A randomized controlled study on the effect of anti cancer formula II on the survival period of advanced gastric cancer

注册号:

Registration number:

ITMCTR2000002993

最近更新日期:

Date of Last Refreshed on:

2020-02-10

注册时间:

Date of Registration:

2020-02-10

注册号状态:

Registration Status:

预注册

Prospective registration

注册题目:

抗癌Ⅱ号方对晚期胃癌生存期影响随机对照研究

Public title:

A randomized controlled study on the effect of anti cancer formula II on the survival period of advanced gastric cancer

注册题目简写:

KA2SC

English Acronym:

研究课题的正式科学名称:

抗癌Ⅱ号方对晚期胃癌生存期影响随机对照研究

Scientific title:

A randomized controlled study on the effect of anti cancer formula II on the survival period of advanced gastric cancer

研究课题的正式科学名称简写:

Yin

Scientific title acronym:

研究课题代号(代码):

Study subject ID:

2019LC007

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:

ChiCTR2000029730 ; ChiMCTR2000002993

申请注册联系人:

殷晓聆

研究负责人:

殷晓聆

Applicant:

Yin Xiaoling

Study leader:

Yin Xiaoling

申请注册联系人电话:

Applicant telephone:

+86 18017122656

研究负责人电话:

Study leader's telephone:

+86 18017122656

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:

yinxiaoling2015@163.com

研究负责人电子邮件:

Study leader's E-mail:

yinxiaoling2015@163.com

申请单位网址(自愿提供):

Study leader's 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:

上海市静安区芷江中路274号

研究负责人通讯地址:

上海市静安区芷江中路274号

Applicant address:

274 Middle Zhijiang Road, Jing'an District, Shanghai

Study leader's address:

274 Middle Zhijiang Road, Jing'an District, Shanghai

申请注册联系人邮政编码:

Applicant postcode:

200071

研究负责人邮政编码:

Study leader's postcode:

200071

申请人所在单位:

上海市中医医院

Applicant's institution:

Shanghai TCM Hospital

是否获伦理委员会批准:

Approved by ethic committee:

伦理委员会批件文号:

Approved No. of ethic committee:

2019SHL-KY-36

伦理委员会批件附件:

Approved file of Ethical Committee:

View

批准本研究的伦理委员会名称:

上海市中医医院伦理委员会

Name of the ethic committee:

Ethics Committee of Shanghai Traditional Chinese Medicine Hospital

伦理委员会批准日期:

Date of approved by ethic committee:

2019/12/25 0:00:00

伦理委员会联系人:

凌丽

Contact Name of the ethic committee:

Ling Li

伦理委员会联系地址:

上海市静安区芷江中路274号

Contact Address of the ethic committee:

274 Middle Zhijiang Road, Jing'an District, Shanghai

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 021-56628310

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:

上海市中医医院

Primary sponsor:

Shanghai TCM Hospital

研究实施负责(组长)单位地址:

上海市静安区芷江中路274号

Primary sponsor's address:

274 Middle Zhijiang Road, Jing'an District, Shanghai

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

上海

市(区县):

Country:

China

Province:

Shanghai

City:

单位(医院):

上海市中医医院

具体地址:

静安区芷江中路274号

Institution
hospital:

Shanghai TCM Hospital

Address:

274 Middle Zhijiang Road, Jing'an District

经费或物资来源:

院级课题

Source(s) of funding:

Hospital

研究疾病:

胃癌

研究疾病代码:

Target disease:

gastric cancer

Target disease code:

研究类型:

Study type:

干预性研究

Interventional study

研究设计:

Study design:

随机平行对照

randomized controlled trial(parallel group design)

研究所处阶段:

Study phase:

探索性研究/预试验

Pilot clinical trial

研究目的:

1.验证抗癌Ⅱ号方对晚期胃癌患者生存期影响的有效性及安全性; 2。评价抗癌Ⅱ号对肿瘤免疫抑制微环境的干预作用。

Objectives of Study:

1. To verify the effectiveness and safety of anti-cancer formula II on the survival of patients with advanced gastric cancer; 2. To evaluate the effect of anticancer II on tumor immune suppression microenvironment.

