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新型CAR-T细胞治疗进展期胃癌的临床试验研究

  • 发布时间:2018-02-02
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新型CAR-T细胞治疗进展期胃癌的临床试验研究...

注册号:

Registration number:

ChiCTR1800014724 

最近更新日期:

Date of Last Refreshed on:

2018-01-31 

注册时间:

Date of Registration:

2018-01-31 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

新型CAR-T细胞治疗进展期胃癌的临床试验研究 

Public title:

Clinical research of new type CAR - T cells treatment for advanced gastric cancer  

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

CEA和HER2双靶向CAR-T细胞治疗进展期胃癌的临床试验研究 

Scientific title:

Clinical research of CEA and HER2 dual targets CAR - T cells treatment for advanced gastric 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:

郭天娇 

研究负责人:

王斌 

Applicant:

Tianjiao Guo 

Study leader:

Bin Wang 

申请注册联系人电话:

Applicant telephone:

+86 15310625853 

研究负责人电话:

Study leader's telephone:

+86 13647638446 

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:

guotianjiao_1990@163.com 

研究负责人电子邮件:

Study leader's E-mail:

wb_tmmu@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:

重庆市渝中区大坪长江支路10号 

研究负责人通讯地址:

重庆市渝中区大坪长江支路10号 

Applicant address:

10 Changjiang Branch Road,Yuzhong District, Chongqing, China 

Study leader's address:

10 Changjiang Branch Road,Yuzhong District, Chongqing, 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:

陆军军医大学第三附属医院(野战外科研究所)消化内科 

Applicant's institution:

Gastroenterology and hepatology department, The Third Hospital Affiliated To Army Medical University (Research Institute of surgery) 

是否获伦理委员会批准:

否 

Approved by ethic committee:

NO 

伦理委员会批件文号:

Approved No. of ethic committee:

 

伦理委员会批件附件:

Approved file of Ethical Committee:

 

批准本研究的伦理委员会名称:

 

Name of the ethic committee:

 

伦理委员会批准日期:

Date of approved by ethic committee:

2013-08-26 

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:

陆军军医大学第三附属医院(野战外科研究所) 

Primary sponsor:

The Third Hospital Affiliated To Army Medical University (Research Institute of surgery) 

研究实施负责(组长)单位地址:

重庆市渝中区大坪长江支路10号 

Primary sponsor's address:

10 Changjiang Branch Road, Yuzhong District, Chongqing, 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):

重庆

市(区县):

重庆

Country:

China

Province:

Chongqing

City:

Chongqing

单位(医院):

陆军军医大学第三附属医院(野战外科研究所)

具体地址:

重庆市渝中区大坪长江支路10号

Institution
hospital:

The Third Hospital Affiliated To Army Medical University (Research Institute of surgery)

Address:

10 Changjiang Branch Road,Yuzhong District, Chongqing, China

经费或物资来源:

院所军事医学创新计划项目 

Source(s) of funding:

Project of academy military medical innovation 

研究疾病:

进展期胃癌 

Target disease:

advanced 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:

I期临床试验 

Study phase:

I (Phase I study) 

研究目的:

1.评估新型CAR-T细胞治疗进展期胃癌的安全性 2.评估新型CAR-T细胞治疗进展期胃癌的有效性 

Objectives of Study:

1. Evaluate the safety of new type CAR-T cells treatment for advanced gastric cancer; 2. Evaluate the effectiveness of new type CAR-T cells treatment for advanced gastric 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:

连续病例 

Study design:

Case series 

纳入标准:

(1)病理学确诊为胃腺癌; (2)肿瘤组织标本中相应的肿瘤抗原表达阳性(病理切片免疫组织化学染色CEA阳性且Her2阳性); (3)局部复发/远处转移/不可手术切除的进展期胃癌:常规治疗无效(一二线化疗失败); (4)前期抗肿瘤治疗(放疗,化疗,靶向治疗等),经过至少一个月恢复期(最近一次治疗所带来的毒副作用应得到了恢复,与最近一次化疗至少间隔4周); (5)入组前至少有1个可测量的病灶b; (6)年龄18-75岁,预期寿命>3个月; (7)患者体力状况按ECOG(WHO)标准评分:0-1分; (8)入组前血常规:外周血常规检查中的白细胞计数4×109/L- 10×109/L,中性粒细胞计数≥1.0×109/L,淋巴细胞计数≥0.4×109/L,血红蛋白浓度≥80g/L,PLT ≥ 60×109/L; (9)其他器官功能水平正常:①肝肾功:总胆红素<2.0mg/dL,AST和ALT<2.5×ULN(有肝转移者<5×ULN);血清肌酐<1.4mg/dl; ②心血管系统:半年内无心肌梗死发作,高血压、其他心血管疾病在可控制范围内,心脏超声提示心脏射血分数≥50%,心电图未见明显异常;③呼吸系统:血氧饱合度≥90%;若患者有肺转移,由临床医生根据转移灶具体情况决定是否将病人纳入;④神经系统:无活动性癫痫发作; (10)具备单采或者静脉采血足够的静脉通路,并且没有其他的血细胞分离禁忌症; (11)意在研究期间及研究结束后6月采取积极的避孕措施; (12)依从性好,同意检查计划及随访计划,并积极配合; (13)受试者能够理解并且自愿签署知情同意书,直系亲属能够理解并同意患者参加本临床试验,并在参加本试验前共同签署知情同意书。  

Inclusion criteria

1. histopathological diagnosed with gastric adenocarcinoma; 2. tumor antigen expression in tumor tissue samples is positive (Both CEA and Her2); 3. unresectable locally advanced, Locally recurrent or metastatic advanced gastric cancer,persist or relapse after clinical treatment; 4. allow pre radiotherapy, chemotherapy, targeted therapy,less than 4 weeks; 5. advanced gastric cancer with at lest one measurable lesion; 6. aged 18-75 years old, the Expected lifetime ≥3 month; 7. ECOG (Eastern Cooperative Oncology Group) 0-1; 8. The standard of blood routine examination should be consistent: WBC 4×10^9/L- 10×10^9/L, ANC≥1.0×10^9/L, LC≥0.4×10^9/L, HB≥ 80 g/L, PLT ≥60×10^9/L; 9. The main organ function is normal, and meet the following standards: (1) Bilirubin < 2.0 mg/dl, ALT and AST ≤ 2.5×ULN, with hepatic metastasisALT≤5×ULN; Creatinine < 1.4 mg/dl; (2) Good cardiac function before the recruitment, no seizure of myocardial infarction in past half years, and controllable hypertension and other coronary heart diseaseLVEF>50%normal ECG; (3) blood oxygen saturat≥90%if patient has lung metastasis,the clinical team will make decisions; (4) no active seizure disorder; 10. with adequate intravenous access for a single blood collection or intravenous blood collection, and no other blood cell separation contraindications 11. patients must take contraception measures at least 6 months after clinical trails 12. Agrees to the assessment schedule and follow-up plan and to cooperate actively 13. patients must be able to understand and voluntarily signed informed consentimmediate family members can understand and signed informed consent. 

排除标准:

(1)患者T细胞在预扩增实验中无法扩增; (2)同时具有其他难以控制的严重疾病(包括心血管系统:房颤、心绞痛、心功能Ⅲ-Ⅳ级;中枢神经系统疾病、脑血管意外或精神障碍史;肝功能:Child-pugh C级;肾功能:CKD4、5期等); (3)患者有尚未控制的严重感染,发热大于38.5°C,或正在接受全身性激素治疗; (4)患者有活动性乙肝,丙肝,HIV或者梅毒等病毒、细菌及真菌感染; (5)患者长期使用免疫抑制剂或有严重自身免疫性疾病; (6)患者有器官移植或异基因造血干细胞移植史,且术后出现显著的移植物抗宿主病(GVHD) (7)凝血功能异常、有严重血栓形成; (8)严重消化道梗阻; (9)患者对输注物和支持治疗药物过敏; (10)妊娠或哺乳期妇女(具备怀孕可能性的女性需要在细胞治疗前48小时内进行一次血清妊娠诊断,以排除怀孕); (11)近1年内有受孕计划的男性或者女性; (12)治疗前4周及治疗过程中参加其他临床研究项目的患者; (13)研究者判断其他可能影响临床研究进行及研究结果判定的情况。  

Exclusion criteria:

1. T cells of patients cannot expand in pre expansion experiments; 2. Organ failure, such as heart: atrial fibrillation, angina pectoris, cardiac function Class III and IV; liver: to Chlid grading of liver function grade C; kidney: kidney failure and uremia stage; lung: symptoms of severe respiratory failure; brain: disorder of consciousness; 3. Patients have not yet control severe infection, fever more than 38.5 degree C, or received systemic steroid therapy; 4. Patients with active viruses infection such as hepatitis b, hepatitis c, HIV, syphilis and bacteria or fungi infection; 5. Long term use of immunosuppressive drugs or people with severe autoimmune diseases; 6. Patients with significant graft versus host disease (GVHD) after organ transplant history or allogeneic hematopoietic stem cell transplantation; 7. Coagulation abnormalities and severe thrombosis; 8. Severe gastrointestinal obstruction; 9. Patients with allergic reactions to drugs for the treatment of infusion and support; 10. Pregnant or lactating women (women of childbearing age undergo a serum pregnancy diagnosis within 48 hours prior to cell treatment to exclude pregnancy; 11. Any man or woman who has a pregnancy plan within 1 year; 12. Patients who have participated in other clinical trials or other clinical trials in the past 30 days; 13. Patients with other factors are not suitable for participation considered by clinical team. 

研究实施时间:

Study execute time:

From2018-01-30To 2020-12-31 

干预措施:

Interventions:

组别:

A组

样本量:

15

Group:

Group A

Sample size:

干预措施:

CEA-CAR-T输注

干预措施代码:

 

Intervention:

CEA-CAR-T infusion

Intervention code:

组别:

B组

样本量:

15

Group:

Group B

Sample size:

干预措施:

HER2-CAR-T输注

干预措施代码:

 

Intervention:

HER2-CAR-T infusion

Intervention code:

组别:

C组

样本量:

15

Group:

Group C

Sample size:

干预措施:

CEA/HER2-CAR-T输注

干预措施代码:

 

Intervention:

CEA-HER2-CAR-T infusion

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

重庆 

市(区县):

重庆 

Country:

China 

Province:

Chongqing 

City:

Chongqing 

单位(医院):

陆军军医大学第三附属医院(野战外科研究所) 

单位级别:

三甲医院 

Institution
hospital:

The Third Hospital Affiliated To Army Medical University(Research Institute of surgery)  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

缓解率

指标类型:

主要指标 

Outcome:

Response rate

Type:

Primary indicator 

测量时间点:

 

测量方法:

 

Measure time point of outcome:

 

Measure method:

 

指标中文名:

肿瘤成像

指标类型:

主要指标 

Outcome:

Tumor imaging

Type:

Primary indicator 

测量时间点:

 

测量方法:

 

Measure time point of outcome:

 

Measure method:

 

指标中文名:

细胞因子IL-6

指标类型:

主要指标 

Outcome:

Cytokine IL-6

Type:

Primary indicator 

测量时间点:

 

测量方法:

 

Measure time point of outcome:

 

Measure method:

 

指标中文名:

细胞因子TNF-α

指标类型:

主要指标 

Outcome:

Cytokine TNF-α

Type:

Primary indicator 

测量时间点:

 

测量方法:

 

Measure time point of outcome:

 

Measure method:

 

指标中文名:

C反应蛋白

指标类型:

主要指标 

Outcome:

CRP

Type:

Primary indicator 

测量时间点:

 

测量方法:

 

Measure time point of outcome:

 

Measure method:

 

指标中文名:

CAR-T细胞体内拷贝数

指标类型:

主要指标 

Outcome:

Copy numbers of CART in vivo

Type:

Primary 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:

 

标本中文名:

肿瘤组织

组织:

 

Sample Name:

Tumor tissue

Tissue:

 

人体标本去向

使用后保存 

说明

 

Fate of sample:

Preservation 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):

非随机

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

non randomized

盲法:

 

Blinding:

 

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):

公开方式:试验完成后6个月公开;公开数据日期:预计2021年6月底;公众查询:通过上传Excel或word文件共享

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

Type of data sharing: six month after the trial finished; The date of data sharing: anticipated at the end of Jun. 2021. The way of data access: share through upload excel or word.

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:

原始记录及病例记录表,纸质版由研究者负责保存,电子版采用excel文件保存。

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

All of the original data records and case records, the paper version materials were preserved by the study leader, and the electronic version records was managed by excel.

数据管理委员会:

Data Managemen Committee:

有/Yes