北京Golcadomide胶囊III期临床试验-一项在复发/难治性滤泡性淋巴瘤受试者中对比Golcadomide 联合利妥昔单抗（Golca+R）与研究者选择的治疗方案的有效性和安全性的研究

登记号	CTR20253038	试验状态	进行中
申请人联系人	宋洋洋	首次公示信息日期	2025-07-31
申请人名称	Celgene Corporation/ 百时美施贵宝（中国）投资有限公司/ Bristol Myers Squibb Company

登记号	CTR20253038
相关登记号	暂无
药物名称	Golcadomide胶囊
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	复发/难治性滤泡性淋巴瘤
试验专业题目	一项在复发/难治性滤泡性淋巴瘤受试者中对比Golcadomide 联合利妥昔单抗（Golca+R）与研究者选择的治疗方案的有效性和安全性的3 期、多中心、随机、开放标签研究
试验通俗题目	一项在复发/难治性滤泡性淋巴瘤受试者中对比Golcadomide 联合利妥昔单抗（Golca+R）与研究者选择的治疗方案的有效性和安全性的研究
试验方案编号	CA0731003	方案最新版本号	原始方案
版本日期:	2025-02-11	方案是否为联合用药	是

申请人名称	[["Celgene Corporation"],["百时美施贵宝（中国）投资有限公司"],["Bristol Myers Squibb Company"]]
联系人姓名	宋洋洋	联系人座机	010-58237432	联系人手机号
联系人Email	song.yangyang@bms.com	联系人邮政地址	北京市-北京市-朝阳区建国门外大街乙12号 汇京双子座大厦12层	联系人邮编	100022

主要 ●评价Golca+R与研究者选择的治疗方案（IC）在无进展生存期（PFS-IRAC）方面的有效性 关键次要 ●评价Golca+R与IC在总体缓解率（ORR-IRAC）方面的有效性 ●评价Golca+R与IC在总生存期（OS）方面的有效性 次要（有效性） ●评价Golca+R与IC在无进展生存期（PFS-研究者）方面的有效性 ●评价Golca+R与IC在ORR（ORR-研究者）方面的有效性 ●评价Golca+R与IC在完全代谢缓解率（CMRR-研究者）方面的有效性 ●评价Golca+R与IC在缓解持续时间（DoR）方面的有效性 ●评价Golca+R与IC在无事件生存期（EFS）方面的有效性 ●评价Golca+R与IC在至下一线抗淋巴瘤治疗的时间（TTNT）方面的有效性 ●评价Golca+R与IC在下一线抗淋巴瘤治疗无进展生存期（NALT）方面的有效性（PFS2） ●对比Golca+R与IC的受试者报告的FL症状、功能及健康相关生活质量 ●评价Golca+R与IC在EOT时MRD阴性方面的有效性 探索性（安全性） ●在R/R FL受试者中评价Golca+R与IC的安全性等

