开放性、随机III期研究
试验方案编号
GO29527;第7.0版
方案最近版本号
11
版本日期
2023-02-16
方案是否为联合用药
企业选择不公示
申请人信息
申请人名称
联系人姓名
赵稚薇
联系人座机
010-65623560
联系人手机号
联系人Email
zhiwei.zhao@roche.com
联系人邮政地址
北京市-北京市-朝阳区金和东路20号院正大中心南塔9层
联系人邮编
100020
临床试验信息
试验分类
安全性和有效性
试验分期
III期
试验目的
1. 疗效目的: 根据研究者评估的无病生存期和总生存期评价Atezolizumab治疗十六个疗程与最佳支持治疗相比的疗效。 2. 安全性目的: (1)安全性和耐受性。(2)评价辅助治疗情况下抗Atezolizumab的抗治疗抗体(ATA)发生率和滴度,并探索性研究其免疫原性反应与药代动力学、安全性、疗效之间的潜在关系 3. 药代动力学目的 4. 探索性目的。
随机化
随机化
盲法
开放
试验范围
国际多中心试验
设计类型
平行分组
年龄
18岁(最小年龄)至
无岁(最大年龄)
性别
男+女
健康受试者
无
入选标准
- (第1-12是入选阶段的入选标准)参与本研究时,要求需提供患者代表性的福尔马林固定石蜡包埋(FFPE)肿瘤标本(首选),或切除的FFPE肿瘤标本的至少15张(或更多)未染色新切的连续组织切片(在载玻片上)。同时必须提供上述标本的相关病理报告;
- 签署知情同意书
- 年龄 ≥ 18岁
- ECOG体能状况评分为0或1
- 组织学或细胞学诊断为IB(肿瘤≥ 4 cm)-IIIA期(T2-3 N0,T1-3 N1,T1 3 N2,T4 N0 1)NSCLC
- 入选前,患者为NSCLC完全切除术后4-12周(≥ 28天且≤ 84天),且必须已完全从手术中恢复。可接受的切除术类型包括:肺叶切除术、袖状肺叶切除术、双肺叶切除术或肺切除术。肺段切除术或楔形切除术不可接受;
- 如果在术前未进行纵隔镜检查,则至少要求实施纵隔淋巴结系统取样,而首选完整的纵隔淋巴结清扫术(MLND)更佳。系统取样定义为在特定位置取至少一个具有代表意义的淋巴结。而MLND则要求清扫同一站的所有淋巴结。对于右侧开胸术,要求在4和7站行取样或MLND,而对于左侧开胸术,则要求在5和/或6和7站。如果手术报告中包括明确记录或要求的淋巴结区域探查的胸外科医生单独递交补充报告证明在上述区域中未发现淋巴结,则患者可以入组研究。如果患者一个N2淋巴结区确诊,则无需对所有淋巴结区采样。如果术前分期成像结果(对比CT和PET扫描)没有提示纵隔病变的证据,如果没有根据外科医生的决定进行N2淋巴结采样,则该患者将被视为符合条件;
- 有资格接受以顺铂为基础的化疗方案
- 满足下述实验室检查结果定义的恰当的血液学和内部器官功能,这些检查结果需在入选前14天内完成:ANC ≥ 1500细胞/μL。血小板计数≥ 100,000细胞/μL。凝血酶原时间/INR ≤ 1.5,或如果患者正在接受抗凝剂治疗,则凝血酶原时间/INR < 3.0。aPTT ≤通用正常值上限(ULN),或如果患者正在接受抗凝剂治疗,则aPTT必须< 1.5×ULN。总胆红素≤ 1.25 × ULN。已知患有Gilbert病的患者,允许血清胆红素水平≤ 3 × ULN。SGOT(AST)≤2.5×ULN。SGPT(ALT)≤2.5×ULN。采用机构指南或标准Cockcroft和Gault公式(1976)计算的肌酐清除率(CRCL)≥60 mL/min;
- 对于有生育能力妇女和具有生育潜力伴侣的男性:同意(由患者和/或伴侣)在研究治疗期间使用高效的避孕形式,使用始终如一且正确,每年的失败率≤ 1%。男性和女性应在最后一剂顺铂化疗(顺铂加长春瑞滨、多西他赛、吉西他滨或培美曲塞)后6个月继续采取避孕措施。使用Atezolizumab治疗的妇女应在最后一次给药后继续避孕5个月。在此期间,女性不得捐献卵子。 如果女性患者已绝经但尚未达到绝经后状态(绝经时间≥连续12个月,除绝经外无其他原因)、并且未接受绝育手术(摘除卵巢和/或子宫),则认为该类患者具备生育能力。 失败率<1%/年的避孕方法实例包括双侧输卵管结扎术、男性绝育法、正确使用可抑制排卵的激素避孕药、释放激素的宫内节育器和含铜宫内节育器。 与应评价临床研究期间、患者的首选和通常生活方式相关的禁欲可靠性。定期禁欲(如推算日历法、排卵期法、征状体温避孕法或排卵后安全期避孕法)和性交中断都不是可接受的避孕方法;
- 未绝经(非治疗诱导性闭经≥ 12个月)或未进行绝育手术的妇女,在开始接受顺铂为基础化疗前14天内,血清妊娠试验结果必须呈阴性;
- (第11-14是随机化期间的入选标准)入选阶段结束和以顺铂为基础化疗达4个疗程后,患者必须符合以下所有标准方可进入随机化期并接受Atezolizumab或BSC
- 满足下述实验室检查结果定义的恰当的血液学和内部器官功能,这些检查结果需在入选前14天内完成:ANC ≥ 1500细胞/μL(未接受粒细胞集落刺激因子支持治疗)。淋巴细胞计数≥ 500细胞/μL。血小板计数≥ 100,000细胞/μL。血红蛋白≥ 9.0 g/dL,患者可通过输血达到该项标准。INR或aPTT ≤ 1.5 × ULN,这一标准仅适用于目前没有接受抗凝治疗的患者;对于目前正在接受抗凝治疗的患者,应接受稳定剂量的抗凝剂治疗。AST、ALT和碱性磷酸酶≤ 2.5 × ULN,血清胆红素≤ 1.25 × ULN;已知患有Gilbert病的患者,允许血清胆红素水平≤ 3×ULN 。计算的CRCL ≥ 30 mL/min,CRCL的计算,采用机构指南或标准Cockcroft和Gault公式(1976)计算;
- 未绝经(绝经定义:非治疗诱导性闭经≥ 12个月)或未进行绝育手术的妇女,在开始接受Atezolizumab或BSC前14天内,血清妊娠试验结果必须呈阴性。
排除标准
- (第1-20是入选阶段的排除标准)可能会影响患者理解、遵循和/或遵守研究程序的能力的疾病或病症;
- 妊娠期或哺乳期妇女;
- 既往接受过系统性化疗。只要最后一次接受的剂量在入选前超过5年,可以在医学监查员批准后允许恶性肿瘤的早期阶段化疗。 医学监查员批准后,可允许对非恶性疾病进行低剂量化疗;
- 入选研究前5年内接受过激素癌症疗法或放射疗法治疗 在入选研究5年前接受过手术、生理疗法、激素疗法或放射疗法治疗恶性肿瘤目前认为达到治愈的患者可进入研究;
- 在入选前28天内,任何其他研究药物治疗以治疗为目的的临床研究必须已结束;
- 连续两次听力损伤(听力测定法)25 dB(仅已经怀疑或确定听力损伤的患者要求听力测定);
- 已知对化疗方案任何成分或甘露醇过敏的患者;
- 既往接受过CD137激动剂或免疫检查点阻断治疗、抗PD-1、抗PD-L1、治疗性抗体治疗。 如果符合以下要求,曾接受过抗CTLA-4治疗的患者可以入选: 随机入组前至少6周末次给予抗CTLA-4, 无抗CTLA-4严重免疫介导的不良反应史(NCI CTCAE 3和4级)
- 入选前5年内有除NSCLC外的恶性肿瘤病史,但转移或死亡风险可忽略不计(例如预期5年OS >90%),且经治疗后预期可痊愈的恶性肿瘤除外(如已适当治疗的宫颈原位癌,基底或鳞状细胞皮肤癌,接受根治性手术治疗的局限性前列腺癌,根治性手术治疗的导管原位癌);
- 患有对嵌合或人源化抗体或融合蛋白产生严重变应性、过敏反应或其他超敏反应的病史;
- 已知对由中国仓鼠卵巢细胞准备的生物药品或Atezolizumab制剂任何成分过敏;
- 自身免疫性疾病病史,包括但不限于重症肌无力、肌炎、自身免疫性肝炎、系统性红斑狼疮、类风湿性关节炎、炎症性肠病、抗磷脂综合征相关的血管血栓形成、Wegener's肉芽肿病、干燥综合征、格林-巴利综合征、多发性硬化、血管炎、肾小球肾炎等。对于有自身免疫性相关甲状腺功能减退病史的患者,若正在接受稳定剂量的甲状腺激素替代治疗,可参与本项研究。 通过稳定的胰岛素给药方案治疗后,血糖得以控制的I型糖尿病患者,可参与本项研究。 只有皮肤症状的湿疹、牛皮癣或慢性单纯性苔癣白癜风患者(如没有牛皮癣性关节炎),如果符合以下条件则允许参与本项研究: 皮疹必须覆盖小于10%的全身表面积(BSA)。 基线时疾病控制良好且仅需要低效外用类固醇类。 过去12个月内,没有需要使用PUVA [补骨脂素光化学疗法]、甲氨蝶呤、类维生素A、生物制剂、口服钙神经磷酸酶抑制剂或高效类固醇或口服类固醇治疗的基础疾病急性恶化;
- HIV检测结果阳性。纳入研究前,所有患者将接受HIV检测,HIV阳性患者将被排除在临床研究之外;
- 活动性乙肝(慢性或急性;定义为筛选期乙肝病毒表面抗原[HBsAg]检测结果呈阳性)或丙肝患者。 既往乙肝病毒(HBV)感染或HBV感染已治愈的患者(定义为乙型肝炎核心(HBc)抗体阳性且HBsAg阴性),只要他们HBV DNA呈阴性,可参与本项研究。在入选前,必须对该类患者实施HBV DNA检测。 丙肝病毒(HCV)抗体呈阳性的患者中,仅聚合酶链反应显示HCV RNA呈阴性的患者可参与本项研究;
- 活动性结核;
