提供 Ramucirumab 用于治疗转移性胃癌的国际扩展获取计划
2023年10月19日 更新者：Eli Lilly and Company
一项国际单臂方案，旨在扩大雷莫芦单抗的使用范围，用于治疗先前氟嘧啶和/或含铂化疗后疾病进展的转移性胃癌或胃食管交界处腺癌
当治疗医师/研究者根据他们的医学意见认为患者符合纳入同情用药计划的标准时，会联系礼来公司。
研究概览
研究类型
扩展访问
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Busan、大韩民国、48108
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Cheong Ju-City、大韩民国、361-711
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Chuncheon、大韩民国、14068
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Dae Jeon、大韩民国、35015
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Deagu、大韩民国、41404
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Gangnam-gu、大韩民国、06351
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Gangwon Do、大韩民国、24289
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Guri City、大韩民国、11923
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Gyeonggi-do、大韩民国、463-070
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Incheon、大韩民国、405-760
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Jeonbuk、大韩民国、54907
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Jin Ju Si、大韩民国、52727
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Jongno-gu、大韩民国、03080
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Namdong-gu、大韩民国、405-760
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Seongnam-si、大韩民国、463-707
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Seowon-gu、大韩民国、28644
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Suwon、大韩民国、16247
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Taegu、大韩民国、41931
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Ulsan-si、大韩民国、44033
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Graz、奥地利、8036
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Innsbruck、奥地利、6020
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Linz、奥地利、4020
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Salzburg、奥地利、5020
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Steyr、奥地利、4400
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Wien、奥地利、1130
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Zams、奥地利、6511
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Athens、希腊、11526
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Athens、希腊、15562
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Heraklion、希腊、71110
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Marousi、希腊、15123
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Neo Faliro、希腊、18547
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Thessaloniki、希腊、57001
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Berlin、德国、13125
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Dresden、德国、01307
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Essen、德国、45122
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Friedrichshafen、德国、88045
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Hamburg、德国、20246