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	[["签署书面知情同意书"],["受试者必须患有经当地病理科组织学确认的FL（1、2 或3a 级）。需提供足够的肿瘤新鲜活检组织或存档活检样本（首选来自末次复发的样本），并附相应的病理报告，以进行回顾性中心病理学确认疾病复发。不允许采用细针穿刺进行的评估。"],["受试者的美国东部肿瘤协作组（ECOG）体能状态评分（PS）必须≤2 分；如果ECOG PS 为3，则必须为淋巴瘤相关且非由合并症引起。"],["受试者必须患有正电子发射断层扫描（PET）阳性疾病，且至少一个PET阳性病灶通过CT断层扫描显示为可测量病灶（符合Lugano分类标准定义）"],["受试者既往至少接受过一线系统性治疗，其中包含抗CD20 单克隆抗体（例如利妥昔单抗、奥妥珠单抗）与烷化剂（例如环磷酰胺、苯达莫司汀）的联合治疗。既往接受的放疗不计入治疗线数。"],["根据研究者评估，符合但不限于以下标准（改良GELF标准）之一且具有抗淋巴瘤治疗指征的受试者：a）大肿块病灶定义为淋巴结或结外（脾脏除外）肿块的最大直径＞7cm，或至少累及3 个淋巴结或结外部位（每个部位直径＞3cm）b）至少存在以下一种B 症状：ni）不明原因发热（＞38℃）nii）盗汗niii）过去6 个月内体重下降超过10%nc）脾肿大，下缘低于脐水平线nd）淋巴瘤导致的以下任意一种血细胞减少症：ni）血小板＜100,000 个细胞/mm3 （100×109 /L）nii）中性粒细胞绝对计数（ANC）＜1,000 个细胞/mm3 （1.0×109 /L）niii）血红蛋白＜10 g/dL（6.25 mmol/L）ne）胸腔或腹腔浆膜腔积液（无论细胞含量如何）nf）任何压迫综合征（例如但不限于输尿管、眼眶、胃肠道压迫）"],["受试者必须满足以下实验室检查值：na）绝对中性粒细胞计数≥1,000 个细胞/mm3 （1.0×10^9 /L），骨髓累及或脾脏累及导致脾功能亢进的情况下≥0.5×10^9 /L，无生长因子支持的情况下持续7天（如使用聚乙二醇化生长因子，则为14 天）。nb）血小板计数≥75,000 个细胞/mm3 （75×10^9 /L），骨髓累及或脾脏累及导致脾功能亢进的情况下≥50,000 个细胞/mm3 （50×10^9 /L）,无输血的情况下持续7 天。nc）血红蛋白≥7.5 g/dL。"],["使用肾疾病膳食改良（MDRD）公式（参见方案附录13）或慢性肾脏病流行病学合作公式（CKD-EPI）估计的肾小球功能（eGFR）≥30 mL/min/1.73 m2 。在肾脏累及的情况下，同样适用上述eGFR 临界值。nd）血清天冬氨酸转氨酶（AST/SGOT）或血清谷丙转氨酶（ALT/SGPT）≤2.5×正常值上限（ULN）。在肝脏累及的情况下，ALT/SGPT 和nAST/SGOT 必须≤5.0×ULN。ne）血清总胆红素≤1.5×ULN（根据美国国家癌症研究所器官功能障碍工作组[NCI ODWG]标准，对应轻度功能障碍）。在肝脏累及的情况下，血清总胆红素必须≤3.0×ULN（根据NCI ODWG 标准，对应中度功能障碍）。对于Gilbert 综合征患者，血清总胆红素≤5.0×ULN。"],["接受蒽环类化疗的受试者需具备足够的心功能，定义为超声心动图n（ECHO）评估或在ECHO 结果不明确时通过多门控采集扫描（MUGA）n评估的左心室射血分数（LVEF）≥40%。"],["具有血栓栓塞事件的高风险的受试者需愿意接受血栓栓塞药物治疗。"],["受试者能够理解并在进行任何研究相关评估/程序之前自愿签署ICF。"],["受试者愿意并能够遵守研究访视计划以及所有其他方案要求。"],["受试者同意在研究干预期间、暂停给药期间以及末次研究给药后至少28天内避免献血。"],["受试者在签署ICF 时必须年满18 岁（含18 岁）。"],["女性（出生性别）受试者必须遵守妊娠预防计划的要求"],["IOCBP（出生时为女性）必须同意在研究期间以及Golcadomide 停药后至n少28天，以及根据化疗方案、利妥昔单抗和来那度胺组分的批准产品/处n方信息要求的时间内避免哺乳。"]]
排除标准	[["具有复合型DLBCL 与FL 或转化型NHL 或任何其他惰性淋巴瘤的证据或n病史。"],["患有符合世界卫生组织（WHO）第5版亚分类标准的定义的滤泡性大细胞n淋巴瘤（WHO 第4 版标准中的3b级FL）或十二指肠型FL。"],["根据研究者的判断，受试者存在任何可能妨碍其研究参与依从性的严重医n学状况、实验室检查异常或精神疾病。"],["根据研究者或申办方的判断，受试者存在任何可能干扰研究数据解释的状况。"],["存在或具有中枢神经系统（CNS）侵犯的病史。"],["入组前6 个月内有卒中或颅内出血病史。"],["入组前1 个月内有深静脉血栓形成/肺栓塞病史。"],["有进行性多灶性脑白质病病史的受试者。"],["受试者患有任何其他亚型的淋巴瘤。"],["受试者存在经治后仍≥2 级持续性腹泻或吸收不良（NCI CTCAE v5.0）。"],["其他原发性恶性肿瘤病史且未达到缓解≥3 年，但以下非侵袭性恶性肿n瘤除外：na) 皮肤基底细胞癌。nb) 皮肤鳞状细胞癌。nc) 宫颈原位癌。nd) 乳腺原位癌。ne) 前列腺癌的偶然组织学发现（使用TNM[肿瘤淋巴结转移]临床分期系n统为T1a 或T1b）或可治愈的前列腺癌。nf) 其他完全切除的1 期实体瘤，治愈性治疗后且研究者判断复发风险较n低。"],["哺乳个体"],["妊娠个体"],["无法遵守临床研究方案第7.7 节合并治疗中列出的限制和禁用治疗要求。"],["对化疗和来那度胺均耐药的受试者，定义为：n● 对CHOP 和苯达莫司汀类免疫化疗的最佳缓解为SD 或疾病进展，n或对CHOP 和苯达莫司汀类免疫化疗的缓解持续时间少于6 个月；n● 对来那度胺类治疗方案的最佳缓解为SD 或疾病进展，或对来那度n胺类治疗方案的缓解持续时间少于6 个月n注：既往对来那度胺耐药和/或接受过来那度胺治疗的受试者将不被随机分n配至R-来那度胺组；对R-化疗（包括CHOP 和苯达莫司汀）耐药的受试者将不n被随机分配至R-化疗治疗组。"],["受试者正在接受慢性全身性免疫抑制治疗或糖皮质激素治疗（过去4 周内n允许使用泼尼松或等效药物，每日剂量不超过10 mg）；允许稳定使用吸n入或外用糖皮质激素。"],["受试者目前正在使用强效细胞色素P450 3A4/5（CYP3A4/5）抑制剂或诱n导剂（相关内容参见第7.7.1 节）。强效CYP3A4/5 抑制剂或诱导剂的洗脱n期为Golcadomide 给药开始前7 天或5 个半衰期（以较长者为准）。在与n医学监查员讨论后，可能允许联合使用中效细胞色素P450 3A4/5n（CYP3A4/5）抑制剂或诱导剂。"],["受试者在研究干预开始前3 个月内接种过减毒活疫苗，或在C1D1 前30 天n内接种过2019 新型冠状病毒病（COVID-19）减毒活疫苗。"],["存在器官功能障碍或体格检查、生命体征、ECG 或临床实验室检查提示与n目标人群不一致的临床显著异常，或这些异常会使受试者参与研究时面临n不可接受的风险。"],["已知受试者的人类免疫缺陷病毒（HIV）血清反应阳性或活动性病毒感染。"],["已知受试者感染慢性活动性乙型肝炎（乙型肝炎病毒表面抗原[HBsAg]阳n性和/或乙型肝炎核心抗体[anti-HBc]阳性且病毒DNA 阳性）或慢性活动性n丙型肝炎（需治疗的血清学检查阳性和/或存在肝损伤证据）。已完成治n疗并清除感染的丙型肝炎受试者（HCV 血清学检查阳性但PCR 阴性）可n能符合入组资格。"],["受试者在治疗开始前≤4 周内接受过重大手术（淋巴结活检除外）。"],["受试者存在任何导致无法吞咽片剂或胶囊的情况。"],["对研究干预的任何成分（包括辅料）或相关化合物有过敏/超敏反应史。"],["既往对CHOP 或苯达莫司汀过敏。"],["已知对鼠源产品敏感或过敏。"],["已知受试者对沙利度胺、泊马度胺或来那度胺过敏。既往因这些药物引起n皮疹但经医学管理后缓解的情况不属于排除标准。"],["囚犯或非自愿被监禁的受试者。（注：在某些特定情况下，且仅在当地法n规允许的国家，可能允许被关押的受试者继续参与研究。适用严格条件。）"],["在参与本研究的同时参与另一项治疗性临床试验。"]]