- 患有严重的心血管疾病,如纽约心脏病学会心功能分级(Ⅱ级或更高)、前3个月内发生的心肌梗塞或脑血管意外、不稳定性心律失常、不稳定型心绞痛。 已知患有冠状动脉疾病、不符合上述标准的充血性心力衰竭、或左心室射血分数< 50%的患者,必须接受主治医生认为最佳的稳定治疗方案治疗,必要时可咨询心脏病专家;
- 患有特发性肺纤维化病史、机化性肺炎(如闭塞性细支气管炎)、药物性肺炎、特发性肺炎或胸部CT扫描筛选时发现活动性肺炎证据。 放射野的放射性肺炎(纤维化)病史的患者可参与本研究;
- 既往接受过同种异体骨髓移植或实体器官移植的患者;
- 任何其它疾病、代谢障碍、体检结果或实验室检查异常结果,并有理由怀疑可能导致禁忌使用研究药物、或影响研究结果可靠性、或使患者处于高风险的治疗并发症的疾病或病症;
- 已知的肿瘤PD-L1表达状态,如通过来自其他临床研究的IHC测定(例如在筛选以备入选抗PD-1或抗PD-L1抗体的研究期间确定PD-L1表达状态,但没有资格入组的患者被排除在外)。
- (第21-25是随机化期的排除标准)随机化前14天内出现感染体征或症状(随机化前28天内出现重度感染),包括但不限于因感染、菌血症或重度肺炎并发症而住院治疗;
- 随机分配前14天内接受过口服或IV抗生素治疗。 接受预防性抗生素治疗(如为预防尿路感染或预防慢性阻塞性肺疾病使用抗生素)的患者可入组;
- 开始研究治疗前4周内接受过重大手术,或预期将在研究期间接受重大手术;
- 随机化前28天内使用减毒活疫苗的患者,或估计研究期间需要使用减毒活疫苗。? 在随机化前4周内或药物的5个半衰期(以较长者为准)接受过全身免疫刺激剂治疗(包括但不限于干扰素或白介素 2)。 允许治疗前接种癌症疫苗。
- 随机化前14天内,接受过全身糖皮质激素或其他免疫抑制药物治疗(包括但不限于泼尼松、地塞米松、环磷酰胺、硫唑嘌呤、甲氨蝶呤、沙利度胺和抗肿瘤坏死因子[抗TNF]药物)。 对于接受过急性、低剂量(≤ 10mg口服泼尼松或同等剂量)、全身性免疫抑制剂治疗的患者,可随机入组至本项研究。 使用皮质类固醇(≤ 10mg口服泼尼松或同等剂量)治疗慢性阻塞肺疾病的患者、盐皮质激素类(如氟氢可的松)治疗体位性低血压的患者,或使用小剂量糖皮质激素补充剂治疗肾上腺皮质功能减退的患者可以入组。
试验分组
试验药
名称 | 用法 |
---|---|
中文通用名:MPDL3280A 注射液
|
用法用量:注射液;规格1200mg/20ml;静脉注射,每3周一次,每次1200mg,用药时程将持续直到失去临床获益、不可耐受的毒性、患者或医生决定中止治疗、或接受试验治疗的患者死亡。
|
中文通用名:MPDL3280A 注射液
|
用法用量:注射液;规格1200mg/20ml;静脉注射,每3周一次,每次1200mg,用药时程将持续直到失去临床获益、不可耐受的毒性、患者或医生决定中止治疗、或接受试验治疗的患者死亡。
|
中文通用名:MPDL3280A 注射液
|
用法用量:注射液;规格1200mg/20ml;静脉注射,每3周一次,每次1200mg,用药时程将持续直到失去临床获益、不可耐受的毒性、患者或医生决定中止治疗、或接受试验治疗的患者死亡。
|
中文通用名:MPDL3280A 注射液
|
用法用量:注射液;规格1200mg/20ml;静脉注射,每3周一次,每次1200mg,用药时程将持续直到失去临床获益、不可耐受的毒性、患者或医生决定中止治疗、或接受试验治疗的患者死亡。
|
对照药
名称 | 用法 |
---|---|
中文通用名:最佳支持治疗
|
用法用量:根治术后NSCLC患者的标准疗法为四个疗程的顺铂为基础辅助化疗之后定期胸部X线检查和/或计算机断层(CT)扫描随访, 由研究者评判临床最佳的治疗方案
|
终点指标
主要终点指标
指标 | 评价时间 | 终点指标选择 |
---|---|---|
在接受过顺铂为基础辅助化疗的完全切除的IB期(肿瘤>= 4 cm)-IIIA期肿瘤患者中,根据研究者评估的无病生存期(DFS)评价Atezolizumab治疗十六个疗程与最佳支持治疗相比的疗效。 | 14个月 | 有效性指标+安全性指标 |
次要终点指标
指标 | 评价时间 | 终点指标选择 |
---|---|---|
在接受过顺铂为基础辅助化疗的完全切除的IB期(肿瘤>= 4 cm)-IIIA期肿瘤患者中,根据总生存期(OS)评价Atezolizumab治疗十六个疗程与最佳支持治疗(BSC)相比的疗效 | 14个月 | 有效性指标+安全性指标 |
数据安全监察委员会(DMC)
有
为受试者购买试验伤害保险
有
研究者信息
姓名 | 学位 | 职称 | 电话 | 邮政地址 | 邮编 | 单位名称 | |
---|---|---|---|---|---|---|---|
王洁 | 医学博士 | 主任医师 | 13910704669 | zlhuxi@163.com | 北京市-北京市-北京市朝阳区潘家园南里17号 | 100021 | 中国医学科学院肿瘤医院 |
各参加机构信息
机构名称 | (主要)研究者 | 国家 | 地区 | 城市 |
---|---|---|---|---|
中国医学科学院肿瘤医院 | 王洁 | 中国 | 北京 | 北京 |
上海市肺科医院 | 周彩存 | 中国 | 上海 | 上海 |
中国医学科学院肿瘤医院 | 李峻岭 | 中国 | 北京 | 北京 |
苏州大学附属第一医院 | 陶敏 | 中国 | 江苏 | 苏州 |
复旦大学肿瘤医院 | 陈海泉 | 中国 | 上海 | 上海 |
广州医科大学第一附属医院属医院 | 何建行 | 中国 | 广州 | 广州 |
广东省人民医院 | 钟文昭 | 中国 | 广州 | 广州 |
301医院 | 胡毅 | 中国 | 北京 | 北京 |
中国医科大学附属第一医院 | 刘云鹏 | 中国 | 辽宁 | 辽宁 |
中山大学肿瘤防治中心 | 张力 | 中国 | 广州 | 广州 |
辽宁省肿瘤医院 | 李晓玲 | 中国 | 辽宁 | 辽宁 |
浙江省肿瘤医院 | 范云 | 中国 | 杭州 | 杭州 |
江苏省人民医院 | 束永前 | 中国 | 江苏 | 南京 |
安徽省立医院 | 潘跃银 | 中国 | 安徽 | 合肥 |
广东医科大学附属医院 | 杨志雄 | 中国 | 广州 | 广州 |
中国医学科学院肿瘤医院 | 王洁 | 中国 | 北京 | 北京 |
Cabrini Hospital Malvern | RICHARDSON GARY | AUSTRALIA | Victoria | Malvern |
Princess Alexandra Hospital | OByrne Kenneth | AUSTRALIA | Queensland | Woolloongabba |
Townsville Hospital | Joshi Abhishek | AUSTRALIA | Queensland | Douglas |
Adelaide Cancer Centre | PARNIS FRANCIS | AUSTRALIA | South Australia | KURRALTA PARK |
Cliniques Universitaires St-Luc | Collard, DR. Philippe | BELGIUM | BRUXELLES | BRUXELLES |
CHU Sart-Tilman | Bourhaba Maryam | BELGIUM | Lige | Lige |
William Osler Health Centre | Conter Henry | CANADA | Ontario | Brampton |
CITE DE LA SANTE DE LAVAL HEMATO-ONCOLOGIE | Comeau Reginald | CANADA | Quebec | LAVAL |
TORONTO EAST GENERAL HOSPITAL | Li Jing | CANADA | Ontario | Toronto |
Clinique Clmentville | Becht Catherine | FRANCE | Montpellier | Montpellier |
Centre Hospitalier de Saint-QuentinPharmacie-URCC | Dayen Charles | FRANCE | Saint-Quentin | Saint-Quentin |
HPITAL SAINT JOSEPHONCOLOGIE MEDICALE | Foa Cyril | FRANCE | MARSEILLE | MARSEILLE |
Centre Hospitalier Regional Sud ReunionService de Pneumologie | Huchot Eric | FRANCE | Saint Pierre | Saint Pierre |
Centre Lon Bard Centre Rgional de Lutte Contre Le Cancer Rhne Alpes | PEROL MAURICE | FRANCE | Lyon | Lyon |
