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A prospective, open and controlled clinical study of traditional Chinese medicine (Astragalus / Panax notoginseng) combined with a new oncolytic vaccine in the treatment of Recurrent or Metastatic Colorectal Cancer

注册号：

Registration number：

ITMCTR2000003898

最近更新日期：

Date of Last Refreshed on：

2020-09-08

注册时间：

Date of Registration：

2020-09-08

注册号状态：

Registration Status：

预注册

Prospective registration

注册题目：

中药（黄芪/三七）联合新型溶瘤疫苗治疗复发、转移结直肠癌的前瞻性、开放、对照临床研究

Public title：

A prospective, open and controlled clinical study of traditional Chinese medicine (Astragalus / Panax notoginseng) combined with a new oncolytic vaccine in the treatment of Recurrent or Metastatic Colorectal Cancer

注册题目简写：

English Acronym：

研究课题的正式科学名称：

中药（黄芪/三七）联合新型溶瘤疫苗治疗复发、转移结直肠癌的前瞻性、开放、对照临床研究

Scientific title：

A prospective, open and controlled clinical study of traditional Chinese medicine (Astragalus / Panax notoginseng) combined with a new oncolytic vaccine in the treatment of Recurrent or Metastatic Colorectal 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：

ChiCTR2000037982 ; ChiMCTR2000003898

申请注册联系人：

杜阳峰

研究负责人：

肖泽民

Applicant：

Yangfeng Du

Study leader：

Zemin Xiao

申请注册联系人电话：

Applicant telephone：

+86 13762600981

研究负责人电话：

Study leader's telephone：

+86 13342566660

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：

dyfer1982@126.com

研究负责人电子邮件：

Study leader's E-mail：

xiaozm2003@qq.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：

湖南省常德市人民路818号

研究负责人通讯地址：

湖南省常德市人民路818号

Applicant address：

818 Renmin Road, Changde, Hunan

Study leader's address：

818 Renmin Road, Changde, Hunan

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：

常德市第一人民医院

Applicant's institution：

The First People's Hospital of Changde City

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：

2020-112-01

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：

常德市第一人民医院伦理委员会

Name of the ethic committee：

Medical Ethics Committee of the First People's Hospital of Chang De City

伦理委员会批准日期：

Date of approved by ethic committee：

2020/8/27 0:00:00

伦理委员会联系人：

周述香

Contact Name of the ethic committee：

Shuxiang Zhou

伦理委员会联系地址：

湖南省常德市人民路818号

Contact Address of the ethic committee：

818 Renmin Road, Changde, Hunan

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：

常德市第一人民医院

Primary sponsor：

The First People's Hospital of Changde City

研究实施负责（组长）单位地址：

湖南省常德市人民路818号

Primary sponsor's address：

818 Renmin Road, Changde, Hunan

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

湖南

市(区县)：

常德

Country：

China

Province：

Hunan

City：

Changde

单位(医院)：

常德市第一人民医院

具体地址：

人民路818号

Institution
hospital：

The First People's Hospital of Chang De City

Address：

818 Renmin Road

经费或物资来源：

国家科技重大专项重大新药创新项目

Source(s) of funding：

Major new drug innovation projects of major national science and technology projects

研究疾病：

结直肠癌

研究疾病代码：

Target disease：

colorectal cancer

Target disease code：

研究类型：

Study type：

干预性研究

Interventional 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：

观察中药（黄芪/三七）联合新型溶瘤疫苗治疗复发及转移结直肠癌的安全性及有效性。

Objectives of Study：

To observe the safety and efficacy of traditional Chinese medicine (Astragalus / Panax notoginseng) combined with a new oncolytic vaccine in the treatment of Recurrent or Metastatic Colorectal Cancer.

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)自愿参加临床研究；完全了解、知情本研究并签署知情同意书；愿意遵循并有能力完成所有试验程序； 2)年龄 18 至 75 岁（含 18 岁和 75 岁）的男性和女性； 3)经组织学证实的结直肠癌患者； 4)经影像学证实的经过三线标准治疗后进展的复发或转移结直肠癌患者和经影像学证实的经过二线标准治疗后进展但拒绝三项标准治疗的复发或转移结直肠癌患者； 5)按照 RECIST 1.1 标准至少存在一个可测量病灶，即根据 CT 横断面影像或 MRI 非淋巴结病灶长径≥ 10 mm，或淋巴结病灶短径≥ 15 mm； 6)美国东部肿瘤协作组（ECOG）体力状态评分为 0 至 1 分； 7)预计生存期不少于 12 周； 8)器官功能和造血功能必须符合以下要求：血红蛋白（HGB）≥ 80g/L；白细胞计数（WBC）≥ 3×10^9/L；中性粒细胞绝对计数（ANC）≥ 1.5×10^9/L；血小板计数（PLT）≥ 80×10^9/L；总胆红素（TBIL）≤ 1.5×正常值上限（ULN）；天冬氨酸氨基转移酶（AST）和丙氨酸氨基转移酶（ALT）≤2.5×ULN；若肝功能异常是由于肿瘤肝转移所致，AST 和 ALT ≤5×ULN；血清肌酐（Cr）≤ 1.5×ULN；或肌酐清除率(CrCl) ≥50 mL/min；国际标准化比率（INR）或血浆凝血酶原时间（PT）≤ 1.5×ULN。 9)育龄期女性受试者必须同意在签署知情同意后、研究期间及最后一次给药后 5 个月内采取有效的避孕措施。 10)能合作观察不良事件和疗效。 11)治疗开始前、治疗过程中、治疗后进行CTC检查，治疗前后完成PET-CT检查。

