患者招募：Pamrevlumab或安慰剂联合吉西他滨/白蛋白紫杉醇（G/N）作为新辅助治疗用于局部晚期不可切除胰腺癌：一项III期、随机、双盲研究

2020-12-28 网络网络

一、题目和背景信息

一、题目和背景信息

登记号	CTR20202359
相关登记号
药物名称	Pamrevlumab 曾用名:
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	局部进展期不可切除胰腺癌
试验专业题目	Pamrevlumab或安慰剂联合吉西他滨/白蛋白紫杉醇（G/N）作为新辅助治疗用于局部晚期不可切除胰腺癌：一项III期、随机、双盲研究。
试验通俗题目	Pamrevlumab或安慰剂联合吉西他滨/白蛋白紫杉醇（G/N）作为新辅助治疗用于局部晚期不可切除胰腺癌：一项III期、随机、双盲研究。
试验方案编号	FGCL-3019-087	方案最新版本号	2.0
版本日期:	2019-09-27	方案是否为联合用药	否

二、申请人信息

申请人名称	1 2 3
联系人姓名	蒋浩	联系人座机	021-68810689	联系人手机号	18621581980
联系人Email	Pjiang@fibrogen.cn	联系人邮政地址	上海市-上海市-浦东新区浦东南路528号北塔2405	联系人邮编	200120

三、临床试验信息

1、试验目的

主要目的：评价Pamrevlumab联合吉西他滨/白蛋白紫杉醇（G/NP）与吉西他滨/白蛋白紫杉醇（G/NP）相比作为新辅助治疗用于局部进展期不可切除胰腺癌的有效性和安全性。次要目的：评价Pamrevlumab联合G/NP或单用G/NP治疗对肿瘤切除率的影响。

2、试验设计

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	双盲	试验范围	国际多中心试验

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	了解并签署知情同意书；愿意遵守研究程序，包括手术。
2	年龄≥18年。
3	男性，或未妊娠、非哺乳期的女性。
4	育龄期女性的血清β-HCG妊娠试验阴性。
5	伴侣有生育潜力的男性受试者及有生育潜力的女性受试者在研究过程中及最后一次用药后3个月内，需要采用双重避孕措施。
6	经组织病理学证实的胰腺导管腺癌(PDAC)。
7	经中心影像学评估存在符合NCCN 2018年第2版指南定义的局部晚期不可切除的胰腺癌。
8	经中心影像学评估存在RECIST1.1定义的可测量病灶。
9	东部肿瘤协作组(ECOG)体能状态评分为0或1 。
10	足够的肝脏功能储备：天冬氨酸转氨酶(AST)、丙氨酸转氨酶(ALT)< 2.5倍正常值上限 (ULN)；胆红素≤1.5×ULN ；碱性磷酸酶<2.5 x ULN；对于碱性磷酸酶、总胆红素、AST和ALT升高的患者，如果随后接受胆道支架置入术且肝功能检查结果正在好转，在总胆红素、AST和ALT已改善至符合研究方案所要求的水平且碱性磷酸酶呈下降趋势的前提下，无需等待碱性磷酸酶降至<2.5x ULN。
11	足够的骨髓功能：血小板>10万/mm3、血红蛋白>9.0 g/dl、中性粒细胞计数绝对值(ANC) > 1500/mm3 。
12	足够的肾功能:肌酐< 1.5 x ULN, 肌酐清除率≥30毫升/分钟。
13	如存在周围神经病变应小于2级(CTCAE标准)。

