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修饰型免疫细胞(NRC-NK)个体化治疗Ⅳ期结直肠癌的临床研究

  • 发布时间:2018-02-02
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修饰型免疫细胞(NRC-NK)个体化治疗Ⅳ期结直肠癌的临床研究...

注册号:

Registration number:

ChiCTR-IID-17011603 

最近更新日期:

Date of Last Refreshed on:

2017-06-09 

注册时间:

Date of Registration:

2017-06-09 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

修饰型免疫细胞(NRC-NK)个体化治疗Ⅳ期结直肠癌的临床研究 

Public title:

Clinical study of modified immune cells (NRC-NK) for the treatment of stage Ⅳ colorectal cancer 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

修饰型免疫细胞(NRC-NK)个体化治疗Ⅳ期结直肠癌的临床研究 

Scientific title:

Clinical study of modified immune cells (NRC-NK) for the treatment of stage Ⅳ colorectal 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:

岑东芝 

研究负责人:

徐学虎 

Applicant:

Cen Dongzhi 

Study leader:

Xu Xuehu 

申请注册联系人电话:

Applicant telephone:

+86 13660672836 

研究负责人电话:

Study leader's telephone:

+86 18928916669 

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:

373057277@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

maxtiger@126.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:

广州市荔湾区多宝路63号 

研究负责人通讯地址:

广州市荔湾区多宝路63号 

Applicant address:

63 Duobao Road, Liwan District, Guangzhou, Guangdong, China 

Study leader's address:

63 Duobao Road, Liwan District, Guangzhou, Guangdong, 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:

广州医科大学附属第三医院 

Applicant's institution:

the Third Affiliated Hospital, Guangzhou 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:

2016-060 

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:

广州医科大学附属第三医院医学伦理委员会 

Name of the ethic committee:

Medical ethic committee of the Third Affiliated Hospital, Guangzhou Medical University 

伦理委员会批准日期:

Date of approved by ethic committee:

2016-08-17 

伦理委员会联系人:

 

Contact Name of the ethic committee:

 

伦理委员会联系地址:

 

Contact Address of the ethic committee:

 

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:

广州医科大学附属第三医院 

Primary sponsor:

the Third Affiliated Hospital, Guangzhou Medical University 

研究实施负责(组长)单位地址:

广州市荔湾区多宝路63号 

Primary sponsor's address:

63 Duobao Road, Liwan District, Guangzhou, Guangdong, 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):

广东

市(区县):

 

Country:

China

Province:

Guangdong

City:

 

单位(医院):

广州医科大学附属第三医院

具体地址:

广州市荔湾区多宝路63号

Institution
hospital:

the Third Affiliated Hospital, Guangzhou Medical University

Address:

63 Duobao Road, Liwan District, Guangzhou, Guangdong, China

国家:

中国

省(直辖市):

浙江

市(区县):

 

Country:

China

Province:

Zhejiang

City:

 

单位(医院):

杭州康万达医药科技有限公司

具体地址:

浙江省杭州市余杭区文一西路未来科技城998号18号楼511-512室

Institution
hospital:

Hangzhou Converd Co.,Ltd.

Address:

Suite 511-512, Building 18, Zhejiang Overseas High-Level Talents Innovation Park, Hangzhou, 311121

经费或物资来源:

杭州康万达医药科技有限公司 

Source(s) of funding:

Hangzhou Converd Co.,Ltd.  