Inclusion criteria

1）Willingness to participate in the clinical trial; completely understanding and knowing about the study and signing the ICF; willingness and capability to comply with the requirements of the study. 2）Female and male aged from 18 to 75 years (margin included). 3）Colorectal cancer patients with histologically confirmed . 4）Recurrent or metastatic colorectal cancer patients who progress after receiving >= 3 standard treatment or colorectal cancer patients after receiving >= 2 standard treatment and refuse to accept the third line standard treatment 5）Based on RECIST 1.1, at least one measurable lesions, i.e. an extranodal lesion >= 10 mm in the longest diameter of cross-sectional areas or a lymph node lesion >= 15 mm in the shortest diameter of cross-sectional areas in CT or MRI test. 6）Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. 7）Life expectancy >= 12 weeks. 8）Organ and hematopoietic function as defined below: Hemoglobin (HGB) >= 80 g/L; White blood cell (WBC) >= 3 x 10^9/L; Absolute neutrophil count (ANC) >= 1.5 x 10^9/L; Platelets (PLT) >= 100 x 10^9/L; Total bilirubin <= 1.5 x upper limit of normal (ULN); AST and ALT <= 2.5 x ULN or, for hepatic dysfunction due to liver metastases, <= 5 x ULN; Serum creatinine (Cr) <= 1.5 x ULN or a creatinine clearance (CrCl) >= 50 mL/min; International normalized ratio (INR) or activated partial thromboplastin time (aPTT) <= 1.5 x ULN; 9）Female patients of childbearing potential should be willing to birth control after ICF signing, the course of the study, and 5 months after the last dose of study medication. 10）Can cooperate to observe adverse events and curative effect. 11) The circulating tumor cells were examined before, during and after treatment, and PET-CT examination was completed before and after treatment.

排除标准：

1）研究治疗开始前 4 周内接受过其他抗肿瘤治疗（包括化疗、分子靶向治疗、放疗、免疫治疗、单克隆抗体治疗），或参与其他未上市药物临床研究的； 2)已知受试者既往对任何试验药物组成成分过敏者； 3)妊娠或哺乳期妇女； 4)有活动性自身免疫性疾病且在过去 2 年内接受系统治疗（如皮质类固醇或免疫抑制药物）（如以下，但不局限于：葡萄膜炎，肠炎，肝炎，垂体炎，血管炎，肾炎，甲状腺功能亢进，甲状腺功能减退[无临床症状的甲减或放化疗导致的甲减可纳入]；受试者患有白癜风或在童年期哮喘已完全缓解，成人后无需任何干预的可纳入）者； 5)入组前 14 天内或研究期间需要接受全身用皮质类固醇（剂量相当于或高于 10 mg/天强的松）或其他免疫抑制药物治疗者； 6)有脑膜转移或有症状的中枢神经系统转移者； 7)治疗开始前 4 周内接受了活疫苗接种者； 8)接受过抗肿瘤疫苗者，或接受具有全身免疫刺激作用的抗肿瘤治疗者； 9)伴有严重的内科疾病，如严重感染、不能控制的糖尿病、心血管疾病（纽约心脏病协会分级定义的Ⅲ级或Ⅳ级心衰、Ⅱ度以上心脏传导阻滞、过去 6 个月内发生心肌梗塞、不稳定性心律失常或不稳定性心绞痛、3 个月内发生脑梗塞等）或肺部疾病（间质性肺炎、阻塞性肺病和有症状的支气管痉挛病史）者； 10)乙肝表面抗原（HBsAg）阳性和/或乙肝核心抗体（HBcAb）阳性且乙肝病毒的脱氧核糖核酸（HBV DNA）>103 拷贝数/ml 者，或丙型肝炎病毒抗体阳性者；梅毒阳性者； 11)有感染人类免疫缺陷病毒病史，或患有其他获得性、先天性免疫缺陷疾病； 12)入组前 1 年内有活动性结核感染病史者； 13)在入组前 5 年内罹患其他恶性肿瘤者，除外既往已治愈的任何类型原位癌以及痊愈的皮肤基底细胞癌或皮肤鳞癌; 14)既往接受过异体造血干细胞移植或实体器官移植； 15)研究治疗开始前 4 周内进行过大的外科手术（基线肿瘤活检除外）或发生严重创伤； 16)近 1 年内有酗酒，吸毒或药物滥用史； 17)既往有明确的神经或精神障碍史，如癫痫、痴呆，依从性差者； 18)可能增加参与研究和研究用药风险、或者可能会干扰研究结果解释的其他重度、急性、或慢性疾病或实验室异常情况； 19)研究者认为由于其他原因不适合参加该研究者；

