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雷莫芦单抗 (LY3009806) 与安慰剂在肝细胞癌和甲胎蛋白基线升高参与者中的研究 (REACH-2)

2022年12月22日 更新者：Eli Lilly and Company

Ramucirumab 和最佳支持治疗 (BSC) 与安慰剂和 BSC 作为一线治疗后基线甲胎蛋白 (AFP) 升高的肝细胞癌患者的二线治疗的随机、双盲、安慰剂对照的 3 期研究与索拉非尼

本研究的目的是评估 ramucirumab 在肝细胞癌 (HCC) 和基线甲胎蛋白升高的参与者中的安全性和有效性。 参与者将以 2:1 的比例随机分配到雷莫芦单抗或安慰剂组（主要全球队列和中国最大化扩展招募 [MEE] 队列）。 如果参与者有资格加入开放标签扩展 (OLE) 队列，也可能会接受 ramucirumab。

研究概览

地位

完全的

条件

干预/治疗

研究类型

介入性

注册 (实际的)

399

阶段

  • 第三阶段

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

  • 中国
      • Beijing、中国
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      • Beijing、中国、100032
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      • Beijing、中国、100142
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      • Beijing、中国
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      • Changsha、中国、410011
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      • Changsha、中国、410013
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      • Chongqing、中国、400038
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      • Guangdong、中国、510515
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      • Guangzhou、中国、510080
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      • Hangzhou、中国、310003
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      • Hangzhou、中国、310009
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      • Hangzhou、中国、310022
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      • Hebei、中国、050011
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      • Hefei、中国、230022
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      • Heilongjiang、中国、150081
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      • Henan、中国、450008
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      • Hubei、中国、56456
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      • Nanjing、中国、210006
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      • Nanjing、中国、210002
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      • Nanning、中国、530021
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      • Qingdao、中国、266003
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      • Shanghai、中国
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      • Shanghai、中国、200030
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      • Shanghai、中国、200127
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      • Shanghai、中国
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      • Shenyang、中国、100042
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      • Wu Han、中国、430030
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      • Xi'an、中国、710032
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  • 以色列
      • Haifa、以色列、3109601
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      • Tel Aviv、以色列、6423906
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  • 加拿大
      • Montreal、加拿大、H2X 3E4
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      • Toronto、加拿大、M5G 2M9
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  • 台湾
      • Kaohsiung city、台湾、83301
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      • Puzi City、台湾、61363
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      • Taichung、台湾、40705
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      • Tainan、台湾、704
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      • Tainan、台湾、71004
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      • Tainan、台湾、736
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      • Taipei city、台湾、10048
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      • Taipei city、台湾、11217
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      • Taoyuan City、台湾、33305
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  • 大韩民国
      • Incheon、大韩民国、21565
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      • Seoul、大韩民国、06351
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      • Seoul、大韩民国、03080
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      • Seoul、大韩民国、05505
        • 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.
      • Seoul、大韩民国、03722
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      • Ulsan、大韩民国、44033
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  • 奥地利
      • Linz、奥地利、4020
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      • Wien、奥地利、1090
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  • 巴西
      • Barretos、巴西、14784-400
        • Fundacao Pio XII
      • Barretos、巴西、14784700
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      • Belo Horizonte、巴西、30130-090
        • Cenantron - Centro Avancado de Tratamento Oncologico
      • Ijui、巴西、98700 000
        • Associacao Hospital de Caridade Ijui
      • Porto Alegre、巴西、90470-340
        • 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.
      • São Paulo、巴西、04039-901
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  • 德国
      • Bayern、德国、81377
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      • Berlin、德国、13125
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      • Essen、德国、45122
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      • Frankfurt、德国、60590
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      • Hamburg、德国、20246
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      • Hannover、德国、30625
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      • Leipzig、德国、04103
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      • Magdeburg、德国、39120
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      • Mainz、德国、55131
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      • München、德国、81675
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      • Tubingen、德国、72076
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  • 意大利
      • Benevento、意大利、82100
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      • Bologna、意大利、40138
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      • Cremona、意大利、26100
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      • Padova、意大利、35128
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      • Rome、意大利、00168
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  • 捷克语
      • Brno、捷克语、656 53
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      • Praha 5、捷克语、150 06
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  • 日本
      • Chuo Ku、日本、104-0045
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      • Fukuoka、日本、810-8563
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      • Fukuoka、日本、811-1395
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      • Iizuka、日本、820-8505
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      • Kanazawa、日本、920-8641
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      • Kashiwa、日本、277 8577
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      • Kyoto、日本、606-8507
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      • Matsuyama、日本、791-0280
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      • Osaka、日本、589-8511
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      • Shimotsuke、日本、329-0498
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      • Suita-shi、日本、565-0871
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      • Sunto-Gun、日本、411-8777
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      • Tokyo、日本、101-0062
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      • Yokohama、日本、241-8515
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      • Ōsaka、日本、541-8567
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  • 比利时
      • Brussels、比利时、1200
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      • Liege、比利时、4000
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  • 法国
      • Amiens、法国、80054
        • 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.
      • Avignon、法国、84918
        • 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.
      • Besancon、法国、25030
        • 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.
      • Caen、法国、14033
        • 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.
      • Clermont-Ferrand、法国、63003
        • 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.
      • Lyon、法国、69317
        • 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.
      • Montpellier、法国、34295
        • 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.
      • Nantes、法国、44093
        • 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.
      • Pessac、法国、33604
        • 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.
      • Rennes、法国、35042
        • 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.
      • Saint Etienne、法国、42000
        • 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.
  • 波兰
      • Gdansk、波兰、80-219
        • 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.
      • Poznan、波兰、61-866
        • 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.
      • Warszawa、波兰、01-748
        • 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.
  • 澳大利亚
      • Kurralta Park、澳大利亚、5037
        • 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.
      • Woodville、澳大利亚、5011
        • 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.
  • 瑞士
      • Bern、瑞士、3010
        • 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.
  • 美国
    • California
      • Daly City、California、美国、94115
        • Pacific Hematology and Oncology Associates
      • Los Angeles、California、美国、90024
        • UCLA Medical Center
    • District of Columbia
      • Washington、District of Columbia、美国、20007
        • Georgetown University Medical Center
    • Iowa
      • Iowa City、Iowa、美国、52242
        • University of Iowa Hospital
    • Massachusetts
      • Boston、Massachusetts、美国、02114
        • Massachusetts General Hospital
    • New York
      • New York、New York、美国、10029
        • Mount Sinai Medical Center
    • Oklahoma
      • Oklahoma City、Oklahoma、美国、73104
        • University of Oklahoma Health Sciences Center
    • Oregon
      • Portland、Oregon、美国、97239
        • Oregon Health and Science University
  • 英国
      • Acton、英国、W12 0HS
        • 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.
      • Acton、英国、w120hs
        • 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.
      • Bebington、英国、CH63 4JY
        • 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.
      • Birmingham、英国、B15 2TH
        • 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.
      • London、英国、SE5 9RS
        • 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.
      • London、英国、NW3 2QG
        • 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.
      • Manchester、英国、M20 4BX
        • 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.
  • 西班牙
      • Girona、西班牙、17007
        • Hospital Universitari de Girona Dr. Josep Trueta
      • Madrid、西班牙、28040
        • Hospital Clinico San Carlos
      • Santander、西班牙、39008
        • 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.
      • Valencia、西班牙、46026
        • 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.
  • 香港
      • Hong Kong、香港
        • "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."
      • Hong Kong、香港
        • 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.
      • Kowloon、香港
        • 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
      • ShaTin、香港
        • 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.
      • Tuen Mun、香港
        • 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.