排除标准

1	既往曾接受胰腺癌化疗或放疗。
2	既往(在过去3年内)被诊断或筛选时合并其他恶性肿瘤，除外非黑色素瘤皮肤癌和原位癌（但不包括原位乳腺癌）。
3	签署知情同意书前4周内接受过大手术。胆道支架手术除外。
4	对人源、人化或嵌合单克隆抗体过敏或有过敏史。
5	存在任何可能增加受试者在研究过程中的风险的内外科疾病。
6	任何可能降低对研究流程的依从性的情况。
7	在首次给药前28天内（或者其他试验药物5个半衰期内，选长者）使用了其他试验药物。
8	未控制的合并症，包括但不限于持续的或者活动性的全身感染、有症状的充血性心力衰竭、不稳定的心绞痛、临床显著的心律失常或精神疾病/社会状况，这些都会限制受试者对研究要求的依从性。
9	在签署知情同意书前6个月内有药物或酒精滥用记录。
10	研究者认为受试者存在以下情况的疾病：可能对受试者在本试验中构成安全风险的、有可能干扰安全性和有效性的评估的、或可能干扰受试者参与研究的。

4、试验分组

试验药

序号	名称	用法
1	中文通用名:FG-3019 英文通用名:Pamrevlumab 商品名称:NA	剂型:注射剂规格:50ml/瓶用法用量:静脉注射；35mg/kg;研究药物的总剂量不超过4.1g。所用剂量制备的液体体积不应超过410 ml 用药时程:6个周期，每个周期28天。其中，第一个周期第1天、第8天、第15天输注给药，其他周期第1天、第15天输注给药。

对照药

序号	名称	用法
1	中文通用名:FG-3019制剂安慰剂英文通用名:NA 商品名称:NA	剂型:注射剂规格:50ml/瓶用法用量:静脉注射；35mg/kg;研究药物的总剂量不超过4.1g。所用剂量制备的液体体积不应超过410 ml 用药时程:6个周期，每个周期28天。其中，第一个周期第1天、第8天、第15天输注给药，其他周期第1天、第15天输注给药。

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	总生存期（OS），定义为从随机化到因任何原因死亡的时间。	从治疗开始至方案规定的随访结束	有效性指标+安全性指标
2	用于加速审批的替代终点：实现R0或R1切除的所有随机受试者的比例	受试者完成新辅助治疗后	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	无进展生存期（PFS）,定义为：从随机化到目标病灶出现进展或受试者死亡（以先发生者为准）的时间。	从治疗开始至方案规定的随访结束	有效性指标+安全性指标
2	患者报告结局（PRO）的变化：治疗期间EORTC-QLQ-C30体能评分相比基线的变化；治疗期间NCI-PRO-CTCAE腹痛分级、NCI-PRO-CTCAE疲劳分级相比基线的平均变化。	EORTC-QLQ-C30体能评分:每个治疗周期的第一天； NCI-PRO-CTCAE腹痛分级、疲劳分级：每次注射化疗药物时。	有效性指标+安全性指标

6、数据安全监查委员会（DMC）

有

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	赵玉沛	学位	医学博士	职称	主任医师
	电话	010-69155818	Email	zhao8028@263.net	邮政地址	北京市-北京市-西城区大木仓胡同41号
	邮编	100032	单位名称	中国医学科学院北京协和医院

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	中国医学科学院北京协和医院	赵玉沛	中国	北京市	北京市
2	江苏省人民医院（南京医科大学第一附属医院）	苗毅	中国	江苏省	南京市
3	复旦大学附属肿瘤医院	虞先濬	中国	上海市	上海市
4	复旦大学附属中山医院	楼文晖	中国	上海市	上海市
5	复旦大学附属华山医院	傅德良	中国	上海市	上海市
6	四川大学华西医院	刘续宝	中国	四川省	成都市
7	西安交通大学第一附属医院	仵正	中国	陕西省	西安市
8	华中科技大学同济医学院附属协和医院	吴河水	中国	湖北省	武汉市
9	北京大学肿瘤医院	郝纯毅	中国	北京市	北京市
10	广东省人民医院	陈汝福	中国	广东省	广州市
11	北京大学第一医院	杨尹默	中国	北京市	北京市
12	上海交通大学医学院附属瑞金医院	沈柏用	中国	上海市	上海市
13	上海交通大学医学院附属仁济医院	刘颖斌	中国	上海市	上海市
14	上海交通大学医学院附属新华医院	龚伟	中国	上海市	上海市

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	中国医学科学院北京协和医院	同意	2020-11-02

