BIBF 1120 或安慰剂联合多西他赛二线治疗非小细胞肺癌

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试验详情

一、临床试验项目名称
BIBF 1120 或安慰剂联合多西他赛二线治疗非小细胞肺癌

二、适应症
非小细胞肺癌二线治疗

三、试验介绍

在接受一线化疗失败后的IIIB/IV期或复发性非小细胞肺癌患者中，比较接受BIBF 1120加标准多西他赛治疗与安慰剂加标准多西他赛治疗的有效性和安全性，生活质量和BIBF1120药代动力学的数据也将进行分析。

研究中心所在省份及城市（具体启动情况以后期咨询为准）

研究中心	主要研究者
上海胸科医院	廖美琳

序号	机构名称	主要研究者	国家	省（州）	城市
1	上海胸科医院	廖美琳	中国	上海	上海
2	复旦大学附属中山医院	白春学	中国	上海	上海
3	大连医科大学附属第二医院	张阳	中国	辽宁	大连
4	武汉同济医院	于世英	中国	湖北	武汉
5	上海肺科医院	周彩存	中国	上海	上海
6	吉林省肿瘤医院	程颖	中国	吉林	长春
7	南京八一医院	秦叔逵	中国	江苏	南京
8	广东省人民医院	吴一龙	中国	广东	广州
9	浙江大学医学院附属邵逸夫医院	潘宏铭	中国	浙江	杭州
10	江苏省肿瘤医院	冯继锋	中国	江苏	南京
11	四川大学华西医院	卢铀	中国	四川	成都
12	大连医科大学附属第一医院	刘基巍	中国	辽宁	大连
13	西南医院	梁后杰	中国	重庆	重庆
14	中山大学肿瘤防治中心	张力	中国	广东	广州
15	福建省肿瘤医院	黄诚	中国	福建	福州
16	浙江省肿瘤医院	张沂平	中国	浙江	杭州
17	复旦大学附属中山医院	常建华	中国	上海	上海
18	中国人民解放军307医院	刘晓晴	中国	北京	北京
19	吉林大学第一医院	李薇	中国	吉林	长春
20	哈尔滨医科大学附属肿瘤医院	陈公琰	中国	黑龙江	哈尔滨
21	Charite - Campus Benjamin Franklin	Ulrich Keilholz	Germany	NA	Berlin
22	Universitaetsklinikum Schleswig-Holstein	Klaus Dalhoff	Germany	NA	Luebeck
23	Krankenhaus Nordwest GmbH	Elke Jaeger	Germany	NA	Frankfurt/Main
24	Asklepios Fachkliniken Muenchen-Gauting	Joachim von Pawel	Germany	NA	Gauting
25	Universitaetsklinikum Leipzig	Hubert Wirtz	Germany	NA	Leipzig
26	Staedtisches Kliniken Frankfurt a. M. - Hoechst	Hans Guenter Derigs	Germany	NA	Frankfurt/Main
27	Helios-Klinikum Emil von Behring GmbH	Jens Kollmeier	Germany	NA	Berlin
28	Pius-Hospital Oldenburg	Frank Griesinger	Germany	NA	Oldenburg
29	Schwerpunkt Praxis	Christian Gessner	Germany	NA	Leipzig
30	Krankenhaus Grosshansdorf	David Heigener	Germany	NA	Grosshansdorf
31	Klinikum der Universitaet Muenchen	Rudolf Maria Huber	Germany	NA	Muenchen
32	Universitaetsklinikum Schleswig-Holstein	Benedict Gahn	Germany	NA	Kiel
33	Gemeinschaftspraxis fuer Haematologie und Onkologie	Stephan Schmitz	Germany	NA	Koeln
34	Staedtisches Krankenhaus Martha-Maria	Wolfgang Schuette	Germany	NA	Halle/Saale
35	Thoraxklinik am	Michael Thomas	Germany	NA	Heidelberg
36	Universitaetsklinikum Freiburg	Cornelius F. Waller	Germany	NA	Freiburg
37	Zentralklinik Bad Berka	Reiner Bonnet	Germany	NA	Bad Berka
38	Asklepios Klinik Harbug	Corinna Eschbach	Germany	NA	Hamburg
39	Klinik Loewenstein gGmbH	Juergen Richard Fischer	Germany	NA	Loewenstein
40	Ev. Krankenhaus Witten gGmbH	Herbert Hoefeler	Germany	NA	Witten
41	Klinikum Bogenhausen	Sebastian Gallenberger	Germany	NA	Muenchen
42	Klinikum rechts der Isar	Folker Schneller	Germany	NA	Muenchen
43	Gemeinschaftspraxis Dr. Brudler / Dr. Heinrich	Bernhard Heinrich	Germany	NA	Augsburg
44	Katholisches Klinikum Mainz	Cornelius Kortsik	Germany	NA	Mainz
45	Universitaetsmedizin Mainz	Berthold Fischer	Germany	NA	Mainz
46	Dr. Horst Schmidt Kliniken GmbH	Norbert Frickhofen	Germany	NA	Fuerth
47	Johann Wolfgang Goethe University Clinic Frankfurt	Wolfgang Gleiber	Germany	NA	Frankfurt
48	Klinikum Kassel GmbH	Martin Wolf	Germany	NA	Kassel
49	Universitaetsklinikum Tuebingen	Werner Spengler	Germany	NA	Tuebingen
