广州BMS-986504-05(MRTX1719)薄膜衣片III期临床试验-BMS-986504联合帕博利珠单抗和化疗对比安慰剂联合帕博利珠单抗和化疗作为携带MTAP纯合缺失的转移性非小细胞肺癌一线治疗的研究

登记号	CTR20254182	试验状态	进行中
申请人联系人	杨明威	首次公示信息日期	2025-10-23
申请人名称	Bristol-Myers Squibb Company/ 百时美施贵宝（中国）投资有限公司/ Bristol Myers Squibb Co.

登记号	CTR20254182
相关登记号	暂无
药物名称	BMS-986504-05 (MRTX1719) 薄膜衣片
药物类型	化学药物
临床申请受理号	企业选择不公示
适应症	携带MTAP纯合缺失的转移性非小细胞肺癌
试验专业题目	一项BMS-986504联合帕博利珠单抗和化疗对比安慰剂联合帕博利珠单抗和化疗作为携带MTAP纯合缺失的转移性非小细胞肺癌参与者一线治疗的随机、2/3期研究
试验通俗题目	BMS-986504联合帕博利珠单抗和化疗对比安慰剂联合帕博利珠单抗和化疗作为携带MTAP纯合缺失的转移性非小细胞肺癌一线治疗的研究
试验方案编号	CA2400029	方案最新版本号	修正案01
版本日期:	2025-06-24	方案是否为联合用药	否

申请人名称	[["Bristol-Myers Squibb Company"],["百时美施贵宝（中国）投资有限公司"],["Bristol Myers Squibb Co."]]
联系人姓名	杨明威	联系人座机	021-23218100	联系人手机号	18516172071
联系人Email	Mingwei.Yang@bms.com	联系人邮政地址	上海市-上海市-静安区南京西路1717号17楼	联系人邮编	200040

在既往未经治疗的存在MTAP 纯合缺失的mNSCLC 参与者中评价BMS-986504+帕博利珠单抗+化疗与安慰剂+帕博利珠单抗+化疗相比的PFS

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	双盲	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	[["参与者必须根据监管、当地和机构指南签署IRB/IEC 批准的书面ICF 并注明日期。"],["转移性（IV 期或复发性）NSCLC（根据美国癌症联合委员会第9 版定义），且既往未针对转移性疾病进行过系统性抗癌治疗。"],["使用申办方提供的中心实验室检测或申办方预先批准的当地实验室检测，组织学确诊为NSCLC 且肿瘤组织中检测到MTAP 纯合缺失或MTAP 表达缺失。必须由研究中心提交肿瘤组织（新鲜组织或在签署预筛选知情同意书前6 个月内获得的存档组织）。组织不可经过干预性系统性治疗或取材部位的放疗，必须提交以下材料之一：a. FFPE 组织块或b, 6 个月内从FFPE 肿瘤组织块切下的未染色切片。"],["基于签署预筛选知情同意书前6 个月内采集的组织，通过申办方预先批准的当地PD-L1 IHC 检测方法，根据检测方法的预期用途确定任何PD-L1 表达水平（范围：0-100%）。如果尽最大努力后仍无法定量结果，则经医学监查员（或指定人员）批准，最多可允许参与者总例数的10%具有不可评价或不可定量的结果。检测必须符合当地的诊断法规，并且必须提供所用PD-L1 检测方法的相关文件。"],["根据RECIST v1.1，至少有1 个可测量病灶。"],["非CNS 病灶的既往姑息性放疗必须在随机化前至少1 周完成。强烈建议基线时存在可能需要姑息性放疗的症状性肿瘤病灶的参与者在随机化前接受姑息性放疗。"],["对于在随机化前接受一个周期SoC 的参与者，与第一个周期SoC 相关的TRAE 必须在随机化前消退至≤1级或基线水平，脱发、2级疲劳或需要治疗或激素替代治疗的内分泌相关AE 除外。"],["ECOG 体能状态为0-1。"],["筛选期内通过实验室检查确定器官功能良好。"],["签署ICF 时年龄≥18 岁（或开展研究的辖区内的法定同意年龄）。"],["生殖状态。参加研究的女性和男性受试者均应遵循方案要求的妊娠预防计划。"]]
排除标准	[["组织学类型为非鳞状细胞癌、证实携带靶向致癌突变或AGA 且有SoC 可作为一线治疗（即EGFR、ALK、ROS1）的参与者。"],["症状性脑转移或脊髓压迫。"],["软脑膜病灶。"],["在过去2 年内需要系统性治疗（即使用疾病调节剂、皮质类固醇或免疫抑制剂）的活动性自身免疫性疾病。替代治疗（例如，甲状腺素、胰岛素或针对肾上腺或垂体功能不全的生理性皮质类固醇替代治疗等）不被视为系统性治疗。"],["参与者患有在随机化前14 天内需要使用皮质类固醇（>10 mg/天泼尼松当量）或其他免疫抑制药物进行系统性治疗的疾病。在无活动性自身免疫性疾病的情况下，允许使用吸入性或局部用类固醇以及类固醇剂量>10 mg/天泼尼松当量的肾上腺替代治疗。"],["有间质性肺疾病、缓慢进展的呼吸困难和干咳、肺结节病、硅肺病、特发性肺纤维化、超敏性肺炎（包括需要类固醇治疗的非感染性肺炎）或混合性过敏病史。"],["已知或疑似胃肠道功能受损，可能妨碍在不咀嚼或压碎药物的情况下吞咽或吸收口服药物的能力。"],["在预筛选期间接受一个周期的SoC，并且发生根据α-PD-(L)1 单克隆抗体（包括帕博利珠单抗）、培美曲塞、卡铂、紫杉醇或白蛋白结合型紫杉醇的产品说明书导致永久停药的TRAE 的参与者。"],["无法或不愿意服用叶酸或维生素B12 补充剂。"],["既往同种异体器官移植。"],["随机化前3 周内接受过任何大手术。参与者必须在随机化前从大手术或严重创伤性损伤的影响中恢复。"],["需要治疗的并发恶性肿瘤（筛选期间存在），或随机化前2 年内有活动性恶性肿瘤既往史。有恶性肿瘤既往史的参与者如果在随机化前至少2 年完成治疗且无疾病证据，则有资格参加研究。有既往早期基底/鳞状细胞皮肤癌或非侵袭性或原位癌病史并在任何时间接受根治性治疗的参与者也有资格参加研究。有前列腺癌病史，但已得到控制且Gleason 评分为非常低或低的参与者也有资格参加研究。"],["心脏异常。"],["需要持续使用已知有尖端扭转性室性心动过速风险的药物，且在入组研究前不能转换为替代治疗。"],["活动性病毒性肝炎。"],["已知HIV 阳性，过去一年内发生符合AIDS 定义的机会感染，或当前CD4 计数<350 个细胞/μL。如果HIV 参与者在随机化前已接受既定的ART 至少4 周，并在入组研究期间根据临床指征继续接受ART，则有资格参加研究。仅在当地强制要求时进行病毒血清学检查，并且如果进行，必须在随机化前28 天内进行。"],["随机化前≤7 天出现需要系统性抗菌、抗病毒或抗真菌治疗的活动性感染证据。"],["根据研究者的评估，既往未列出的可能损害参与者参加研究能力的任何其他医学疾病。"],["不能遵守研究方案规定的合并治疗中所列的限制和禁用的治疗。"],["既往接受过mNSCLC 系统性治疗（化疗、免疫治疗、靶向治疗或生物治疗）。"],["既往接受过PRMT5 或MAT2A 抑制剂治疗。"],["随机化前30 天内接种过活疫苗/减毒疫苗。研究期间允许使用灭活的季节性流感疫苗（例如Fluzone&reg; ），没有限制。"],["随机化前4 周内接受任何植物制剂（例如，草药补充剂或中药）治疗研究疾病。研究期间不允许合并使用任何植物制剂。"],["随机化前4 周内接受任何试验用药物或器械治疗。"],["需要持续接受CYP3A4 和/或P-gp 强效抑制剂或强效诱导剂或PPI 治疗，且无法在随机化前更换为替代治疗。可使用以下药物相互作用数据库和其他文献确定CYP3A4/P-gp 抑制剂和诱导剂。"],["对研究药物和/或其任何辅料有重度超敏反应史。"],["囚犯或非自愿被监禁的参与者。（注：在某些特定情况下，仅在当地法规允许的国家，在研究期间被监禁的人可继续作为参与者参与研究。需满足严格的条件）。"],["因精神疾病或身体疾病（如传染病）而被强制拘留接受治疗的参与者。"]]

试验药