Hpital Universitaire Dupuytren | Bennouna Jaafar | FRANCE | St Herblain | St Herblain |
Centre Paul Strauss | VERGNENEGRE ALAIN | FRANCE | Limoges | Limoges |
Centre Hospitalier Intercommunal Toulon - La Seyne sur Mer | SCHOTT ROLAND | FRANCE | STRASBOURG | STRASBOURG |
Hpital dInstruction des Armes de Sainte Anne | Audigier Valette Clarisse | FRANCE | Toulon | Toulon |
Hopital dInstruction des Armees de Begin | BERARD HENRI | FRANCE | Toulon | Toulon |
Centre Paul Papin | Helissey Carole | FRANCE | Saint-Mande | Saint-Mande |
Centre Hospitalier de Mont de Marsan - Hopital Layne | Bennouna Jaafar | FRANCE | DAX | DAX |
Universittsklinikum Hamburg-Eppendorf | Loges Sonja | GERMANY | Hamburg | Hamburg |
Lungenklinik Hemer | SERKE | GERMANY | HEMER | HEMER |
Augusta Kranken-Anstalt gGmbH | Behringer Dirk | GERMANY | Bochum | Bochum |
Thorax Klinik | Bischoff Helge | GERMANY | Heidelberg | Heidelberg |
Krankenhaus Nordwest | Atmaca Akin | GERMANY | Frankfurt | Frankfurt |
Evang. Lungenklinik Berlin Klinik fr Pneumologie | Grohé Christian | GERMANY | Berlin | Berlin |
Fachklinik fr Lungenerkrankungen | Rittmeyer Achim | GERMANY | Immenhausen | Immenhausen |
Asklepios Klinik Harburg | Wesseler Claas | GERMANY | Hamburg | Hamburg |
Krankenhaus Barmherzige Bruder Regensburg | Stauder Heribert | GERMANY | Regensburg | Regensburg |
Klinik Loewenstein gGmbHOnk & Pal | Fischer Juergen Richard | GERMANY | Loewenstein | Loewenstein |
Universittsklinikum des Saarlandes | Weissinger Florian | GERMANY | Homburg | Homburg |
Krankenhaus Martha-Maria Halle-Dolau gGmbH | Schütte Wolfgang | GERMANY | Halle | Halle |
LungenClinic Grosshansdorf | Reck Martin | GERMANY | GROSSHANSDORF | GROSSHANSDORF |
Kliniken der Stadt Koln gGmbH Lungenklinik Onkologische Ambulanz | Engel-Riedel Walburga | GERMANY | Koln | Koln |
Pius-Hospital | Griesinger Frank | GERMANY | Oldenburg | Oldenburg |
Ev.Krankenhaus Bielefeld gGmbH Klinik für Innere Medizin und Geriatrie | SERKE MONIKA | GERMANY | Würzburg | Würzburg |
Klinikum Bogenhausen | Kokowski Konrad | GERMANY | München | München |
Gemeinschaftspraxis fr Hmatologie und Onkologie | Liersch Rüdiger | GERMANY | München | München |
Prince of Wales Hosp Dept. Of Clinical Onc | MOK TONY SHU KAM | 中国香港 | HK | HK |
Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rend.Int. | Csoszi Tibor | HUNGARY | SZOLNOK | SZOLNOK |
Pecsi Tudomanyegyetem I. sz. Belgyogyaszati Klinika | Sarosi Veronika | HUNGARY | Pecs | Pecs |
Semmelweis Egyetem | Losonczy Gyorgy | HUNGARY | Budapest | Budapest |
Tudogyogyintezet Torokbalint | MARK ZSUZSANNA | HUNGARY | Torokbalint | Torokbalint |
Tel Aviv Sourasky Medical CtrOncology | MERIMSKY OFER | ISRAEL | TEL AVIV | TEL AVIV |
Kaplan Medical Center | Katsnelson Rivka | ISRAEL | Rehovot | Rehovot |
Rabin Medical Center | STEMMER SALOMON | ISRAEL | PETACH TIKVA | PETACH TIKVA |
RAMBAM MEDICAL CENTER ONCOLOGY | Wollner Mirjana | ISRAEL | Haifa | Haifa |
CHAIM SHEBA MEDICAL CENTERONCOLOGY DEPT | Bar Jair | ISRAEL | Ramat Gan | Ramat Gan |
Assaf Harofeh Medical Center | Cyjon Arnold | ISRAEL | ZERIFIN | ZERIFIN |
MEIR MEDICAL CENTER ONCOLOGY | GOTTFRIED MAYA | ISRAEL | KFAR SABA | KFAR SABA |
Azienda Sanitaria Ospedaliera S Luigi Gonzaga | Novello Silvia | ITALY | Piemonte | Orbassano |
A.O.U. Maggiore della Carità | Borra Gloria | ITALY | Piemonte | Novara |
Azienda Sanitaria Ospedaliera s. Croce e Carle Oncologia Medica | Colantonio Ida | ITALY | Piemonte | CUNEO |
Azienda per lAssistenza Sanitaria N° 5 - Friuli OccidentaleS.C. Oncologia Pordenone | Del Conte Alessandro | ITALY | Friuli-Venezia Giulia | Pordenone |
Azienda Ospedaliera Universitaria Integrata Verona UOC Oncologia | Santo Antonio | ITALY | Veneto | VERONA |
Ospedale San Raffaele | GIANNI LUCA | ITALY | Lombardia | MILANO |
