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抗PD-1联合腹腔局部免疫细胞治疗晚期胃癌伴腹水/腹膜转移临床试验
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注册号:

Registration number:

ChiCTR1900024440 

最近更新日期:

Date of Last Refreshed on:

2019-07-12 

注册时间:

Date of Registration:

2019-07-12 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

抗PD-1联合腹腔局部免疫细胞治疗晚期胃癌伴腹水/腹膜转移临床试验 

Public title:

Combination of anti-PD-1 and introperitoneal cell therapy in gastric cancer patients with ascites/ peritoneal metastasis 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

抗PD-1联合腹腔局部免疫细胞治疗晚期胃癌伴腹水/腹膜转移临床试验 

Scientific title:

Combination of anti-PD-1 and introperitoneal cell therapy in gastric cancer patients with ascites/ peritoneal metastasis 

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:

魏嘉 

研究负责人:

魏嘉 

Applicant:

Jia Wei 

Study leader:

Jia Wei 

申请注册联系人电话:

Applicant telephone:

+86 13951785234 

研究负责人电话:

Study leader's telephone:

+86 13951785234 

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:

weijia01627@hotmail.com 

研究负责人电子邮件:

Study leader's E-mail:

weijia01627@hotmail.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:

南京市中山路321号 

研究负责人通讯地址:

南京市中山路321号 

Applicant address:

321 Zhongshan Road, Nanjing, Jiangsu, China 

Study leader's address:

321 Zhongshan Road, Nanjing, Jiangsu, 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:

南京大医学院附属鼓楼医院 

Applicant's institution:

The Affiliated Hospital of Nanjing University Medical School 

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:

201903702 

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:

南京大学医学院附属鼓楼医院伦理委员会 

Name of the ethic committee:

Ethics Committee of the Affiliated Hospital of Nanjing University Medical School 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-06-26 

伦理委员会联系人:

沙莉莉 

Contact Name of the ethic committee:

Lili Sha 

伦理委员会联系地址:

南京市中山路321号 

Contact Address of the ethic committee:

321 Zhongshan Road, Nanjing, Jiangsu, 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:

南京大学医学院附属鼓楼医院 

Primary sponsor:

The Affiliated Hospital of Nanjing University Medical School 

研究实施负责(组长)单位地址:

南京市中山路321号 

Primary sponsor's address:

321 Zhongshan Road, Nanjing, Jiangsu, 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):

江苏

市(区县):

南京

Country:

China

Province:

Jiangsu

City:

Nanjing

单位(医院):

南京大学医学院附属鼓楼医院

具体地址:

中山路321号

Institution
hospital:

The Affiliated Hospital of Nanjing University Medical School

Address:

321 Zhongshan Road

经费或物资来源:

自筹 

Source(s) of funding:

Self financing 

研究疾病:

胃癌 

Target disease:

gastric 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:

探索性研究/预试验 

Study phase:

研究目的:

评价抗PD-1联合腹腔局部免疫细胞治疗对既往治疗失败的伴有恶性腹腔积液或腹膜转移的晚期胃癌患者的生存期的影响。 次要观察指标为疗效(肿瘤疗效评估,腹水疗效评估)、安全性评估、生活质量改善、血CA125变化情况。 

Objectives of Study:

To evaluate the combination effect of anti-PD-1 and introperitoneal cell therapy on the survival of patient with gastric cancer with ascites/ peritoneal metastasis who failed previous treatment. To evaluate the efficacy, safety, improvement of quality of life and changes of blood CA125. 

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. 年龄≥18 岁。 2. 组织学或细胞学证实的胃癌患者,且伴有恶性腹腔积液或腹膜转移。 3. 既往标准治疗失败的胃癌患者,或者拒绝后续化疗,预计生存期大于8周。 4. 患者既往未接受过免疫治疗。 5. 育龄期患者在入组前和试验中需采取恰当的保护措施 (避孕措施或其它控制生育的方法)。 6. 已签署知情同意书。 7. 能够遵循研究方案和随访流程。 

Inclusion criteria

1. Aged >= 18 years. 2. Histologically or cytologically confirmed gastric cancer with malignant peritoneal effusion or peritoneal metastasis. 3. Patients with gastric cancer who failed previous standard treatment, or who refused follow-up chemotherapy, expected to survive for more than 8 weeks. 4. The patient has not previously received immunotherapy. 5. Appropriate protective measures (contraception or other methods of birth control) should be taken before and during the trial. 6. Informed consent has been signed. 7. Ability to follow study protocol and follow up procedures. 