[["中文通用名:BMS-986504-05(MRTX1719)薄膜衣片 英文通用名:NA 商品名称:NA","剂型:片剂 规格:200m/片 用法用量:口服。2期：A组400mgQD；B组600mgQD。3期：选定剂量的BMS-986504（根据2期研究中的选定剂量确定片剂数量） 用药时程:研究者评估的疾病进展，除非研究者认为进行进展后的治疗可提供获益或出现不可接受的不良事件。"],["中文通用名:帕博利珠单抗 英文通用名:Pembrolizumab 商品名称:Keytruda","剂型:注射液 规格:25mg/mL 用法用量:静脉输注。2期研究和3期研究：A、B、C、D、E和F组：200mg，在每个21天周期的第1天给药。如果当地产品说明书允许，根据研究者的判断，参与者可从第5周期开始转换为400mgQ6W给药 用药时程:最长2年（或根据当地说明书）"],["中文通用名:注射用顺铂 英文通用名:Cisplatinofinjection 商品名称:NA","剂型:冻干粉 规格:20mg/支 用法用量:静脉输注。2期研究和3期研究：A、B、C、D、E和F组（仅非鳞状细胞癌）：75mg/m2，在每个21天周期的第1天给药 用药时程:最多4个周期"],["中文通用名:卡铂注射液 英文通用名:Carboplatininjection 商品名称:NA","剂型:注射液 规格:100mg/瓶 用法用量:静脉输注。2期研究和3期研究：A、B、C、D、E和F组：对于非鳞状细胞癌参与者：AUC5，在每个21天周期的第1天给药 用药时程:最多4个周期"],["中文通用名:注射用培美曲塞二钠 英文通用名:PemetrexedDisodiumforinjection 商品名称:普来乐","剂型:冻干粉 规格:500mg/瓶 用法用量:静脉输注。2期研究和3期研究：A、B、C、D、E和F组（仅非鳞状细胞癌）：前4个周期：500mg/m2，在每个21天周期的第1天给药。可选的维持治疗：500mg/m2，从第5周期开始在每个21天周期的第1天给药，Q3W。 用药时程:最多4个周期。维持治疗，直至疾病进展。"],["中文通用名:紫杉醇注射液 英文通用名:Paclitaxelinjection 商品名称:NA","剂型:注射液 规格:30mg/5mL 用法用量:静脉输注。2期研究和3期研究：A、B、C、D、E和F组（仅鳞状细胞癌）：200mg/m2，在每个21天周期的第1天给药。 用药时程:最多4个周期"],["中文通用名:注射用紫杉醇（白蛋白结合型） 英文通用名:PaclitaxelforInjection（AlbuminBound） 商品名称:Abraxane®","剂型:冻干粉 规格:100mg/瓶 用法用量:静脉输注。2期研究和3期研究：A、B、C、D、E和F组（仅鳞状细胞癌）：100mg/m2，在每个21天周期的第1、8和15天给药。 用药时程:最多4个周期"]] 序号 名称 用法

对照药

[["中文通用名:BMS-986504-05(MRTXl719)薄膜衣片200mg的安慰剂 英文通用名:NA 商品名称:NA","剂型:片剂 规格:200m/片 用法用量:口服。2期：C组400mg匹配安慰剂QD；D组600mg匹配安慰剂QD.3期：选定剂量的BMS-986504匹配安慰剂（根据2期研究中的选定剂量确定片剂数量）。 用药时程:研究者评估的疾病进展，除非研究者认为进行进展后的治疗可提供获益或出现不可接受的不良事件。"],["中文通用名:帕博利珠单抗 英文通用名:Pembrolizumab 商品名称:Keytruda","剂型:注射液 规格:25mg/mL 用法用量:静脉输注。2期研究和3期研究：A、B、C、D、E和F组：200mg，在每个21天周期的第1天给药。如果当地产品说明书允许，根据研究者的判断，参与者可从第5周期开始转换为400mgQ6W给药 用药时程:最长2年（或根据当地说明书）"],["中文通用名:注射用顺铂 英文通用名:Cisplatinofinjection 商品名称:NA","剂型:冻干粉 规格:20mg/支 用法用量:静脉输注。2期研究和3期研究：A、B、C、D、E和F组（仅非鳞状细胞癌）：75mg/m2，在每个21天周期的第1天给药 用药时程:最多4个周期"],["中文通用名:卡铂注射液 英文通用名:Carboplatininjection 商品名称:NA","剂型:注射液 规格:100mg/瓶 用法用量:静脉输注。2期研究和3期研究：A、B、C、D、E和F组：对于非鳞状细胞癌参与者：AUC5，在每个21天周期的第1天给药 用药时程:最多4个周期"],["中文通用名:注射用培美曲塞二钠 英文通用名:PemetrexedDisodiumforinjection 商品名称:普来乐","剂型:冻干粉 规格:500mg/瓶 用法用量:静脉输注。2期研究和3期研究：A、B、C、D、E和F组（仅非鳞状细胞癌）：前4个周期：500mg/m2，在每个21天周期的第1天给药。可选的维持治疗：500mg/m2，从第5周期开始在每个21天周期的第1天给药，Q3W。 用药时程:最多4个周期。维持治疗，直至疾病进展。"],["中文通用名:紫杉醇注射液 英文通用名:Paclitaxelinjection 商品名称:NA","剂型:注射液 规格:30mg/5mL 用法用量:静脉输注。2期研究和3期研究：A、B、C、D、E和F组（仅鳞状细胞癌）：200mg/m2，在每个21天周期的第1天给药。 用药时程:最多4个周期"],["中文通用名:注射用紫杉醇（白蛋白结合型） 英文通用名:PaclitaxelforInjection（AlbuminBound） 商品名称:Abraxane®","剂型:冻干粉 规格:100mg/瓶 用法用量:静脉输注。2期研究和3期研究：A、B、C、D、E和F组（仅鳞状细胞癌）：100mg/m2，在每个21天周期的第1、8和15天给药。 用药时程:最多4个周期"]] 序号 名称 用法

主要终点指标及评价时间

[["2期：研究者根据RECIST v1.1 评估的PFS，定义为从随机化日期至疾病进展或全因死亡（以先发生者为准）日期的时间","从随机化开始每6周（±7天）一次，直至第48周，此后每12周（±7天）一次，直至疾病进展（2期研究由研究者根据RECIST v1.1评估）、撤回知情同意、死亡、失访或研究结束（以先发生者为准）。","有效性指标"],["3期：BICR根据RECIST v1.1评估的PFS，定义为从随机化日期至疾病进展或全因死亡（以先发生者为准）日期的时间","从随机化开始每6周（±7天）一次，直至第48周，此后每12周（±7天）一次，直至疾病进展（3期研究由BICR根据RECIST v1.1确认）、撤回知情同意、死亡、失访或研究结束（以先发生者为准）。","有效性指标"],["3期：OS，定义为从随机化日期至全因死亡日期的时间","从安全性随访访视2开始，每3个月进行一次生存状态评估，最长持续至2期研究部分末例参与者随机化后2年，或3期研究部分末例参与者随机化后5年，直至死亡、撤回知情同意、失访或研究结束（以先发生者为准）。","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

[["2期：研究者根据RECIST v1.1 评估的OR（确认的CR 或PR）","从随机化开始每6周（±7天）一次，直至第48周，此后每12周（±7天）一次，直至疾病进展（2期研究由研究者根据RECIST v1.1评估）、撤回知情同意、死亡、失访或研究结束（以先发生者为准）。","有效性指标"],["2期：研究者根据RECIST v1.1 评估的疾病控制（BOR 为确认的CR、确认的PR 或SD）","从随机化开始每6周（±7天）一次，直至第48周，此后每12周（±7天）一次，直至疾病进展（2期研究由研究者根据RECIST v1.1评估）、撤回知情同意、死亡、失访或研究结束（以先发生者为准）。","有效性指标"],["2期：研究者根据RECIST v1.1 评估的TTOR（CR或PR），定义为从随机化日期至首次记录到客观肿瘤缓解日期的时间","从随机化开始每6周（±7天）一次，直至第48周，此后每12周（±7天）一次，直至疾病进展（2期研究由研究者根据RECIST v1.1评估）、撤回知情同意、死亡、失访或研究结束（以先发生者为准）。","有效性指标"],["2期：研究者根据RECIST v1.1 评估的DOR（CR或PR），定义为从首次记录到客观肿瘤缓解的日期至疾病进展或全因死亡（以先发生者为准）日期的时间","从随机化开始每6周（±7天）一次，直至第48周，此后每12周（±7天）一次，直至疾病进展（2期研究由研究者根据RECIST v1.1评估）、撤回知情同意、死亡、失访或研究结束（以先发生者为准）。","有效性指标"],["3期：BICR根据RECIST v1.1评估的OR（确认的CR 或PR）","从随机化开始每6周（±7天）一次，直至第48周，此后每12周（±7天）一次，直至疾病进展（3期研究由BICR根据RECIST v1.1确认）、撤回知情同意、死亡、失访或研究结束（以先发生者为准）。","有效性指标"],["3期：BICR根据RECIST