Azienda Ospedaliero Universitaria Pisana | Chella Antonio | ITALY | Toscana | PISA |
Ospedale Clinicizzato SS Annunziata | Natoli Clara | ITALY | Abruzzo | Chieti |
Asst Papa Giovanni XXIII Oncologia Medica | Bettini Anna Cecilia | ITALY | Lombardia | Bergamo |
Ospedale Santa Chiara Oncologia Medica | Caffo Orazio | ITALY | Trentino-Alto Adige | Trento |
Azienda Ospedaliera Di Rilievo Nazionale E Di Alta Specializzazione Garibaldi | BORDONARO ROBERTO | ITALY | Sicilia | Catania |
Presidio Ospedaliero Centrale | Pisconti Salvatore | ITALY | Puglia | Statte |
Policlinico Universitario Campus Biomedico Di Roma U.O.Oncologia Medica | TONINI GIUSEPPE | ITALY | Lazio | ROMA |
Ospedale Silvestrini | Chiari Rita | ITALY | Umbria | Perugia |
Azienda Ospedaliera Città della Salute e della Scienza di Torino | CIUFFREDA LIBERO | ITALY | Piemonte | TORINO |
ASST Spedali Civili di Brescia | Ferrari Vittorio | ITALY | Lombardia | Brescia |
Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital | Hosomi Yukio | JAPAN | TOKYO | TOKYO |
Hiroshima University Hospital | Okada Morihito | JAPAN | Hiroshima | Hiroshima |
Okayama University Hospital | Kubo Toshio | JAPAN | Okayama | Okayama |
Kyoto University Hospital | Kim Young Hak | JAPAN | Kyoto | Kyoto |
Juntendo University Hospital | Tajima Ken | JAPAN | Tokyo | Tokyo |
Tokyo Medical University Hospital | Ikeda Norihiko | JAPAN | Shinjuku-ku | Shinjuku-ku |
Hospital of the University of Occupational and Environmental Health,Japan | Tanaka Fumihiro | JAPAN | Fukuoka | Fukuoka |
Shizuoka Cancer Center | Kenmotsu Hirotsugu | JAPAN | Sunto-gun | Sunto-gun |
National Cancer Center Hospital | Ohe Yuichiro | JAPAN | Chuo | Chuo |
Saitama Cancer Center | Sakai Hiroshi | JAPAN | Saitama | Saitama |
National Hospital Organization Hokkaido Cancer Center | Harada Masao | JAPAN | Hokkaido | Hokkaido |
Toranomon Hospital | Kishi Kazuma | JAPAN | Tokyo | Tokyo |
Wakayama Medical University Hospital | Tokudome Nahomi | JAPAN | Wakayama-shi | Wakayama-shi |
National Cancer Center East | Matsumoto Shingo | JAPAN | TOKYO | TOKYO |
Kanagawa Cancer Center | Saito Haruhiro | JAPAN | Kanagawa | Kanagawa |
Kyushu University Hospital | Okamoto Tatsuro | JAPAN | Fukuoka | Fukuoka |
Shikoku Cancer Center | Yamashita Motohiro | JAPAN | Matsuyama-shi | Matsuyama-shi |
Hyogo Cancer Center | Yoshimura Masahiro | JAPAN | Akashi | Akashi |
Niigata Cancer Center Hospital | Yoshiya Katsuo | JAPAN | Niigata-shi | Niigata-shi |
Sendai Kousei Hospital | Sugawara Shunichi | JAPAN | Sendai | Sendai |
Kyorin University Hospital | Kondo Haruhiko | JAPAN | Mitaka-shi | Mitaka-shi |
Aichi Cancer Center Hospital | Sakao Yukinori | JAPAN | Aichi | Aichi |
Nagoya University Hospital | Yokoi Kohei | JAPAN | Nagoya | Nagoya |
Kumamoto University Hospital | Kohrogi Hirotsugu | JAPAN | Kumamoto | Kumamoto |
Chonnam National University Hwasun Hospital | KIM YOUNG-CHUL | KOREA | GWANGJU | GWANGJU |
The Catholic University of Korea St. Vincents Hospital | KIM HOON-KYO | KOREA | SUWON | SUWON |
Seoul National University Bundang Hospital | LEE JONG-SEOK | KOREA | BUNDANG CITY | BUNDANG CITY |
Catharina ziekenhuis | VAN DEN BORNE BEN | NETHERLANDS | Eindhoven | Eindhoven |
Jeroen Bosch Ziekenhuis | BIESMA B. | NETHERLANDS | Den Bosch | Den Bosch |
St. Antonius Ziekenhuis Nieuwegein | Schramel F. | NETHERLANDS | Utrecht | Utrecht |
Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis | Van den Heuvel Michel | NETHERLANDS | Amsterdam | Amsterdam |
Martini Ziekenhuis | Wouter Jacobs | NETHERLANDS | Groningen | Groningen |
Universitair Medisch Centrum Utrecht | van Lindert Anne | NETHERLANDS | Utrecht | Utrecht |
Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy | SZCZESNA ALEKSANDRA | POLAND | Otwock | Otwock |
Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu | Bryl Maciej | POLAND | Poznan | Poznan |
