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肿瘤新生抗原多肽疫苗联合新生抗原反应性T细胞(NRT)治疗晚期恶性肿瘤单中心单臂临床研究
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注册号:

Registration number:

ChiCTR1800017836 

最近更新日期:

Date of Last Refreshed on:

2019-09-25 

注册时间:

Date of Registration:

2018-08-17 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

肿瘤新生抗原多肽疫苗联合新生抗原反应性T细胞(NRT)治疗晚期恶性肿瘤单中心单臂临床研究 

Public title:

Single center single arm clinical study of individualized neoantigen peptides vaccine combined with neoantigen reactive T cells (NRTs) in the treatment of advanced malignancies 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

肿瘤新生抗原多肽疫苗联合新生抗原反应性T细胞(NRT)治疗晚期恶性肿瘤单中心单臂临床研究 

Scientific title:

Single center single arm clinical study of individualized neoantigen peptides vaccine combined with neoantigen reactive T cells (NRTs) in the treatment of advanced malignancies 

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:

李振丽 

研究负责人:

曾永毅 

Applicant:

Zhenli Li 

Study leader:

Zeng Yongyi 

申请注册联系人电话:

Applicant telephone:

+86 13685010232 

研究负责人电话:

Study leader's telephone:

+86 0591-83705927 

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:

11218083@zju.edu.cn 

研究负责人电子邮件:

Study leader's E-mail:

xiaoloong.liu@gmail.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:

福建省福州市西洪路312号 

研究负责人通讯地址:

福建省福州市西洪路312号 

Applicant address:

312 Xihong Road, Fuzhou, Fujian, China 

Study leader's address:

312 Xihong Road, Fuzhou, Fujian, China 

申请注册联系人邮政编码:

Applicant postcode:

350025 

研究负责人邮政编码:

Study leader's postcode:

350025 

申请人所在单位:

福建医科大学孟超肝胆医院 

Applicant's institution:

Mengchao Hepatobiliary Hospital of Fujian Medical University 

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:

2018_028_01 

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:

福建医科大学孟超肝胆医院医学伦理委员会 

Name of the ethic committee:

Institution Review Board of Mengchao Hepatobiliary Hospital of Fujian Medical University 

伦理委员会批准日期:

Date of approved by ethic committee:

2018-08-01 

伦理委员会联系人:

原津津 

Contact Name of the ethic committee:

Jinjin Yuan 

伦理委员会联系地址:

福建省福州市西洪路312号 

Contact Address of the ethic committee:

312 Xihong Road, Fuzhou, Fujian, 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:

福建医科大学孟超肝胆医院 

Primary sponsor:

Mengchao Hepatobiliary Hospital of Fujian Medical University 

研究实施负责(组长)单位地址:

福建省福州市西洪路312号 

Primary sponsor's address:

312 Xihong Road, Fuzhou, Fujian, 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):

福建省

市(区县):

福州

Country:

China

Province:

Fujian

City:

Fuzhou

单位(医院):

福建医科大学孟超肝胆医院

具体地址:

福建省福州市西洪路312号

Institution
hospital:

Mengchao Hepatobiliary Hospital of Fujian Medical University

Address:

312 Xihong Road, Fuzhou, Fujian, China

经费或物资来源:

自筹 

Source(s) of funding:

self-financing 

研究疾病:

晚期恶性肿瘤 

Target disease:

Advanced malignancies 

研究疾病代码:

 

Target disease code:

 

研究类型:

治疗研究 

Study type:

Treatment study 

研究所处阶段:

I期临床试验 

Study phase:

研究目的:

评价肿瘤新生抗原多肽疫苗联合新生抗原反应性T细胞治疗晚期恶性肿瘤的疗效及安全性。 

Objectives of Study:

To evaluate the efficacy and safety of neoantigen peptides vaccine combined with NRTs in the treatment of patients with advanced malignancies. 