v1.1评估的疾病控制（BOR为确认的CR、确认的 PR 或SD）","从随机化开始每6周（±7天）一次，直至第48周，此后每12周（±7天）一次，直至疾病进展（3期研究由BICR根据RECIST v1.1确认）、撤回知情同意、死亡、失访或研究结束（以先发生者为准）。","有效性指标"],["3期：BICR根据RECIST v1.1评估的DOR（CR或PR）定义为从首次记录到客观肿瘤缓解的日期至疾病进展或全因死亡（以先发生者为准）日期的时间","从随机化开始每6周（±7天）一次，直至第48周，此后每12周（±7天）一次，直至疾病进展（3期研究由BICR根据RECIST v1.1确认）、撤回知情同意、死亡、失访或研究结束（以先发生者为准）。","有效性指标"],["3期：研究者根据RECIST v1.1评估的PFS","从随机化日期至首次记录到客观肿瘤缓解或全因死亡（以先发生者为准）日期的时间","有效性指标"],["3期：研究者根据RECIST v1.1评估的PFS2","从随机化日期至开始下一线治疗后首次记录到客观肿瘤缓解（临床或放射学）的日期或至全因死亡（以先发生者为准）的时间","有效性指标"]] 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	教授/主任医师
	电话	020-83827812	Email	syylwu@live.cn	邮政地址	广东省-广州市-越秀区惠福西路123号
	邮编	510120	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","高惠冰","中国","广东省","广州市"],["福建省肿瘤医院","黄韵坚","中国","福建省","福州市"],["华中科技大学同济医学院附属协和医院","孟睿","中国","湖北省","武汉市"],["北京肿瘤医院","方健","中国","北京市","北京市"],["湖南省肿瘤医院","邬麟","中国","湖南省","长沙市"],["浙江省肿瘤医院","余新民","中国","浙江省","杭州市"],["湖北省肿瘤医院","杨彬","中国","湖北省","武汉市"],["唐都医院","苏海川","中国","陕西省","西安市"],["临沂市肿瘤医院","石建华","中国","山东省","临沂市"],["北京大学人民医院","杨帆","中国","北京市","北京市"],["厦门大学附属第一医院","叶峰","中国","福建省","厦门市"],["四川省肿瘤医院","姚文秀","中国","四川省","成都市"],["哈尔滨医科大学附属肿瘤医院","于雁","中国","黑龙江省","哈尔滨市"],["四川大学华西医院","李亚伦","中国","四川省","成都市"],["南昌大学第一附属医院","孙龙华","中国","江西省","南昌市"],["上海市胸科医院","钟华","中国","上海市","上海市"],["浙江大学医学院附属第一医院","周建英","中国","浙江省","杭州市"],["复旦大学附属中山医院","张勇","中国","上海市","上海市"],["河南省肿瘤医院","赵艳秋","中国","河南省","郑州市"],["广西医科大学肿瘤医院","周韶璋","中国","广西壮族自治区","南宁市"],["中山大学附属第一医院","唐可京","中国","广东省","广州市"],["辽宁省肿瘤医院","刘宏旭","中国","辽宁省","沈阳市"],["南京市第一医院","方苏榕","中国","江苏省","南京市"],["青岛大学附属医院","王静","中国","山东省","青岛市"],["浙江大学附属邵逸夫医院","陈恩国","中国","浙江省","杭州市"],["安徽省肿瘤医院","胡长路","中国","安徽省","合肥市"],["中国医科大学附属盛京医院","郑伟","中国","辽宁省","沈阳市"],["郑州大学第一附属医院","郭三星","中国","河南省","郑州市"],["深圳市人民医院","吴迪","中国","广东省","深圳市"],["山西省肿瘤医院","郭伟","中国","山西省","太原市"],["中国医科大学附属第一医院","金波","中国","辽宁省","沈阳市"],["北京肿瘤医院","赵军","中国","北京市","北京市"],["河北医科大学第四医院","葛晖","中国","河北省","石家庄市"],["贵州省人民医院","张瑜","中国","贵州省","贵阳市"],["中南大学湘雅医院","杨华平","中国","湖南省","长沙市"],["南方医科大学南方医院","刘来昱","中国","广东省","广州市"],["Hospital Británico de Buenos Aires","Karina Vera","阿根廷","Santa Fe","ROSARIO"],["Centro Oncologico Korben","Nicolas Minatta","阿根廷","Santa Fe","ROSARIO"],["Grampians Health","Wasek Faisal","澳大利亚","Victoria","Ballarat Central"],["Canberra Hospital","Geoffrey Peters","澳大利亚","Australian Capital Territory","garran"],["Princess Alexandra Hospital","Kenneth O'Byrne","澳大利亚","Queensland","Queensland"],["Lyell McEwin Hospital","Dainik Patel","澳大利亚","South Australia","Adelaide"],["Sunshine Coast University Hospital","Bryan Chan","澳大利亚","Queensland","Birtinya"],["Royal Hobart Hospital","Rebecca Tay","澳大利亚","Tasmania","Hobart"],["Liverpool Hospital","Victoria Bray","澳大利亚","New South Wales","Liverpool"],["Klinik Floridsdorf","Maximilian Hochmair","奥地利","Vienna","Wien"],["Ordensklinikum Linz GmbH Elisabethinen","Michael Schumacher","奥地利","Upper Austria","Linz"],["Landeskrankenhaus Rankweil","Thomas Winder","奥地利","Vorarlberg","Rankweil"],["Jessa Ziekenhuis","Kristof Cuppens","比利时","Limburg","Hasselt"],["Antwerp University Hospital","Jo Raskin","比利时","Antwerp","Edegem"],["AZ Delta vzw","Ingel Demedts","比利时","West Flanders","Roeselare"],["Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman","Pierre FRERES","比利时","Liège","Liège"],["UZ Brussel","Lore Decoster","比利时","Brussels","Jette"],["NAIC - Instituto do Cancer","Marcelo Antunes","巴西","Sao Paulo","Bauru"],["ICESP - INSTITUTO DO CANCER DO ESTADO DE SAO PAULO","Marcelo Felizola","巴西","Sao Paulo","Sao Paulo"],["Liga Norte Riograndense Contra o Cancer","Wendel Costa","巴西","Rio Grande do Norte","Natal"],["Fundacao Pio XII - Hospital de Cancer de Barretos","Gustavo Dix Junqueira Pinto","巴西","Sao Paulo","Barretos"],["Clínica de Oncologia