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A Study of the Addition of Avastin (Bevacizumab) to Carboplatin and Paclitaxel Therapy in Patients With Ovarian Cancer

2016年5月3日 更新者：Hoffmann-La Roche

Global Study to Assess the Addition of Bevacizumab to Carboplatin and Paclitaxel as Front-line Treatment of Epithelial Ovarian Cancer, Fallopian Tube Carcinoma or Primary Peritoneal Carcinoma

This open-label, non-comparative, multi-center study will assess the safety profile and efficacy of Avastin (bevacizumab) when added to carboplatin and paclitaxel therapy in participants with epithelial ovarian cancer, fallopian tube carcinoma or primary peritoneal carcinoma. Participants will receive 15 milligrams/kilogram (mg/kg) Avastin intravenously (IV) on Day 1 of every cycle for up to 36 cycles of 3 weeks each, carboplatin (area under the plasma concentration-time curve [AUC] 5-6 mg/ml/min) on Day 1 every 3 weeks for a maximum of 8 cycles and paclitaxel 175 milligram per square meter (mg/m^2) on Day 1 every 3 weeks or 80 mg/m^2 every week for a maximum of 8 cycles. The anticipated time on study drug will be 108 weeks or until disease progression or unacceptable toxicity.

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)

1021

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

  • 丹麦
      • Aalborg、丹麦、9000
      • Roskilde、丹麦、4000
      • Vejle、丹麦、7100
  • 乌拉圭
      • Montevideo、乌拉圭、11600
  • 以色列
      • Afula、以色列、18101
      • Beer Sheva、以色列、8410101
      • Haifa、以色列、34362
      • Haifa、以色列、31096
      • Holon、以色列、58100
      • Jerusalem、以色列、91120-01
      • Jerusalem、以色列、9372212
      • Kfar Saba、以色列、44281
      • Petach Tikva、以色列、49100
      • Ramat Gan、以色列、52621
      • Rehovot、以色列、7610001
      • Tel Aviv、以色列、64239-06
  • 俄罗斯联邦
      • Barnaul、俄罗斯联邦、656049
      • Moscow、俄罗斯联邦、115478
      • Obninsk, Kaluzhskaya Region、俄罗斯联邦、249034
      • Saint-Petersburg、俄罗斯联邦、197022
      • Stavropol、俄罗斯联邦、355045
      • UFA、俄罗斯联邦、450054
  • 保加利亚
      • Sofia、保加利亚、1756
      • Varna、保加利亚、9010
      • Veliko Tarnovo、保加利亚、5000
  • 加拿大
      • Quebec、加拿大、G1R 3S1
    • Alberta
      • Calgary、Alberta、加拿大、T2N 4N2
    • Ontario
      • Ottawa、Ontario、加拿大、K1H 8L6
      • Toronto、Ontario、加拿大、M5G 2M9
    • Quebec
      • Montreal、Quebec、加拿大、H2L 4M1
  • 匈牙利
      • Budapest、匈牙利、1125
      • Budapest、匈牙利、1122
      • Debrecen、匈牙利、4032
      • Pecs、匈牙利、7624
      • Szeged、匈牙利、6720
  • 南非
      • Durban、南非、4058
      • Johannesburg、南非、2193
      • Sandton、南非、2196
  • 印度
      • Bangalore、印度、560017
      • Bangalore、印度、560054
      • Hyderabad、印度、650034
      • Jaipur、印度、302013
      • Kochi、印度、682304
      • New Delhi、印度、110029
      • Pune、印度、411004
  • 台湾
      • Taipei City、台湾、110
      • Taipei City、台湾、112
      • Taoyuan Hsien、台湾、333
  • 埃及
      • Cairo、埃及、11555
      • Tanta、埃及
  • 塞尔维亚
      • Belgrade、塞尔维亚、11000
      • Nis、塞尔维亚、18000
  • 墨西哥
      • Distrito Federal、墨西哥、14080
      • Oaxaca、墨西哥、68000
      • Toluca、墨西哥、50180
  • 奥地利
      • Graz、奥地利、8020
      • Graz、奥地利、8036
