患者招募：重组人源化抗PD-1单克隆抗体（HX008）联合化疗对比帕博利珠单抗联合化疗作为一线方案治疗晚期或转移性非鳞非小细胞肺癌（NSCLC）的II/III期临床研究

2020-12-28 CDE CDE

基本信息

基本信息

登记号	CTR20202387	试验状态	进行中
申请人联系人	王丽艳	首次公示信息日期	2020-11-26
申请人名称	泰州翰中生物医药有限公司/ 杭州翰思生物医药有限公司/ 中山康方生物医药有限公司

公示的试验信息

一、题目和背景信息

登记号	CTR20202387
相关登记号
药物名称	HX008注射液（重组人源化抗PD-1单克隆抗体）
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	既往未接受过系统性标准治疗的晚期或转移性非鳞非小细胞肺癌患者
试验专业题目	重组人源化抗PD-1单克隆抗体（HX008）联合化疗对比帕博利珠单抗联合化疗作为一线方案治疗晚期或转移性非鳞非小细胞肺癌（NSCLC）的II/III期临床研究
试验通俗题目	重组人源化抗PD-1单克隆抗体（HX008）联合化疗对比帕博利珠单抗联合化疗作为一线方案治疗晚期或转移性非鳞非小细胞肺癌（NSCLC）的II/III期临床研究
试验方案编号	HX008-NSCLC-II/III-01	方案最新版本号	1.1版
版本日期:	2020-05-26	方案是否为联合用药	是

二、申请人信息

申请人名称	1 2 3
联系人姓名	王丽艳	联系人座机	010-80123990	联系人手机号	15910915260
联系人Email	liyan_wang@lepubiopharma.com	联系人邮政地址	北京市-北京市-昌平区超前路37号院7号楼	联系人邮编	102200

三、临床试验信息

1、试验目的

主要目的：探索HX008联合化疗作为一线方案治疗晚期或转移性非鳞非小细胞肺癌的安全性和耐受性及客观有效率（ORR）次要目的：1)探索HX008联合化疗作为一线方案治疗晚期或转移性非鳞非小细胞肺癌的无进展生存期（PFS）、缓解持续时间（DOR）、1年无进展生存率、总生存期（OS）； 2) 评价HX008的药代动力学及免疫原性

2、试验设计

试验分类	安全性和有效性	试验分期	II期	设计类型	单臂试验
随机化	非随机化	盲法	开放	试验范围	国内试验

3、受试者信息

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

1	自愿签署知情同意书，了解本研究并愿意遵循而且有能力完成所有试验程序
2	男女不限，年龄≥18岁者
3	组织学或细胞学确诊为IV期(M1a/b-AJCC第七版)非鳞状NSCLC者
4	针对晚期或转移性NSCLC未接受过系统性治疗
5	无EGFR或ALK靶向治疗指征的患者（无EGFR突变、ALK基因重排）
6	受试者须有至少1个可测量病灶（按照RECIST1.1标准），如果将既往接受过放疗的病灶作为靶病灶，须确认该病灶为疾病进展，如果有至少1个其他可测量的靶病灶，则可将既往接受过放疗的病灶作为非靶病灶进行随访
7	随机前需提供组织样本检测PD-L1表达水平
8	预计生存期至少3个月者
9	美国东部肿瘤协作组（ECOG）评分体能状态为0或1者
10	有适宜的器官功能, 根据以下实验室检查：血清白蛋白≥2.5g/dL；嗜中性细胞绝对计数(ANC)≥1.5×109/L；白细胞绝对计数(WBC)≥3.0×109/L；血小板≥100×109/L；血红蛋白≥90g/L，入组前4周内未输血；肌酐清除率(CrCl)≥50 mL/min； AST 和 ALT≤2.5 倍 ULN，肝转移患者≤5倍ULN；血清总胆红素(TBIL)≤1.5倍ULN，对于血清总胆红素>1.5倍ULN的患者，直接胆红素需≤ULN；国际标准化比率(INR)或凝血酶原时间（PT）≤1.5倍ULN (正在接受抗凝血治疗的病人除外)，或活化部分凝血活酶时间 (APTT) 或部分凝血活酶时间（PTT）≤1.5倍 ULN (正在接受抗凝血治疗的病人除外)
11	有妊娠可能性的女性，需在首次给药前72小时内进行尿液或血清妊娠试验，且结果为阴性；如果尿检呈阳性或不能确认为阴性，则需进行血清妊娠检查