50	Evangelische Lungenklinik Berlin	Christian Grohe	Germany	NA	Berlin-Buch
51	Allgemeines Krankenhaus Linz	Roland Kropfmueller	Austria	NA	Linz
52	Universitaetsklinik fuer Innere Medizin	Horst Olschewski	Austria	NA	Graz
53	Bezirkskrankenhaus Kufstein	August Zabernigg	Austria	NA	Kufstein
54	CHR de la Citadelle	Frederique Bustin	Belgium	NA	Liege
55	CHU Liege	Leon Bosquee	Belgium	NA	Liege
56	Specialized Hospital for Active Treatment in Oncolcogy	Danail Damyanov	Bulgaria	BG	Sofia
57	University Multiprofile Hospital for Active Treatment	Nina Ivanova	Bulgaria	NA	Pleven
58	District Oncolcogy Dispensary	Hristina Markova	Bulgaria	BG	Shumen
59	District Oncology Dispensary	Petar Petrov	Bulgaria	BG	Plovdiv
60	Interdistrict Oncology Dispensary with In-patient	Katerina Guenova	Bulgaria	NA	Ruse
61	Multiprofile Hospital for Active Treatment	Blaga Baeva	Bulgaria	NA	Gabrovo
62	Mogilov Regional Oncological Dispensary	Anton Lysov	Belarus	NA	Mogilov
63	Gomel Regional Clinical	Vasili Beliakouski	Belarus	BY	Gomel
64	Bobruisk Inter-distict	Vadim Bogdan	Belarus	BY	Bobruisk
65	Brest Regional Clinical	Konstantin Shelepen	Belarus	BY	Brest
66	N.N.Alexandrov National	Edvard Zhavrid	Belarus	BY	Minsk
67	Vitebsk Regional Clinical	Anzhelika Tomchina	Belarus	NA	Vitebsk
68	Minsk City Clinical	Aliaksandr Prokharau	Belarus	NA	Minsk
69	Kantonsspital Baden AG	Clemens Caspar	Switzerland	NA	Baden
70	Kantonsspital Aarau AG	Christoph Mamot	Switzerland	NA	Aarau
71	Krajska Nemocnice Liberec	Jiri Chalupa	Czech Republic	NA	Liberec
72	Klinika Komplexni Onkologicke Pece	Helena Coupkova	Czech Republic	NA	Brno
73	Oblastni Nemocnice	Elena Karasova	Czech Republic	NA	Pribram
74	Fakultni Nemocnice Brno	Jana Skrickova	Czech Republic	NA	Brno
75	Institut Onkologie a Rehabilitace Na Plesi s.r.o.	Jan Vydra	Czech Republic	NA	Nova Ves pod Plesi
76	Herlev Hospital	Anders Mellemgaard	Denmark	NA	Herlev
77	Odense Universitetshospital	Peter Sorensen	Denmark	NA	Odense C
78	Hospital Quiron Madrid	Ramon Maria Perez	Spain	NA	Pozuelo de Alarcon
79	Hospital General Universitario de Elche	Natividad Martinez	Spain	NA	Elche
80	Hospital Universitario de La Princesa	Ulpiano Jimenez	Spain	NA	Madrid
81	Hospital Arnau de Vilanova	Oscar Juan	Spain	NA	Valencia
82	Hospital Clinico, Universitario de Valencia	Amelia Insa	Spain	NA	Valencia
83	Hospital Clinic I Provincial de Barcelona	Nuria Vinolas	Spain	NA	Barcelona
84	Fundacion Instituto Valenciano de Oncologia	Miguel Munoz	Spain	NA	Valencia
85	Hospital de Jerez	Inmaculada Fernandez	Spain	NA	Jerez de la Frontera-Cadiz
86	Hopital de la Croix Rousse	Maurice Perol	France	NA	Lyon
87	Hopital d'Instruction des	Henri Berard	France	NA	Toulon
88	Institut de Cancerologie de la Loire	Pierre Fournel	France	NA	Saint-Priest en Jarez
89	Institut Paoli-Calmettes	Anne Madroszyk	France	NA	Marseille
90	Nouvel Hopital Civil	Elisabeth Quoix	France	NA	Strasbourg
91	Centre Hospitalier Lyon Sud	Pierre-Jean Souquet	France	NA	Pierre Benite