Reichow","Sandro Reichow","巴西","Sao Paulo","Sao Paulo"],["CEDOES","Mauricio Pereira","巴西","Espírito Santo","Vitória"],["Instituto Nacional de Cancer - INCA","Victor Santos","巴西","Rio de Janeiro","Rio de Janeiro"],["Centro de Pesquisa Sao Lucas","Andre Sasse","巴西","Sao Paulo","Campinas"],["A. C. Camargo Cancer Center","Thiago Oliveira","巴西","Sao Paulo","Sao Paulo"],["Hospital Nossa Senhora da Conceicao","Juliana de Menezes","巴西","Rio Grande do Sul","Canoas"],["Fundacao Faculdade Regional de Medicina de Sao José do Rio Preto","JOAO SOLER","巴西","Sao Paulo","SAO JOSE DO RIO PRETO"],["Centro de Oncologia - CEON+ - Unidade Sao Caetano do Sul","Claudia Vaz de Melo Sette","巴西","Sao Paulo","Santo Andre"],["Trakia Hospital","Rumyana Ilieva","保加利亚","Stara Zagora","Stara Zagora"],["Complex Oncology Center - Ruse EOOD","Nikolay Nikolaev","保加利亚","Ruse","Ruse"],["Specialized Hospital for Active Treatment of Oncology - Haskovo","Stoil Boychev","保加利亚","Haskovo","Haskovo"],["MBAL Uni Hospital","Rossitza Krasteva","保加利亚","Sofia City","Sofia"],["Instituto Nacional De Cancerologia","Ricardo Bruges","哥伦比亚","Distrito Capital","Bogota"],["Instituto Médico de Alta Tecnología S.A.S - IMAT S.A.S","Jose Fernando Lobaton Ramirez","哥伦比亚","Córdoba","Montería"],["Fundación Colombiana de Cancerología Clínica Vida","Javier Cuello Lopez","哥伦比亚","Antioquia","Medellin"],["Fakultni nemocnice Olomouc","Juraj Kultan","捷克共和国","Olomouc Region","Olomouc"],["Fakultni nemocnice Hradec Kralove","Michal Hrnciarik","捷克共和国","Hradec Králové Region","Hradec Kralove"],["Rigshospitalet, University of Copenhagen_Do not use – Duplicate facility","Edyta Maria Urbanska","丹麦","Capital Region","Copenhagen"],["Centre Hospitalier Régional Universitaire de Nancy - Hopitaux de Brabois","Bertrand Mennecier","法国","Meurthe-et-Moselle","Vandoeuvre-les-Nancy"],["Centre Georges Francois Leclerc","Coureche Kaderbhai","法国","Cote-d'Or","DIJON"],["centre hospitalier lyon sud","Michael Duruisseaux","法国","Auvergne-Rhone-Alpes","Lyon"],["CHU de Toulouse – Hopital Larrey","Julien Mazieres","法国","Occitanie","Toulouse"],["Centre Francois Baclesse","Hubert CURCIO","法国","Normandy","Caen"],["Institut Curie","nicolas girard","法国","lle-de-France","Paris"],["CHU Bordeaux Haut-Leveque","Remi Veillon","法国","Nouvelle-Aquitaine","Pessac"],["Institut Régional du Cancer Montpellier","Quentin THOMAS","法国","Occitanie","Montpellier"],["Centre Hospitalier Régional Universitaire de Brest - Hopital Morvan","Gilles Quere","法国","Brittany","Brest"],["Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou","Charles Ricordel","法国","Brittany","Rennes"],["CHU GABRIEL MONTPIED","Patrick MERLE","法国","Auvergne-Rhone-Alpes","Clemont-Ferrand"],["Institut Paoli-Calmettes","Anne Madroszyk","法国","Provence-Alpes-Cote d'Azur","Marseille"],["Centre Hospitalier Régional Universitaire de Tours - Hopital Bretonneau","Eric Pichon","法国","Centre-Val de Loire","Tours"],["Chu Jean Minjoz","Virginie Westeel","法国","Bourgogne-Franche-Comté","Besancon"],["Groupe hospitalier Paris saint Joseph","Carole Helissey Danis","法国","lle-de-France","Paris"],["LungenClinic Grosshansdorf","Martin Reck","德国","Hamburg","Hamburg"],["Klinik Lowenstein","Jonas Kuon","德国","Baden-Wurttemberg","Heilbronn"],["Robert Bosch Krankenhaus GmbH","Martin Kimmich","德国","Baden-Wurttemberg","Stuttgart"],["Pius Hospital Oldenburg","Frank Griesinger","德国","Lower Saxony","Osnabrueck"],["Folker Schneller","TUM Klinikum","德国","Bavaria","München"],["Evangelisches Krankenhaus Herne - Eickel","Daniel Christoph","德国","North Rhine-Westphalia","Herne"],["Lungenfachklinik Immenhausen","Achim Rittmeyer","德国","Hesse","Immenhausen"],["Krankenhaus Barmherzige Brüder Regensburg","Bernhard