试验药

[["中文通用名:无 英文通用名:Golcadomide 商品名称:无","剂型:胶囊 规格:0.1mg 用法用量:第1天-第14天/28天，0.4mg,每日一次 用药时程:最长可达12个周期(28天周期)"],["中文通用名:无 英文通用名:Golcadomide 商品名称:无","剂型:胶囊 规格:0.2mg 用法用量:第1天-第14天/28天，0.4mg,每日一次 用药时程:最长可达12个周期(28天周期)"],["中文通用名:无 英文通用名:Golcadomide 商品名称:无","剂型:胶囊 规格:0.3mg 用法用量:第1天-第14天/28天，0.4mg,每日一次 用药时程:最长可达12个周期(28天周期)"],["中文通用名:无 英文通用名:Golcadomide 商品名称:无","剂型:胶囊 规格:0.4mg 用法用量:第1天-第14天/28天，0.4mg,每日一次 用药时程:最长可达12个周期(28天周期)"],["中文通用名:利妥昔单抗注射液 英文通用名:RituximabInjection 商品名称:美罗华","剂型:注射液 规格:500mg/50ml 用法用量:C1第1、8、15和22天，C2-5每个周期第1天以375mg/m2注射 用药时程:5个周期(28天周期)"],["中文通用名:利妥昔单抗注射液 英文通用名:RituximabInjection 商品名称:美罗华","剂型:注射液 规格:500mg/50ml 用法用量:C1第1、8、15和22天，C2-5每个周期第1天以375mg/m2注射 用药时程:5个周期(28天周期)"]] 序号 名称 用法

