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本帖最后由 成长的烦恼 于 2012-11-13 07:49 编辑
很多病友想了解肠癌新药临床试验的信息,但是寻找起来倍觉困难。这个帖子的宗旨是希望帮助到有需要的战友,也希望凡是知道临床试验的战友把相关信息站短或是QQ我,我会即时更新本帖。
1. 转移性结直肠癌患者可有机会免费接受爱必妥或帕尼单抗治疗
北京解放军307医院
联系人:消化肿瘤内科葛飞娇、刘建芝医师
联系电话:010-66947178
入组条件见网站链接
http://www.gicancer307.com/main/ ... wsId=20119114503745
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2. 一项旨在比较FOLFOX-4 (奥沙利铂、亚叶酸、5FU)化疗联合或是不联合爱必妥一线治疗转移性结直肠癌在中国的临床实验 (病患KRAS基因为野生型)
A Trial to Compare Oxaliplatin, Folinic Acid (FA) and 5-Fluorouracil (5FU) Combination Chemotherapy (FOLFOX-4) With or Without Cetuximab in the 1st Line Treatment of Metastatic Colorectal Cancer (mCRC) in Chinese V-Ki-ras2 Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Wild-type Patients (TAILOR)
Estimated Enrollment(预计招收总人数): 360
Study Start Date(研究起始日期): September 2010
Estimated Primary Completion Date(预计主目标完成日期): October 2013 (Final data collection date for primary outcome measure)
参与临床的全国各大医院(拼音应该看的明白),具体入组条件请咨询相关医院
China, Fujian
Fuzhou General Hospital Recruiting
Fuzhou, Fujian, China, 350025
Contact: Shuyi CHEN (86) 591-22859750 xiaoyi307@126.com
Principal Investigator: Xuenong OUYANG
China, Fujian
Fujian Province Cancer Hospital Recruiting
Fuzhou, Fujian, China, 350014
Contact: Wei GAO 86 13960986882 gaowei@medmail.com.cn
Principal Investigator: Jianwei YANG
China, Guangdong
Nanfang Hospital of Southern Medical University Recruiting
Guangzhou, Guangdong, China, 510515
Contact: Jinzhang CHEN 86 0 13902251269 chenjinzhang@hotmail.com
Principal Investigator: Rongchang LUO
First Hospital Affiliated to Guangzhou University of Chinese Medicine Recruiting
Guangzhou, Guangdong, China, 510405
Contact: Xinting ZHENG 86-20-36596380 zxt710@yahoo.com.cn
Principal Investigator: Lizhu LIN
China, Hubei Province
Union Hospital of Tongji Medical College of Huazhong University of Science and Technology Recruiting
Wuhan, Hubei Province, China, 430023
Contact: Tao ZHANG 86-27-65650733 taozhangwh@yahoo.com.cn
Principal Investigator: Gang WU
China, Jilin
Jilin Cancer Hospital Recruiting
Changchun, Jilin, China, 130012
Contact: Juying XING 86-431-85536383 xjy730202@hotmail.com
Principal Investigator: Ying CHENG
China, Zhejiang
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University Recruiting
Hangzhou, Zhejiang, China, 310016
Contact: Hongming PAN (86) 13605716662 panhongming@tom.com
Principal Investigator: Hongming PAN
The First Affiliated Hospital of College of Medicine, Zhejiang University Recruiting
Hangzhou, Zhejiang, China, 310009
Contact: Nong XU (+86)13515715262 xunonghz@163.com
Principal Investigator: Nong XU
China
307 Hospital of PLA Recruiting
Beijing, China, 100071