Braun","德国","Bavaria","Regensburg"],["THORACIC GENERAL HOSPITAL OF ATHENS","Konstantinos Syrigos","希腊","Attica","Athens"],["University General Hospital of Larissa","Athanasios Kotsakis","希腊","Thessaly","Larissa"],["Errikos Dunant Hospital Center","IOANNIS MOUNTZIOS","希腊","Attica","Athens"],["Theagenio Cancer Hospital of Thessaloniki","Anastasios Boutis","希腊","Central Macedonia","Thessaloniki"],["UNIVERSITY HOSPITAL OF PATRAS","Angelos Koutras","希腊","Western Greece","Patras"],["Alexandra General Hospital of Athens","Michalis Liontos","希腊","Attica","ATHENS"],["Queen Mary Hospital","Dennis Leung","中国香港","Hong Kong","Hong Kong"],["Prince of Wales Hospital","Siu Ching Li","中国香港","Hong Kong","Hong Kong"],["Farkasgyepui Tudogyogyintezet","Zsolt Kiraly","匈牙利","Veszprem","Farkasgyepu"],["Semmelweis Egyetem","Veronika Muller","匈牙利","Budapest","Budapest"],["Békés Vármegyei Kozponti Kórház Pándy Kálmán Tagkórház","Ibolya Laczo","匈牙利","Békés","Gyula"],["Clinexpert Kft.","Istvan Albert","匈牙利","Heves","Matrahaza"],["Aster CMI Hospital","C N Patil","印度","Karnataka","Bangalore"],["Tata Memorial Centre - Homi Bhabha Cancer Hospital","Akhil Kapoor","印度","Uttar Pradesh","Varanasi"],["Apollo Institute of Medical Sciences and Research","Nikhil Ghadyalpatil","印度","Telangana","Hyderabad"],["Tata Memorial Hospital","Kumar Prabhash","印度","Maharashtra","Mumbai"],["All India Institute of Medical Sciences","Deepam Pushpam","印度","Delhi","New Delhi"],["Manipal Hospitals","Amit Rauthan","印度","Karnataka","Bengaluru"],["Sir H. N. Reliance Foundation Hospital and Research Centre","Sewanti Limaye","印度","Maharashtra","Mumbai"],["Meir Medical Center","Maya Gottfried","以色列","Central District","Kfar Saba"],["Sheba Medical Center","Jair Bar","以色列","Tel Aviv District","Ramat Gan"],["Hadassah Medical Center","Hovav Nechushtan","以色列","Jerusalem District","Jerusalem"],["Rambam Health Care Campus","Alona Zer","以色列","Haifa District","Haifa"],["Emek Medical Center","Gil Bar-Sela","以色列","Northern District","afula"],["Shaare Zedek Medical Center","Nir Peled","以色列","Jerusalem District","Jerusalem"],["Azienda USL della Romagna","Manolo D Arcangelo","意大利","Galicia","Lugo"],["Azienda Ospedaliero-Universitaria San Luigi Gonzaga","Silvia Novello","意大利","Piedmont","Orbassano"],["Fondazione IRCCS Istituto Nazionale dei Tumori","Claudia Proto","意大利","Lombardy","Milano"],["CRO-IRCCS","Alessandra Bearz","意大利","Friuli-Venezia Giulia","Aviano"],["AO Santa Maria della Misericordia","Giulio Metro","意大利","Umbria","Perugia"],["Ospedale San Raffaele","Alessandra Bulotta","意大利","Lombardy","Milano"],["IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola","Francesco Gelsomino","意大利","Emilia-Romagna","Bologna"],["AOU della Campania Luigi Vanvitelli","Floriana Morgillo","意大利","Campania","Napoli"],["Azienda Ospedaliera Specialistica dei Colli Monaldi-Cotugno-CTO","Danilo Rocco","意大利","Campania","Napoli"],["Sendai Kousei Hospital","Shunichi Sugawara","日本","Miyagi","Sendai"],["Hokkaido University Hospital","Jun Sakakibara","日本","Hokkaido","Sapporo"],["Nippon Medical School Hospital","Kazuo Kasahara","日本","Tokyo","Bunkyo-ku"],["Dokkyo Medical University Hospital","Seiji Niho","日本","Tochigi","Mibu"],["National Cancer Center Hospital East","Hibiki Udagawa","日本","Chiba","Kashiwa"],["Matsusaka City Hospital","Osamu Hataji","日本","Mie","Matsusaka"],["Kanagawa cancer center","Shuji Murakami","日本","Kanagawa","Yokohama"],["Osaka City General Hospital","Haruko Daga","日本","Osaka","Osaka"],["Kansai Medical University Hospital","Takayasu Kurata","日本","Osaka","Hirakata"],["Kochi Medical School Hospital","TOSHIYUKI KOZUKI","日本","Kochi","Nankoku"],["National Hospital Organization Yamaguchi Ube Medical Center","Kenichi