对照药

[["中文通用名:利妥昔单抗注射液 英文通用名:RituximabInjection 商品名称:美罗华","剂型:注射液 规格:500mg/50ml 用法用量:来那度胺+利妥昔单抗组：C1第1、8、15和22天，C2-5每个周期第1天以375mg/m2注射；其余对照组：每个周期第1天以375mg/m2注射 用药时程:来那度胺+利妥昔单抗组：5个周期(28天周期)；利妥昔单抗-CHOP组：6个周期（21天周期）；苯达莫司汀-利妥昔单抗组：6个周期（28天周期）"],["中文通用名:利妥昔单抗注射液 英文通用名:RituximabInjection 商品名称:美罗华","剂型:注射液 规格:500mg/50ml 用法用量:来那度胺+利妥昔单抗组：C1第1、8、15和22天，C2-5每个周期第1天以375mg/m2注射；其余对照组：每个周期第1天以375mg/m2注射 用药时程:来那度胺+利妥昔单抗组：5个周期(28天周期)；利妥昔单抗-CHOP组：6个周期（21天周期）；苯达莫司汀-利妥昔单抗组：6个周期（28天周期）"],["中文通用名:来那度胺胶囊 英文通用名:LenalidomideCapsules 商品名称:瑞复美","剂型:胶囊 规格:5mg 用法用量:20mg，第1天-第21天/28天，每日一次 用药时程:共12个周期（28天周期）"],["中文通用名:来那度胺胶囊 英文通用名:LenalidomideCapsules 商品名称:瑞复美","剂型:胶囊 规格:10mg 用法用量:20mg，第1天-第21天/28天，每日一次 用药时程:共12个周期（28天周期）"],["中文通用名:来那度胺胶囊 英文通用名:LenalidomideCapsules 商品名称:瑞复美","剂型:胶囊 规格:15mg 用法用量:20mg，第1天-第21天/28天，每日一次 用药时程:共12个周期（28天周期）"],["中文通用名:注射用环磷酰胺 英文通用名:CyclophosphamideforInjection 商品名称:安道生","剂型:注射液 规格:500mg/支/200mg/mL 用法用量:每个周期第1天注射750mg/m2 用药时程:共6个周期（21天周期）"],["中文通用名:注射用盐酸多柔比星 英文通用名:DoxorubicinHydrochloride 商品名称:无","剂型:注射液 规格:2mg/mL 用法用量:每个周期第1天注射50mg/m2 用药时程:共6个周期（21天周期）"],["中文通用名:注射用硫酸长春新碱 英文通用名:VincristineSulfateforInjection 商品名称:无","剂型:注射液 规格:1mg/mL 用法用量:每个周期第1天,注射1.4mg/m2（总计最多2.0mg） 用药时程:共6个周期（21天周期）"],["中文通用名:醋酸泼尼松片 英文通用名:PrednisoneAcetateTablets 商品名称:无","剂型:片剂 规格:50mg 用法用量:每个周期第1天-第5天，口服，100mg 用药时程:共6个周期（21天周期）"],["中文通用名:注射用盐酸苯达莫司汀 英文通用名:BendamustineHydrochlorideforInjection 商品名称:注射用盐酸苯达莫司汀","剂型:注射液 规格:100mg/支/25mg/mL 用法用量:每个周期第1天-第2天注射90mg/m2 用药时程:共6个周期（28天周期）"]] 序号 名称 用法

主要终点指标及评价时间

[["在R/R FL 受试者中评价Golca+R 与研n究者选择的治疗方案（IC）在无进展n生存期（PFS-IRAC）方面的有效性","随机分组至首次疾病进展","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