      • Innsbruck、奥地利、6020
      • Ried-innkreis、奥地利、4910
      • Salzburg、奥地利、5020
      • Steyr、奥地利、4400
      • Villach、奥地利、9500
      • Wien、奥地利、1130
      • Wien、奥地利、1090
  • 巴西
    • BA
      • Salvador、BA、巴西、41950-610
    • CE
      • Fortaleza、CE、巴西、60125-120
    • GO
      • Goiania、GO、巴西、74605-070
    • PR
      • Curitiba、PR、巴西、80530-010
    • RJ
      • Rio de Janeiro、RJ、巴西、20230-130
    • RS
      • Porto Alegre、RS、巴西、90430-090
      • Porto Alegre、RS、巴西、90020-090
    • SP
      • Piracicaba、SP、巴西、13419-155
      • Sao Paulo、SP、巴西、01246-000
      • Sao Paulo、SP、巴西、01308-050
      • Sao Paulo、SP、巴西、01317-000
      • Sao Paulo、SP、巴西、01509-010
  • 希腊
      • Athens、希腊、11527
      • Athens、希腊、115 28
      • Athens、希腊、145 64
      • Heraklion, Crete、希腊、71110
      • Larissa、希腊、41 110
      • Patras、希腊、265 00
      • Thessaloniki、希腊、56429
  • 意大利
    • Campania
      • Napoli、Campania、意大利、80131
    • Emilia-Romagna
      • Bologna、Emilia-Romagna、意大利、40138
      • Meldola、Emilia-Romagna、意大利、47014
    • Lazio
      • Roma、Lazio、意大利、00128
      • Roma、Lazio、意大利、00157
    • Liguria
      • Genova、Liguria、意大利、16128
    • Lombardia
      • Brescia、Lombardia、意大利、25123
      • Milano、Lombardia、意大利、20162
      • Milano、Lombardia、意大利、20141
      • Monza、Lombardia、意大利、20052
      • Saronno、Lombardia、意大利、21047
    • Piemonte
      • Novara、Piemonte、意大利、28100
      • Torino、Piemonte、意大利、10126
      • Torino、Piemonte、意大利、10128
    • Sicilia
      • Palermo、Sicilia、意大利、90146
    • Toscana
      • Firenze、Toscana、意大利、50139
      • Pisa、Toscana、意大利、56126
    • Umbria
      • Perugia、Umbria、意大利、06123
      • Terni、Umbria、意大利、05100
  • 拉脱维亚
      • Daugavpils、拉脱维亚、5417
      • Riga、拉脱维亚、LV-1002
      • Riga、拉脱维亚、LV 1079
  • 斯洛伐克
      • Bratislava、斯洛伐克、833 10
      • Kosice、斯洛伐克、04001
  • 斯洛文尼亚
      • Ljubljana、斯洛文尼亚、1000
      • Maribor、斯洛文尼亚、2000
  • 沙特阿拉伯
      • Dammam、沙特阿拉伯、31444
  • 法国
      • Amiens、法国、80090
      • Bordeaux、法国、33076
      • Brest、法国、29200
      • Caen、法国、14076
      • Clermont Ferrand、法国、63011
      • Grenoble、法国、38028
      • Lille、法国、59020
      • Lyon、法国、69373
      • Marseille、法国、13273
      • Mougins、法国、06250
      • Paris、法国、75970
      • Paris、法国、75908
      • Paris、法国、75651
      • Paris、法国、75674
      • Paris、法国、75231
      • Paris、法国、75571
      • Reims CEDEX、法国、51056
      • Strasbourg、法国、67065
      • Toulouse、法国、31059
      • Villejuif、法国、94805
  • 波兰
      • Bydgoszcz、波兰、85-796
      • Warszawa、波兰、03-242
  • 火鸡
      • Ankara、火鸡、06500
      • Ankara、火鸡、06230
      • Diyarbakir、火鸡、10000
      • Istanbul、火鸡、34390
  • 爱尔兰
      • Dublin、爱尔兰、7
  • 爱沙尼亚
      • Tallinn、爱沙尼亚、11312
      • Tallinn、爱沙尼亚、13419
      • Tartu、爱沙尼亚、50406
  • 瑞典
      • Eskilstuna、瑞典、63188
      • Falun、瑞典、79182
      • Karlstad、瑞典、65185
      • Umeå、瑞典
      • Uppsala、瑞典、75185
      • Örebro、瑞典、701 85
  • 瑞士
      • Aarau、瑞士、5001
      • Baden、瑞士、5405
      • Bellinzona、瑞士、6500
      • Bern、瑞士、3010
      • Genève 14、瑞士、1211
      • Zürich、瑞士、8091
  • 科威特