Chikamori","日本","Yamaguchi","Ube"],["National Hospital Organization Nagoya Medical Center","Masahide Oki","日本","Aichi","Nagoya"],["National Hospital Organization Okayama Medical Center","Keiichi Fujiwara","日本","Okayama","Okayama"],["Saitama Medical University International Medical Center","Hiroshi Kagamu","日本","Saitama","Hidaka"],["National Hospital Organization Kyushu Cancer Center","Masafumi Yamaguchi","日本","Fukuoka","Fukuoka"],["Kobe City Medical Center General Hospital","Yuki Sato","日本","Hyogo","Kobe"],["St. Marianna University Hospital","Naoki Furuya","日本","New York","New York"],["Gunma Prefectural Cancer Center","ken masubuchi","日本","Gunma","Ota"],["Iwate Medical University Hospital","Hiromi Nagashima","日本","Kochi","shiwagun"],["Himeji Medical Center","Tetsuji Kawamura","日本","Hyogo","Himeji"],["Asan Medical Center","Dae Ho Lee","韩国","Seoul","Seoul"],["Severance Hospital, Yonsei University Health System","Hye Ryun Kim","韩国","Seoul","Seoul"],["Seoul National University Hospital","Tae Min Kim","韩国","Seoul","SEOUL"],["National Cancer Center","Ji-Youn Han","韩国","Gyeonggi-do","Goyang-Si"],["Chungbuk National University Hospital","Ki Hyeong Lee","韩国","North Chungcheong","Cheongju si"],["Seoul National University Bundang Hospital","Yu Jung Kim","韩国","Gyeonggi-do","Seongnam-si"],["Samsung Medical Center","Jin Seok Ahn","韩国","Seoul","Seoul"],["Sarawak General Hospital","Pei Jye Voon","马来西亚","Sarawak","Kuching"],["University Malaya Medical Centre","Jiunn Liang Tan","马来西亚","Kuala Lumpur","Kuala Lumpur"],["CENEIT Oncologicos","Alberto Suarez Zaizar","墨西哥","Mexico City","CIUDAD DE MEXICO"],["CANCER TREAMTENT CLINIC AND CLINICAL TRIALS SA DE CV","Juan Carlos Vazquez Limon","墨西哥","Jalisco","Guadalajara"],["Centro de Investigacion Clinica de Oaxaca","YOLANDA LIZBETH BAUTISTA ARAGON","墨西哥","Oaxaca","Oaxaca de Juarez"],["Hospital Universitario Dr. Jose Eleuterio Gonzalez","Victor Oyervides Juarez","墨西哥","Nuevo León","Monterrey"],["Actualidad Basada en la Investigación del Cáncer","Emmanuel de la Mora Jimenez","墨西哥","Jalisco","Guadalajara"],["Scientia Investigacion Clinica S.C.","Manuel Lara Banuelas","墨西哥","Chihuahua","CHIHUAHUA"],["Hospital H+ Queretaro","Juan Feregrino","墨西哥","Querétaro","Queretaro"],["Oncocenter","Julio Garibay Diaz","墨西哥","Puebla","Heroica Puebla de Zaragoza"],["University Medical Center Groningen","T.Jeroen Hiltermann","荷兰","Groningen","Groningen"],["Maxima Medisch Centrum, locatie Veldhoven","Magdolen Youssef","荷兰","North Brabant","Veldhoven"],["Drammen Sykehus, Vestre Viken HF","Odd Terje Brustugun","挪威","Buskerud","Drammen"],["Szpital Specjalistyczny w Prabutach Spolka z o.o.","Anna Lowczak","波兰","Pomeranian Voivodeship","Prabuty"],["Pratia MCM Krakow","Anna Drosik Kwasniewska","波兰","Lesser Poland Voivodeship","KRAKOW"],["Centrum Onkologii im. Prof. Franciszka Lukaszczyka","Bogdan Zurawski","波兰","Kuyavian-Pomeranian","Bydgoszcz"],["Lux med onkologia sp. z o.o.","Ewa Salt","波兰","Masovian Voivodeship","Warszawa"],["Pratia Poznań","Marek Kotlarski","波兰","Greater Poland Voivodeship","Skórzewo"],["SC Radiotherapy Center Cluj SRL","Andrei Ungureanu","罗马尼亚","Cluj County","Floresti Cluj"],["Centrul de Diagnostic si Tratament Provita","Mircea Dediu","罗马尼亚","Bucharest","Bucuresti"],["Institutul Oncologic Bucuresti","Aurelia Alexandru","罗马尼亚","Bucharest","Bucharest"],["Institutul Oncologic Cluj","Tudor Ciuleanu","罗马尼亚","Cluj County","Cluj-Napoca"],["Institutul Oncologic Cluj","Cristina Cebotaru","罗马尼亚","Cluj County","Cluj-Napoca"],["Centrul de Oncologie Sfantul Nectarie","Michael Schenker","罗马尼亚","Dolj County","Craiova"],["Institutul Regional de Oncologie","Dana Clement","罗马尼亚","Iasi County","Iasi"],["Radiology Therapeutic Center","Elena