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

有资格学习的性别

全部

描述

纳入标准：

  • 基于组织病理学发现的 HCC 诊断，或肝硬化和具有典型 HCC 影像学特征的肿瘤的诊断。
  • 索拉非尼是 HCC 的唯一全身性疗法，因疾病进展或不耐受而停药（仅限全球主要和 MEE 队列）。
  • 参与者接受了 ≤ 2 个先前的全身治疗方案，不包括先前的索拉非尼或化疗，用于治疗 HCC（仅限 OLE 队列）。
  • 根据实体瘤反应评估标准 (RECIST) 1.1 版，≥1 个可测量的病灶先前未接受过局部治疗。 如果病灶在局部治疗后有进展并且可以测量，那么先前接受过局部治疗的病灶参与者也符合资格。
  • Child-Pugh 评分 <7（Child-Pugh A 级）。
  • 巴塞罗那临床肝癌 (BCLC) C 期疾病或 BCLC B 期疾病不适合局部治疗或对局部治疗无效。
  • 基线 AFP ≥400 纳克/毫升。
  • 东部肿瘤协作组 (ECOG) 表现状态为 0 或 1。
  • 解决先前治疗的所有临床显着毒性作用。
  • 总胆红素≤1.5倍正常值上限（ULN），天冬氨酸转氨酶（AST）和丙氨酸转氨酶（ALT）≤5×ULN。
  • 肌酐清除率≥60 毫升/分钟。
  • 试纸或常规尿液分析或 24 小时尿液显示蛋白质 <1 克时，尿蛋白≤1+。
  • 中性粒细胞绝对计数≥1.0×10^9/升，血红蛋白≥9克/分升，血小板≥75×10^9/升。
  • 国际标准化比值 (INR) ≤1.5 且部分凝血活酶时间 (PTT) ≤ ULN 以上 5 秒。
  • 手术绝育、绝经后或符合高效避孕方法。
  • 如果是有生育能力的女性，随机化前血清妊娠试验阴性。
  • 愿意为研究提供血液。 参与者在任何研究特定程序之前提供了签署的知情同意书，并且能够遵守协议时间表和测试。