Hospital de Sao JoaoServico de Pneumologia | QUEIROGA HENRIQUE | PORTUGAL | Porto | Porto |
Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe | Oliveira Júlio | PORTUGAL | Porto | Porto |
Instituto Portugues de Oncologia de Lisboa Francisco Gentil, E.P.E.Pneumologia | Almodovar Teresa | PORTUGAL | Lisbon | Lisbon |
Centro Hospitalar E Universitrio de Coimbra EPE | BARATA FERNANDO | PORTUGAL | Coimbra | Coimbra |
Centro Hospitalar de Lisboa Norte E.P.E – Hospital Pulido Valente | Teixeira Encarnaao | PORTUGAL | Lisboa | Lisboa |
Institutul Regional de Oncologie IasiClinica de Hematologie | Marinca Mihai | ROMANIA | Lasi | Lasi |
Oncology Center Sf. Nectarie | Schenker Michael | ROMANIA | Craiova | Craiova |
Principal Military Clinical Hospital n.a. N.N. Burdenko | SMOLIN ALEXEY | RUSSIAN FEDERATION | Moscow | Moscow |
Clinical Oncology Dispensary | Galiulin Rinat | RUSSIAN FEDERATION | Omsk | Omsk |
Filial 1 Regional Oncology Dispensary of Nizhniy Novgorod | MATROSOVA MARINA | RUSSIAN FEDERATION | NIZHNY NOVGOROD | NIZHNY NOVGOROD |
St. Petersburg Med Univn.a. I.P. PavlovPulmonology Research | Akopov Andrey | RUSSIAN FEDERATION | SANKT PETERSBURG | St. Petersburg |
Mordovia State University | Skopin Pavel | RUSSIAN FEDERATION | Saransk | Saransk |
State Budgetary Institution of Health Volzhskii Regional Clinical Oncology Dispensary 3 | Kovalenko Nadezhda | RUSSIAN FEDERATION | STAVROPOL | STAVROPOL |
City Clinical Oncology Dispensary | KARASEVA NINA | RUSSIAN FEDERATION | ST PETERSBURG | ST PETERSBURG |
Leningrad Regional Clinical Hospital | Luft Alexander V. | RUSSIAN FEDERATION | SANKT PETERSBURG | St. Petersburg |
GBUZ Saint Petersburg Clinical Research Center of Specialized Types of Care (Oncology) | MOISEYENKO VLADIMIR | RUSSIAN FEDERATION | ST. PETERSBURG | ST. PETERSBURG |
HOSPITAL UNIVERSITARIO SON ESPASES | Guillot Morales Monica | SPAIN | ISLAS BALEARES | PALMA DE MALLORCA |
Hospital Universitario Marques de Valdecilla Servicio de Oncologia | Lopez-Brea Piqueras Marta | SPAIN | CANTABRIA | SANTANDER |
Hospital Universitario de Canarias | Oramas Rodriguez Maria Juana | SPAIN | TENERIFE | LA LAGUNA |
Hospital Ramon y Cajal Servicio de Oncologia | Garrido Lopez Pilar | SPAIN | MADRID | MADRID |
Hospital Santa Creu i Sant Pau | Majem Tarruella Margarita | SPAIN | BARCELONA | BARCELONA |
Hospital Universitario Reina Sofia | Barneto Aranda Isidoro Carlos | SPAIN | CORDOBA | CóRDOBA |
Hosp Clinico Univ Lozano Blesa | Isla Casado Dolores | SPAIN | ZARAGOZA | ZARAGOZA |
Hospital Universitari i Politecnic La Fe de Valencia | Juan Vidal Oscar | SPAIN | VALENCIA | VALENCIA |
Fundación Jimenez Daz | Domine Gomez Manuel | SPAIN | MADRID | MADRID |
Hospital Lucus Augusti Servicio de Oncologia | Vazquez Estevez Sergio | SPAIN | LUGO | LUGO |
Hospital Universitario Miguel Servet | Artal Cortes Angel | SPAIN | ZARAGOZA | ZARAGOZA |
Hospital Clinico Universitario de Valencia | Insa Molla Amelia | SPAIN | VALENCIA | VALENCIA |
Hospital Universitari Germans Trias i Pujol Servicio de Oncologia | Moran Bueno Teresa | SPAIN | BARCELONA | BARCELONA |
Hospital del Mar | Taus Garcia Alvaro | SPAIN | BARCELONA | BARCELONA |
Hospital Universitario La Paz | De Castro Carpeno Javier | SPAIN | MADRID | MADRID |
Hospital Universitario HM Sanchinarro-CIOCC Oncologa Mdica | Belda Iniesta Cristobal | SPAIN | MADRID | MADRID |
Hospital Univ Vall dHebronServicio de Oncologia | Martinez Alex | SPAIN | BARCELONA | BARCELONA |
Hosp. Clinico San Carlos | Puente Vazquez Javier | SPAIN | MADRID | MADRID |
Changhua Christian Hospital | Li Chien-Te | 中国 | Changhua City | Changhua City |
NATIONAL TAIWAN UNI HOSPITAL | YU CHONG-JEN | 中国 | TAIPEI | TAIPEI |
Kaohsiung Medical University Hospital Department of Urology | HUANG MING-SHYAN | 中国 | KAOHSIUNG | KAOHSIUNG |
Taipei Veterans General Hospital | CHEN YUH-MIN | 中国 | TAIPEI | TAIPEI |