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2021-03-29 freve

#MRE#

0 0
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GetPortalCommentsPageByObjectIdResponse(id=1594846, encodeId=447c159484600, content=<a href='/topic/show?id=b317956200' target=_blank style='color:#2F92EE;'>#III期#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=30, 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 02:48:01 CST 2020, time=2020-12-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1573104, encodeId=e60f15e310413, content=<a href='/topic/show?id=fef43e52220' target=_blank style='color:#2F92EE;'>#双盲#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=34, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=37522, encryptionId=fef43e52220, topicName=双盲)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a12645, createdName=智慧医人, createdTime=Wed Dec 30 02:48:01 CST 2020, time=2020-12-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1406011, encodeId=76401406011fa, content=<a href='/topic/show?id=a5404e589d7' target=_blank style='color:#2F92EE;'>#局部#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=27, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=47589, encryptionId=a5404e589d7, topicName=局部)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=d14c2562456, createdName=chg122, createdTime=Wed Dec 30 02:48:01 CST 2020, time=2020-12-30, status=1, ipAttribution=)]
2021-11-08 zzc2219

#pamrevlumab#

59 0
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createdBy=d09323837847, createdName=zzc2219, createdTime=Mon Nov 08 13:48:01 CST 2021, time=2021-11-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1912502, encodeId=4a2019125029a, content=<a href='/topic/show?id=4de7112046c' target=_blank style='color:#2F92EE;'>#mAb#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=41, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=11204, encryptionId=4de7112046c, topicName=mAb)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=25e7304, createdName=snf701207, createdTime=Tue Jun 15 06:48:01 CST 2021, time=2021-06-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1678652, encodeId=4c9116e8652ac, content=<a href='/topic/show?id=110c5869153' target=_blank style='color:#2F92EE;'>#新辅助#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=26, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=58691, encryptionId=110c5869153, topicName=新辅助)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=941f27706894, createdName=charl1234576, createdTime=Thu Sep 23 12:48:01 CST 2021, time=2021-09-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1916385, encodeId=e0f1191638597, content=<a href='/topic/show?id=c5a89550ff' target=_blank style='color:#2F92EE;'>#III#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9550, encryptionId=c5a89550ff, topicName=III)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=e68e415, createdName=juliusluan78, createdTime=Sun Mar 14 22:48:01 CST 2021, time=2021-03-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1650785, encodeId=7ff31650e8519, content=<a href='/topic/show?id=ffae4e614b6' target=_blank style='color:#2F92EE;'>#局部晚期#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=47614, encryptionId=ffae4e614b6, topicName=局部晚期)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=901d24099859, createdName=yhy100208, createdTime=Tue May 25 11:48:01 CST 2021, time=2021-05-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1548557, encodeId=3220154855e35, content=<a href='/topic/show?id=6a4756229d9' target=_blank style='color:#2F92EE;'>#招募#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=36, 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 02:48:01 CST 2020, time=2020-12-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1594846, encodeId=447c159484600, content=<a href='/topic/show?id=b317956200' target=_blank style='color:#2F92EE;'>#III期#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=30, 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 02:48:01 CST 2020, time=2020-12-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1573104, encodeId=e60f15e310413, content=<a href='/topic/show?id=fef43e52220' target=_blank style='color:#2F92EE;'>#双盲#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=34, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=37522, encryptionId=fef43e52220, topicName=双盲)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a12645, createdName=智慧医人, createdTime=Wed Dec 30 02:48:01 CST 2020, time=2020-12-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1406011, encodeId=76401406011fa, content=<a href='/topic/show?id=a5404e589d7' target=_blank style='color:#2F92EE;'>#局部#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=27, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=47589, encryptionId=a5404e589d7, topicName=局部)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=d14c2562456, createdName=chg122, createdTime=Wed Dec 30 02:48:01 CST 2020, time=2020-12-30, status=1, ipAttribution=)]
2021-06-15 snf701207

