Today is 2020-02-29

Phase I clinical research of personalized neoantigen peptides for the treatment of lung cancer
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注册号:

Registration number:

ChiCTR-INR-16009867 

最近更新日期:

Date of Last Refreshed on:

2019-05-12 

注册时间:

Date of Registration:

2016-11-15 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

个体特异性突变肽链治疗肺癌的I期临床研究 

Public title:

Phase I clinical research of personalized neoantigen peptides for the treatment of lung cancer 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

个体化新抗原肽疫苗对非小细胞肺癌的I期临床研究 

Scientific title:

Phase I clinical research of personalized neoantigen peptides vaccine for non-small cell lung cancer 

研究课题代号(代码):

Study subject ID:

 

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:

 

申请注册联系人:

杜学明 

研究负责人:

杜学明 

Applicant:

Xueming Du 

Study leader:

Xueming Du 

申请注册联系人电话:

Applicant telephone:

+86 13752713866 

研究负责人电话:

Study leader's telephone:

+86 13752713866 

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:

dudaming73@163.com 

研究负责人电子邮件:

Study leader's E-mail:

dudaming73@163.com 

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:

天津市北辰区北医道7号 

研究负责人通讯地址:

天津市北辰区北医道7号 

Applicant address:

7 Beiyi Road, Beichen District, Tianjin, China 

Study leader's address:

7 Beiyi Road, Beichen District, Tianjin, 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:

天津市北辰医院 

Applicant's institution:

Tianjin Beichen Hospital 

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:

20150617 

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:

天津市北辰医院伦理委员会 

Name of the ethic committee:

Ethics Committee of Tianjin Beichen Hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

2015-06-17 

伦理委员会联系人:

赵宝莲 

Contact Name of the ethic committee:

Baolian Zhao 

伦理委员会联系地址:

天津市北辰区北医道7号 

Contact Address of the ethic committee:

7 Beiyi Road, Beichen District, Tianjin, 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:

天津市北辰医院 

Primary sponsor:

Tianjin Beichen Hospital 

研究实施负责(组长)单位地址:

天津市北辰区北医道7号 

Primary sponsor's address:

7 Beiyi Road, Beichen District, Tianjin, 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):

天津

市(区县):

北辰

Country:

China

Province:

Tianjin

City:

Beichen

单位(医院):

天津北辰医院

具体地址:

天津市北辰区北医道7号

Institution
hospital:

Tianjin Beichen Hospital

Address:

7 Beiyi Road, Beichen District, Tianjin

经费或物资来源:

天津亨佳生物科技发展有限公司投资 

Source(s) of funding:

Investment from Tianjin HengJia Biotechnology Development Co., Ltd. 

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:

个体化新抗原肽疫苗在非小细胞肺癌治疗中的安全性和可行性 

Objectives of Study:

To investigate the safety and feasibility of personalized neoantigen peptides vaccine on non-small cell lung cancer 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

单臂 

Study design:

Single arm 

纳入标准:

(1) III期或IV期,复发的非小细胞肺癌(经病理确诊)患者。 (2) EGFR-TKI治疗或手术或放化疗治疗后进展患者。 (3) 年龄≥18岁。 (4) 预计生存时间3个月以上 (5) ECOG体力状况为0-3。 (6) 活检组织或病理切片可获得,检测到1个以上突变。 (7)既往及目前未接受免疫治疗,包括抗PD-1、抗PD-L1或抗PD-L2药物或针对性T细胞受体(例如CTLA-4、OX-40、CD137)的药物治疗,多肽/mRNA新抗原免疫治疗和细胞治疗。 (8) 能够遵循研究方案和随访流程。 (9) 有能力并愿意签署参与本试验的可资证明的书面知情同意书。 

Inclusion criteria

1. III or IV stage patients with recurrence non-small cell lung cancer; 2. EGFR-TKI resistance or progress after surgery or radiotherapy or chemotherapy; 3. Adult patients aged 18 or more; 4. expected survival three months or more; 5. Eastern Cooperative Oncology Group(ECOG) is 0 to 3; 6. Biopsy samples or pathology slice available, and more than one genetic mutation ; 7. No previous immunotherapyIncluding PD-1, anti-PD-L1 or anti-PD-L2 drugs or T cell receptor (such as CTLA-4OX-40CD137) drugs, peptide/mRNA neoantigen Immunotherapy and cell therapy; 8. Be able to follow the research program and follow up process; 9. To be able to and willing to give witnessed, written informed consent for participation in the trial. 