排除标准:

1. 既往一月内接受过肿瘤化疗、放疗等抗肿瘤治疗;既往 3 个月内接受过任何一种形式的免疫治疗。 2. 患者既往有其它肿瘤病史,除非是原位宫颈癌,治疗过的鳞癌或膀胱上皮肿瘤(Ta 和 TIS),或其它已经接受根治性治疗的恶性肿瘤(至少在入组前 5 年以上)。 3. 白细胞计数<3×10^9/L,血小板计数<80×10^9/L。 4. AST 和 ALT >3 ×正常值上限(ULN),总胆红素>2×ULN;肝转移患者AST 和 ALT >6 ×ULN。 5. 肌酐清除率<60ml/min。 6. 凝血功能异常。 7. 患者有活动性细菌或真菌感染(>= 2 级 of NCI-CTC, 第 3 版)。 8. 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。 9. 妊娠、哺乳期妇女。育龄期妇女入组前 7 天内必须测试妊娠试验阴性。 10. 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。 11. 可能对研究药物过敏者。 12. 不能进行淋巴细胞分离术或外周静脉通道不能开放患者等。 13. 任何对患者的安全或依从性有影响的不确定因素。 14. 筛查过程中可行性评估显示T淋巴细胞对CD3、IL-2刺激信号不足以引发细胞增殖响应。 

Exclusion criteria:

1. Previously received tumor chemotherapy, radiotherapy and other anti-tumor treatment within one month; Received any form of immunotherapy within the previous 3 months. 2. Patients had a history of other tumors, except for cervical carcinoma in situ, treated squamous cell carcinoma or bladder epithelial neoplasm (Ta and TIS), or other malignancies that had undergone radical treatment (at least 5 years prior to enrollment). 3. Leukocyte count <3x10^9/L,Platelet count<80x10^9/L. 4. AST, ALT > 3 x Upper normal value,Total bilirubin. 5. Creatinine clearance < 60ml/min. 6. Abnormal coagulation function. 7. Patients with active bacterial or fungal infection (>= level 2 of NCI-CTC, Third edition). 8. Patients have HIV infection, HCV infection, uncontrolled coronary artery disease or asthma, uncontrollable cerebrovascular disease or other diseases that the investigator believes are unincorporated. 9. Pregnant, lactating women. Women of childbearing age must be tested negative for pregnancy test within 7 days prior to enrollment. 10. Drug abuse, clinical or psychological or social factors affect informed consent or research implementation. 11. Those who may be allergic to research drugs. 12. Patients who are unable to perform lymphocyte separation or peripheral venous access cannot be opened. 13. Any uncertainty that affects patient safety or compliance. 14. Feasibility assessment during the screening process showed that T lymphocytes were not sufficient for CD3 and IL-2 stimulation signals to trigger a cell proliferation response. 

研究实施时间:

Study execute time:

From2019-08-22To 2022-02-22 

干预措施:

Interventions:

组别:

单组

样本量:

30

Group:

single group

Sample size:

干预措施:

anti-PD1 antibody,Smart-T

干预措施代码:

Intervention:

anti-PD1 antibody,Smart-T

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

江苏 

市(区县):

南京 

Country:

China 

Province:

Jiangsu 

City:

Nanjing 

单位(医院):

南京大学医学院附属鼓楼医院 

单位级别:

三级甲等 

Institution
hospital:

The Affiliated Hospital of Nanjing University Medical School  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

总生存期

指标类型:

主要指标 

Outcome:

OS

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

影像学评估

指标类型:

次要指标 

Outcome:

Imaging evaluation

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

腹水量

指标类型:

次要指标 

Outcome:

Ascites volume

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

生活质量改善

指标类型:

次要指标 

Outcome:

improvement of quality of life

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

安全性评估

指标类型:

次要指标 

Outcome:

safety 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:

尚未开始

Not yet recruiting

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):

未使用

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

Not used

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:

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):

CRF 2022年

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

CRF 2022y

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 EDC

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2019-07-12
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