92	CHU de Rouen - Hopital de Bois Guillaume	Jean-Francois Muir	France	NA	Rouen
93	Centre Rene Gauducheau	Jaafar Bennouna	France	NA	Saint Herblain
94	Broomfield Hospital	Neville Davidson	Great Britain	NA	Chelmsford
95	Royal Bournemouth Hospital	Tom Geldart	Great Britain	NA	Bournemouth
96	Wythenshawe Hospital	Paul Taylor	Great Britain	NA	Manchester
97	Poole Hospital Foundation Trust	Virginia Laurence	Great Britain	NA	Poole
98	Bristol Haematology and Oncology Centre	Adam Dangoor	Great Britain	NA	Bristol
99	National Centre of Oncology	Revaz Gagua	Georgia	NA	Tbilisi
100	Chemotherapy & immunotherapy clinic	David Tabagari	Georgia	NA	Tbilisi
101	Cancer Prevention Center	Ioseb Abesadze	Georgia	NA	Tbilisi
102	Center of Thoracic Surgery	Vakhtang Katsarava	Georgia	NA	Tbilisi
103	General Hospital of Thessaloniki	Kostas Zarogoulidis	Greece	NA	Thessaloniki
104	Iaso General Hospital	Spiros Tzannes	Greece	NA	Holargos, Athens
105	University Hospital of Heraklio	Vasilios Georgoulias	Greece	NA	Heraklio
106	'Papageorgiou' General Hospital of Thessaloniki	George Fountzilas	Greece	NA	Thessaloniki
107	Sotiria General Hospital Chest Diseases	Michalis Toumbis	Greece	NA	Athens
108	Klinika bolnica	Zvonko Kusic	Croatia	NA	Zagreb
109	Klinicki bolnicki centar Zagreb	Miroslav Samarzija	Croatia	NA	Zagreb
110	A.O. Santa Maria della Misericordia	Lucio Crino	Italy	NA	Perugia
111	A.O.U. Policlinico Sant'Orsola Malpighi	Barbara Melotti	Italy	NA	Bologna
112	A.O.U. Umberto I-G.M.Lancisi-G. Salesi	Stefano Cascinu	Italy	NA	Ancona
113	Istituto Ospedaliero	Alberto Zaniboni	Italy	NA	Brescia
114	Ospedale Niguarda Ca' Granda	Salvatore Siena	Italy	NA	Milano
115	Centro di Riferimento Oncologico	Alessandra Bearz	Italy	NA	Aviano
116	Fondazione Salvatore Maugeri	Lorenzo Pavesi	Italy	NA	Pavia
117	Azienda Ospedaiero Universitaria Careggi	Francesco Di Costanzo	Italy	NA	Firenze
118	Istituto Scientifico Romagnolo	Dino Amadori	Italy	NA	Meldola
119	Ospedale di Ivrea - ASL	Sergio Bretti	Italy	NA	Ivrea
120	Azienda Sanitaria	Giorgio Scagliotti	Italy	NA	Orbassano
121	Assaf Harofeh Medical Center	Arnold Cyjon	Israel	NA	Zerifin
122	Meir Medical Centre	Maya Gottfried	Israel	NA	Kfar Saba
123	The Chaim Sheba Medical Center	Amir Onn	Israel	NA	Israel
124	Hadassah Medical Organization	Nili Peylan-Ramu	Israel	NA	Jerusalem
125	The Oncology Clinic	Joseph Brenner	Israel	NA	Holon
126	Tel-Aviv Sourasky Medical Center	Ofer Merimsky	Israel	NA	Tel-Aviv
127	Kidwai Memorial Institute of Oncology	Kuntegowdenahalli C. Lakshmaiah	India	NA	Bangalore
128	Rajiv Gandhi Cancer Institute and Clinical Research	Dinesh Chandra Doval	India	NA	New Delhi
129	Kasturba Medical College Hospital	Krishna Prasad	India	NA	Mangalore
130	Rajalakshmi Multispeciality Hospital	Dev Vashishta Ganesha	India	NA	Bangalore
131	Apollo Hospital	Ranjan Kumar Mohapatra	India	NA	Chennai
132	Indraprastha Apollo Hospitals	Rakesh Chopra	India	NA	New Delhi