[["在R/R FL 受试者中评价Golca+R 与ICn在总体缓解率（ORR-IRAC）方面的n有效性","整个研究期间","有效性指标"],["在R/R FL 受试者中评价Golca+R 与ICn在总生存期（OS）方面的有效性","随机分组至全因死亡的时间","有效性指标"],["评价Golca+R 与IC在无进展生存期（PFS-研究者）方面的有效性","随机分组至首次疾病进展","有效性指标"],["评价Golca+R 与IC，在ORR（ORR-研究者）方面的有效性","整个研究期间","有效性指标"],["评价Golca+R 与ICn在完全代谢缓解率（CMRR-研究者）n方面的有效性","整个研究期间","有效性指标"],["评价Golca+R 与ICn在缓解持续时间（DoR）方面的有效n性。","首次缓解（CR 或PR）至首次疾病进展","有效性指标"],["评价Golca+R 与ICn在无事件生存期（EFS）方面的有效性","随机分组至全因死亡、首次疾病进展","有效性指标"],["评价Golca+R 与ICn在至下一线抗淋巴瘤治疗的时间n（TTNT）方面的有效性","随机分组至开始新抗淋巴瘤治疗或全因n死亡的时间（以先发生者为准）","有效性指标"],["评价Golca+R 与ICn在PFS2 方面的有效性","随机分组至NALT 后疾病进展（由研究n者评估）或全因死亡的时间（以先发生n者为准）","有效性指标"],["对比Golca+R 与ICn的受试者报告的FL 症状、功能及健康n相关生活质量","EORTC QLQ-C30 和EORTC QLQ-NHL-nLG20 各领域较基线的变化","有效性指标"],["评价Golca+R 与ICn在EOT 时MRD 阴性方面的有效性","EOT","有效性指标"]] 序号 指标 评价时间 终点指标选择

1	姓名	宋玉琴	学位	医学博士	职称	主任医师
	电话	010-88196118	Email	songyq22622@163.com	邮政地址	北京市-北京市-海淀区阜成路52号（定慧寺）
	邮编	100142	单位名称	北京肿瘤医院