排除标准：

  • 纤维板层癌或混合性肝细胞胆管癌。
  • 并发恶性肿瘤。 患有任何来源的原位癌的参与者和先前患有缓解期恶性肿瘤的参与者可能有资格获得赞助商批准。
  • 既往有脑转移、软脑膜疾病或不受控制的脊髓压迫。
  • 肝性脑病或有临床意义的腹水的病史或当前。
  • 正在进行或最近的肝肾综合征。
  • 肝移植（仅限主要全球和 MEE 队列；之前进行过肝移植的参与者可能有资格参加 OLE 队列）。
  • 既往全身治疗后或随机分组前 28 天内的肝脏局部治疗。
  • 随机分组前 ≤ 28 天的主要外科手术、创伤性损伤、未愈合伤口或消化性溃疡。
  • 在随机分组前 14 天内接受过任何非肝脏（例如骨骼）部位的放疗。
  • 在研究治疗的首次给药前 7 天内放置皮下静脉通路装置，除非该程序被判断为低出血风险。
  • 参加涉及研究产品或未经批准使用药物的临床试验，或参加被认为在科学或医学上与本研究不相容的医学研究。
  • 在随机分组前 28 天内从另一项临床试验中停止研究治疗。
  • 已知对任何治疗成分过敏。
  • 不受控制的高血压。
  • 任何动脉血栓形成事件，包括心肌梗塞、不稳定型心绞痛、脑血管意外或短暂性脑缺血发作，发生时间小于随机分组前 6 个月。
  • 在需要干预的随机分组前 3 个月内，任何被认为危及生命的出血事件，或任何 3 级或 4 级胃肠道出血事件。
  • 需要干预或代表高出血风险的食管或胃底静脉曲张。 有门静脉高压症或既往出血证据的参与者必须在随机分组前 3 个月内进行过内窥镜评估。
  • 随机分组前 6 个月内胃肠道穿孔或瘘管。
  • 有症状的充血性心力衰竭（纽约心脏协会 II-IV）、不稳定型心绞痛或有症状或控制不佳的心律失常。
  • 怀孕或哺乳。

  • 任何可能增加与研究参与相关的风险或可能干扰研究结果解释的医学或精神疾病。 条件包括但不限于：

    • 人类免疫缺陷病毒感染或获得性免疫缺陷综合症相关疾病。
    • 活动性或不受控制的临床严重感染。 （患有慢性病毒性肝炎的参与者符合条件。）
    • 持续或最近的药物滥用史。
    • 不受控制的遗传性或获得性血栓形成或出血性疾病。
  • 肠梗阻、炎症性肠病病史或存在或广泛性肠切除术。
  • 使用华法林、低分子肝素或类似药物进行治疗剂量的抗凝治疗。
  • 使用非甾体类抗炎药或其他抗血小板药物进行长期治疗。 允许剂量高达 100 毫克/天的阿司匹林。

  • 参与者之前接受过免疫治疗并且正在经历或已经经历过以下任何情况（仅限 OLE 队列）：

    • 任何有临床意义的 ≥ 3 级免疫相关不良事件 (irAE)
    • 任何级别的神经系统或眼部 irAE
    • 任何级别的免疫相关性肺炎、心肌病或肝炎
  • 参与者之前接受过免疫治疗，并且在研究登记时需要类固醇或其他免疫抑制剂（仅限 OLE 队列）。