133	Sir Ganga Ram Hospital	Shyam Aggarwal	India	NA	New Delhi
134	Shatabdi Superspeciality Hospital	Bondarde Shailesh	India	NA	Nashik
135	Tata Memorial Centre	Hari Menon	India	NA	Mumbai
136	Birla Cancer Centre	Hemant Malhotra	India	Rajasthan	Jaipur
137	Jawaharlal Nehru Cancer Hospital & Research Centre	Prasad Sahoo Tarini	India	NA	Bhopal, M.P.
138	Bhagwan Mahaveer	Naresh Somani	India	Rajasthan	Jaipur
139	Jehangir Hospital	Shona Nag	India	Maharahtra	Pune
140	Medical Oncology	Chanchal Goswami	India	West Bengal	Kolkata
141	Regional Cancer Center	Choondal Devan Sivanandan	India	Kerala	Trivandrum
142	SEAROC cancer center,S.K.soni Hospital	Anish Maru	India	Rajasthan	Jaipur
143	Vedanta Institute of Medical Sciences	Chirag Jyotirker Desai	India	NA	Ahmedabad
144	City Cancer Centre, Cancer Hospital & Research	Mamillapalli GopiChand	India	NA	Vijayawada
145	King George Hospital	Ravi Mohan	India	NA	Visakhapatnam
146	Vilniaus Universiteto ligonines Santariskiu klinikos	Rolandas Zablockis	Lithuania	LT	Vilnius
147	Siauliu apskrities ligonine	Augenija Zlabiene	Lithuania	LT	Siauliai
148	Hospital of Lithuanian	Raimundas Sakalauskas	Lithuania	NA	Kaunas
149	Centro Hospitalar de Setubal - Hospital de Sao Bernardo	Antonio Meleiro	Portugal	NA	Setubal
150	Hospital de Santa Maria, Serviso de Neurologia	Encarnacao Teixeira	Portugal	NA	Lisboa
151	Centro Hospitalar de Vila Nova de Gaia, Dep. de Pneumologia	Barbara Parente	Portugal	NA	Vila Nova de Gaia
152	Hospital Sao Joao	Henrique Queiroga	Portugal	NA	Porto
153	Instituto Portugues	Teresa Almodovar	Portugal	NA	Lisboa
154	Instituto Portugues	Marta Soares da Rocha	Portugal	NA	Porto
155	Centro Hospitalar de Coimbra	Fernando Barata	Portugal	NA	Coimbra
156	Kujawsko-Pomorskie	Grazyna Jagiello	Poland	NA	Bydgoszcz
157	Szpital Specjalistyczny im.	Piotr Serwatowski	Poland	NA	Szczecin
158	Mazowieckiego Centrum	Aleksandra Szczesna	Poland	NA	Otwock
159	SPZ Gruzlicy i Chrob Pluc	Andrzej Kazarnowicz	Poland	NA	Olsztyn
160	Wielkopolskie Centrum Pulmonologii i Torakochirurgii	Rodryg Ramlau	Poland	NA	Poznan
161	Samodzielny Publiczny	Marek Siemczonek	Poland	NA	Suwalki
162	Centrum Onkologii-Instytut	Maciej Krzakowski	Poland	NA	Warszawa
163	Wojewodzki Szpital Zespolony	Iwona Ryniewicz-Zander	Poland	NA	Elblag
164	Wojewodzki Szpital Specjalistyczny im.	Ryszard Kwiatkowski	Poland	NA	Slupsk
165	State Budgetary Institution of Healthcare	Oleg Gladkov	Russia	NA	Chelyabinsk
166	St. Petersburg GUZ City	Georgy Manikhas	Russia	NA	St. Petersburg
167	GUZ Regional Oncology	Nina Chekha	Russia	NA	Magnitogorsk
168	FGU Research Institute of Oncology	Svetlana Protsenko	Russia	NA	St. Petersburg
169	GUZ Kurskiy Regional	Igor Kiselev	Russia	NA	Kurski
170	GUZ 'Regional Clinical Oncology Dispensary'	Evgeny Kulikov	Russia	NA	Ryazan
171	GU Russian Oncological Research Centre	Dmitry Komov	Russia	NA	Moscow
172	GUZ Irkutsk Regional	Viktoriya Dvornichenko	Russia	NA	Irkutsk