Chang Gung Memorial Hospital Chiayi | TSAI YING-HUANG | 中国 | CHAI YI | CHAI YI |
Mackay Memorial Hospital | HSIEH RUEY-KUEN | 中国 | TAIPEI | TAIPEI |
Chi Mei Medical Center Liou Ying Campus | TSAO CHAO-JUNG | 中国 | TAINAN | TAINAN |
TAICHUNG VETERANS GENERAL HOSPITAL | CHANG GEE-CHEN | 中国 | TAICHUNG | TAICHUNG |
Chang Gung Medical Foundation Linkou Branch | Yang Cheng-Ta | 中国 | Toayuan | Toayuan |
MI Zaporizhzhia Regional Clinical Oncological Dispensary Zaporizhzhia SMU Ch of Oncology | Kolesnik Oleksii | UKRAINE | Zaporizhzhya | Zaporizhzhya |
MIHC Kharkiv Regional Clinical Oncology Center Chemotherapy Department 1 | Shapovalov Dmytro | UKRAINE | Kharkiv | Kharkiv |
Mun. Multifield Clin.Hosp.4,Dept. of Chemotherapy, DSMUChair of Oncology and Medical Radiology | BONDARENKO IGOR | UKRAINE | Dnipropetrovsk | Dnipropetrovsk |
Regional Municipal Institution Sumy Regional Clinical Oncology Dispensary | Vynnychenko Ihor | UKRAINE | Sumy | Sumy |
Vinnytsia Regional Council Vinnytsia Regional Clinical Oncological Dispensary Dpt of Chemotherapy | Shamrai Volodymyr | UKRAINE | Zaporizhzhya | Zaporizhzhya |
Poltava Regional Clinical Oncology Dispensary of Poltava Regional Council Thoracic department | Chornobai Anatolii | UKRAINE | Poltava | Poltava |
MI Kryvyi Rih Oncology Dispensary of Dnipropetrovsk Regional Council Chemotherapy Department | Adamchuk Hryhoriy | UKRAINE | Kryvyi Rih | Kryvyi Rih |
Transcarpathian Regional Clinical Oncology DispensaryChemotherapy Department | Rusyn Andriy | UKRAINE | Uzhgorod | Uzhgorod |
Belfast City Hospital | Campbell Lynn | UNITED KINGDOM | Belfast | Belfast |
Diana Princess of Wales Hosp. | Upadhyay Sunil | UNITED KINGDOM | Grimsby | Grimsby |
Sarah Cannon Research Institute | Arkenau Tobias | UNITED KINGDOM | London | London |
BIRMINGHAM HEARTLANDS HOSPITAL | THOMPSON JOYCE | UNITED KINGDOM | BIRMINGHAM | BIRMINGHAM |
Colchester General Hospital | Muthukumar Dakishinamoorthy | UNITED KINGDOM | Colchester | Colchester |
Highlands Oncology Group | Beck Joseph | UNITED STATES | AR | Fayetteville |
Walter Reed National Military Medical Center | Brzezniak Christina | UNITED STATES | MD | Bethesda |
University Hospitals of Cleveland | Dowlati MD Afshin | UNITED STATES | OH | Cleveland |
Kaiser Permanente Oncology Clinical Trials | Suga Jennifer-M | UNITED STATES | CA | Vallejo |
University of Illinois at Chicago | Feldman Lawrence | UNITED STATES | IL | Chicago |
Karmanos Cancer Institute | Gadgeel Shirish | UNITED STATES | MI | Detroit |
Norton Cancer Institute | Hamm John | UNITED STATES | KY | Louisville |
Presbyterian Hospital | Mitchell William | UNITED STATES | NC | Huntersville |
Cedars Sinai Medical Center | Natale Ronald | UNITED STATES | CA | Los Angeles |
University Cancer & Blood Center, LLC | Nikolinakos Petros | UNITED STATES | GA | ATHENS |
Lynn Cancer Institute - West | Santos Edgardo | UNITED STATES | FL | MIAMI |
Joliet Oncology-Hematology Associates, Ltd. | Suh Jason | UNITED STATES | IL | Joliet |
University of Cincinnati | Abdel Karim Nagla | UNITED STATES | OH | West Chester |
Praxair Cancer Center at Danbury Hospital | Cohenuram Michael | UNITED STATES | CT | Danbury |
University Oncology Associates | Graham Robert | UNITED STATES | TN | Chattanooga |
University of California Los Angeles | Goldman Jonathan | UNITED STATES | CA | Los Angeles |
Mark H. Zangmeister Center | Knapp Mark | UNITED STATES | OH | Columbus |
Hematology Oncology Associates of the Treasure Coast | Rosen Seth | UNITED STATES | FL | Port Saint Lucie |
New England Cancer Specialists | THOMAS CHRISTIAN | UNITED STATES | ME | Scarborough |
Hematology Oncology Associates of Fredericksburg, Inc. | Vaughn Christopher | UNITED STATES | VA | Fredericksburg |
California Cancer Associates for Research & Excellence, Inc. | Bessudo Alberto | UNITED STATES | CA | Encinitas |
Clinical Research Alliance | Coleman Morton | UNITED STATES | NY | New York |