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. 自愿加入本研究,并签署知情同意书的患者; 2. 年龄:18-75岁,男女不限; 3.经影像学和组织学细胞学证实的晚期恶性肿瘤(无法切除或出现转移)患者,至少有一个影像学可测量的病灶,病灶有两个或两个以上; 4. TNM分期为II-IV期; 5. 预期生存期≥3个月的患者; 6. ECOG评分在0-1分的患者; 7.患者需满足以下血液学指标:中性粒细胞计数≥1.5×10^9/L;血红蛋白≥10.0g/dL;血小板计数≥100×109/L; 8.患者需满足以下生化指标:总胆红素≤1.5×正常值上限(ULN); AST和ALT≤2.5×ULN;肌酐清除率≥60ml/min; 9.有生育能力的女性患者应排除怀孕可能,早孕检测试验HCG必须阴性;整个研究过程中应采取恰当的避孕措施。 

Inclusion criteria

1. The patients volunteer to join in the trial and sign the informed consents; 2. Adult patients aged 18 to 75 years oldno gender limitation; 3. Histologic or cytologic confirmation of advanced refractory tumors with no available curative treatment options(can not be resected or have already metastasized); with at least two lesions and at least one measurable lesion; 4. TNM stage II-IV (AJCC 7th); 5. Expected survival time three months or more; 6. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1; 7. Hematology Index including: neutrophile granulocyte greater than 1.5×10^9/L; hemoglobin greater than 10g/dL; platelet greater than 100×10^9/L; 8. Biochemical index including: Serum bilirubin not greater than 1.5× upper limit of reference range (ULN); ALT or AST not greater than 2.5× ULN; creatinine clearance no less than 60ml/min; 9. Negative pregnancy test for women of childbearing potential, and patients must be willing to practice birth control during the research. 

排除标准:

1.患者有HIV感染,HCV感染,不可控制的冠状动脉疾病或哮喘,不可控制的脑血管疾病或研究者认为的不可入组的其它疾病; 2.有骨髓、肝细胞或器官移植史者;消化道出血或消化道出血倾向者;凝血功能障碍者; 3.患有免疫缺陷疾病或自身免疫性疾病的受试者; 4.1个月内进行过其他免疫治疗的患者; 5.可能对免疫治疗过敏者; 6.滥用药物,临床或心理的或社会的因素使知情同意或研究实施受影响; 7.妊娠、哺乳期妇女; 8.正在参与或者1个月内曾参与其他临床性试验; 9. 任何对患者的安全或依从性有影响的不确定因素。  

Exclusion criteria:

1. Patients with HIV infection, HCV infection, serious coronary artery disease or asthma, serious cerebrovascular disease or other diseases that the researchers think can not be entered into the group; 2. History of bone marrow transplantation, stem cell transplantation or organ transplantationpatients with definite hemorrhage of digestive tract or hemorrhagic tendency; 3. Any form of primary immunodeficiency or history of autoimmune disease; 4. Prior treatment with other immunotherapy within 1 month; 5. May be allergic to immunotherapy; 6. Drug abuse, clinical or psychological or social factors which will influence the informed consent or the study implementation; 7. Women who are pregnant or breast feeding; 8. Patients who are participating in or have participated in other clinical trials within a month; 9. Any other uncertain factors that will influence the safety or compliance of the patients. 

研究实施时间:

Study execute time:

From2018-09-01To 2022-12-01 

征募观察对象时间:

Recruiting time:

From2018-09-01To 2021-12-01 

干预措施:

Interventions:

组别:

Case series

样本量:

25

Group:

Case series

Sample size:

干预措施:

新生抗原多肽疫苗+NRT

干预措施代码:

Intervention:

neoantigen peptides caccine combined with neoantigen reactive T cells

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

福建省 

市(区县):

福州市 

Country:

China 

Province:

Fujian 

City:

Fuzhou 

单位(医院):

福建医科大学孟超肝胆医院 

单位级别:

三级甲等 

Institution
hospital:

Mengchao Hepatobiliary Hospital of Fujian Medical University  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

客观缓解率

指标类型:

主要指标 

Outcome:

ORR

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

无进展生存期

指标类型:

次要指标 

Outcome:

PFS

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

总生存期

指标类型:

次要指标 

Outcome:

OS

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

疾病控制率

指标类型:

次要指标 

Outcome:

DCR

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

安全性

指标类型:

次要指标 

Outcome:

safety

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

免疫指标

指标类型:

次要指标 

Outcome:

immune indexes

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:

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:

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:

尿液

组织:

Sample Name:

urine

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:

粪便

组织:

Sample Name:

stool

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:

外周血单个核细胞

组织:

Sample Name:

peripheral blood mononuclear cel

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 75 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):

单臂临床试验,不涉及随机

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

no

盲法:

N/A

Blinding:

N/A

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

即时公开/Real time access

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):

中国临床试验注册中心,论文发表后公开

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

http://www.chictr.org.cn,post publication

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:

病例记录表、电子采集和管理系统

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

CRF and EDC

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2018-08-17
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