#mAb#

41 0
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createdBy=d09323837847, createdName=zzc2219, createdTime=Mon Nov 08 13:48:01 CST 2021, time=2021-11-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1912502, encodeId=4a2019125029a, content=<a href='/topic/show?id=4de7112046c' target=_blank style='color:#2F92EE;'>#mAb#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=41, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=11204, encryptionId=4de7112046c, topicName=mAb)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=25e7304, createdName=snf701207, createdTime=Tue Jun 15 06:48:01 CST 2021, time=2021-06-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1678652, encodeId=4c9116e8652ac, content=<a href='/topic/show?id=110c5869153' target=_blank style='color:#2F92EE;'>#新辅助#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=26, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=58691, encryptionId=110c5869153, topicName=新辅助)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=941f27706894, createdName=charl1234576, createdTime=Thu Sep 23 12:48:01 CST 2021, time=2021-09-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1916385, encodeId=e0f1191638597, content=<a href='/topic/show?id=c5a89550ff' target=_blank style='color:#2F92EE;'>#III#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9550, encryptionId=c5a89550ff, topicName=III)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=e68e415, createdName=juliusluan78, createdTime=Sun Mar 14 22:48:01 CST 2021, time=2021-03-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1650785, encodeId=7ff31650e8519, content=<a href='/topic/show?id=ffae4e614b6' target=_blank style='color:#2F92EE;'>#局部晚期#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=47614, encryptionId=ffae4e614b6, topicName=局部晚期)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=901d24099859, createdName=yhy100208, createdTime=Tue May 25 11:48:01 CST 2021, time=2021-05-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1548557, encodeId=3220154855e35, content=<a href='/topic/show?id=6a4756229d9' target=_blank style='color:#2F92EE;'>#招募#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=36, 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 02:48:01 CST 2020, time=2020-12-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1594846, encodeId=447c159484600, content=<a href='/topic/show?id=b317956200' target=_blank style='color:#2F92EE;'>#III期#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=30, 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 02:48:01 CST 2020, time=2020-12-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1573104, encodeId=e60f15e310413, content=<a href='/topic/show?id=fef43e52220' target=_blank style='color:#2F92EE;'>#双盲#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=34, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=37522, encryptionId=fef43e52220, topicName=双盲)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a12645, createdName=智慧医人, createdTime=Wed Dec 30 02:48:01 CST 2020, time=2020-12-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1406011, encodeId=76401406011fa, content=<a href='/topic/show?id=a5404e589d7' target=_blank style='color:#2F92EE;'>#局部#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=27, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=47589, encryptionId=a5404e589d7, topicName=局部)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=d14c2562456, createdName=chg122, createdTime=Wed Dec 30 02:48:01 CST 2020, time=2020-12-30, status=1, ipAttribution=)]
2021-09-23 charl1234576

