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Clinical study of the traditional Chinese medicine wenyangtongluo formula combined with toripalimab plus apatinib and tegio as the third line for advanced gastric cancer

注册号：

Registration number：

ITMCTR2200005508

最近更新日期：

Date of Last Refreshed on：

2022-01-07

注册时间：

Date of Registration：

2022-01-07

注册号状态：

Registration Status：

预注册

Prospective registration

注册题目：

中药温阳通络方联合特瑞普利单抗+阿帕替尼+替吉奥三线治疗晚期胃癌的临床观察

Public title：

Clinical study of the traditional Chinese medicine wenyangtongluo formula combined with toripalimab plus apatinib and tegio as the third line for advanced gastric cancer

注册题目简写：

English Acronym：

研究课题的正式科学名称：

中药温阳通络方联合特瑞普利单抗+阿帕替尼+替吉奥三线治疗晚期胃癌的临床观察

Scientific title：

Clinical study of the traditional Chinese medicine wenyangtongluo formula combined with toripalimab plus apatinib and tegio as the third line for advanced gastric cancer

研究课题的正式科学名称简写：

Scientific title acronym：

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：

ChiCTR2200055330 ; ChiMCTR2200005508

申请注册联系人：

许雯雯

研究负责人：

张锋利

Applicant：

Wenwen Xu

Study leader：

Fengli Zhang

申请注册联系人电话：

Applicant telephone：

18709851637

研究负责人电话：

Study leader's telephone：

15156992099

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：

2192784612@qq.com

研究负责人电子邮件：

Study leader's E-mail：

zfl8510@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：

安徽医科大学第一附属医院高新院区6号楼19楼

研究负责人通讯地址：

安徽医科大学第一附属医院高新院区6号楼19楼

Applicant address：

19th Floor, Building 6, High-tech District, The First Affiliated Hospital of Anhui Medical University

Study leader's address：

19th Floor, Building 6, High-tech District, The First Affiliated Hospital of Anhui Medical University

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：

安徽中医药大学

Applicant's institution：

Anhui University of Traditional Chinese Medicine

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：

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：

2013/8/26 0:00:00

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：

安徽医科大学第一附属医院高新院区中西医结合肿瘤科

Primary sponsor：

Department of Oncology of Integrated Traditional Chinese and Western Medicine, High-tech Campus, First Affiliated Hospital of Anhui

研究实施负责（组长）单位地址：

安徽省合肥市蜀山区高新技术产业开发区安徽医科大学第一附属医院高新院区

Primary sponsor's address：

High-tech District, The First Affiliated Hospital of Anhui Medical University, Shushan District, Hefei City, Anhui Province

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

安徽

市(区县)：

合肥

Country：

China

Province：

Anhui

City：

Hefei

单位(医院)：

安徽医科大学第一附属医院

具体地址：

安徽省合肥市蜀山区高新技术产业开发区安徽医科大学第一附属医院高新院区

Institution
hospital：

The First Affiliated Hospital of Anhui Medical University

Address：

High-tech District, The First Affiliated Hospital of Anhui Medical University, Shushan District, Hefei City, Anhui Province

经费或物资来源：

安徽医科大学第一附属医院高新院区中西医结合肿瘤科

Source(s) of funding：

Department of Oncology of Integrated Traditional Chinese and Western Medicine, High-tech Campus, First Affiliated Hospital of Anhui Medical University

研究疾病：

胃癌

研究疾病代码：

Target disease：

Stomach cancer

Target disease code：

研究类型：

Study type：

观察性研究

Observational study

研究设计：

Study design：

非随机对照试验

Non randomized control

研究所处阶段：

Study phase：

探索性研究/预试验

Pilot clinical trial

研究目的：

晚期胃癌预后差，三线治疗疗效有限，从联合治疗机制及本科室前期临床观察结果来看，中药温阳通络方联合PD-1特瑞普利单抗联合小分子血管内皮生长因子（VEGF）受体抑制剂阿帕替尼及替吉奥化疗可能为晚期胃癌的三线治疗带来突破。探索中药温阳通络方联合特瑞普利单抗联合阿帕替尼及替吉奥三线治疗晚期胃癌的疗效及安全性，有可能给晚期胃癌患者的三线治疗提供新的选择，为今后提高晚期胃恶性肿瘤临床疗效和改善晚期胃恶性肿瘤患者的生活质量奠定基础。因此，开展本项研究具有重要的现实意义。

Objectives of Study：

The prognosis of advanced gastric cancer is poor, and the efficacy of third-line treatment is limited. From the combined treatment mechanism and the clinical observation results of the undergraduate room, the traditional Chinese medicine Wenyang Tongluo Decoction combined with PD-1 teriprizumab combined with small molecule vascular endothelial growth factor (VEGF) receptor Inhibitors apatinib and tigio chemotherapy may bring breakthroughs in the third-line treatment of advanced gastric cancer. To explore the efficacy and safety of the traditional Chinese medicine Wenyang Tongluo Prescription combined with teriprizumab in combination with apatinib and tigio in the third-line treatment of advanced gastric cancer. It may provide new options for the third-line treatment of patients with advanced gastric cancer and improve the future of advanced gastric cancer. The clinical efficacy of malignant tumors and the improvement of the quality of life of patients with advanced gastric malignant tumors lay the foundation. Therefore, carrying out this research has important practical significance.