Contact: Jianming XU 86 01-66947176 jmxu2003@yahoo.com
Principal Investigator: Jianming XU
The General Hospital of the People's Liberation Army Recruiting
Beijing, China, 100853
Contact: Fangfang JING 86 10 66937003 Jingfangfang8@163.com
Principal Investigator: Guanghai DAI
Affiliated Hospital of Bengbu Medical College Recruiting
Bengbu, China, 233004
Contact: ZHANG Jingjing 0086 13615528053 qiongwu68@yahoo.com.cn
Principal Investigator: WU Qiong
Southwest Hospital Recruiting
Chongqing, China, 4000388
Contact: Xiaoxin ZHAO (86) 23-68765704 zhaoxx2025@yahoo.cn
Principal Investigator: Houjie LIANG
The Tumor Hospital of Harbin Medical University Recruiting
Harbin, China, 150040
Contact: Xiaoli WEI 86 451 86298265 weixiaoli2008@sohu.com
Principal Investigator: Yuxian BAI
The Affiliated Hospital of Medical College Qingdao University Recruiting
Qingdao, China, 266003
Contact: QUI Wensheng 0086 13370698518 Liangjun1959@yahoo.com.cn
Principal Investigator: LIANG Jun
Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine Recruiting
Shanghai, China, 200025
Contact: LIU Ying 0086 21 64370045 jun_zj10977@yahoo.com.cn
Principal Investigator: ZHANG Jun
Shanghai First People's Hospital Recruiting
Shanghai, China, 200080
Contact: Haiyan YANG 86 21 63240090 briannayang@gmail.com
Principal Investigator: Liwai WANG
Fudan University Shanghai Cancer Center Recruiting
Shanghai, China, 200032
Contact: Weijian GUO 86 21 64433755 fudanlijin@163.com
Principal Investigator: Jin LI
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3. 西妥昔单抗联合FOLFOX4和单用FOLFOX4一线治疗中国KRAS 野生型结直肠癌
中国人民解放军第八一医院
联系方式:肿瘤内科 025-84453667 韩凝
入组标准:
1. 组织学确诊的结肠或直肠腺癌
2. 首次出现转移性病灶(无法进行根治性切除)
3. 肿瘤组织KRAS 状态为野生型(检测免费)
4. 经 CT 或MRI 证实,至少存在一个符合RECIST标准可测量的病灶(非放射治疗野)
排除标准:
1. 既往曾接受针对CRC 的化疗,研究开始前> 9个月(含奥沙利铂的化疗),> 6 个月(不含奥沙利铂的化疗)结束的辅助治疗除外
2. 既往曾行单克隆抗体治疗、VEGF 通路靶向治疗、EGFR 通路靶向治疗、或其他信号转导通路抑制剂
3、已知的脑和/或软脑膜转移。有神经系统症状的受试者应接受脑CT/MRI检查,以除外转移
网站链接:http://dpt54286.d.81yy.com/news. ... te=277080&page=
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4. 一项关于帕尼单抗与爱必妥单抗在效果与安全性方面的对比性研究(转移性结直肠癌且KRAS为野生型)
A Study of Panitumumab Efficacy and Safety Compared to Cetuximab in Subjects With KRAS Wild-Type Metastatic Colorectal Cancer
Estimated Enrollment(预计招收总人数): 1000
Study Start Date(研究起始日期): February 2010
Estimated Study Completion Date(预计研究完成日期): August 2013
Estimated Primary Completion Date(预计主目标完成日期): January 2013 (Final data collection date for primary
outcome measure)
特别说明:
1. clinicaltrials网站上并没有注明中国区临床实验的具体医院,病友们如有需要可根据邮编进行排除查找。如果有具体医院被确定,请大家站短我或是QQ留言,我会及时更新。(目前唯一被确认的是北京地区的医院,就是第1条信息里的北京307医院)
2. 招收总人数是针对全球范围的不单单只有中国
参与临床的全国各大城市和区域,具体入组条件请咨询相关医院
China, Sichuan
Research Site Recruiting