      • Shuwaikh、科威特、70653
  • 立陶宛
      • Kaunas、立陶宛、50009
      • Klaipeda、立陶宛、92288
      • Vilnius、立陶宛、08660
  • 罗马尼亚
      • Bucuresti、罗马尼亚、022328
      • Cluj Napoca、罗马尼亚、400015
      • Iasi、罗马尼亚、700106
  • 荷兰
      • Alkmaar、荷兰、1815 JD
      • Amsterdam、荷兰、1091 AC
      • Apeldoorn、荷兰、7334 DZ
      • Blaricum、荷兰、1261 AN
      • Breda、荷兰、4819 EV
      • Capelle a/d IJssel、荷兰、NL 2900 AR
      • Den Haag、荷兰、2545 CH
      • Den Haag、荷兰、2512 VA
      • Deventer、荷兰、7416 SE
      • Dordrecht、荷兰、3318 AT
      • Eindhoven、荷兰、5623 EJ
      • Leidschendam、荷兰、2262 BA
      • Rotterdam、荷兰、3045 PM
      • Sittard-Geleen、荷兰、6162 BG
      • Utrecht、荷兰、3582 KE
  • 葡萄牙
      • Porto、葡萄牙、4200-072
  • 西班牙
      • Albacete、西班牙、02006
      • Alicante、西班牙、3010
      • Badajoz、西班牙、06080
      • Barcelona、西班牙、08036
      • Barcelona、西班牙、08003
      • Barcelona、西班牙、08906
      • Barcelona、西班牙、08017
      • Burgos、西班牙、09006
      • Caceres、西班牙、10003
      • Castellon、西班牙、12002
      • Ciudad Real、西班牙、13005
      • Cordoba、西班牙、14004
      • Girona、西班牙、17007
      • Granada、西班牙、18014
      • Guadalajara、西班牙、19002
      • Jaen、西班牙、23007
      • La Coruña、西班牙、15006
      • Lugo、西班牙、27003
      • Madrid、西班牙、28040
      • Madrid、西班牙、28041
      • Madrid、西班牙、28007
      • Madrid、西班牙、28222
      • Madrid、西班牙、28033
      • Madrid、西班牙、28002
      • Madrid、西班牙、28050
      • Malaga、西班牙、29010
      • Malaga、西班牙、29011
      • Navarra、西班牙、31008
      • Salamanca、西班牙、37007
      • Segovia、西班牙、40002
      • Sevilla、西班牙、41014
      • Sevilla、西班牙、41009
      • Toledo、西班牙、45004
      • Valencia、西班牙、46017
      • Valencia、西班牙、46026
      • Valencia、西班牙、46009
      • Valencia、西班牙、46015
      • Valladolid、西班牙、47010
      • Zaragoza、西班牙、50009
    • Alicante
      • Elda、Alicante、西班牙、03600
    • Asturias
      • Oviedo、Asturias、西班牙、33011
    • Badajoz
      • Llerena (Badajoz)、Badajoz、西班牙、06900
    • Barcelona
      • Manresa、Barcelona、西班牙、08243
    • Cadiz
      • Cádiz、Cadiz、西班牙、11009
      • Jerez de La Frontera、Cadiz、西班牙、11407
    • Guipuzcoa
      • San Sebastian、Guipuzcoa、西班牙、20080
      • San Sebastian de Los Reyes、Guipuzcoa、西班牙、28702
    • Islas Baleares
      • Palma De Mallorca、Islas Baleares、西班牙、07014
      • Palma de Mallorca、Islas Baleares、西班牙、07198
    • La Coruña
      • Santiago de Compostela、La Coruña、西班牙、15706
    • Las Palmas
      • Las Palmas de Gran Canaria、Las Palmas、西班牙、35020
    • Madrid
      • Leganes、Madrid、西班牙、28911
    • Tarragona
      • Reus、Tarragona、西班牙、43204
    • Tenerife
      • La Laguna、Tenerife、西班牙、38320
      • Santa Cruz de Tenerife、Tenerife、西班牙、38010
    • Valencia
      • San Juan、Valencia、西班牙、03550
    • Vizcaya
      • Barakaldo、Vizcaya、西班牙、48903
      • Bilbao、Vizcaya、西班牙、48013
  • 阿根廷
      • Buenos Aires、阿根廷、C1199ACI
      • Buenos Aires、阿根廷、C1280AEB
      • Buenos Aires、阿根廷、C1426ANZ
      • Rosario、阿根廷、S2002KDS
      • Tucuman、阿根廷、T4000IAK
  • 香港
      • Hong Kong、香港
      • Hong Kong、香港、852
  • 马其顿，前南斯拉夫共和国
      • Bitola、马其顿，前南斯拉夫共和国、7000
      • Skopje、马其顿，前南斯拉夫共和国、1000