研究疾病:

结直肠癌 

Target disease:

colorectal cancer 

研究疾病代码:

 

Target disease code:

 

研究类型:

干预性研究 

Study type:

Interventional study 

研究所处阶段:

I期临床试验 

Study phase:

I (Phase I study) 

研究目的:

主要目的:评价针对NKG2D配体的CAR-NK腹腔注射在治疗结直肠癌腹膜转移患者时的临床安全性、使用指征。 次要目的:初步预估NKG2D配体的CAR-NK腹腔注射在治疗结直肠癌腹膜转移患者时的有效性。 

Objectives of Study:

Primary objective: to evaluate the clinical safety of intraperitoneal injection of CAR-NK cells targeting NKG2D ligand in the treatment of patients with peritoneal metastases of colorectal cancer; Secondary objectives: to evaluate the clinical efficacy of intraperitoneal injection of CAR-NK cells targeting NKG2D ligand in the treatment of patients with peritoneal metastases of colorectal 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:

不同剂量对照 

Study design:

Dose comparison 

纳入标准:

年龄18-70周岁; 有组织学或细胞学证实的结直肠癌腹膜转移,恶性腹水; 预计生存期大于90天; ECOG体力状态评分0-1或KPS评分≥60分; 心、肝、肾功能在正常范围内或可控范围内(心功能不超过2级,ALT和/或AST不超过正常上限1.5倍,Cr不超过正常上限); 具备单采或者静脉采血足够的静脉通路,并且没有其他的血球分离禁忌症; 经MDT讨论无确定依据从手术治疗中获益; 经MDT讨论无确定依据从化疗治疗中获益(已经完成FOLFOX/FOFIRI方案化疗,或者未完成患者无法耐受/拒绝进一步化疗),化疗在患者接受NRC-NK细胞免疫治疗之前4周已经停止; 自愿参加本实验并签署知情同意书者。 

Inclusion criteria

1. Aged 18-70 years old; 2. Histological or cytologically confirmed peritoneal metastasis of colorectal cancer, malignant ascites; 3. Expected life is greater than 90 days; 4. ECOG physical status score 0-1 or KPS score ≥ 60 points; 5. Heart, liver and kidney function within the normal range or controllable range (heart function does not exceed 2, ALT and / or AST does not exceed the normal upper limit of 1.5 times, Cr does not exceed the normal upper limit); 6. With a single or intravenous blood intake sufficient venous access, and no other blood separation contraindications; 7. By MDT discussion without a definite basis to benefit from surgery; 8. Treatment by MDT No benefit from chemotherapy therapy (FOLFOX / FOFIRI regimen has been completed, or incomplete patient can not tolerate / reject further chemotherapy), chemotherapy has stopped 4 weeks before patient receiving NRC-NK cell immunotherapy; 9. Volunteer to participate in this study and sign the informed consent. 

排除标准:

有急性或慢性感染相关的血液疾病、心血管疾病、肺部疾病、肝部疾病、肾病、胰腺疾病、内分泌疾病; 有免疫缺陷、自身免疫性疾病; 有严重过敏疾病; 在之前3个月接受过细胞治疗; 接受过系统性类固醇治疗; 孕妇或哺乳期妇女; 脑转移患者; 在被告知实验方案后,不愿意入组或者没有符合医学伦理委员会对本项目的决议。 

Exclusion criteria:

1. With acute or chronic infections associated with blood diseases, cardiovascular disease, lung disease, liver disease, kidney disease, pancreatic disease, endocrine disease; 2. Immune deficiency, autoimmune diseases; 3. Have severe allergies; 4. Received cell therapy in the previous 3 months; 5. Received systemic steroid therapy; 6. Pregnant or lactating women; 7. Brain metastases; 8. After being informed of the program, do not want to enter the group or not in line with the medical ethics committee on the project resolution. 