Chongqing, Sichuan, China, 400038
西南医院
具体联系方式不详,可查询以下网站
http://www.swhospital.com/XNYYFore/
China, Zhejiang
Research Site Recruiting
Hangzhou, Zhejiang, China, 310016
China
Research Site Recruiting
Beijing, China, 100071
北京解放军307医院
联系人:消化肿瘤内科葛飞娇、刘建芝医师
联系电话:010-66947178
China
Research Site Recruiting
Tianjin, China, 300060
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5. 雷替曲塞单药治疗不能耐受或不适合5-FU/CF治疗的局部晚期或转移复发性结直肠癌
中国人民解放军第八一医院
联系方式:肿瘤内科 025-84453667 韩凝
入组条件:
1. 年龄18-75岁,预计生存期≥12周;
2. 经病理组织学和/或细胞学检查确诊的局部晚期或转移性的结直肠癌受试者,且不能耐受或者不适合5-Fu或其类似物治疗
(应用5-Fu出现明显的毒性,如腹泻,静脉炎等或患者不同意应用PICC管、不能进行48小时静脉持续滴注等情况,以及研究 者判断不能耐受或者不适合5-Fu的其它情况);如为复治,受试者距末次化疗或放疗结束时间至少间隔4周以上,且化疗无效或本研究观察病灶在非放疗靶区。
3. 至少有一个可测量的肿瘤客观病灶,螺旋CT检查,其最大直径须 ≥ 1 cm;
排除标准:
1. 3个月内有心肌梗塞病史的受试者;
2. 5年内有其他部位恶性肿瘤病史(皮肤基底细胞癌、原位宫颈癌除外);
3. 结直肠癌合并脑转移、病情不稳定者;
网站链接:http://dpt54286.d.81yy.com/news. ... te=277122&page=
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6. 雷替曲塞单药治疗不能耐受或不适合5-FU/CF治疗的局部晚期或转移复发性结直肠癌
吉林省肿瘤医院内一科
联系方式:肿瘤内科 025-84453667 韩凝
入组条件:
1.年龄18-75岁,预计生存期≥12周;
2.经病理组织学和/或细胞学检查确诊的局部晚期或转移性的结直肠癌受试者,且不能耐受或者不适合5-Fu或其类似物治疗;如为复治,受试者距末次化疗或放疗结束时间至少间隔4周以上,且化疗无效或本研究观察病灶在非放疗靶区。
3.至少有一个可测量的肿瘤客观病灶,螺旋CT检查,其最大直径须 ≥ 1 cm
4. 入组前1周之内的实验室检查结果符合以下条件:
中性粒细胞(ANC)>1.5×109/L,血小板(PLT)>80×109/L,总胆红素(TBI)≤1.5×ULN,血肌酐(Cr)≤1.5×ULN,谷丙转氨酶(ALT)、谷草转氨酶(AST)均≤2.5×ULN(如有肝转移则≤5×ULN)
排除标准:
1.严重肝肾功能不全者;
2.3个月内有心肌梗塞病史的受试者;
3.5年内有其他部位恶性肿瘤病史(皮肤基底细胞癌、原位宫颈癌除外);
4.结直肠癌合并脑转移、病情不稳定者;
5.有未控制的其他严重疾病或急性感染者;
6.妊娠或哺乳期妇女;
7.合并完全性肠梗阻者;
8.其他研究者认为应该排除的情况。
网站链接:http://www.jlcancer.com/newsView.php?id=88
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7. 关于Regorafenib与安慰剂治疗转移性结直肠癌的亚州对比性实验(所有标准治疗失败以后)
Asian Subjects With Metastatic Colorectal Cancer Treated With Regorafenib or Placebo After Failure of Standard Therapy (CONCUR)
Estimated Enrollment: 200
招募人数:200
Study Start Date: April 2012
起始日期:2012.4
Estimated Study Completion Date: May 2014
终止日期:2014.5
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
主目标完成日期:2013.10
以下是中国各大招募城市,医院可按邮政编码索引。
China, Guangdong
Not yet recruiting
Guangzhou, Guangdong, China, 510080
Recruiting
Guangzhou, Guangdong, China, 510060
China, Heilongjiang
Recruiting
Harbin, Heilongjiang, China
China, Jiangsu
Recruiting
Nanjing, Jiangsu, China, 210002
China, Shandong
Not yet recruiting
Qingdao, Shandong, China, 266003
China, Shannxi
Not yet recruiting
Xi'an, Shannxi, China, 710032
China, Sichuan
Not yet recruiting
Chengdu, Sichuan, China, 610041
China, Zhejiang
Recruiting
Hangzhou, Zhejiang, China, 310016
China
Recruiting
Beijing, China, 100021
Not yet recruiting
Beijing, China, 100142
Recruiting
Beijing, China, 100071
Recruiting
Changchun, China, 130021
Not yet recruiting
Shanghai, China, 200080
Not yet recruiting