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

女性

描述

Inclusion Criteria:

  • Histologically confirmed epithelial ovarian carcinoma, fallopian tube carcinoma, primary peritoneal carcinoma or clear cell carcinoma or carcinosarcoma. Participants with recurrent ovarian cancer who have been previously treated with surgery alone for their early stage disease are eligible.
  • Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0, 1 or 2
  • Life expectancy greater than or equal to (>=3) months

Exclusion Criteria:

  • Participants with non-epithelial ovarian cancer, ovarian tumors with low malignant potential (i.e., borderline tumors), or synchronous primary endometrial carcinoma
  • Previous systemic therapy for ovarian cancer. Prior neo-adjuvant chemotherapy is allowed
  • Planned intraperitoneal cytotoxic chemotherapy
  • Radiotherapy within 28 days of Day 1, Cycle 1
  • Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to first dose of Avastin
  • History or evidence of National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Grade >=1 arterial thromboembolic event or Grade >=3 venous thromboembolic event within 6 months prior to enrollment

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：不适用
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Bevacizumab + Paclitaxel + Carboplatin
Participants will receive bevacizumab 15 mg/kg IV on Day 1 every 3 weeks from Cycle 1 to Cycle 36 (initially concurrent with chemotherapy, then continued as a single agent following the completion of chemotherapy), or until protocol defined disease progression or until unacceptable toxicity (whichever occurred first). Participants will receive paclitaxel 175 mg/m^2 IV on Day 1 every 3 weeks or 80 mg/m^2 IV every week and carboplatin (AUC 5-6) IV on Day 1 every 3 weeks for a minimum of 4 and maximum of 8 cycles (including up to 4 pre-surgical cycles), or until protocol defined disease progression, or unacceptable toxicity (whichever occurred first).
药品：Paclitaxel
175 mg/m^2 on Day 1 every 3 weeks or at a dose of 80 mg/m^2 every week for a minimum of 4 cycles and not more than 8 cycles or until disease progression or unacceptable toxicity, whichever occurs first
药品：Bevacizumab
15 mg/kg intravenously on Day 1 of every cycle for up to 36 cycles of 3 weeks each or until disease progression or unacceptable toxicity, whichever occurs first
其他名称：
  • 阿瓦斯汀
药品：Carboplatin
AUC 5-6 mg/ml/min on Day 1 every 3 weeks for a minimum of 4 cycles and not more than 8 cycles or until disease progression or unacceptable toxicity, whichever occurs first

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
Percentage of Participants With at Least One Adverse Event (AE)
大体时间：Day 1 up to 30 days after last dose of study treatment (until data cutoff 07 December 2014, up to 4 years)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
Day 1 up to 30 days after last dose of study treatment (until data cutoff 07 December 2014, up to 4 years)