#新辅助#

26 0
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createdBy=d09323837847, createdName=zzc2219, createdTime=Mon Nov 08 13:48:01 CST 2021, time=2021-11-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1912502, encodeId=4a2019125029a, content=<a href='/topic/show?id=4de7112046c' target=_blank style='color:#2F92EE;'>#mAb#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=41, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=11204, encryptionId=4de7112046c, topicName=mAb)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=25e7304, createdName=snf701207, createdTime=Tue Jun 15 06:48:01 CST 2021, time=2021-06-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1678652, encodeId=4c9116e8652ac, content=<a href='/topic/show?id=110c5869153' target=_blank style='color:#2F92EE;'>#新辅助#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=26, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=58691, encryptionId=110c5869153, topicName=新辅助)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=941f27706894, createdName=charl1234576, createdTime=Thu Sep 23 12:48:01 CST 2021, time=2021-09-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1916385, encodeId=e0f1191638597, content=<a href='/topic/show?id=c5a89550ff' target=_blank style='color:#2F92EE;'>#III#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9550, encryptionId=c5a89550ff, topicName=III)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=e68e415, createdName=juliusluan78, createdTime=Sun Mar 14 22:48:01 CST 2021, time=2021-03-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1650785, encodeId=7ff31650e8519, content=<a href='/topic/show?id=ffae4e614b6' target=_blank style='color:#2F92EE;'>#局部晚期#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=47614, encryptionId=ffae4e614b6, topicName=局部晚期)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=901d24099859, createdName=yhy100208, createdTime=Tue May 25 11:48:01 CST 2021, time=2021-05-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1548557, encodeId=3220154855e35, content=<a href='/topic/show?id=6a4756229d9' target=_blank style='color:#2F92EE;'>#招募#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=36, 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 02:48:01 CST 2020, time=2020-12-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1594846, encodeId=447c159484600, content=<a href='/topic/show?id=b317956200' target=_blank style='color:#2F92EE;'>#III期#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=30, 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 02:48:01 CST 2020, time=2020-12-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1573104, encodeId=e60f15e310413, content=<a href='/topic/show?id=fef43e52220' target=_blank style='color:#2F92EE;'>#双盲#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=34, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=37522, encryptionId=fef43e52220, topicName=双盲)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a12645, createdName=智慧医人, createdTime=Wed Dec 30 02:48:01 CST 2020, time=2020-12-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1406011, encodeId=76401406011fa, content=<a href='/topic/show?id=a5404e589d7' target=_blank style='color:#2F92EE;'>#局部#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=27, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=47589, encryptionId=a5404e589d7, topicName=局部)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=d14c2562456, createdName=chg122, createdTime=Wed Dec 30 02:48:01 CST 2020, time=2020-12-30, status=1, ipAttribution=)]
2021-03-14 juliusluan78

#III#

33 0
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createdTime=Wed Dec 30 02:48:01 CST 2020, time=2020-12-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1406011, encodeId=76401406011fa, content=<a href='/topic/show?id=a5404e589d7' target=_blank style='color:#2F92EE;'>#局部#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=27, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=47589, encryptionId=a5404e589d7, topicName=局部)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=d14c2562456, createdName=chg122, createdTime=Wed Dec 30 02:48:01 CST 2020, time=2020-12-30, status=1, ipAttribution=)]
2021-05-25 yhy100208

#局部晚期#

35 0
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createdTime=Wed Dec 30 02:48:01 CST 2020, time=2020-12-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1406011, encodeId=76401406011fa, content=<a href='/topic/show?id=a5404e589d7' target=_blank style='color:#2F92EE;'>#局部#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=27, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=47589, encryptionId=a5404e589d7, topicName=局部)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=d14c2562456, createdName=chg122, createdTime=Wed Dec 30 02:48:01 CST 2020, time=2020-12-30, status=1, ipAttribution=)]
2020-12-30 ms1260584454294838

#招募#

36 0
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GetPortalCommentsPageByObjectIdResponse(id=1594846, encodeId=447c159484600, content=<a href='/topic/show?id=b317956200' target=_blank style='color:#2F92EE;'>#III期#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=30, 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 02:48:01 CST 2020, time=2020-12-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1573104, encodeId=e60f15e310413, content=<a href='/topic/show?id=fef43e52220' target=_blank style='color:#2F92EE;'>#双盲#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=34, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=37522, encryptionId=fef43e52220, topicName=双盲)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a12645, createdName=智慧医人, createdTime=Wed Dec 30 02:48:01 CST 2020, time=2020-12-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1406011, encodeId=76401406011fa, content=<a href='/topic/show?id=a5404e589d7' target=_blank style='color:#2F92EE;'>#局部#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=27, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=47589, encryptionId=a5404e589d7, topicName=局部)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=d14c2562456, createdName=chg122, createdTime=Wed Dec 30 02:48:01 CST 2020, time=2020-12-30, status=1, ipAttribution=)]
2020-12-30 智智灵药