[["北京肿瘤医院","宋玉琴","中国","北京市","北京市"],["福建医科大学附属协和医院","沈建箴","中国","福建省","福州市"],["中山大学附属肿瘤医院","李志铭","中国","广东省","广州市"],["河南省肿瘤医院","刘艳艳","中国","河南省","郑州市"],["哈尔滨医科大学附属肿瘤医院","赵丽娜","中国","黑龙江省","哈尔滨市"],["华中科技大学同济医学院附属协和医院","张利玲","中国","湖北省","武汉市"],["中南大学湘雅医院","徐雅婧","中国","湖南省","长沙市"],["吉林大学第一医院","白鸥","中国","吉林省","长春市"],["吉林省肿瘤医院","鲍慧铮","中国","吉林省","长春市"],["苏州大学附属第一医院","黄海雯","中国","江苏省","苏州市"],["南昌大学第一附属医院","李菲","中国","江西省","南昌市"],["中国医科大学附属盛京医院","廖爱军","中国","辽宁省","沈阳市"],["辽宁省肿瘤医院","邢晓静","中国","辽宁省","沈阳市"],["北京大学肿瘤医院内蒙古医院","平凌燕","中国","内蒙古自治区","呼和浩特市"],["山东省肿瘤医院","李增军","中国","山东省","济南市"],["复旦大学附属肿瘤医院","陶荣","中国","上海市","上海市"],["西南医科大学附属医院","李晓明","中国","四川省","泸州市"],["天津市肿瘤医院","钱正子","中国","天津市","天津市"],["天津市人民医院","赵邢力","中国","天津市","天津市"],["云南省肿瘤医院","王小沛","中国","云南省","昆明市"],["浙江省肿瘤医院","杨海燕","中国","浙江省","杭州市"],["北京世纪坛医院","仲凯励","中国","北京市","北京市"],["上海市同济医院","修冰","中国","上海市","上海市"],["Hattiesburg Clinic Hematology/Oncology","John Hrom","美国","MS","Hattiesburg"],["Infirmary Cancer Care","Furhan Yunus","美国","AL","Mobile"],["Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital","Dean Kirkel","美国","GA","Marietta"],["University of Maryland","Seung Tae Lee","美国","MD","Baltimore"],["Greater Baltimore Medical Center","Zhuoyan Li","美国","MD","Towson"],["City of Hope Comprehensive Cancer Center","Alex Herrera","美国","CA","Duarte"],["UCSF Helen Diller Medical Center at Parnassus Heights","Charalambos Andreadis","美国","CA","San Francisco"],["Northwest Cancer Specialists, P.C.","Tristan Bice","美国","WA","Vancouver"],["Rhode Island Hospital","Adam Olszewski","美国","RI","Providence"],["Massachusetts General Hospital","Julie Erika Haydu","美国","MA","Boston"],["Blue Ridge Cancer Care","Amanda Gillespie-Twardy","美国","VA","Roanoke"],["Texas Oncology – DFW","Khoan Vu","美国","TX","Fort Worth"],["Tampa General Hospital","Daniel Kerr","美国","FL","Tampa"],["University of Arkansas for Medical Sciences","Sorena Lo","美国","AR","Little Rock"],["The University of Kansas Cancer Center – Westwood","Marc Hoffmann","美国","KS","Westwood"],["Moffitt Cancer Center","Sameh Gaballa","美国","FL","Tampa"],["University of Kentucky Chandler Medical Center","Chaitanya Iragavarapu","美国","KY","Lexington"],["University of Alabama at Birmingham","Aditi Saha","美国","AL","Birmingham"],["Texas Oncology-San Antonio Medical Center","John S Renshaw","美国","TX","San Antonio"],["Texas Oncology - Central/South Texas","Jason Melear","美国","TX","Austin"],["Texas Oncology - Northeast Texas","Habte Yimer","美国","TX","Tyler"],["Illinois Cancer Specialists","Destry Elms","美国","IL","Arlington Heights"],["Mission Cancer + Blood","Tara Graff","美国","IA","Waukee"],["Dana-Farber Cancer Institute","Reid Merryman","美国","MA","Boston"],["Southeastern Regional Medical Center","Sabarish Ayyappan","美国","GA","Newnan"],["Beth Israel Deaconess Medical Center","Michael Leukam","美国","MA","Boston"],["Norfolk and Norwich University Hospitals NHS Foundation Trust","Hammersmith Hospital","英国","England","Cringleford"],["The Christie NHS Foundation Trust","Kim Linton","英国","NA","Manchester"],["Kent and Canterbury Hospital","Moya Young","英国","Kent","Canterbury"],["Hammersmith Hospital","Edward Bataillard","英国","London","London"],["Istanbul Universitesi Cerrahpasa","Muhlis Cem Ar","土耳其","？stanbul","Istanbul- Fatih"],["Ankara University Health Practice and Research Hospitals","Muhit Ozcan","土耳其","Ankara","Ankara"],["Akdeniz Universitesi Hastanesi","Ozan Salim","土耳其","Antalya","Antalya"],["Mersin University","Pelin Aytan","土耳其","Mersin","Mersin"],["Sheikh Shakhbout Medical City (SSMC)","Hussni Al Hateeti","阿拉伯联合酋长国","Abū Zaby","Abu Dhabi"],["Burjeel Medical City","Amin Abyad","阿拉伯联合酋长国","Abū Zaby","Abu Dhabi"],["King Faisal Specialist Hospital and Research Center","Alfadel Alshaibani","沙特阿拉伯","NA","Riyadh"],["King Abdulaziz Medical City - National Guard Hospital","Ayman Ibrahim","沙特阿拉伯","NA","Riyadh"],["King Fahad Specialist Hospital - Dammam","John Apostolidis","沙特阿拉伯","Ash Sharqīyah","Dammam"],["HOSPITAL CLINICO DE VALENCIA","Blanca Ferrer Lores","西班牙","Valenciana, Comunitat","Valencia"],["Hospital Universitario Fundación Jiménez Díaz","Raul Cordoba Mascunano","西班牙","Madrid","Madrid"],["Hospital Universitario Infanta Leonor","Jose Angel Hernandez Rivas","西班牙","Madrid, Comunidad