次要结果测量

结果测量
措施说明
大体时间
Progression-Free Survival (PFS)
大体时间：Day 1, at end of Cycles 3 and 6, then every 6 cycles while receiving bevacizumab, and then at bevacizumab cessation, every 26 weeks after cessation of bevacizumab until disease progression or death until data cutoff 07 December 2014, up to 4 years
PFS was defined as the time between the date of first administration of any study treatment and the date of first documented protocol-defined disease progression (that is [i.e.], radiologically by Response Evaluation Criteria In Solid Tumors [RECIST], clinical, or symptomatic) or death, whichever occurred first. Participants who had neither progressed nor died at the time of data cut-off (07 December 2014), or participants who were withdrawn from study, or lost to follow-up without documented progression, were censored. Kaplan-Meier estimation was used for median time to PFS.
Day 1, at end of Cycles 3 and 6, then every 6 cycles while receiving bevacizumab, and then at bevacizumab cessation, every 26 weeks after cessation of bevacizumab until disease progression or death until data cutoff 07 December 2014, up to 4 years
Percentage of Participants Achieving Best Overall Response of Complete Response (CR) or Partial Response (PR) According to RECIST Version 1.0
大体时间：Day 1, at end of Cycles 3 and 6, then every 6 cycles while receiving bevacizumab, and then at bevacizumab cessation, every 26 weeks (Q26W) after cessation of bevacizumab until disease progression or death until data cutoff 07 December 2014, up to 4 years
Best overall response (BOR) according to RECIST Version 1.0 was categorized as: CR, PR, progressive disease (PD), stable disease (SD). CR: disappearance of all target lesions and non-target lesions. PR: >=30% decrease in sum of the longest diameters (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST associated to non-progressive disease response for non-target lesions. PD: Natural progression or deterioration of the malignancy under study (including new sites of metastasis). SD: neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum longest diameter since the treatment started. Participants with a BOR of CR and PR were defined as responders, while participants with a BOR of SD, PD, or unable to assess were defined as non-responders.
Day 1, at end of Cycles 3 and 6, then every 6 cycles while receiving bevacizumab, and then at bevacizumab cessation, every 26 weeks (Q26W) after cessation of bevacizumab until disease progression or death until data cutoff 07 December 2014, up to 4 years
Percentage of Participants Achieving an Overall Response by 50% Carcinoma Antigen 125 (CA-125) Response Criteria
大体时间：3 days prior to Day 1 of every cycle, then every 6 weeks (Q6W) during the first year, every 3 months (Q3M) in the second and third year, every 6 months (Q6M) in the fourth year of the study (until data cutoff 07 December 2014, up to 4 years)
CA-125 responders: Participants with the value of CA-125 reduced by at least 50% and confirmed with a consecutive CA-125 assessment performed at an interval of at least 28 days. Overall response according to CA-125 was only evaluated for participants with a pre-treatment CA-125 within 3 days prior to start of any study treatment of at least twice the upper limit of normal (ULN).
3 days prior to Day 1 of every cycle, then every 6 weeks (Q6W) during the first year, every 3 months (Q3M) in the second and third year, every 6 months (Q6M) in the fourth year of the study (until data cutoff 07 December 2014, up to 4 years)
Percentage of Participants Achieving an Overall Response by RECIST Version 1.0 and/or 50% CA-125 Response Criteria
大体时间：RECIST: Day 1, at end of Cycles 3 and 6, then every 6 cycles, at bevacizumab cessation, Q26W after cessation; CA-125: 3 days before Day 1 of every cycle, then Q6W(1st year), Q3M(2nd-3rd year), Q6M(4th year); until data cutoff 07Dec2014, up to 4 years
Overall response was only evaluated for participants who were evaluable according to RECIST v1.0 with a measurable disease at baseline and/or according to CA-125 with a pre-treatment CA-125 within 3 days prior to start of any study treatment of at least twice the ULN. RECIST responders: Participants achieving an overall response of CR (disappearance of all target lesions and non-target lesions) or PR (>=30% decrease in sum of the LD of the target lesions taking as a reference the baseline sum LD according to RECIST associated to non-progressive disease response for non target lesions). CA-125 responders: Participants with the value of CA-125 reduced by at least 50% and confirmed with a consecutive CA-125 assessment performed at an interval of at least 28 days.