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)根据国际胃癌研究协会和美国癌症分类联合委员会第 8 版胃癌 TNM 分期，具有组织病理学或细胞学诊断为晚期胃癌IV 期患者； (2)年龄在18~75岁之间； (3)已接受过两种化疗方案治疗失败后的三线治疗患者，根据 RECIST 1.1 标准证实一、二线治疗失败或不能耐受； (4)KPS评分大于60分；预计生存期超过3月； (5)无明显血液系统疾病征象，无出血倾向；无严重的肝肾功能损害； (6)入选试验前2周内完成影像学检查作为基础资料； (7)病人知情,依从性好,签署知情同意书者。

Inclusion criteria

(1) According to the 8th edition of the TNM staging of gastric cancer by the International Association for Gastric Cancer Research and the Joint Committee on Cancer Classification of the United States, patients with histopathological or cytological diagnosis of advanced gastric cancer stage IV; (2) Between 18 and 75 years old; (3) Third-line treatment patients who have received two chemotherapy regimens after treatment failure, according to the RECIST 1.1 standard proved that the first and second-line treatment failed or were intolerable; (4) The KPS score is greater than 60 points; the expected survival period is more than 3 months; (5) No obvious signs of blood system disease, no bleeding tendency; no serious liver and kidney damage; (6) Complete the imaging examination within 2 weeks before the selected trial as the basic data; (7) The patient is informed, has good compliance, and has signed an informed consent.

排除标准：

(1)不符合纳入标准； (2)妊娠或哺乳期妇女； (3)中医辨证为非“阳虚毒滞证”患者； (4)严重的肝、肾及造血系统功能不全、精神病患者； (5)伴有其他恶性或不可控制的疾病，定义如下： ·进入研究前 6 个月患心肌梗死、不稳定型心绞痛或充血性心力衰竭； ·存在需要临床治疗的不稳定的心律失常； ·存在难以控制的感染； ·慢性阻塞性肺疾病恶化或者存在需住院治疗的其他呼吸系统疾病； ·糖尿病控制不佳（空腹血糖（FBG）＞10mmol/L）； ·尿常规提示尿蛋白≥++，且证实24小时尿蛋白定量＞1.0 g者； ·活动性肺结核等； (6)正在接受其他临床研究药物治疗或其他临床试验的患者； (7)已知对特瑞普利单抗、阿帕替尼、替吉奥药物过敏者； (8)研究者认为患者不宜参加本试验的其它情况。

Exclusion criteria：

(1) Does not meet the inclusion criteria; (2) Pregnant or lactating women; (3) TCM syndrome differentiation is for patients with non-"Yang deficiency and toxin stagnation syndrome"; (4) Patients with severe liver, kidney and hematopoietic system dysfunction, and mental illness; (5) Accompanied by other malignant or uncontrollable diseases, defined as follows: · Suffered from myocardial infarction, unstable angina or congestive heart failure 6 months before entering the study; · There is an unstable arrhythmia that requires clinical treatment; · There are infections that are difficult to control; ·Chronic obstructive pulmonary disease worsens or there are other respiratory diseases that require hospitalization; · Diabetes is poorly controlled (fasting blood glucose (FBG)> 10mmol/L); ·Urine routines suggest that urine protein is ≥++, and the 24-hour urine protein quantitative is confirmed to be greater than 1.0 g; · Active tuberculosis, etc.; (6) Patients who are receiving other clinical research drug treatments or other clinical trials; (7) Those who are known to be allergic to teriprizumab, apatinib, and ticgio drugs; (8) Other situations in which the investigator believes that the patient should not participate in this trial.

研究实施时间：

Study execute time：

从From 2022-02-01

至To      2023-12-01

征募观察对象时间：

Recruiting time：

从From 2022-02-01

至To      2022-08-01

干预措施：

Interventions：

组别：

对照组

样本量：

30

Group：

Control group

Sample size：

干预措施：

中药温阳通络方+特瑞普单抗+阿帕替尼+替吉奥

干预措施代码：

Intervention：

Teripuzumab+Apatinib+Tigio

Intervention code：

组别：

观察组

样本量：

30

Group：

Observation group

Sample size：

干预措施：

中药温阳通络方+特瑞普单抗+阿帕替尼+替吉奥

干预措施代码：

Intervention：

Traditional Chinese Medicine Wenyang Tongluo Recipe+Teripuzumab+Apatinib+Tigio

Intervention code：

样本总量 Total sample size ： 60

研究实施地点：

Countries of recruitment
and research settings：

国家：

中国

省(直辖市)：

安徽

市(区县)：

合肥

Country：

China

Province：

Anhui

City：

Hefei

单位(医院)：

安徽医科大学第一附属医院

单位级别：

三级甲等

Institution/hospital：

The First Affiliated Hospital of Anhui Medical University

Level of the institution：

Level 3 Class A

测量指标：

Outcomes：

指标中文名：

肿瘤标志物

指标类型：

主要指标

Outcome：

Tumor markers

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

肿瘤大小

指标类型：

主要指标

Outcome：

Tumor size

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：

正在进行

Recruiting

年龄范围：

最小 岁
Min age years
最大 岁
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）：

研究负责人使用随机数字表法将60患者随机分配至两组中

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

The study leader used a random number table method to randomly assign 60 patients to two groups

盲法：

Blinding：

是否共享原始数据：

IPD sharing：

是

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）：

无

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

no

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：

受试者原始资料册

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

Subject's original data book

数据管理委员会：

Data Managemen Committee：

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):

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