de","Madrid"],["Hospital Universitario Marqués de Valdecilla","Sonia Gonzalez de Villambrosia","西班牙","Cantabria","Santander"],["Hospital Universitario Virgen Nieves","Jose Puerta Puerta","西班牙","Granada","Granada"],["Hospital Universitari Parc Tauli","Xavier Vilaseca Creus","西班牙","Barcelona [Barcelona]","Sabadell"],["Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie","Ewa Paszkiewicz-Kozik","波兰","Mazowieckie","Warszawa"],["Szpitale Pomorskie Sp. z o. o.","Adam Witkowski","波兰","Pomorskie","Gdynia"],["AIDPORT Sp. z o.o.","Michal Kwiatek","波兰","Wielkopolskie","Skórzewo"],["Pratia MCM Krakow","Wojciech Jurczak","波兰","Malopolskie","Kraków"],["Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi","Joanna Gora-Tybor","波兰","lódzkie","lódz"],["Amsterdam UMC, locatie VUmc","Sanne Tonino","荷兰","Noord-Holland","Amsterdam"],["University Medical Center Groningen","Marcel Nijland","荷兰","Groningen","Groningen"],["Universitair Medisch Centrum Utrecht","Margot Jak","荷兰","NA","Utrecht"],["Samsung Medical Center","Seok Jin Kim","韩国","Seoul-teukbyeolsi [Seoul]","Seoul"],["The Catholic University of Korea, Yeouido St. Mary's Hospital","Youngwoo Jeon","韩国","Seoul-teukbyeolsi [Seoul]","Seoul"],["Seoul National University Hospital","YOUNGIL KOH","韩国","Seoul-teukbyeolsi [Seoul]","Seoul"],["Asan Medical Center","Dok Hyun Yoon","韩国","Seoul-teukbyeolsi [Seoul]","Seoul"],["Istituto Clinico Humanitas","Armando Santoro","意大利","Milano","Rozzano"],["IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola","Pier Luigi Zinzani","意大利","Emilia-Romagna","Bologna"],["Azienda Ospedaliero Universitaria Pisana","Sara Galimberti","意大利","Toscana","Pisa"],["IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST)","Gerardo Musuraca","意大利","Emilia-Romagna","Meldola"],["Azienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare Arrigo","Marco Ladetto","意大利","Alessandria","Alessandria"],["Istituto Nazionale Tumori IRCCS Fondazione Pascale","Antonio Pinto","意大利","Napoli","Napoli"],["Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino","CAROLA BOCCOMINI","意大利","Torino","Torino"],["Nagoya University Hospital","Kazuyuki Shimada","日本","Aichi","Nagoya"],["National Hospital Organization Kyushu Medical Center","Ken Takase","日本","Fukuoka","Fukuoka"],["University of Yamanashi Hospital","Ichiro Kawashima","日本","Yamanashi","Chuo"],["Japanease Red Cross Society Himeji Hospital","Yasushi Hiramatsu","日本","Hyogo","Himeji"],["Iwate Prefectural Central Hospital","Kazunori Murai","日本","Iwate","Morioka"],["Tohoku University Hospital","NORIKO FUKUHARA","日本","Miyagi","Sendai-shi"],["Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital","Tsuyoshi Muta","日本","Hiroshima","Hiroshima"],["Osaka Red Cross Hospital","Kazunori Imada","日本","Osaka","Osaka"],["Nihon University Itabashi Hospital","Katsuhiro Miura","日本","Tokyo","Itabashiku"],["Aiiku Hospital","Koh Izumiyama","日本","Hokkaido","Sapporo"],["Kyushu University Hospital","Kohta Miyawaki","日本","Fukuoka","Fukuoka"],["National Cancer Center Hospital","Suguru Fukuhara","日本","Tokyo","Chuo-ku"],["University Hospital of Ioannina","Eleftheria Hatzimichael","希腊","ípeiros","Ioannina"],["Evangelismos General Hospital of Athens","Maria Bouzani","希腊","Attikí","Athens"],["General Hospital of Athens","Theodoros Vassilakopoulos","希腊","Attikí","Athens"],["University Hospital of Alexandroupolis","IOANNIS KOTSIANIDIS","希腊","NA","Alexandroupolis"],["G. Papanikolaou General Hospital","Niki Stavroyianni","希腊","Thessaloniki","Thessaloniki"],["Yashoda Hospitals - Hitech City","Ganesh Jaishetwar","印度","Telangana","Hyderabad"],["Apollo Institute of Medical Sciences and Research","Prasad S","印度","Telangana","Hyderabad"],["Mazumdar shaw Medical Centre-A Unit Of Narayana Health","sharat damodar","印度","Karnataka","Bengaluru"],["Mumbai Oncocare Centre - Nanachowk","vashista maniar","印度","Maharashtra","Mumbai"],["All India Institute of Medical Sciences","Deepam Pushpam","印度","Delhi","New Delhi"],["CHU SAINT ELOI","Guillaume Cartron","法国","Languedoc-Roussillon","Montpellier"],["centre hospitalier lyon sud","Emmanuel Bachy","法国","Rhone","Pierre-Bénite"],["Institut Curie - site Saint-Cloud","Clementine SARKOZY","法国","Hauts-de-Seine","Saint-Cloud"],["Hopital Claude Huriez - CHU de Lille","Franck