RECIST: Day 1, at end of Cycles 3 and 6, then every 6 cycles, at bevacizumab cessation, Q26W after cessation; CA-125: 3 days before Day 1 of every cycle, then Q6W(1st year), Q3M(2nd-3rd year), Q6M(4th year); until data cutoff 07Dec2014, up to 4 years
Duration of Objective Response (DOR)
大体时间：Day 1, at end of Cycles 3 and 6, then every 6 cycles while receiving bevacizumab, and then at bevacizumab cessation, every 26 weeks after cessation of bevacizumab until disease progression or death until data cutoff 07 December 2014, up to 4 years
DOR was defined as the time from the first documented response (CR or PR per RECIST v1.0), to the first documented protocol-defined disease progression (i.e., radiologically by RECIST, clinical, or symptomatic) or death, whichever occurred first. Participants who had neither progressed nor died at the time of data cut-off (07 December 2014), or participants who were withdrawn from study, or lost to follow-up without documented progression, were censored. RECIST responders: Participants achieving an overall response of CR (disappearance of all target lesions and non-target lesions) or PR (>=30% decrease in sum of the LD of the target lesions taking as a reference the baseline sum LD according to RECIST associated to non-progressive disease response for non-target lesions). Disease progression: Natural progression or deterioration of the malignancy under study (including new sites of metastasis).
Day 1, at end of Cycles 3 and 6, then every 6 cycles while receiving bevacizumab, and then at bevacizumab cessation, every 26 weeks after cessation of bevacizumab until disease progression or death until data cutoff 07 December 2014, up to 4 years
Overall Survival (OS)
大体时间：First administration of any study treatment until death or data cutoff 07 December 2014, up to 4 years
OS was defined as the time from the date of the first administration of any study treatment to the date of death, regardless of the cause of death. Participants without the event of death were censored at the last date in the study, defined as the latest date of the following: the date of first administration of study treatment, date of last study treatment, date of last visit, or date last known to be alive. Kaplan-Meier estimation was used for OS.
First administration of any study treatment until death or data cutoff 07 December 2014, up to 4 years
Biological Progression-free Interval
大体时间：3 days prior to Day 1 of every cycle, then every 6 weeks during the first year, every 3 months in the second and third year, every 6 months in the fourth year of the study (until data cutoff 07 December 2014, up to 4 years)
Biological progression-free interval is defined as the interval from the date of the first administration of any study treatment to the date of the first documented serial elevation of the ovarian cancer mucin CA-125. More precisely, this is defined as the first documented increase in CA-125 levels as follows: (1) CA-125 greater than or equal to 2 times the upper level of normal (ULN) on 2 occasions at least 1 week apart (for participants with CA-125 within normal range pre-treatment) or (2) CA-125 greater than or equal to 2 times the ULN on 2 occasions at least 1 week apart (for participants with elevated CA-125 pre-treatment and initial normalization of CA-125 on-treatment) or (3) CA-125 greater than or equal to 2 times the nadir value, which is the lowest observed CA-125 value per participant on 2 occasions at least 1 week apart (for participants with elevated CA-125 pre-treatment which never normalized).
3 days prior to Day 1 of every cycle, then every 6 weeks during the first year, every 3 months in the second and third year, every 6 months in the fourth year of the study (until data cutoff 07 December 2014, up to 4 years)

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Hoffmann-La Roche

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研究主要日期

学习开始

2010年12月1日

初级完成 (实际的)

2015年3月1日

研究完成 (实际的)

2015年3月1日

研究注册日期

首次提交

2010年11月10日

首先提交符合 QC 标准的

2010年11月10日

首次发布 (估计)

2010年11月11日

研究记录更新

最后更新发布 (估计)

2016年6月10日

上次提交的符合 QC 标准的更新

2016年5月3日

最后验证

2016年5月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • MO22923
  • 2010-019525-34 (EudraCT编号)

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