173	GUZ Kazansky Oncology Dispensary	Rustem Khasanov	Russia	NA	Kazan
174	GUZ Leningrad Regional Clinical Hospital	Alexander Luft	Russia	NA	St. Petersburg
175	GOU VPO St. Petersburg	Sergey Orlov	Russia	NA	St. Petersburg
176	GUZ Sverdlovsky Regional	Irina Bulavina	Russia	NA	Yekaterinburg
177	GUZ Pyatigorsky Oncological Dispensary	Vladimir Vladimirov	Russia	NA	Pyatigorsk
178	GUZ Oncological Dispesary #2	Dmitriy Udovitsa	Russia	NA	Sochi
179	GUZ Arkhangelsk Regional	Ekaterina Solovieva	Germany	NA	Arkhangelsk
180	Spitalul Judetean de Urgenta	Doina-Elena Ganea-Motan	Romania	NA	Suceava
181	Oncomed SRL	Cristina Oprean	Romania	NA	Timisoara
182	Spitalul Judetean 'Dr. Alex Simionescu'	Lucian Vata	Romania	NA	Hunedoara
183	Centrul de Oncologie Medicala	Constantin Volovat	Romania	NA	Iasi
184	Spitalul Clinic Judetean de Urgenta Brasov	Ioan-Catalin Iacob	Romania	NA	Brasov
185	Institutul Oncologic	Mircea Dediu	Romania	NA	Bucuresti
186	Institutul Oncologic 'Prof. Dr. Ion Chiricuta'	Cristina Cebotaru	Romania	NA	Cluj-Napoca
187	Spitalul Judetean de Urgenta Baia-Mare	Dumitru Filip	Romania	NA	Baia Mare
188	Spitalul Municipal Onesti	Iuliu Ionas	Romania	NA	Onesti
189	Spitalul Clinic Judetean de Urgenta 'Sf. Spiridon' Iasi	Lucian Miron	Romania	NA	Iasi
190	Seoul St. Mary's Hospital	Jin-Hyoung Kang	Korea, Republic of	NA	Seoul
191	Gachon University Gil Hospital	Eun Kyung Cho	Korea, Republic of	NA	Incheon
192	Seoul Veterans Hospital	Bong Seog Kim	Korea, Republic of	NA	Gangdong-gu, Seoul
193	Onkologicka klinika	Ludovit Jurga	Slovakia	NA	Trnava
194	Ternopilskyi derzhavnyi medychnyi universytet	Igor Galaychuk	Ukraine	NA	Ternopil
195	Donetskyi oblasnyi	Natalya Lisovska	Ukraine	NA	Donetsk
196	Oblasnyi komunalnyi zaklad	Volodymyr Komisarenko	Ukraine	NA	Kryvyi Rig
197	Kharkivska Medychna Akademiia Pisliadyplomnoii Osvity	Oleksandr Dudnichenko	Ukraine	NA	Kharkiv
198	Komunalnyi Likuvalnoprofilaktychnyi zaklad	Sergii Matviychuk	Ukraine	NA	Chernigiv
199	Kafedra onkologii, promenevoi diagnostyky,promenevoi terapii	Roman Senyutovich	Ukraine	NA	Chernivtsi
200	Chmelnytskyi Oblasnnyi Oncologichnyi Tsentr	Igor Drobner	Ukraine	NA	Chmelnytskyi
201	Odeskyi oblasnyi	Sergiy Prokhoda	Ukraine	NA	Odesa
202	Oblasnyi klinichnyi onkologichnyi dyspanser	Petro Odarchenko	Ukraine	NA	Vinnytsia
203	Dnepropetrovska Derzhavna Medychna Academiya	Igor Bondarenko	Ukraine	NA	Dnipropetrovks
204	Uzhgorodskoi tsentralnoi	Yevhen Hotko	Ukraine	NA	Uzhgorod
205	Langenhoven Drive	Henri Louis Dupper	South Africa	NA	Pretoria
206	GVI Oncology Research Unit	Conrad Jacobs	South Africa	NA	Western Cape
207	Wilgers Oncology	J. Erhardus Bouwer	South Africa	NA	Pretoria
208	The Oncology Centre	Gregory Landers	South Africa	NA	Durban
209	Medical Oncology Centre of Rosebank	Bernardo Rapoport	South Africa	NA	Johannesburg
210	Wits Health Consortium	Paul Ruff	South Africa	NA	Johannesburg
211	University of Pretoria and Steve Biko Academic Hospital	Lydia Mary Dreosti	South Africa	NA	Pretoria