药物成份或治疗方案详述:

Description for medicine or protocol of treatment in detail:

纳入标准:

(1)所有病例均经病理学或细胞学证实为Ⅲb、Ⅳ期胃癌患者; (2)年龄≤75岁; (3)预计生存期超过3个月; (4)一般状况KPS≧60分; (5)具有化疗适应症; (6)入选观察前应停用其他抗癌药物治疗1个月以上;之前已经过西医三线治疗方案疾病进展者; (7)病人知情,依从性好;

Inclusion criteria

(1) All cases were confirmed as stage IIIB and IV gastric cancer by pathology or cytology; (2) Aged <= 75 years old; (3) The estimated survival time is more than 3 months; (4) KPS >= 60 points; (5) Indications for chemotherapy; (6) The patients who had been treated with western medicine for more than one month should not be treated with other anticancer drugs before being selected for observation; (7) The patient was informed and had good compliance;

排除标准:

(1)未按规定用药; (2)无法判断疗效;或资料不全,影响疗效判断者; (3)合并有严重的心、肝、肾功能损害者; (4)妊娠或哺乳期妇女。

Exclusion criteria:

(1) Failing to use the medicine as required; (2) It is unable to judge the curative effect, or the data is incomplete, which affects the judgment of curative effect; (3) Patients with severe impairment of heart, liver and kidney function; (4) Pregnant or lactating women.

研究实施时间:

Study execute time:

From 2020-01-01

To      2021-12-31

征募观察对象时间:

Recruiting time:

From 2020-03-01

To      2021-10-31

干预措施:

Interventions:

组别:

试验组

样本量:

100

Group:

experimental group

Sample size:

干预措施:

抗癌二号方

干预措施代码:

Intervention:

Anti-cancer formula II

Intervention code:

组别:

对照组

样本量:

100

Group:

control group

Sample size:

干预措施:

西药治疗

干预措施代码:

Intervention:

western medicine treatment

Intervention code:

样本总量 Total sample size : 200

研究实施地点:

Countries of recruitment
and research settings:

国家:

中国

省(直辖市):

上海

市(区县):

Country:

China

Province:

Shanghai

City:

单位(医院):

上海市中医医院

单位级别:

三级甲等

Institution/hospital:

Shanghai TCM Hospital

Level of the institution:

Tertiary A

测量指标:

Outcomes:

指标中文名:

细胞免疫

指标类型:

主要指标

Outcome:

CD

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

生活质量评分

指标类型:

主要指标

Outcome:

KPS

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

中医证候

指标类型:

主要指标

Outcome:

TCM syndrome

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

疗效评定

指标类型:

主要指标

Outcome:

RECIST

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

生存期

指标类型:

主要指标

Outcome:

Survival Time

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:

征募研究对象情况:

尚未开始

Not yet recruiting

年龄范围:

最小 18
Min age years
最大 75
Max age years

Recruiting status:

Participant age:

性别:

Gender:

男女均可

Both

随机方法(请说明由何人用什么方法产生随机序列):

徐静采用SAS制定随机序列

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

Xu Jing uses SAS to make random sequence

盲法:

Not stated

Blinding:

Not stated

是否共享原始数据:

IPD sharing:

Yes

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):

2022年6月 数据查阅

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

June 2022, Data Review

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:

项目组负责CRF表格,数据有医院数据管理中心保存管理

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

The project team is responsible for CRF forms, and the data is stored and managed by the hospital data management center

数据管理委员会:

Data Managemen Committee:

Yes

研究计划书或研究结果报告发表信息
(杂志名称、期、卷、页,时间;或网址):

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

ITMCTR BJ-ICP:07032215-5 Tip: IE8 is recommended Use the system with widescreen display resolution above