Ciubotaru","罗马尼亚","Ilfov County","Otopeni"],["Spitalul Municipal Schuller Ploiesti","Nita Amedeia","罗马尼亚","Prahova County","Ploiesti"],["S.C. Centrul de Oncologie Euroclinic S.R.L.","Constantin Volovat","罗马尼亚","Iasi County","Iasi"],["Hospital Universitari Vall d'Hebron","Enriqueta Felip Font","西班牙","Catalonia","barcelona"],["H.R.U Málaga - Hospital General","Manuel Cobo-Dols","西班牙","Andalusia","Malaga"],["HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARANON","Antonio Calles Blanco","西班牙","Madrid","Madrid"],["Institut Català d'Oncologia - L'Hospitalet","Ernest Nadal Alforja","西班牙","Catalonia","Hospitalet de Llobregat"],["HOSPITAL UNIVERSITARIO PUERTA DE HIERRO MAJADAHONDA","Mariano Provencio Pulla","西班牙","Madrid","Madrid"],["Hospital Universitario 12 de Octubre","Luis Paz-Ares Rodriguez","西班牙","Madrid","Madrid"],["Hospital Universitari i Politecnic La Fe","Oscar Juan Vidal","西班牙","Valencian Community","Valencia"],["HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO","Reyes Bernabe Caro","西班牙","Andalusia","seville"],["Sahlgrenska Universitetssjukhuset","Andreas Hallqvist","瑞典","Vastra Gotaland","Goteborg"],["National Cheng Kung University Hospital","Chun-Hui Lee","中国台湾","Taiwan","Taiwan"],["Chang Gung Medical Foundation-Linkou Branch","Wen-Cheng Chang","中国台湾","Taiwan","Taiwan"],["National Taiwan University Hospital","Chia-Chi Lin","中国台湾","Taiwan","Taiwan"],["Chi Mei Hospital - Liouying Branch","Cheng-Yao Lin","中国台湾","Taiwan","Taiwan"],["Taipei Medical University Hospital","Chao-Hua Chiu","中国台湾","Taiwan","Taiwan"],["Chulalongkorn University","Virote Sriuranpong","泰国","Bangkok","Bangkok"],["Faculty of Medicine Siriraj Hospital","Pongwut Danchaivijitr","泰国","Bangkok","Bangkok"],["Adana City Hospital","Timucin Cil","土耳其","Adana","Adana"],["Adana Medical Park Seyhan Hastanesi","Ahmet Sezer","土耳其","Adana","Adana"],["？.A.U VM Medical Park Florya Hastanesi","Irfan Cicin","土耳其","Istanbul","Istanbul"],["Uludag Universitesi","Erdem Cubukcu","土耳其","Bursa","Bursa"],["Liv Hospital Ankara","Saadettin Kilickap","土耳其","Ankara","Ankara"],["I.E.U. Medical Point Hastanesi","Cagatay Arslan","土耳其","izmir","izmir"],["Akdeniz Universitesi Hastanesi","Sema Sezgin Goksu","土耳其","Antalya","Antalya"],["Leicester Royal Infirmary","Sean Dulloo","英国","England","Leicester"],["Sarah Cannon Research Institute UK","Elisa Fontana","英国","England","London"],["Royal Free Hospital","Alexandra Pender","英国","England","London"],["Alaska Oncology and Hematology","Steven Liu","美国","Alaska","Anchorage"],["University of Arizona Cancer Center","Ricklie Julian","美国","Arizona","Tucson"],["St. Luke’s Cancer Institute: Boise","Peyman Haghighat","美国","Idaho","Boise"],["University of Kentucky Chandler Medical Center","John Villano","美国","Kentucky","Lexington"],["Clinical Research Alliance","James D'Olimpio","美国","New York","Westbury"],["The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer Center","Logan Roof","美国","Ohio","Columbus"],["University of Texas MD Anderson Cancer Center","Natalie Vokes","美国","California","San Diego"],["Highlands Oncology Group","Eric Schaefer","美国","Arkansas","Springdale"],["Infirmary Cancer Care","Jan Kemnade","美国","Alabama","Mobile"],["Fred Hutchinson Cancer Center","Lei Deng","美国","Washington","Seattle"],["University Hospitals Cleveland Medical Center","Afshin Dowlati","美国","Ohio","Cleveland"],["Cancer Specialists of North Florida","Daniel Kobrinski","美国","Florida","Jacksonville"],["Helios Clinical Research - Fort Lauderdale","Edgardo Santos","美国","Florida","Aventura"],["Dana-Farber Cancer Institute","Pasi Janne","美国","Massachusetts","Boston"],["Oncology Hematology West P.C. dba Nebraska Cancer Specialists","Geetha Palaniappan","美国","Nebraska","Grand