#III期#

30 0
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beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=47614, encryptionId=ffae4e614b6, topicName=局部晚期)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=901d24099859, createdName=yhy100208, createdTime=Tue May 25 11:48:01 CST 2021, time=2021-05-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1548557, encodeId=3220154855e35, content=<a href='/topic/show?id=6a4756229d9' target=_blank style='color:#2F92EE;'>#招募#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=36, 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 02:48:01 CST 2020, time=2020-12-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1594846, encodeId=447c159484600, content=<a href='/topic/show?id=b317956200' target=_blank style='color:#2F92EE;'>#III期#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=30, 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 02:48:01 CST 2020, time=2020-12-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1573104, encodeId=e60f15e310413, content=<a href='/topic/show?id=fef43e52220' target=_blank style='color:#2F92EE;'>#双盲#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=34, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=37522, encryptionId=fef43e52220, topicName=双盲)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a12645, createdName=智慧医人, createdTime=Wed Dec 30 02:48:01 CST 2020, time=2020-12-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1406011, encodeId=76401406011fa, content=<a href='/topic/show?id=a5404e589d7' target=_blank style='color:#2F92EE;'>#局部#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=27, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=47589, encryptionId=a5404e589d7, topicName=局部)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=d14c2562456, createdName=chg122, createdTime=Wed Dec 30 02:48:01 CST 2020, time=2020-12-30, status=1, ipAttribution=)]
2020-12-30 智慧医人

#双盲#

34 0
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createdBy=d09323837847, createdName=zzc2219, createdTime=Mon Nov 08 13:48:01 CST 2021, time=2021-11-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1912502, encodeId=4a2019125029a, content=<a href='/topic/show?id=4de7112046c' target=_blank style='color:#2F92EE;'>#mAb#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=41, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=11204, encryptionId=4de7112046c, topicName=mAb)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=25e7304, createdName=snf701207, createdTime=Tue Jun 15 06:48:01 CST 2021, time=2021-06-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1678652, encodeId=4c9116e8652ac, content=<a href='/topic/show?id=110c5869153' target=_blank style='color:#2F92EE;'>#新辅助#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=26, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=58691, encryptionId=110c5869153, topicName=新辅助)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=941f27706894, createdName=charl1234576, createdTime=Thu Sep 23 12:48:01 CST 2021, time=2021-09-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1916385, encodeId=e0f1191638597, content=<a href='/topic/show?id=c5a89550ff' target=_blank style='color:#2F92EE;'>#III#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9550, encryptionId=c5a89550ff, topicName=III)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=e68e415, createdName=juliusluan78, createdTime=Sun Mar 14 22:48:01 CST 2021, time=2021-03-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1650785, encodeId=7ff31650e8519, content=<a href='/topic/show?id=ffae4e614b6' target=_blank style='color:#2F92EE;'>#局部晚期#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=47614, encryptionId=ffae4e614b6, topicName=局部晚期)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=901d24099859, createdName=yhy100208, createdTime=Tue May 25 11:48:01 CST 2021, time=2021-05-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1548557, encodeId=3220154855e35, content=<a href='/topic/show?id=6a4756229d9' target=_blank style='color:#2F92EE;'>#招募#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=36, 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 02:48:01 CST 2020, time=2020-12-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1594846, encodeId=447c159484600, content=<a href='/topic/show?id=b317956200' target=_blank style='color:#2F92EE;'>#III期#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=30, 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 02:48:01 CST 2020, time=2020-12-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1573104, encodeId=e60f15e310413, content=<a href='/topic/show?id=fef43e52220' target=_blank style='color:#2F92EE;'>#双盲#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=34, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=37522, encryptionId=fef43e52220, topicName=双盲)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a12645, createdName=智慧医人, createdTime=Wed Dec 30 02:48:01 CST 2020, time=2020-12-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1406011, encodeId=76401406011fa, content=<a href='/topic/show?id=a5404e589d7' target=_blank style='color:#2F92EE;'>#局部#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=27, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=47589, encryptionId=a5404e589d7, topicName=局部)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=d14c2562456, createdName=chg122, createdTime=Wed Dec 30 02:48:01 CST 2020, time=2020-12-30, status=1, ipAttribution=)]
2020-12-30 chg122

#局部#

27 0

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患者招募：Pamrevlumab或安慰剂联合吉西他滨/白蛋白紫杉醇（G/N）作为新辅助治疗用于局部晚期不可切除胰腺癌：一项III期、随机、双盲研究

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