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？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的：雷莫芦单抗 + 最佳支持治疗 (BSC)
在每 14 天周期的第 1 天静脉注射 8 毫克每千克 (mg/kg) 雷莫芦单抗。 参与者可以继续治疗，直到达到停药标准。
药品：雷莫芦单抗
管理IV
其他名称：
  • LY3009806
  • 西拉姆萨
安慰剂比较：安慰剂 + BSC
安慰剂在每 14 天周期的第 1 天进行静脉注射。 参与者可以继续治疗，直到达到停药标准。
药品：雷莫芦单抗
管理IV
其他名称：
  • LY3009806
  • 西拉姆萨
药品：安慰剂
管理IV
实验性的：开放标签 Ramucirumab + BSC
在每个 14 天周期的第 1 天静脉注射 8 mg/kg ramucirumab。 参与者可以继续治疗，直到达到停药标准。
药品：雷莫芦单抗
管理IV
其他名称：
  • LY3009806
  • 西拉姆萨
实验性的：雷莫芦单抗 MEE 队列 + BSC
在每个 14 天周期的第 1 天静脉注射 8 mg/kg ramucirumab。 参与者可以继续治疗，直到达到停药标准。
药品：雷莫芦单抗
管理IV
其他名称：
  • LY3009806
  • 西拉姆萨
安慰剂比较：安慰剂 MEE 队列 + BSC
安慰剂在每 14 天周期的第 1 天进行静脉注射。 参与者可以继续治疗，直到达到停药标准。
药品：雷莫芦单抗
管理IV
其他名称：
  • LY3009806
  • 西拉姆萨
药品：安慰剂
管理IV

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
总生存期（OS）
大体时间：从随机化日期到全因死亡（最多 28 个月）
OS 时间是从随机化日期到任何原因死亡的日期。 不知道在数据截止日期或之前死亡的参与者，在已知参与者还活着的最后一天（在截止日期或之前）对 OS 数据进行审查。
从随机化日期到全因死亡（最多 28 个月）