排除标准:

满足下列任一标准的病人不得入选本研究: (1) 妊娠或哺乳期妇女; (2) 患有活动性、已知或可疑的自身免疫性疾病或其他并发免疫系统疾病 (3) 首次给予个体化新抗原疫苗前4周内接受全身性细胞毒性化疗或用于转移性NSCLC的试验用药物(不包括EGFR-TKI) (4) 首次给予个体化新抗原疫苗前4周内参加过关于别的研究制剂的任何其它临床试验 (5) 肝肾功能障碍、严重心脏疾病、凝血功能障碍及造血功能损害者 (6) 患有全身性感染 (7) 患有已知的其他恶性肿瘤,其正在进展或在过去5年内需要进行积极治疗 (8) 任何对患者的依从性有影响的不确定因素 (9) 任何影响本研究结果或影响参与者参与整个研究过程的疾病、治疗、实验室检查异常或病史,或治疗研究者认为这类受试者并不适于参与本研究。 

Exclusion criteria:

1. Pregnancy or lactation woman; 2. Patients with known or suspected autoimmune disease or other complicated immune system disease; 3. Systemic cytotoxic chemotherapy or experimental drugs for metastatic NSCLC within 4 weeks prior to first dose of personalized neoantigen vaccine (not including EGFR-TKI); 4. Participation in any other clinical trial involving another investigational agent within 4 weeks prior to first dose of personalized neoantigen vaccine; 5. Patients with liver and kidney dysfunction, severe heart disease, coagulation dysfunction and hematopoietic impairment; 6. Patients with systemic infections; 7. Suffering from other malignancies in progress or accepting active treatment in the past five years; 8. Influence the compliance of the patients; 9. Any disease, treatment, laboratory examination abnormality or medical history that may affect the results of this study or affect the participants' inability to participate in the entire study, or the researchers believe that such subjects are not suitable for participation in the study. 

研究实施时间:

Study execute time:

From2016-11-16To 2019-11-16 

干预措施:

Interventions:

组别:

Case series

样本量:

60

Group:

Case series

Sample size:

干预措施:

新抗原肽疫苗

干预措施代码:

Intervention:

neoantigen peptides vaccine

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

天津 

市(区县):

北辰 

Country:

China 

Province:

Tianjin 

City:

Beichen 

单位(医院):

天津北辰医院 

单位级别:

三级综合医院 

Institution
hospital:

Tianjin Beichen Hospital  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

安全性

指标类型:

主要指标 

Outcome:

safety

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

可行性

指标类型:

主要指标 

Outcome:

feasibility

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

免疫学指标

指标类型:

次要指标 

Outcome:

Immunological indexes

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肿瘤标记物

指标类型:

次要指标 

Outcome:

Tumor markers

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

ECOG评分

指标类型:

次要指标 

Outcome:

ECOG score

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

无疾病进展时间

指标类型:

次要指标 

Outcome:

Progression-free survival

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

总体生存时间

指标类型:

次要指标 

Outcome:

Overall survival

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:

肿瘤组织

组织:

Sample Name:

Tumor tissue

Tissue:

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

标本中文名:

外周血

组织:

Sample Name:

Peripheral 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:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 85 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):

本研究为单臂试验,不涉及随机方法

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

This study is a single trial and does not involve randomization procedure

盲法:

N/A

Blinding:

N/A

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

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):

公开原始数据时间2020月5月16日;方式:CRF表

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

Publication time of metadata:16 May, 2020; Way: CRF table

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:

本课题有临床专用CRF表,专人进行纸质记录,保存于研究者处

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

Each patient is required to fill one CRF table, all the CRF tables saved by researchers.

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2016-11-15
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