Southern Illinois University, Simmons Cancer Institute | Desai Meghna | UNITED STATES | IL | Springfield |
Allegheny General Hospital | Van Deusen Mathew | UNITED STATES | PA | Kittanning |
St. Joseph Mercy Health System | STELLA PHILLIP | UNITED STATES | MI | ANN ARBOR |
Cancer and Hematology Centers of Western Michigan | Chen Yuanbin | UNITED STATES | MI | Grand Rapids |
UNI OF ARKANSAS FOR MEDICAL SCIENCES | Arnaoutakis Konstantinos | UNITED STATES | AR | LITTLE ROCK |
St. Lukes Cancer Care Associates | Belman Neil | UNITED STATES | PA | Bethlehem |
VA Boston Healthcare System Hematology and Oncology | Boosalis Valia | UNITED STATES | MA | Boston |
Holy Cross Hospital Inc | Drew David-Zhu | UNITED STATES | FL | Fort Lauderdale |
Valley Hospital Oncology Research | Kirshner Eli | UNITED STATES | NJ | Westwood |
VA GREATER LOS ANGELES HEALTHCARE SYSTEM | Rettig Matthew | UNITED STATES | CA | Los Angeles |
Eastern Connecticut Hematology and Oncology Associates(ECHO) | Slater Dennis | UNITED STATES | CT | Norwich |
Premiere Oncology | Tsai Frank | UNITED STATES | AZ | Scottsdale |
Baptist Health Louisville | Zhong Wangjian | UNITED STATES | KY | Louisville |
Providence Everett Med Ctr | Costas Kimberly | UNITED STATES | WA | Everett |
Bend Memorial Clinic | Erickson Brian | UNITED STATES | OR | Bend |
Atlantic Health Cancer Center | Lowenthal Dennis | UNITED STATES | NJ | Summit |
Pinnacle Health | Veytsman Irina | UNITED STATES | DC | Washington |
VA Puget Sound Health Care Sys | Wu Daniel | UNITED STATES | WA | Seattle |
Illinois Cancer Care | Gerstner Gregory J. | UNITED STATES | AZ | Tucson |
Oncology Specialists, S.C. | Hooberman Arthur | UNITED STATES | IL | Park Ridge |
Mercy Medical Center | Kotiah Sandy | UNITED STATES | MD | Baltimore |
CHAO FAMILY COMPREHENSIVE CANCER CENTER UC IRVINE MEDICAL CENTER | OU SAI-HONG | UNITED STATES | CA | ORANGE |
St. Lukes Cancer Institute | Subramanian Janakiraman | UNITED STATES | TN | Knoxville |
Southeast Nebraska Cancer Ctr | Dunder Steven | UNITED STATES | NE | Lincoln |
Quincy Medical Group Canc Ctr at Blessing Hosp | El-Khoury Christian | UNITED STATES | IL | Quincy |
FREDERICK MEMORIAL HOSPITAL | Eskander Elhamy | UNITED STATES | MD | Frederick |
Georgetown University Medical Center | Subramaniam Deepa | UNITED STATES | DC | Washington |
Regional Cancer Care Associates LLC | Gurubhagavatula Sarada | UNITED STATES | NJ | MORRISTOWN |
University of Miami School of Medicine - Sylvester at Deerfield | Ikpeazu Chukwuemeka | UNITED STATES | TN | Nashville |
Lancaster General Hospital | Kerr Samuel | UNITED STATES | PA | Lancaster |
RHODE ISLAND HOSPITAL | Khurshid Humera | UNITED STATES | RI | Providence |
MultiCare Regional Cancer Center - Auburn | Masood Nehal | UNITED STATES | WA | Auburn |
Comprehensive Cancer Centers of Nevada | Braiteh Fadi | UNITED STATES | NV | Henderson |
W.G. Bill Hefner VA Medical Center | Ruiz Jimmy | UNITED STATES | NC | Winston-Salem |
Oregon Health and Science University | Tolba Kalhed | UNITED STATES | OR | Portland |
Southern California Permanente Medical Group Bellflower | Buchschacher Gary | UNITED STATES | CA | Bellflower |
Central Georgia Cancer Care PC | SCHNELL FREDERICK M. | UNITED STATES | GA | MACON |
Hematology and Oncology Associates at Bridgepoint | Kellum Andrew H. | UNITED STATES | MS | Tupelo |
Greenville Health System | Bolemon Britt | UNITED STATES | SC | Greenville |
Regional Cancer Care Associates LLC | Dobrescu Andrei | UNITED STATES | NJ | Somerville |
Lewis Hall Singletary Oncology Center | Coleman Teresa | UNITED STATES | GA | AUGUSTA |
Wellmont Medical Associates | Nakhoul Ibrahim | UNITED STATES | TN | BRISTOL |
Virginia Cancer Institute | Mitchell Reed | UNITED STATES | VA | Richmond |
Weill Cornell Medical College | Altorki Nasser | UNITED STATES | NY | New York |