Exclusion criteria：

1)Prior anti-tumor therapy,(including chemotherapy, targeted small molecule therapy , radiotherapy, immunotherapy, mAb therapy) , or treatment with investigational products having not been launched onto the market in China in other clinical trials within 4 weeks prior to the first dose. 2)A past history of allergic reactions attributed to any macromolecular protein preparation/monoclonal antibody, or any other composition of the investigational product. 3)Pregnancy or lactation. 4)Patients with any autoimmune disease and received systemic therapy within 2 years (i.e. corticosteroids or immunosuppressive medications) [i.e.,but not limited to, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism (hypothyroidism without clinical symptoms or caused by radiotherapy and chemotherapy can be included), patients with vitiligo or asthma CR in Childhood, not requiring any intervention in adulthood are permitted to enroll; patients with asthma requiring a bronchiectasis intervention are not permitted to enroll]. 5)Subjects that requires systemic corticosteroids (dose equivalent to or above 10 mg prednisone daily) or other immunosuppressive medications within 14 days prior to enrollment or for the course of the study. 6)Patients with known active central nervous system (CNS) metastases and/or carcinomatous meningitis. 7)Having received a live vaccine within 4 weeks prior to the first dose of investigational drug. 8)Having received a live anti-tumor vaccine, or anti-tumor treatment with immunostimulation. 9)Serious medical illness, such as severe infections, uncontrollable diabetes mellitus, cardiovascular diseases (i.e., grade 3 or 4 congestive heart failure (New York Heart Association (NYHA)), >= grade 2 heart block, myocardial infarction, uncontrolled arrhythmias, or unstable angina within 6 months prior to screening, and cerebral infarction within 3 months prior to screening) or lung diseases (i.e. interstitial pneumonia, obstructive pulmonary disease and symptomatic bronchospasm). 10)Patients with positive HBsAg and/or positive HBcAb with positive hepatitis B virus DNA > 103 copies/mL, or positive hepatitis C virus antibody; or positive syphilis. 11)A known history of human immunodeficiency virus (HIV) infection, or other acquired and congenital immune deficiency diseases. 12)A known history of active tuberculosis within 1 year prior to the first dose of investigational drug. 13)Presence of other malignant cancers within 5 years prior to enrollment. Patients with cured carcinoma in situ and cured skin basal cell carcinoma or cutaneous squamous cell carcinoma are eligible. 14)Having undergone allogeneic hematopoietic stem cell transplantation or solid organ transplantation. 15)Having undergone major surgery (with the exception of baseline tumor biopsy), or serious trauma within 4 weeks prior to the first dose of therapy. 16)A history of alcoholism or drug abuse within 1 year. 17)A clear history of neurological or mental disorders, i.e. epilepsy, dementia, and poor compliance 18)Patients with other severe, acute or chronic disease that might increase risk of study drug use and participation, or laboratory abnormality that might confound the results of the trial. 19)Subjects not eligible for the study for other reasons, evaluated by the investigator.

研究实施时间：

Study execute time：

从From 2020-09-07

至To      2022-09-01

征募观察对象时间：

Recruiting time：

从From 2020-09-07

至To      2022-09-01

干预措施：

Interventions：

组别：

Group 1

样本量：

25

Group：

Group 1

Sample size：

干预措施：

新型溶瘤疫苗

干预措施代码：

Intervention：

the new oncolytic vaccine

Intervention code：

组别：

Group2

样本量：

25

Group：

Group2

Sample size：

干预措施：

中药（黄芪/三七）联合新型溶瘤疫苗

干预措施代码：

Intervention：

traditional Chinese medicine (A stragalus / Panax notoginseng)combined with the new oncolytic vaccine