排除标准

1	组织学检测显示以鳞状细胞为主的非小细胞肺癌，混合型肿瘤如果存在小细胞成分，则受试者不能入组
2	本研究首次给药之前：a. 针对转移性疾病接受过全身性细胞毒性化疗或抗肿瘤生物治疗
3	合并有临床活动性憩室炎、腹腔脓肿、胃肠道梗阻、腹膜癌、活动性消化道溃疡、消化道活动性出血、消化道穿孔
4	首次使用研究药物前5年内曾诊断为任何其它恶性肿瘤的患者，除外经充分治疗后具有低转移风险和死亡风险的恶性肿瘤（5年生存率>90%），如经充分治疗的基底细胞或鳞状细胞皮肤癌或宫颈原位癌及其它原位癌
5	已知对大分子蛋白制剂/单克隆抗体、顺铂、卡铂或培美曲塞的任何成分过敏
6	有器官移植史，或干细胞移植史
7	曾接受过其他抗PD-1、PD-L1或PD-L2制剂或针对其他免疫调节受体或机制的抗体治疗，包括(但不限于)针对IDO、PD-L1、IL-2R、GITR的抗体；或曾接受过帕博利珠单抗治疗者；
8	首次给药前有严重感染由研究者判定不符合参加试验的患者
9	经治疗未控制稳定的系统性疾病，如心脑血管疾病、糖尿病、高血压等
10	既往有明确的神经或精神障碍史，如癫痫、痴呆症，或经常使用任何非法药物或(在最近一年内)有药物滥用(包括酒精)史，可能影响试验依从性者
11	妊娠期或哺乳期者，或计划在试验期间妊娠或生育者
12	患有活动性肺结核

4、试验分组

试验药

序号	名称	用法
1	中文通用名:HX008注射液（重组人源化抗PD-1单克隆抗体）英文通用名:HX008 商品名称:NA	剂型:注射剂规格:10ml：100mg 用法用量:剂型：HX008注射液规格：100mg/10mL/支给药途径：静脉滴注用药频次：每三周给药一次（q3W）剂量：200mg/人/次固定剂量用药时程:45min（±15min）

对照药

序号	名称	用法
暂未填写此信息

5、终点指标

主要终点指标及评价时间

序号	指标	评价时间	终点指标选择
1	不良事件；ORR	入组50%进行中期分析，试验结束后进行整体统计分析	有效性指标+安全性指标

次要终点指标及评价时间

序号	指标	评价时间	终点指标选择
1	DCR；DOR；PFS；OS	入组50%进行中期分析，试验结束后进行整体统计分析	有效性指标

6、数据安全监查委员会（DMC）

无

7、为受试者购买试验伤害保险

有

四、研究者信息

1、主要研究者信息

1	姓名	周彩存	学位	医学博士	职称	主任医师
	电话	021-65115006-3051	Email	caicunzhoudr@163.com	邮政地址	上海市-上海市-上海市政民路507号上海市肺科医院肿瘤科
	邮编	200433	单位名称	同济大学附属上海市肺科医院

2、各参加机构信息

序号	机构名称	主要研究者	国家	省（州）	城市
1	同济大学附属上海市肺科医院	周彩存	中国	上海市	上海市
2	北京大学肿瘤医院	方健	中国	北京市	北京市
3	杭州市肿瘤医院	陈雪琴	中国	浙江省	杭州市
4	安徽省立医院	操乐杰	中国	安徽省	合肥市
5	中南大学湘雅医院	潘频华	中国	湖南省	长沙市
6	湖南省肿瘤医院	邬麟	中国	湖南省	长沙市
7	首都医科大学附属北京朝阳医院	葛洋	中国	北京市	北京市
8	北京大学第三医院	曹宝山	中国	北京市	北京市
9	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
10	辽宁省肿瘤医院	李晓玲	中国	辽宁省	沈阳市