Ingalls Memorial Hospital | Kozloff Mark | UNITED STATES | IL | Harvey |
Spartanburg Regional Medical Center | ROCHA LIMA CAIO MAX S. | UNITED STATES | FL | Miami |
Florida Hospital | Mekhail Tarek | UNITED STATES | FL | Orlando |
The Christ Hospital | Bhandari Manish | UNITED STATES | OH | Cincinnati |
Florida Cancer Specialists-Broadway, Fort Myers | Percent Ivor J. | UNITED STATES | FL | Englewood |
Sarah Cannon Cancer Center | Spigel David | UNITED STATES | TN | Nashville |
Houston Methodist Cancer Center | Bernicker Eric | UNITED STATES | TX | Houston |
SCRI The Center For Cancer and Blood Disorders | PAGE RAY | UNITED STATES | TX | Fort Worth |
SCRI Tennessee Oncology Chattanooga | Daniel Davey | UNITED STATES | TN | Chattanooga |
Oncology Hematology Care - SCRI | Crane Edward | UNITED STATES | OH | Cincinnati |
SWEDISH MEDICAL CENTER | West Howard | UNITED STATES | WA | Seattle |
Kaiser Permanente - Sacramento Medical Center and Medical Offices | Suga Jennifer-M | UNITED STATES | CA | Vallejo |
Kaiser Permanente - Santa Clara | Suga Jennifer-M | UNITED STATES | CA | Vallejo |
Kaiser Permanente - San Jose Medical Center | Suga Jennifer-M | UNITED STATES | CA | Vallejo |
Kaiser Permanente - San Francisco Medical Center | Suga Jennifer-M | UNITED STATES | CA | Vallejo |
Kaiser Permanente Medical Center - Roseville | Suga Jennifer-M | UNITED STATES | CA | Vallejo |
Kaiser Permanente Oakland Medical Center | Suga Jennifer-M | UNITED STATES | CA | Vallejo |
Kaiser Permanente - San Leandro Medical Center | Suga Jennifer-M | UNITED STATES | CA | Vallejo |
Kaiser Permanente - South San Francisco | Suga Jennifer-M | UNITED STATES | CA | Vallejo |
Kaiser Permanente - Walnut Creek | Suga Jennifer-M | UNITED STATES | CA | Vallejo |
University of California San Diego | Patel Sandip | UNITED STATES | CA | La Jolla |
SCRI Florida Cancer Specialists East | Patel Pareshkumar | UNITED STATES | FL | Tallahassee |
Stanford University | Wakelee Heather | UNITED STATES | CA | Stanford |
SCRI Florida Cancer Specialists East | Rothschild Neal | UNITED STATES | FL | West Palm Beach |
Montefiore Medical Center | Keller Steven | UNITED STATES | NY | Bronx |
SCRI Florida Cancer Specialists North Research Office North Region. | Hussein Maen | UNITED STATES | FL | St.Petersburg |
Rush University Medical Center | Batus Marta | UNITED STATES | IL | Chicago |
Ironwood Cancer & Research Ctr | Kalmadi Sujith | UNITED STATES | AZ | Chandler |
First Health of the Carolinas | Kuzma Charles | UNITED STATES | NC | Pinehurst |
Northwest Georgia Oncology Centers P.C. | McCune Steven L. | UNITED STATES | GA | MARIETTA |
Englewood Hospital and Medical Center | Attas Lewis | UNITED STATES | NJ | Englewood |
MARYLAND ONCOLOGY HEMATOLOGY, P.A. | Narang Mohit | UNITED STATES | PA | Gettysburg |
Siouxland Hematology - Oncology Associates LLP | Wender Donald | UNITED STATES | IA | Sioux |
Marin Cancer Care Inc | EISENBERG PETER | UNITED STATES | CA | GREENBRAE |
Mount Sinai Medical Center | Rodriguez Estelamari | UNITED STATES | FL | Miami Beach |
COMPASSIONATE CANCER CARE MEDICAL GROUP, INC | JHANGIANI HARESH | UNITED STATES | CA | Fountain Valley |
伦理委员会信息
名称 | 审查结论 | 审查日期 |
---|---|---|
苏州大学附属第一医院医院伦理委员会 | 同意 | 2016-11-17 |
中国医学科学院肿瘤医院 | 修改后同意 | 2017-06-14 |
中国医学科学院肿瘤医院 | 同意 | 2017-12-25 |
中国医学科学院肿瘤医院 | 同意 | 2018-07-13 |
中国医学科学院肿瘤医院 | 同意 | 2018-12-14 |
中国医学科学院肿瘤医院 | 同意 | 2019-07-15 |
中国医学科学院肿瘤医院 | 同意 | 2020-08-17 |
中国医学科学院肿瘤医院伦理委员会 | 同意 | 2021-05-14 |
中国医学科学院肿瘤医院伦理委员会 | 同意 | 2021-08-13 |
中国医学科学院肿瘤医院伦理委员会 | 同意 | 2023-05-15 |
试验状态信息
试验状态
进行中-招募完成
目标入组人数
国内: 150 ;
国际: 760 ;
已入组例数
国内: 94 ;
国际: 1280 ;
实际入组总例数
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:2017-07-17;
国际:2015-10-07;
第一例受试者入组日期
国内:2017-07-27;
国际:2015-10-07;
试验终止日期
国内:登记人暂未填写该信息;
国际:登记人暂未填写该信息;
临床试验结果摘要
版本号 | 版本日期 |
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