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癌症治疗用重组人表皮生长因子(EGF)偶联疫苗治疗 晚期非小细胞肺癌Ⅰ期临床试验
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注册号:

Registration number:

ChiCTR-OID-17014048 

最近更新日期:

Date of Last Refreshed on:

2017-12-20 

注册时间:

Date of Registration:

2017-12-20 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

癌症治疗用重组人表皮生长因子(EGF)偶联疫苗治疗 晚期非小细胞肺癌Ⅰ期临床试验 

Public title:

Therapeutic cancer vaccine: Phase I clinical tolerance study of hu-rEGF-rP64k/Mont in patients with advanced Non-Small Cell Lung Cancer 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

癌症治疗用重组人表皮生长因子(EGF)偶联疫苗治疗 晚期非小细胞肺癌Ⅰ期临床试验 

Scientific title:

Therapeutic cancer vaccine: Phase I clinical tolerance study of hu-rEGF-rP64k/Mont in patients with advanced Non-Small Cell Lung Cancer 

研究课题代号(代码):

Study subject ID:

国家重大新药创制项目 (2012ZX09303012-001和2014ZX09102041-006) 

在二级注册机构或其它机构的注册号:

The registration number of the Partner Registry or other register:

CTR20131039 

申请注册联系人:

邢镨元 

研究负责人:

石远凯 

Applicant:

Xing Puyuan 

Study leader:

Shi Yuankai 

申请注册联系人电话:

Applicant telephone:

+86 18611417207 

研究负责人电话:

Study leader's telephone:

+86 13701251865 

申请注册联系人传真 :

Applicant Fax:

 

研究负责人传真:

Study leader's fax:

 

申请注册联系人电子邮件:

Applicant E-mail:

xingpuyuan@163.com 

研究负责人电子邮件:

Study leader's E-mail:

syuankai@cicams.ac.cn 

申请单位网址(自愿提供):

Applicant website(voluntary supply):

 

研究负责人网址(自愿提供):

Study leader's website(voluntary supply):

 

申请注册联系人通讯地址:

中国北京市朝阳区潘家园南里17号 

研究负责人通讯地址:

中国北京市朝阳区潘家园南里17号 

Applicant address:

17 Panjiayuan Street South, Chaoyang District, Beijing, China 

Study leader's address:

17 Panjiayuan Street South, Chaoyang District, Beijing, China 

申请注册联系人邮政编码:

Applicant postcode:

 

研究负责人邮政编码:

Study leader's postcode:

 

申请人所在单位:

中国医学科学院肿瘤医院 

Applicant's institution:

National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences 

是否获伦理委员会批准:

是 

Approved by ethic committee:

Yes 

伦理委员会批件文号:

Approved No. of ethic committee:

12-001/535 

伦理委员会批件附件:

Approved file of Ethical Committee:

查看附件View

批准本研究的伦理委员会名称:

中国医学科学院肿瘤医院伦理委员会 

Name of the ethic committee:

Commitee of Cancer Institute and Hospital, Chinese Academy of Medical Sciences 

伦理委员会批准日期:

Date of approved by ethic committee:

2012-02-23 

伦理委员会联系人:

 

Contact Name of the ethic committee:

 

伦理委员会联系地址:

中国北京市朝阳区潘家园南里17号 

Contact Address of the ethic committee:

17 Panjiayuan Street South, Chaoyang District, Beijing, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

 

研究实施负责(组长)单位:

中国医学科学院肿瘤医院 

Primary sponsor:

National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences 

研究实施负责(组长)单位地址:

中国北京市朝阳区潘家园南里17号 

Primary sponsor's address:

17 Panjiayuan Street South, Chaoyang District, Beijing, China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

北京市

市(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

中国医学科学院肿瘤医院

具体地址:

中国北京市朝阳区潘家园南里17号

Institution
hospital:

National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences

Address:

17 Panjiayuan Street South, Chaoyang District, Beijing, China

经费或物资来源:

国家重大新药创制项目 (2012ZX09303012-001和2014ZX09102041-006) 

Source(s) of funding:

The Chinese Major Project for New Drug Innovation Project (2012ZX09303012-001 and 2014ZX09102041-006) 

研究疾病:

非小细胞肺癌 

Target disease:

Non-Small Cell Lung Cancer 

研究疾病代码:

 

Target disease code:

 

研究类型:

观察性研究 

Study type:

Observational study 

研究所处阶段:

I期临床试验 

Study phase:

研究目的:

评价IIIb或IV期非小细胞肺癌(NSCLC)患者接种不同剂量组的EGF疫苗后的安全性和免疫应答 

Objectives of Study:

To evaluated the safety and the immunological response of Hu-rEGF-rP64k vaccine in advanced NSCLC patients. 

药物成份或治疗方案详述:

药物成分:hu-rEGF-P64K蛋白 

Description for medicine or protocol of treatment in detail:

Description for the medicine: It's he recombinant protein rhEGF, and the recombinant protein rP64K, using glutaraldehyde as a linker reagent of drug substance intermediates. 

研究设计:

不同剂量对照 

Study design:

Dose comparison 

纳入标准:

1.书面签署知情同意书。 2.年龄18-70岁,男女均可。 3.组织病理学或细胞病理学确认的晚期(Ⅲb或Ⅳ期)不可手术的NSCLC患者,痰细胞学结果不能作为诊断依据。 4.接受一线含铂双药化学治疗结束(完成4-6个周期)并评价为SD或PR,且距末次化疗结束4周~8周。 5.具有至少一个可测量的病灶(RECIST1.1标准,如经放疗,放射野内的病灶不作为可测量病灶)。 6.生育期的女性妊娠测试为阴性,且保证参加研究的男、女性均在研究期间避孕; 7.ECOG体力状况分级0-2。 8.预计生存时间不少于3个月; 9.患者肝肾和骨髓功能正常,符合下列指标: 血红蛋白≥100 g/L, WBC≥4×10^9 /L, 粒细胞≥1.5×10^9 /L, 血小板≥100×10^9 /L。 血清胆红素(TBIL)≤1.5倍的正常值上限(ULN); 谷草转氨酶(AST)和谷丙转氨酶(ALT)≤2.5倍ULN或≤5倍ULN(肝转移者); 血清肌酐≤1.5倍ULN,血尿素氮≤1.5倍ULN。  

Inclusion criteria

1. Adult patients, regardless of gender, aged from 18 to 70 years with histologically or cytologically confirmed NSCLC at stages IIIB or IV; 2. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 2; 3. All patients received 4 to 6 cycles of platinum-based first-line chemotherapy, from 4 to 8 weeks, and were evaluated as SD or PR after the first line chemotherapy; 4. Patients were required to have at least 1 measurable lesion (lesions were defined by Response Evaluation Criteria in Solid Tumors (RECIST, 1.1). If patients have ever received radiotherapy, the disease in the field of radiotherapy cannot be the target lesions; 5. Adequate organ function and CBC results; 6. Life expectancy of at least 3 months; 7. Women participants should have negative pregnancy test results; 8. All the participants should take contraception measures during the study period; 9. Participants should sign informed consent before the study. 