Intervention code：

样本总量 Total sample size ： 50

研究实施地点：

Countries of recruitment
and research settings：

国家：

中国

省(直辖市)：

湖南

市(区县)：

常德

Country：

China

Province：

Hunan

City：

Changde

单位(医院)：

常德市第一人民医院

单位级别：

三级甲等

Institution/hospital：

The First People's Hospital of Changde City

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

总生存期

指标类型：

次要指标

Outcome：

OS

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

生存质量

指标类型：

次要指标

Outcome：

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：

症状缓解率

指标类型：

次要指标

Outcome：

Symptom relief rate

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

肿瘤进展时间

指标类型：

次要指标

Outcome：

TTP

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

客观缓解率

指标类型：

主要指标

Outcome：

Objective 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：

安全性指标

指标类型：

主要指标

Outcome：

Safety index

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

疾病控制率

指标类型：

次要指标

Outcome：

DCR

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：

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）：

非随机对照

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

Non Randomized Controlled trial

盲法：

开放

Blinding：

open-label

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）：

科技部网站

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

http://www.most.gov.cn/

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：

数据采集 研究病历为最原始记录，必须妥善保存。本研究采用电子病例报告表进行数据的采集。病例报告表来自研究病历，由研究者完成。每个筛选和入选病例必须完成病例报告表。研究者将确保数据采集的准确性和可靠性。所有数据都将采用基于因特网的电子CRF加以记录，在线自动检查数据的完整性。输入用户名和密码后可获取研究数据，用户应严格保密自己的密码。服务器和用户个人电脑之间的电子通讯是加密的，不会传输被保护的数据(患者姓名、地址、身份证号等)。对于研究数据的所有更改，可获得完整的审核跟踪。实验室数据将采用取决于中心和性别的正常值范围加以确认。描述性和逻辑性数据检查在不断完善的数据库中进行，任何不合理或不一致的数据输入将告知研究单位和/或监查人员，由研究单位的工作人员加以解释和纠正。研究者必须对患者毒性反应分级及肿瘤疗效反应作出决定，而主要研究者应该对诊断作出最后判断。在研究过程中，研究者应允许申办方的监查人员或代表到研究机构检查研究相关文件(如病人知情同意书、研究药物清点表、伦理委员会的批准文件)。监查人员到访时会对病人的档案进行严格审阅，以核对记录在病例报告表(CRF)的信息，尤其是安全性和疗效有关的关键信息和病人的原始记录是否吻合。 数据管理 1、管理 （1）建立数据管理委员会，招聘熟练计算机操作人员组建数据管理委员会，由本课题组成员担任组长，其余数据管理人员均对该研究方案不知情。 （2）数据保存与录入所有受试者数据及量表资料由DDC组员进行电脑录入，将原始资料全部录入保存在课题数据库，该数据库录入内容与原始资料保持一致。纸质资料专人管理。 （3）数据质控与备份课题组成员定期对录入数据进行质控，及时报告、记录数据缺失项，对明显错误数据重新核对、校准。定期导出、备份数据至物理存储装置，专人保管，防治数据库损坏。

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

data acquisition The research medical record is the most original record and must be kept properly. In this study, electronic case report form was used to collect data. The case report form is from the study medical record and completed by the investigator. The case report form must be completed for each screened and selected case. Researchers will ensure the accuracy and reliability of data collection. All data will be recorded by Internet based electronic CRF, and the integrity of data will be checked automatically online. After entering the user name and password, the research data can be obtained, and the user should keep his password strictly confidential. The electronic communication between the server and the user's personal computer is encrypted, and the protected data (patient name, address, ID number, etc.) will not be transmitted. A complete audit trail is available for all changes to study data. Laboratory data will be confirmed using a range of normal values depending on the center and gender. Descriptive and logical data check is carried out in the constantly improved database. Any unreasonable or inconsistent data input will be informed to the research unit and / or the inspector, and the staff of the research unit will explain and correct it. The researchers must make a decision on the classification of toxic reactions and the response of tumor efficacy, and the main researchers should make a final judgment on the diagnosis. During the research process, the investigator shall allow the sponsor's inspectors or representatives to inspect the research related documents (such as the informed consent of patients, the inventory of research drugs, and the approval documents of the ethics committee) in the research institution. During the visit, the inspectors will strictly review the patient's files to check whether the information recorded in the CRF, especially the key information related to safety and efficacy, is consistent with the original record of the patient. data management 1, management (1) Establish a data management committee, recruit skilled computer operators to establish a data management committee, with the members of the research group as the team leader, and the rest of the data management personnel are unaware of the research scheme. (2) Data saving and inputting all subjects' data and scale data shall be input by DDC team members by computer, and all the original data shall be input and saved in the subject database, and the input content of the database shall be consistent with the original data. Paper materials shall be managed by special personnel. (3) The members of the data quality control and backup research group regularly control the input data, timely report and record the missing items of the data, and recheck and calibrate the obviously wrong data. Regularly export and backup the data to the physical storage device, and assign special personnel to keep it to prevent database damage.

数据管理委员会：

Data Managemen Committee：

有

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):

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