中国临床试验注册中心 - 世界卫生组织国际临床试验注册平台一级注册机构

注册号： Registration number：	ChiCTR2400080963
最近更新日期： Date of Last Refreshed on：	2024-02-19 15:43:21
注册时间： Date of Registration：	2024-02-19 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	乙肝相关肝癌基于槲芪癥消方的全病程中西医结合诊疗临床新方案及临床能力提升研究
Public title：	A new clinical program of integrated Chinese and Western medicine diagnosis and treatment of hepatitis B-related liver cancer based on Huqizhengxiao (HQZX) formula in the whole course of the disease and the enhancement of clinical ability research
注册题目简写：
English Acronym：
研究课题的正式科学名称：	乙肝相关肝癌基于槲芪癥消方的全病程中西医结合诊疗临床新方案及临床能力提升研究
Scientific title：	A new clinical program of integrated Chinese and Western medicine diagnosis and treatment of hepatitis B-related liver cancer based on Huqizhengxiao (HQZX) formula in the whole course of the disease and the enhancement of clinical ability research
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：	郑小勤	研究负责人：	汪晓军
Applicant：	Xiaoqin Zheng	Study leader：	Xiaojun Wang
申请注册联系人电话： Applicant telephone：	+86 151 1018 7939	研究负责人电话： Study leader's telephone：	+86 137 1821 7343
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：	xiaoqin.zheng@ccmu.edu.cn	研究负责人电子邮件： Study leader's E-mail：	w_xiaojun@ccmu.edu.cn
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：	北京市丰台区右安门外西头条8号	研究负责人通讯地址：	北京市丰台区右安门外西头条8号
Applicant address：	No. 8, Xitoutiao, Youanmenwai, Fengtai District, Beijing City	Study leader's address：	No. 8, Xitoutiao, Youanmenwai, Fengtai District, Beijing City
申请注册联系人邮政编码： Applicant postcode：	100069	研究负责人邮政编码： Study leader's postcode：	100069
申请人所在单位：	首都医科大学附属北京佑安医院
Applicant's institution：	Beijing Youan Hospital, Capital Medical University
研究负责人所在单位：	首都医科大学附属北京佑安医院
Affiliation of the Leader：	Beijing Youan Hospital, Capital Medical University

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：	京佑科伦字[2024]004号	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：	首都医科大学附属北京佑安医院伦理委员会
Name of the ethic committee：	The Ethics Committee of Beijing Youan Hospital,Affiliated to Capital Medical University
伦理委员会批准日期： Date of approved by ethic committee：	2024-01-08 00:00:00
伦理委员会联系人：	孟莎
Contact Name of the ethic committee：	Sha Meng
伦理委员会联系地址：	北京市丰台区右安门外西头条8号
Contact Address of the ethic committee：	No. 8, Xitoutiao, Youanmenwai, Fengtai District, Beijing City
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 10 8399 7028	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：

首都医科大学附属北京佑安医院

Primary sponsor：

Beijing Youan Hospital, Capital Medical University

研究实施负责（组长）单位地址：

北京市丰台区右安门外西头条8号

Primary sponsor's address：

No. 8, Xitoutiao, Youanmenwai, Fengtai District, Beijing City

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：	中国	省(直辖市)：	北京	市(区县)：
Country：	China	Province：	Beijing	City：
单位(医院)：	首都医科大学附属北京佑安医院	具体地址：	北京市丰台区右安门外西头条8号
Institution hospital：	Beijing Youan Hospital, Capital Medical University	Address：	No. 8, Xitoutiao, Youanmenwai, Fengtai District, Beijing City

经费或物资来源：

北京市医院管理中心

Source(s) of funding：

Beijing Hospitals A

研究疾病：

原发性肝癌

Target disease：

Hepatocellular carcinoma

研究疾病代码：

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

其它

Study phase：

N/A

研究设计：

随机平行对照

Study design：

Parallel

研究目的：

1.基于本项目研究的成果及“十二五”、“十三五”课题中已有的肝癌治疗方案，优化形成基于槲芪癥消方的原发性肝癌全病程中西医结合治疗新模式，通过形成全面、规范的中医与西医，内科与介入科、外科、放射科等多学科协同诊疗，推动乙肝相关肝癌中西医结合临床诊疗能力的提升。 2.针对乙肝相关肝癌患者行肝癌介入消融治疗、肝癌部分切除术后可能出现的各种并发症、不良反应，形成基于槲芪癥消方的乙肝相关肝癌各种术后并发症、不良反的辨证调理。 3.针对乙肝相关肝癌患者行肝癌介入消融治疗、肝癌部分切除术后可能出现各种目前无有效缓解方法的主观不适，形成基于槲芪癥消方的乙肝相关肝癌术后长期康复治疗的辨证调理。 4.申请槲芪癥消方专利，并在国内广泛推广应用。 5.改进现有的乙肝相关肝癌患者对于治疗方案先入为主的、分散的诊疗模式，制定新的《乙肝相关肝癌基于槲芪癥消方的全病程中西医综合诊疗指南》。以本项目为依托，通过专科培训、临床理论知识系统学习、实操能力训练、科研素质培养等多种途径，形成较高质量的肝癌相关临床复合型人才的长期培养计划，形成较合理的、较完善的肝癌中西医综合诊疗人才梯队。