五、伦理委员会信息

序号	名称	审查结论	批准日期/备案日期
1	上海市肺科医院伦理审查委员会	同意	2020-07-24

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time=2020-12-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1548556, encodeId=078815485561d, content=<a href='/topic/show?id=6a4756229d9' target=_blank style='color:#2F92EE;'>#招募#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=94, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=56229, encryptionId=6a4756229d9, topicName=招募)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=038c14086626, createdName=ms1260584454294838, createdTime=Wed Dec 30 02:43:07 CST 2020, time=2020-12-30, status=1, ipAttribution=)]
2021-10-26 gao_jian4217

#非鳞非小细胞肺癌#

101 0
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time=2020-12-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1548556, encodeId=078815485561d, content=<a href='/topic/show?id=6a4756229d9' target=_blank style='color:#2F92EE;'>#招募#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=94, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=56229, encryptionId=6a4756229d9, topicName=招募)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=038c14086626, createdName=ms1260584454294838, createdTime=Wed Dec 30 02:43:07 CST 2020, time=2020-12-30, status=1, ipAttribution=)]
2021-04-15 tastas

#III期临床研究#

95 0
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content=<a href='/topic/show?id=21a496002b' target=_blank style='color:#2F92EE;'>#II期临床研究#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=88, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9600, encryptionId=21a496002b, topicName=II期临床研究)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=891023951385, createdName=huiwelcome, createdTime=Wed Jun 02 01:43:07 CST 2021, time=2021-06-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1594845, encodeId=adad159484585, content=<a href='/topic/show?id=b317956200' target=_blank style='color:#2F92EE;'>#III期#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=89, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9562, encryptionId=b317956200, topicName=III期)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a12645, createdName=智智灵药, createdTime=Wed Dec 30 02:43:07 CST 2020, time=2020-12-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1548556, encodeId=078815485561d, content=<a href='/topic/show?id=6a4756229d9' target=_blank style='color:#2F92EE;'>#招募#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=94, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=56229, encryptionId=6a4756229d9, topicName=招募)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=038c14086626, createdName=ms1260584454294838, createdTime=Wed Dec 30 02:43:07 CST 2020, time=2020-12-30, status=1, ipAttribution=)]
2021-02-02 lingaifan

#非小细胞#

78 0
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time=2020-12-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1548556, encodeId=078815485561d, content=<a href='/topic/show?id=6a4756229d9' target=_blank style='color:#2F92EE;'>#招募#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=94, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=56229, encryptionId=6a4756229d9, topicName=招募)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=038c14086626, createdName=ms1260584454294838, createdTime=Wed Dec 30 02:43:07 CST 2020, time=2020-12-30, status=1, ipAttribution=)]
2021-05-27 aids221