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Heidelberg、德国、69115
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Kaiserslautern、德国、67655
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Moenchengladbach、德国、41238
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Mönchengladbach、德国、41063
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Ulm、德国、02763
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Wolfsburg、德国、38440
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Amsterdam、荷兰、1105 AZ
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不适用
描述
纳入标准：
- 参与者患有经组织学或细胞学证实的胃癌，包括胃腺癌或胃食管交界处 (GEJ) 腺癌。 （如果原发肿瘤累及 GEJ，则患有远端食管腺癌的参与者符合条件）
- 参与者患有转移性疾病或局部复发、不可切除的疾病
- 参与者患有通过标准计算机断层扫描 (CT) 或磁共振成像 (MRI) 成像确定的可测量或可评估疾病。 可评估、不可测量疾病的例子包括已知疾病区域的胃、腹膜或肠系膜增厚，或腹膜结节太小而不能被实体瘤反应评估标准（RECIST 1.1 版）测量
参与者在治疗期间或在转移性疾病的最后一剂一线治疗后 4 个月内，或在治疗期间，或在最后一剂辅助治疗后 6 个月内经历过疾病进展
o 本方案可接受的既往化疗方案是包括铂和/或氟嘧啶成分的联合化疗方案。 如果使用氟嘧啶和/或铂，包括第三种药物（例如蒽环类药物或紫杉烷）的方案是可接受的。
- 根据美国国家癌症研究所不良事件通用术语标准 (NCI-CTCAE) 第 4.03 版，参与者已解决先前化疗的所有临床显着毒性作用的 ≤1 级（或在神经病变的情况下为 ≤2 级），手术、放疗或激素治疗（脱发除外）
- 参与者的东部合作肿瘤组表现状态 (ECOG PS) 得分为 0 或 1
- 参与者有足够的肝功能
参与者没有：
- Child-Pugh B（或更糟）水平的肝硬化或
- 肝硬化（任何程度）和肝性脑病病史或肝硬化引起的有临床意义的腹水。 有临床意义的腹水定义为需要利尿剂或穿刺术的肝硬化腹水
- 参与者具有足够的肾功能，定义为血清肌酐≤正常上限 (ULN) 的 1.5 倍，或肌酐清除率（通过 24 小时尿液收集测量）≥40 毫升/分钟（mL/分钟）
- 参与者的尿蛋白在试纸或常规尿液分析 (UA) 上≤1+
- 参与者具有足够的血液学功能
- 参与者必须具有足够的凝血功能
- 如果参与者之前接受过蒽环类药物治疗作为他或她的一线治疗方案的一部分，则参与者能够进行普通的体育活动而不会出现明显的疲劳或呼吸困难（相当于纽约心脏协会 I 类功能）
- 由于 ramucirumab 的致畸性未知，如果性活跃，参与者必须是绝经后、手术绝育或使用有效避孕措施（激素或屏障方法）
- 有生育能力的女性参与者必须在入组前 7 天内进行血清妊娠试验阴性
排除标准：
- 参与者有记录和/或有症状的脑或软脑膜转移
- 参与者在入组前 3 个月内经历过任何 3 至 4 级胃肠道 (GI) 出血
- 参与者在入组前 6 个月内经历过任何动脉血栓栓塞事件，包括但不限于心肌梗塞、短暂性脑缺血发作、脑血管意外或不稳定型心绞痛
- 参与者患有持续或活动性感染、有症状的充血性心力衰竭、不稳定型心绞痛、有症状或控制不佳的心律失常、不受控制的血栓形成或出血性疾病，或主治医师认为的任何其他严重的不受控制的医学疾病
- 参与者患有持续或活跃的精神疾病或社会状况，这会限制对治疗的依从性
- 尽管进行了标准的医疗管理，参与者仍患有不受控制或控制不佳的高血压 [>160 毫升汞 (mmHg) 收缩压或 >100 毫米汞柱舒张压 >4 周]
- 参与者在入组前 28 天内有严重或未愈合的伤口、溃疡或骨折
- 参与者在入组前2周内接受过胃癌化疗、放疗、免疫治疗或靶向治疗
- 参与者在入组前 30 天内接受过任何研究性治疗
- 参与者在入组前 28 天内接受过大手术，或入组前 7 天内接受过皮下静脉通路装置植入
- 参与者之前接受过直接抑制血管内皮生长因子 (VEGF)（包括贝伐珠单抗）或血管内皮生长因子受体 2 (VEGFR-2) 活性的药物或任何抗血管生成药物的治疗
- 参与者正在接受慢性抗血小板治疗，包括阿司匹林、非甾体类抗炎药（NSAIDs；包括布洛芬、萘普生等）、双嘧达莫或氯吡格雷或类似药物。 允许每天使用一次阿司匹林（最大剂量 325 毫克/天）
- 参与者在临床试验过程中选择或计划进行大手术
- 参与者已知对任何治疗成分过敏
- 参与者怀孕或哺乳
- 已知参与者感染人类免疫缺陷病毒 (HIV) 呈阳性
- 参与者已知有酒精或药物依赖
- 除充分治疗的非黑色素瘤皮肤癌、其他非浸润性癌或原位肿瘤外，参与者同时患有活动性恶性肿瘤
- 参与者已知对雷莫芦单抗或任何赋形剂过敏
- 患者在转移情况下可能未接受过超过 1 次既往治疗。
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究注册日期
首次提交
2014年2月17日
首先提交符合 QC 标准的
2014年2月17日
首次发布 (估计的)
2014年2月19日
研究记录更新
最后更新发布 (实际的)
2023年10月23日
上次提交的符合 QC 标准的更新
2023年10月19日
最后验证
2023年10月15日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
雷莫芦单抗的临床试验
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H. Lee Moffitt Cancer Center and Research Institute主动，不招人
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Fondazione IRCCS Istituto Nazionale dei Tumori,...招聘中