1	年龄为18岁或18岁以上的男性或女性患者
2	组织学或细胞学证实的、局部晚期和/或转移性IIIB或IV期NSCLC（根据美国癌症联合委员会）或复发性NSCLC（所有组织学类型）
3	既往一线化疗后复发或失败（对于复发性疾病，既往可接受辅助化疗、新辅助化疗或新辅助化疗加辅助化疗）
4	在过去3个月内至少存在1处尚未接受放疗的靶病灶，并在至少1个方向上（需要记录最大直径）可通过核磁共振成像（MRI）或计算机断层摄影术（CT）准确测量，其中常规CT≥20 mm或螺旋CT下≥10 mm
5	预期寿命至少为3个月
6	ECOG体能状况评分为0或1
7	患者必须签署知情同意书

1	对于晚期和/或转移性或复发性NSCLC患者接受过1种以上的化疗方案
2	对于晚期和/或转移性或复发性NSCLC患者在接受一线化疗前接受了1种以上的化疗（新辅助化疗或辅助化疗或新辅助化疗加辅助化疗）
3	既往因NSCLC接受过其它VEGFR抑制剂（贝伐单抗除外）或多西他赛治疗
4	既往化疗和/或放疗相关的临床治疗相关毒性持续存在
5	在试验药物治疗前4周内接受过化疗、激素治疗、放疗（脑部和四肢除外）或免疫治疗或单克隆抗体或小分子酪氨酸激酶抑制剂治疗。即最后一次抗癌治疗与第一次BIBF 1120治疗之间至少相隔4周
6	在基线影像学检查前3个月内接受放疗（四肢和脑除外）
7	活动性脑转移或软脑膜疾病
8	放射学证据表明存在空洞性或坏死性肿瘤
9	放射学证据（CT或MRI）表明存在侵入局部大血管的中心型肿瘤
10	在过去3个月内出现临床显著的咯血（每日咯血大于1茶匙）
11	接受抗凝剂（小剂量肝素除外）或抗血小板药物治疗
12	过去6个月内出现严重的血栓或临床相关的严重的出血事件
13	存在遗传性出血或血栓形成倾向
14	严重的心血管疾病
15	安全性实验室指标不符合
16	在这项研究治疗前6周内出现严重的体重减轻（大于10%）
17	目前存在≥CTCAE 2度的周围神经病，创伤导致除外
18	存在腹水和/或临床显著的胸腔积液
19	随机分组前10天内出现严重创伤和/或手术，并且创口愈合不完全
20	需要全身抗生素治疗的严重的感染
21	失代偿性糖尿病或存在大剂量糖皮质激素治疗的其它禁忌症
22	可能干扰研究药物吸收的胃肠道疾病或异常
23	活动性或慢性丙肝和/或乙肝感染
24	增加参加研究或研究药物相关的风险，并且根据研究者的判断，可导致患者不适合入选研究的严重的疾病或非肿瘤合并症
25	患者发生性生活，并且不愿意在试验期间和药物治疗结束后至少12个月内使用医学上可接受的避孕措施
26	妊娠或正在哺乳
27	可能妨碍患者对研究方案和随访方案的依从性的心理学、家族性、社会或地理因素
28	患者不能依从试验方案
29	酗酒或药物滥用
30	在过去3年内出现皮肤基底细胞癌或宫颈原位癌外的其它恶性肿瘤
31	存在多西他赛治疗的任何禁忌症
32	对多西他赛或其它含有聚山梨酯80（吐温80）的药物有严重过敏反应史
33	对BIBF 1120和/或试验药物中的赋形剂发生过敏反应
34	对造影剂发生过敏反应

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