#克隆#

78 0
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createdBy=c66088, createdName=gao_jian4217, createdTime=Tue Oct 26 08:43:07 CST 2021, time=2021-10-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2050180, encodeId=fd8e2050180b4, content=<a href='/topic/show?id=581595e015' target=_blank style='color:#2F92EE;'>#III期临床研究#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=95, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9570, encryptionId=581595e015, topicName=III期临床研究)], attachment=null, authenticateStatus=null, createdAvatar=/v1.0.0/img/user_icon.png, createdBy=47c5349, createdName=tastas, createdTime=Thu Apr 15 10:43:07 CST 2021, time=2021-04-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2059950, encodeId=42df20599507f, content=<a href='/topic/show?id=2cc599381bd' target=_blank style='color:#2F92EE;'>#非小细胞#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=78, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=99381, encryptionId=2cc599381bd, topicName=非小细胞)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=2e07307, createdName=lingaifan, createdTime=Tue Feb 02 00:43:07 CST 2021, time=2021-02-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1660237, encodeId=0cfc166023ed1, content=<a href='/topic/show?id=8d0d28912db' target=_blank style='color:#2F92EE;'>#克隆#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=78, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=28912, encryptionId=8d0d28912db, topicName=克隆)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=596825099872, createdName=aids221, createdTime=Thu May 27 23:43:07 CST 2021, time=2021-05-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1916384, encodeId=32c31916384ad, content=<a href='/topic/show?id=c5a89550ff' target=_blank style='color:#2F92EE;'>#III#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=82, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9550, encryptionId=c5a89550ff, topicName=III)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=e68e415, createdName=juliusluan78, createdTime=Wed Jun 02 14:43:07 CST 2021, time=2021-06-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2056872, encodeId=021320568e21a, content=<a href='/topic/show?id=7ca2484816b' target=_blank style='color:#2F92EE;'>#帕博利珠#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=90, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=48481, encryptionId=7ca2484816b, topicName=帕博利珠)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=8ebc122, createdName=yankaienglish, createdTime=Fri Sep 10 11:43:07 CST 2021, time=2021-09-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1650014, encodeId=6c9c1650014d6, content=<a href='/topic/show?id=21a496002b' target=_blank style='color:#2F92EE;'>#II期临床研究#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=88, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9600, encryptionId=21a496002b, topicName=II期临床研究)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=891023951385, createdName=huiwelcome, createdTime=Wed Jun 02 01:43:07 CST 2021, time=2021-06-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1594845, encodeId=adad159484585, content=<a href='/topic/show?id=b317956200' target=_blank style='color:#2F92EE;'>#III期#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=89, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9562, encryptionId=b317956200, topicName=III期)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a12645, createdName=智智灵药, createdTime=Wed Dec 30 02:43:07 CST 2020, time=2020-12-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1548556, encodeId=078815485561d, content=<a href='/topic/show?id=6a4756229d9' target=_blank style='color:#2F92EE;'>#招募#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=94, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=56229, encryptionId=6a4756229d9, topicName=招募)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=038c14086626, createdName=ms1260584454294838, createdTime=Wed Dec 30 02:43:07 CST 2020, time=2020-12-30, status=1, ipAttribution=)]
2021-06-02 juliusluan78

#III#

82 0
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createdBy=c66088, createdName=gao_jian4217, createdTime=Tue Oct 26 08:43:07 CST 2021, time=2021-10-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2050180, encodeId=fd8e2050180b4, content=<a href='/topic/show?id=581595e015' target=_blank style='color:#2F92EE;'>#III期临床研究#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=95, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9570, encryptionId=581595e015, topicName=III期临床研究)], attachment=null, authenticateStatus=null, createdAvatar=/v1.0.0/img/user_icon.png, createdBy=47c5349, createdName=tastas, createdTime=Thu Apr 15 10:43:07 CST 2021, time=2021-04-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2059950, encodeId=42df20599507f, content=<a href='/topic/show?id=2cc599381bd' target=_blank style='color:#2F92EE;'>#非小细胞#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=78, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=99381, encryptionId=2cc599381bd, topicName=非小细胞)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=2e07307, createdName=lingaifan, createdTime=Tue Feb 02 00:43:07 CST 2021, time=2021-02-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1660237, encodeId=0cfc166023ed1, content=<a href='/topic/show?id=8d0d28912db' target=_blank style='color:#2F92EE;'>#克隆#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=78, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=28912, encryptionId=8d0d28912db, topicName=克隆)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=596825099872, createdName=aids221, createdTime=Thu May 27 23:43:07 CST 2021, time=2021-05-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1916384, encodeId=32c31916384ad, content=<a href='/topic/show?id=c5a89550ff' target=_blank style='color:#2F92EE;'>#III#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=82, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9550, encryptionId=c5a89550ff, topicName=III)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=e68e415, createdName=juliusluan78, createdTime=Wed Jun 02 14:43:07 CST 2021, time=2021-06-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2056872, encodeId=021320568e21a, content=<a href='/topic/show?id=7ca2484816b' target=_blank style='color:#2F92EE;'>#帕博利珠#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=90, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=48481, encryptionId=7ca2484816b, topicName=帕博利珠)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=8ebc122, createdName=yankaienglish, createdTime=Fri Sep 10 11:43:07 CST 2021, time=2021-09-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1650014, encodeId=6c9c1650014d6, content=<a href='/topic/show?id=21a496002b' target=_blank style='color:#2F92EE;'>#II期临床研究#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=88, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9600, encryptionId=21a496002b, topicName=II期临床研究)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=891023951385, createdName=huiwelcome, createdTime=Wed Jun 02 01:43:07 CST 2021, time=2021-06-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1594845, encodeId=adad159484585, content=<a href='/topic/show?id=b317956200' target=_blank style='color:#2F92EE;'>#III期#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=89, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9562, encryptionId=b317956200, topicName=III期)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a12645, createdName=智智灵药, createdTime=Wed Dec 30 02:43:07 CST 2020, time=2020-12-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1548556, encodeId=078815485561d, content=<a href='/topic/show?id=6a4756229d9' target=_blank style='color:#2F92EE;'>#招募#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=94, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=56229, encryptionId=6a4756229d9, topicName=招募)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=038c14086626, createdName=ms1260584454294838, createdTime=Wed Dec 30 02:43:07 CST 2020, time=2020-12-30, status=1, ipAttribution=)]
2021-09-10 yankaienglish