Shanghai, China, 200030
Not yet recruiting
Shanghai, China, 200032
recruiting
Tianjin, China
项目承担部门:消化肿瘤内科
联系人:巴一主任医师
联系电话:022-23340123-1032
项目主管部门:天津市肿瘤医院国家药物临床试验研究机构办公室
联系人:孙悦
联系电话:022-23340123-6012
Hong Kong
Not yet recruiting
Shatin, New Territories, Hong Kong
Not yet recruiting
Hong Kong, Hong Kong
相关网站链接:
http://clinicaltrials.gov/ct2/sh ... =ES%3ACN&rank=4
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8. 阿柏西普(Aflibercept) 治疗晚期结直肠癌的临床研究
Aflibercept是一种基因重组的融合蛋白质,与贝伐单抗相比,VEGF Trap与VEGF-A的亲和力更高,并能够与VEGF-B和胎盘生长因子相结合,可能能成为治疗结直肠癌的有效方案。
入选标准
1 组织学/细胞学证实的结肠或直肠腺癌。
2 不适于进行根治性治疗的转移癌(即无法手术)。
3 可测量病灶(根据1.0 版RECIST 标准)。
4 曾且仅接受过一种治疗转移癌的化疗方案。曾接受的化疗必须是含奥沙利铂的方案。
具体可咨询我科刘容锐医师,电话:010-66947178
关于阿柏西普在中国开展的所有临床试验。
China
Investigational Site Number 156001 Recruiting
Beijing, China, 100142
Investigational Site Number 156003 Recruiting
Beijing, China, 100071
Investigational Site Number 156004 Recruiting
Beijing, China, 100853
Investigational Site Number 156016 Recruiting
Chengdu, China, 610041
Investigational Site Number 156008 Recruiting
Guangzhou, China, 510060
Investigational Site Number 156011 Recruiting
Hangzhou, China, 310009
Investigational Site Number 156009 Recruiting
Hangzhou, China, 310016
Investigational Site Number 156015 Recruiting
Harbin, China, 150081
Investigational Site Number 156013 Recruiting
Nanjing, China, 210029
Investigational Site Number 156012 Recruiting
Nanjing, China, 210002
Investigational Site Number 156006 Recruiting
Shanghai, China, 200032
临床招募信息链接
http://clinicaltrials.gov/ct2/sh ... ES%3ACN&rank=16
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9. A Study of Avastin (Bevacizumab) in Combination With 5-FU Based Doublet Chemotherapy in Patients With Colorectal Cancer And Previously Untreated Unresectable Liver-Only Metastases
一项关于阿瓦斯汀联合基于5FU化疗方案针对晚期结直肠癌(仅带有不能切除肝转移)的研究
Estimated Enrollment: 50
Study Start Date: October 2012
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
临床招募相关信息
Locations
China
Not yet recruiting
Guangzhou, China, 510060
Recruiting
Hangzhou, China, 310009
临床招募信息链接:
http://clinicaltrials.gov/ct2/sh ... ES%3ACN&rank=15
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10. Study of Bevacizumab Plus Chemotherapy in Patients With Metastatic Colorectal Cancer
阿瓦斯汀联合化疗针对晚期结直肠癌病人
Estimated Enrollment: 100
Study Start Date: March 2012
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
临床招募相关信息
Locations
China
Cancer Institute&Hospital Chinese Academy of Medical Sciences Recruiting
Beijing, China
Contact: Yihebali Chi, MD 8610-87788145 Yihebalichi@yahoo.com
临床招募信息链接:
http://clinicaltrials.gov/ct2/sh ... ES%3ACN&rank=34
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