Island"],["Cleveland Clinic","Khaled Hassan","美国","Ohio","Columbus"],["Providence Portland Medical Center","Rachel Sanborn","美国","Oregon","Portland"],["WMCHealth Advanced Physician Services","Marjorie Zauderer","美国","New York","Valhalla"],["Mayo Clinic in Rochester, Minnesota","Konstantinos Leventakos","美国","New York","Rochester"],["The Christ Hospital Cancer Center","Alexander Starodub","美国","Ohio","Cincinnati"],["VCU Health Adult Outpatient Pavillion","Renato Martins","美国","Virginia","Richmond"],["Johns Hopkins Hospital","Julie Brahmer","美国","Maryland","Baltimore"],["Virginia Mason Medical Center","Kevin Chang","美国","Washington","Seattle"],["Roper St. Francis Healthcare","James Orcutt","美国","South Carolina","Charleston"],["Illinois Cancer Care","Gary MacVicar","美国","Illinois","Peoria"],["Good Samaritan Regional Medical Center","John Strother","美国","Oregon","Corvallis"],["Baptist Health Lexington","Firas Badin","美国","Kentucky","Lexington"],["Kaiser Permanente Interstate Medical Office Central","Sandeep Mashru","美国","Oregon","Portland"],["Huntsman Cancer Institute","Matthew Gumbleton","美国","Utah","Salt Lake City"],["Renovatio Clinical - El Paso","Mary Crow","美国","California","San Diego"],["Renovatio Clinical","Mahran Shoukier","美国","California","San Diego"],["Mayo Clinic in Arizona – Phoenix","Vinicius Ernani","美国","New York","Rochester"],["Mayo Clinic in Florida","Shenduo Li","美国","New York","Rochester"],["HonorHealth Research Institute","Michael Gordon","美国","Arizona","Scottsdale"],["Tufts Medical Center","Lori Pai","美国","Massachusetts","Boston"],["Cancer Center Of Central Connecticut","Brian Byrne","美国","Massachusetts","Plainville"],["Providence St. Jude Medical Center","David Park","美国","California","Fullerton"],["UCLA Health","Maria Velez Velez","美国","California","Los Angeles"],["Good Samaritan Hospital","Bryan Rabatic","美国","Ohio","Cincinnati"],["MetroHealth Medical Center","Peter Xie","美国","Ohio","Cleveland"],["Karmanos Cancer Institute","Hirva Mamdani","美国","Michigan","Detroit"],["USC/Norris Comprehensive Cancer Center","Robert Hsu","美国","California","Los Angeles"],["Yuma Regional Medical Center","Abhinav Chandra","美国","Arizona","Yuma"],["Gettysburg Cancer Center","Satish Shah","美国","California","Westminster"],["Center For Cancer And Blood Disorders","Victor Priego","美国","Maryland","Bethesda"],["Houston Methodist Hospital","Jenny C. Chang","美国","Texas","Houston"],["University Of Michigan Health Centers","Angel Qin","美国","Michigan","Ann Arbor"],["Fort Wayne Medical Oncology and Hematology, Inc.","Sunil Babu","美国","Indiana","Fort Wayne"],["Munson Medical Center","Yelena Kier","美国","Michigan","Traverse City"],["Pacific Central Coast Health Center - San Luis Obispo","Thomas Spillane","美国","California","San Luis Obispo"],["Northern Light Eastern Maine Medical Center","Sarah Sinclair","美国","Maine","Brewer"],["MaineHealth Cancer Care","Vatche Tchekmedyian","美国","Maine","South Portland"],["UT Southwestern Medical Center","Arthi Sridhar","美国","Virginia","Arlington"],["Pacific Shores Medical Group","Danny Nguyen","美国","California","Long Beach"],["Kaiser Permanente San Jose","Meghna Desai","美国","California","Oakland"],["City Of Hope - Chicago","Daniel Bruetman","美国","Illinois","Chicago"],["University of Wisconsin - Madison","Anthony Serritella","美国","Washington","Puyallup"],["Mission Hope Cancer Center - Arroyo Grande","Wei Bai","美国","Texas","Arlington"],["Valkyrie Clinical Trials","David Berz","美国","Rhode Island","Providence"]]

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","2025-09-18"]]

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: 75 ； 国际: 590 ；
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；