排除标准:

1.在筛选前 1 个月内使用免疫抑制剂如硫唑嘌呤、他克莫司、环孢素等治疗者;试验前3个月内接受其他免疫治疗; 2.筛选前30天内参加过其他临床试验; 3.有严重的过敏史或过敏体质者; 4.有脾切除术史者; 5.患有原发或继发免疫缺陷疾病(如艾滋病)者;患有自身免疫性疾病者; 6.在筛选前 1 个月内口服、肌注或静注皮质类固醇激素的患者。吸入皮质类固醇激素治疗呼吸功能不全(如慢性阻塞性肺病[COPD]),或局部使用类固醇是允许的。 7.病人有不可控制的癫痫发作、中枢神经系统紊乱或因精神病丧失认知力者; 8.有中枢神经系统转移病史或怀疑中枢神经系统转移; 9.患者近期(筛选前6个月)有慢性酒精或药物滥用史; 10.有不稳定的全身性疾病(包括活动性感染、不稳定高血压、 不稳定型心绞痛、 充血性心力衰竭、一年内发生过心肌梗死、需要药物治疗的严重心律失常、肝、肾及代谢性疾病)。 11.孕妇或哺乳期女性及男女性治疗期拒绝避孕者; 12.既往患其它恶性肿瘤(皮肤基底细胞癌和宫颈原位癌治疗后无瘤生存5年以上除外); 13.研究者认为不宜参加本试验者。 

Exclusion criteria:

1. Patients receiving immunosuppressant drugs 1 month before study or receiving other immunotherapy 3 months before; 2. Patients receiving corticosteroid within 1 month before the research (including oral, intramuscular or intravenous injection). Inhaled corticosteroid for for respiratory insufficiency or for local use were not excluded; 3. Patients with uncontrolled epilepsy seizure, central nervous system dysfunction or cognitive ability lose due to psychosis; 4. Patients with CNS metastasis (confirmed or suspicious); 5. Patients with chronic alcohol or drug abuse within 6 months before the research; 6. Patiens who are pregnant or lactating or those who refused to take contraception measures during the study were excluded; 7. Patients with a history of severe allergy or allergic constitution; splenectomy; 8. Patients with autoimmune disease or secondary immunodeficiency (such as AIDS, et al); 9. Patients with secondary malignancy within 5 years (except for basal cell carcinoma of the skin or intraepithelial carcinoma of the cervix) were also excluded. 

研究实施时间:

Study execute time:

From2012-03-28To 2017-04-19 

干预措施:

Interventions:

组别:

Case series

样本量:

21

Group:

Case series

Sample size:

干预措施:

EGF疫苗

干预措施代码:

Intervention:

EGF Vaccine

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

北京市 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

中国医学科学院肿瘤医院 

单位级别:

中国北京市朝阳区潘家园南里17号 

Institution
hospital:

National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences  

Level of the institution:

17 Panjiayuan Street South, Beijing 

测量指标:

Outcomes:

指标中文名:

最大耐受剂量

指标类型:

主要指标 

Outcome:

maximum-tolerated dose

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

Anti-EGF滴度

指标类型:

主要指标 

Outcome:

antiEGF antibodies detection

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血清EGF水平

指标类型:

主要指标 

Outcome:

Serum EGF concentration

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

疗效评价

指标类型:

次要指标 

Outcome:

Clinical response evaluation

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

血液

组织:

Sample Name:

Blood

Tissue:

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

征募研究对象情况:

Recruiting status:

结束

Completed

年龄范围:

Participant age:

最小 Min age years
最大 Max age years

性别:

男女均可

Gender:

Both

随机方法(请说明由何人用什么方法产生随机序列):

此试验为开放、非随机临床试验

Randomization Procedure (please state who generates the random number sequence and by what method):

This clinical trial is a open, nonrandomized trial.

盲法:

Blinding:

原始数据公开时间:

The time of sharing IPD:

试验完成后6个月内公开/Within six months after the trial complete

共享原始数据的方式(说明:请填入公开原始数据日期和方式,如采用网络平台,需填该网络平台名称和网址):

中国医学科学院肿瘤医院

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url):

National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences

数据采集和管理(说明:数据采集和管理由两部分组成,一为病例记录表(Case Record Form, CRF),二为电子采集和管理系统(Electronic Data Capture, EDC),如ResMan即为一种基于互联网的EDC:

病历记录表

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture:

Case Record Form, CRF

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2017-12-20
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