#帕博利珠#

90 0
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objectType=article, channel=null, level=null, likeNumber=82, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9550, encryptionId=c5a89550ff, topicName=III)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=e68e415, createdName=juliusluan78, createdTime=Wed Jun 02 14:43:07 CST 2021, time=2021-06-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2056872, encodeId=021320568e21a, content=<a href='/topic/show?id=7ca2484816b' target=_blank style='color:#2F92EE;'>#帕博利珠#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=90, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=48481, encryptionId=7ca2484816b, topicName=帕博利珠)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=8ebc122, createdName=yankaienglish, createdTime=Fri Sep 10 11:43:07 CST 2021, time=2021-09-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1650014, encodeId=6c9c1650014d6, content=<a href='/topic/show?id=21a496002b' target=_blank style='color:#2F92EE;'>#II期临床研究#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=88, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9600, encryptionId=21a496002b, topicName=II期临床研究)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=891023951385, createdName=huiwelcome, createdTime=Wed Jun 02 01:43:07 CST 2021, time=2021-06-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1594845, encodeId=adad159484585, content=<a href='/topic/show?id=b317956200' target=_blank style='color:#2F92EE;'>#III期#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=89, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9562, encryptionId=b317956200, topicName=III期)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a12645, createdName=智智灵药, createdTime=Wed Dec 30 02:43:07 CST 2020, time=2020-12-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1548556, encodeId=078815485561d, content=<a href='/topic/show?id=6a4756229d9' target=_blank style='color:#2F92EE;'>#招募#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=94, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=56229, encryptionId=6a4756229d9, topicName=招募)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=038c14086626, createdName=ms1260584454294838, createdTime=Wed Dec 30 02:43:07 CST 2020, time=2020-12-30, status=1, ipAttribution=)]
2021-06-02 huiwelcome

#II期临床研究#

88 0
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topicList=[TopicDto(id=99381, encryptionId=2cc599381bd, topicName=非小细胞)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=2e07307, createdName=lingaifan, createdTime=Tue Feb 02 00:43:07 CST 2021, time=2021-02-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1660237, encodeId=0cfc166023ed1, content=<a href='/topic/show?id=8d0d28912db' target=_blank style='color:#2F92EE;'>#克隆#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=78, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=28912, encryptionId=8d0d28912db, topicName=克隆)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=596825099872, createdName=aids221, createdTime=Thu May 27 23:43:07 CST 2021, time=2021-05-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1916384, encodeId=32c31916384ad, content=<a href='/topic/show?id=c5a89550ff' target=_blank style='color:#2F92EE;'>#III#</a>, beContent=null, 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time=2020-12-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1548556, encodeId=078815485561d, content=<a href='/topic/show?id=6a4756229d9' target=_blank style='color:#2F92EE;'>#招募#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=94, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=56229, encryptionId=6a4756229d9, topicName=招募)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=038c14086626, createdName=ms1260584454294838, createdTime=Wed Dec 30 02:43:07 CST 2020, time=2020-12-30, status=1, ipAttribution=)]
2020-12-30 智智灵药

#III期#

89 0
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2020-12-30 ms1260584454294838

#招募#

94 0

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患者招募：重组人源化抗PD-1单克隆抗体（HX008）联合化疗对比帕博利珠单抗联合化疗作为一线方案治疗晚期或转移性非鳞非小细胞肺癌（NSCLC）的II/III期临床研究

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