次要结果测量

结果测量
措施说明
大体时间
无进展生存期 (PFS)
大体时间：从随机分组到客观进展或全因死亡（长达 28 个月）
无进展生存期定义为从随机分组日期到首次观察到客观进展或任何原因死亡日期的时间。
从随机分组到客观进展或全因死亡（长达 28 个月）
放射学进展时间
大体时间：从随机化到客观进展（长达 28 个月）
放射学进展时间定义为从随机化日期到首次观察到客观进展日期的时间。
从随机化到客观进展（长达 28 个月）
具有完全反应 (CR) 或部分反应 (PR) 的最佳总体反应的参与者百分比：客观反应率 (ORR)
大体时间：从随机化到客观进展（长达 28 个月）
客观反应率定义为达到完全反应（CR）+部分反应（PR）的最佳整体反应的参与者百分比。 ORR = CR + PR。 CR是所有非靶病灶消失，肿瘤标志物水平正常化。 所有淋巴结的大小必须是非病理性的（<10 mm 短轴）。 PR 是目标病灶直径总和至少减少 30%，以基线总直径为参考。 CR：所有目标病变消失。 任何病理性淋巴结（无论是目标淋巴结还是非目标淋巴结）的短轴必须缩小到 <10 毫米。 肿瘤标志物结果必须已经正常化。 最佳总体反应是根据研究人员根据实体瘤反应评估标准 (RECIST) 1.1 版评估的总体反应进行分类的。
从随机化到客观进展（长达 28 个月）
药代动力学 (PK)：第 2、4、7 和 10 次输注前的最低血清浓度 (Cmin)
大体时间：给药前，第 2、6、12 和 18 周，第 1 天；输注前最多 3 天（14 天周期）
Ramucirumab 的 PK Cmin 在指定时间点和在输注相关反应事件中收集血样，用于评估 ramucirumab 血清浓度。
给药前，第 2、6、12 和 18 周，第 1 天；输注前最多 3 天（14 天周期）
PK：第 1、2、4、7 和 10 次 Ram 输注后的血清浓度最大值 (Cmax)
大体时间：第 0、2、6、12 和 18 周，第 1 天；输注结束后 1 小时至 1.5 小时（14 天周期）
Ramucirumab 的 PK Cmax 在指定时间点收集血样，和在输注相关反应事件中，为评估 ramucirumab 血清浓度。
第 0、2、6、12 和 18 周，第 1 天；输注结束后 1 小时至 1.5 小时（14 天周期）
具有抗雷莫芦单抗抗体的参与者百分比
大体时间：第 1 周期给药前：首次输注前 ​​7 天，第 4 周期：输注前 3 天，第 7 周期至随访（长达 28 个月）
按治疗组总结了治疗后出现阳性抗药抗体的参与者的百分比。 治疗中出现的 ADA (TEADA) 定义为：基线 ADA 呈阴性且 ADA 滴度大于或等于 1:20（即（即）大于最小所需稀释度 1 的 2 倍： 10) 基线后的任何时间（即治疗引起的）；对于在基线时具有可检测的 ADA 滴度（即，加强治疗）的参与者，ADA 滴度相对于基线有 4 倍或更大的变化。
第 1 周期给药前：首次输注前 ​​7 天，第 4 周期：输注前 3 天，第 7 周期至随访（长达 28 个月）
癌症治疗功能评估恶化的时间 (FACT) 肝胆症状指数 8 (FHSI-8)
大体时间：从随机分组到恶化观察的第一天（≥ 3 点减少）（最多 28 个月）
FACT 肝胆症状指数 (FHSI-8) 是一种特别关注肝胆恶性肿瘤参与者最常见和最关心的症状的工具，包括缺乏活力、恶心、疼痛、体重减轻、背部疼痛、疲劳、黄疸、胃痛或不适。 (FHSI-8) 问卷用于评估从随机化日期到观察到恶化的第一天发布的 FSHI-8 总分恶化的时间，恶化阈值定义为从基线减少 ≥ 3 分。 在没有恶化的情况下，参与者在最后一次 FSHI-8 项目记录时被审查。 FHSI-8 总分范围从 0 到 32，其中“0”是严重症状参与者，最高分表示无症状参与者。 Kaplan-Meier 方法 风险比用于估计（雷莫芦单抗对比安慰剂），95% 置信区间 (CI) (Wald) 由未分层/分层 Cox 模型估计。
从随机分组到恶化观察的第一天（≥ 3 点减少）（最多 28 个月）
EuroQol 5 维 5 级 (EQ-5D-5L) 问卷基线的变化
大体时间：从随机分组到研究结束（长达 28 个月）
EQ-5D-5L 是一种非特异性和标准化的仪器，用于衡量自我报告的健康状况（EuroQol Group 1990；Herdman 等人，2011 年）。 参与者完成了 5 级（无问题、轻微问题、中度问题、严重问题和极端问题）、5 维（行动能力、自我护理、日常活动、疼痛/不适和焦虑/抑郁）关于他们当前的问卷健康状况。 一个独特的 EQ-5D-5L 健康状态量表范围从 0 到 100，并通过组合 5 个维度中每个维度的 1 个级别来定义。 参与者通过标记从 100（可想象的最佳健康状态）到 0（可想象的最差健康状态）的连续统一体来表明他们当前的健康状况。
从随机分组到研究结束（长达 28 个月）
东部合作肿瘤小组绩效状态 (ECOG PS) 恶化的时间
大体时间：从随机分组到首次恶化观察日期 (ECOG PS≥2)（最多 28 个月）
ECOG PS 恶化的时间定义为从随机化日期到观察 ECOG PS 2 的第一个日期的时间（即从基线状态 0 [完全活跃] 或 1 [体力活动受限但能够走动并能够进行轻松的工作]）。 没有 PS 恶化的参与者在他们最后记录的评估为 0 或 1 时被审查。评估包括 ECOG 表现状态 (PS)：2- 可以走动并且能够进行所有自我护理但无法进行任何工作活动。 起床和大约超过 50% 的清醒时间， 3 - 只能进行有限的自我照顾，超过 50% 的清醒时间被限制在床上或椅子上， 4 - 完全残疾，不能进行任何自我照顾。 完全被限制在床上或椅子上，5- 死了。
从随机分组到首次恶化观察日期 (ECOG PS≥2)（最多 28 个月）

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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。

研究主要日期

学习开始 (实际的)

2015年7月20日

初级完成 (实际的)

2018年3月15日

研究完成 (实际的)

2021年11月19日

研究注册日期

首次提交

2015年5月1日

首先提交符合 QC 标准的

2015年5月1日

首次发布 (估计)

2015年5月6日

研究记录更新

最后更新发布 (实际的)

2023年1月20日

上次提交的符合 QC 标准的更新

2022年12月22日

最后验证

2022年12月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 15755
  • I4T-MC-JVDE (其他标识符：Eli Lilly and Company)
  • 2014-005068-13 (EudraCT编号)

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是的

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IPD 共享支持信息类型

  • 研究协议
  • 统计分析计划 (SAP)
  • 临床研究报告（CSR）

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