Morschhauser","法国","Nord","Lille"],["CHU Bordeaux Haut-Leveque","Francois-Xavier Gros","法国","Aquitaine","Pessac"],["Centre Hospitalier Universitaire de Nantes - L' Hopital l'hotel-Dieu","Thomas Gastinne","法国","Loire-Atlantique","Nantes"],["Institut Universitaire du Cancer Toulouse - Oncopole - CHU de TOULOUSE","Loic Ysebaert","法国","NA","Toulouse"],["Hopital Saint-Louis","Catherine Thieblemont","法国","Paris","Paris"],["Klinikum Augsburg","Rainer Claus","德国","Bayern","Augsburg"],["Klinikum der Universitat München GroBhadern","Martin Dreyling","德国","NA","München"],["Universitaetsklinikum Ulm","Christian Buske","德国","Baden-Württemberg","Ulm"],["Universitaetsklinikum des Saarlandes","Konstantinos Christofyllakis","德国","Saarland","Homburg"],["GEFOS Gesellschaft f. onkologische Studien","Sandra Ketzler-Henkel","德国","Nordrhein-Westfalen","Dortmund"],["Klinikum Chemnitz","Mathias Haenel","德国","Sachsen","Chemnitz"],["Universitatsklinikum Jena","Ulf Schnetzke","德国","Thüringen","Jena"],["Gemeinschaftspraxis Hamatologie - Onkologie Freiberg-Richter, Jacobasch, Illmer, Wolf","Thomas Illmer","德国","NA","Dresden"],["Universitaetsklinikum Duesseldorf","Nora Liebers","德国","Nordrhein-Westfalen","Düsseldorf"],["Universitaetsklinikum Wuerzburg","Johannes Duell","德国","NA","Wuerzburg"],["Universitatsmedizin Gottingen - Georg-August-Universitat","Raphael Koch","德国","Niedersachsen","Gottingen"],["HELIOS Klinikum Erfurt","Sebastian Scholl","德国","Thüringen","Erfurt"],["Gemeinschaftspraxis für Hamatologie und Onkologie Münster","Rüdiger Liersch","德国","Nordrhein-Westfalen","Münster"],["Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Sy？p？keskus)","Sirpa Leppa","芬兰","NA","Helsinki"],["Oulun yliopistollinen sairaala","Hanne Kuitunen","芬兰","Pohjois-Pohjanmaa","Oulu"],["Turku University Hospital","Taina Reunamo","芬兰","Varsinais-Suomi","Turku"],["Bradfordhill","Sergio Portino","智利","Región Metropolitana de Santiago","Santiago"],["Clínica Alemana de Santiago","Daniel Ernst","智利","Región Metropolitana de Santiago","Santiago"],["Clínica Inmunocel","Alejandro Berkovits Cáceres","智利","Región Metropolitana de Santiago","Santiago"],["Centro Gaucho Integrado De Oncologia, Hematologia, Ensino E Pesquisa","Marcelo Capra","巴西","Rio Grande do Sul","Porto Alegre"],["Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein","Guilherme Perini","巴西","Sao Paulo","Sao Paulo"],["ICESP - INSTITUTO DO CANCER DO ESTADO DE SAO PAULO","Juliana Pereira","巴西","Sao Paulo","Sao Paulo"],["Instituto D'Or de Pesquisa e Ensino (IDOR)","Abel Costa","巴西","Sao Paulo","SAO PAULO"],["Instituto Oncomed de Educacao e Pesquisa","Roberto Magalhaes","巴西","Rio de Janeiro","Niterói"],["Centro de Tratamento de Tumores Botafogo para Oncoclinicas Rio de Janeiro SA","Adriana Scheliga","巴西","Rio de Janeiro","Rio de Janeiro"],["Hospital Santa Rita de Cassia","MARCELO ADUAN","巴西","Espírito Santo","Vitoria"],["Oncocentro Oncologia","Livia Ponte","巴西","Ceará","Fortaleza"],["Flinders Medical Centre","Kate Manos","澳大利亚","South Australia","Adelaide"],["Royal Perth Hospital","Collin Chin","澳大利亚","Western Australia","Perth"],["Austin Health","Eliza Hawkes","澳大利亚","Victoria","Heidelberg"],["Royal Hobart Hospital","Rosemary Harrup","澳大利亚","Tasmania","Hobart"],["Westmead Hospital","Amanda Johnston","澳大利亚","New South Wales","Westmead"],["Cabrini Hospital - Malvern","Adrian Minson","澳大利亚","Victoria","Malvern"],["Princess Margaret Cancer Centre","Robert Kridel","加拿大","Ontario","Toronto"],["Centre intégré universitaire de santé et de services sociaux de l'Estrie – Centre Hospitalier Universitaire de Sherbrooke (CIUS","Eva Laverdure","加拿大","Quebec","Sherbrooke"],["BC Cancer Victoria","Arnaud Blanchet St-Pierre","加拿大","British Columbia","Victoria"],["Centre intégré de cancérologie du CHU de Québec Université Laval, Hopital de l'Enfant-Jésus","Olivier Dumas","加拿大","Quebec","Quebec City"],["Hematology Oncology Associates of Fredericksburg","Christopher Vaughn","美国","VA","Fredericksburg"],["Alaska Oncology and Hematology","Steven Liu","美国","AK","Anchorage"]]

序号	机构名称	主要研究者	国家	省（州）	城市

[["北京肿瘤医院医学伦理委员会","同意","2025-06-09"]]

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: 60 ； 国际: 400 ；
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；