研究实施时间:

Study execute time:

From2018-01-01To 2019-12-31 

干预措施:

Interventions:

组别:

患者1

样本量:

1

Group:

Patient1

Sample size:

干预措施:

在第0天接受1 x10^7/m^2 NRC-NK细胞输入,接下来在第7天的时候接受第二次6 x10^7/m^2 NRC-NK细胞输入,在第14天接受第三次3 x10^8/m^2 NRC-NK细胞输入

干预措施代码:

 

Intervention:

Received 1 x 10^7 / m^2 NRC-NK cells infusion on day 0, followed by a second 6 x 10^7 / m^2 NRC-NK cells infusion on day 7 and a third 3 x 10^8 / m^2 NRC -NK cells infusion on day 14

Intervention code:

组别:

患者1

样本量:

1

Group:

Patient1

Sample size:

干预措施:

6 x10^7/m2 NRC-NK细胞每次,一周2次和3 x10^8/m2 NRC-NK细胞每次,一周2次,中间休息一周时间

干预措施代码:

 

Intervention:

6 x10^7/m2 NRC-NK cells,twice a week and 3 x10^8/m2 NRC-NK cells, twice a week, with one week between the two doses

Intervention code:

组别:

患者2

样本量:

1

Group:

Patient2

Sample size:

干预措施:

接受3 x10^8/m^2 CAR-NK细胞输入,每周2次,共输入3周

干预措施代码:

 

Intervention:

Accept 3 x 10 ^ 8 / m ^ 2 CAR-NK cell input twice a week for 3 weeks

Intervention code:

组别:

患者3

样本量:

1

Group:

Patient3

Sample size:

干预措施:

接受3 x10^8/m^2 CAR-NK细胞输入,每周2次,共输入3周

干预措施代码:

 

Intervention:

Accept 3 x 10 ^ 8 / m ^ 2 CAR-NK cell input twice a week for 3 weeks

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

广东 

市(区县):

 

Country:

China 

Province:

Guangdong 

City:

 

单位(医院):

广州医科大学附属第三医院 

单位级别:

三级甲等医院 

Institution
hospital:

the Third Affiliated Hospital, Guangzhou Medical University  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

血常规

指标类型:

主要指标 

Outcome:

blood routine

Type:

Primary indicator 

测量时间点:

入组前,治疗后

测量方法:

 

Measure time point of outcome:

Before enrollment and after treatment

Measure method:

 

指标中文名:

尿常规

指标类型:

主要指标 

Outcome:

Urine routine

Type:

Primary indicator 

测量时间点:

入组前,治疗后

测量方法:

 

Measure time point of outcome:

Before enrollment and after treatment

Measure method:

 

指标中文名:

肝肾功能

指标类型:

主要指标 

Outcome:

Liver and kidney function

Type:

Primary indicator 

测量时间点:

入组前,治疗后

测量方法:

 

Measure time point of outcome:

Before enrollment and after treatment

Measure method:

 

指标中文名:

心电图

指标类型:

主要指标 

Outcome:

Electrocardiogram

Type:

Primary indicator 

测量时间点:

入组前,治疗后

测量方法:

 

Measure time point of outcome:

Before enrollment and after treatment

Measure method:

 

指标中文名:

体重

指标类型:

主要指标 

Outcome:

weight

Type:

Primary indicator 

测量时间点:

入组前,治疗后

测量方法:

 

Measure time point of outcome:

Before enrollment and after treatment

Measure method:

 

指标中文名:

体力状况评分

指标类型:

主要指标 

Outcome:

Physical status score

Type:

Primary indicator 

测量时间点:

入组前

测量方法:

 

Measure time point of outcome:

Before enrollment

Measure method:

 

指标中文名:

腹水彩超

指标类型:

主要指标 

Outcome:

Ultra sound examination of ascites

Type:

Primary indicator 

测量时间点:

治疗前,治疗后

测量方法:

 

Measure time point of outcome:

Before enrollment and after treatment

Measure method:

 

指标中文名:

CT

指标类型:

主要指标 

Outcome:

CT

Type:

Primary indicator 

测量时间点:

治疗前,治疗后

测量方法:

 

Measure time point of outcome:

Before and after tretment

Measure method:

 

指标中文名:

MRI

指标类型:

主要指标 

Outcome:

MRI

Type:

Primary indicator 

测量时间点:

入组前

测量方法:

 

Measure time point of outcome:

Before enrollment

Measure method:

 

指标中文名:

生存期

指标类型:

主要指标 

Outcome:

Survival period

Type:

Primary indicator 

测量时间点:

治疗后

测量方法:

 

Measure time point of outcome:

After treatment

Measure method:

 

指标中文名:

肝胆彩超

指标类型:

主要指标 

Outcome:

Ultra sound examination of liver and gallbladder

Type:

Primary indicator 

测量时间点:

入组前,治疗后

测量方法:

 

Measure time point of outcome:

Before enrollment and after treatment

Measure method:

 

指标中文名:

循环肿瘤细胞

指标类型:

主要指标 

Outcome:

Circulating tumor cells

Type:

Primary indicator 

测量时间点:

治疗前,治疗后

测量方法:

 

Measure time point of outcome:

Before and after tretment

Measure method:

 

指标中文名:

血清CEA水平分析

指标类型:

主要指标 

Outcome:

Analysis of serum CEA levels

Type:

Primary indicator 

测量时间点:

治疗前,治疗后

测量方法:

 

Measure time point of outcome:

Before and after tretment

Measure method:

 

指标中文名:

血液细胞表型分析

指标类型:

主要指标 

Outcome:

Blood cell phenotype analysis

Type:

Primary indicator 

测量时间点:

治疗前,治疗后

测量方法:

 

Measure time point of outcome:

Before and after tretment

Measure method:

 

指标中文名:

血浆细胞因子检测

指标类型:

主要指标 

Outcome:

Plasma cytokine detection

Type:

Primary indicator 

测量时间点:

治疗前,治疗后

测量方法:

 

Measure time point of outcome:

Before and after tretment

Measure method:

 

指标中文名:

腹水细胞表型分析

指标类型:

主要指标 

Outcome:

Ascites cell phenotype analysis

Type:

Primary indicator 

测量时间点:

治疗前,治疗后

测量方法:

 

Measure time point of outcome:

Before and after tretment

Measure method:

 

指标中文名:

腹水细胞因子检测

指标类型:

主要指标 

Outcome:

Ascites cytokine detection

Type:

Primary indicator 

测量时间点:

治疗前,治疗后

测量方法:

 

Measure time point of outcome:

Before and after tretment

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:

 

标本中文名:

腹水

组织:

 

Sample Name:

ascites

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:

 

征募研究对象情况:

Recruiting status:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age 17  years
最大 Max age 80  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):

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

No

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):

杭州康万达医药科技有限公司于试验完成后6个月内公开

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

Released by Converd within six months after the trial complete

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:

数据库建立及数据录入 1) 建立数据库:根据病例报告表表格的项目采用Epi-Data2.0软件建立相应的录入程序,并设定录入时的逻辑审查限定条件,对数据库进行试运行,进而建立本试验专用的数据库系统, 2) 数据录入:由数据管理员进行数据同步录入,采用两次录入法。 3) 数据的审核:对数据采用Epi-DaLa2.0软件中的核查功能进行每一项目的查对,报告不一致的结果值,逐项核对原始调查表,予以更正。 4) 数据管理员在录入过程中如有疑问,可填写“数据问题表”,由研究者对疑问表中的问题进行书面解答并签名,交回数据管理员,“数据问题表”应妥善保管。

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

Database establishment and data entry 1) the establishment of the database: According to the case report table form of the project using Epi-Data2.0 software to establish the corresponding entry procedures, and set the logic of the entry review review conditions, the database test run, and then set up this test dedicated database system , 2) data entry: data from the data entry by the administrator, using two input method. 3) Data audit: the data using Epi-DaLa2.0 software in the verification function of each project to check the report of the results of inconsistent results, one by one to check the original questionnaire, to be corrected. 4) Data administrator in the process of entry if in doubt, you can fill out the "data problem table" by the researchers in the question table in a written answer and signature, return to the data administrator, "data table" should be properly kept.

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

上一资讯:没有了