Objectives of Study：

1. Based on the results of this project and the existing HCC treatment plans in the 12th and 13th Five-Year Plans, optimize the formation of a new model of combined Chinese and Western medicine treatment for the whole course of HCC based on the Huqizhengxiao (HQZX) formula, and promote the improvement of the clinical diagnosis and treatment capacity of hepatitis B-related HCC through the formation of comprehensive and standardized multidisciplinary synergistic diagnosis and treatment of Chinese medicine and Western medicine, internal medicine and intervention, surgery and radiology. Through the formation of comprehensive and standardized multidisciplinary synergistic diagnosis and treatment between TCM and Western medicine, internal medicine and interventional medicine, surgery, radiology and other disciplines, the clinical diagnosis and treatment capacity of hepatitis B-associated hepatocellular carcinoma with TCM and Western medicine will be improved. 2. For the various complications and adverse reactions that may occur after interventional ablation therapy and partial resection of hepatocellular carcinoma in hepatitis B-related hepatocellular carcinoma patients, to form the identification and regulation of postoperative complications and adverse reactions of hepatocellular carcinoma related to hepatitis B based on the Huqizhengxiao (HQZX) formula. 3. For hepatitis B-related HCC patients who may suffer from various subjective discomforts after interventional ablation therapy for liver cancer and partial resection of liver cancer, form the identification and regulation of long-term postoperative rehabilitation therapy for hepatitis B-related liver cancer based on the Huqizhengxiao (HQZX) formula. 4. Apply for the patent of the Huqizhengxiao (HQZX) formula, and widely popularize its application in China. 5. Improve the existing preconceived and decentralized diagnosis and treatment model for hepatitis B-related HCC patients, and formulate the new "Integrated diagnosis and treatment guideline of hepatitis B-related HCC based on the Huqizhengxiao (HQZX) formula in the whole course of disease". Relying on this project, a long-term training program for high-quality liver cancer-related clinical complex talents will be formed through specialized training, systematic learning of clinical theoretical knowledge, training of practical skills, and cultivation of scientific research qualities, so as to form a more reasonable and complete talent ladder for comprehensive diagnosis and treatment of hepatocellular carcinoma with Chinese and Western medicines.

药物成份或治疗方案详述：

Description for medicine or protocol of treatment in detail：

纳入标准：

Inclusion criteria

排除标准：

1）妊娠或哺乳期妇女； 2）合并人免疫缺陷病毒（HIV）感染或其他严重感染性疾病； 3）并发严重心肺疾病、糖尿病、原发性肾脏疾病、多器官功能衰竭者、其他严重的全身性疾病和精神病患者； 4）合并活动性肝炎或严重感染且不能同时治疗者； 5）预期生存期＜3个月者； 6）除乙肝病毒以外其余原因所致的肝硬化、肝癌者； 7）严重的肝动脉-门静脉瘘或肝动脉-肝静脉且不易栓塞封堵者； 8）对碘过敏或其余原因无法完善增强CT或MRI者； 9）目前活动性消化道出血者，或近2周内有消化道出血史者； 10）合并其他恶性肿瘤患者； 11）应用其他具有治疗肝癌适应证的现代中药制剂（包括但不限于：康莱特注射液/软胶囊、艾迪注射液、康艾注射液、榄香烯注射液、华蟾素胶囊、肝复乐、槐耳颗粒等）； 12）不签署知情同意书； 13）研究者认为不适合参加研究的其他情况。

Exclusion criteria：

1) Pregnant or breastfeeding women. 2) Comorbid human immunodeficiency virus (HIV) infection or other serious infectious diseases; 3) Those with comorbid severe cardiopulmonary disease, diabetes, primary kidney disease, multiple organ failure, other serious systemic diseases, and psychiatric patients; 4) Those with coexisting active hepatitis or serious infections that cannot be treated at the same time; 5) Those with expected survival <3 months; 6) those with cirrhosis and hepatocellular carcinoma due to causes other than hepatitis B virus; 7) severe hepatic artery-portal vein fistula or hepatic artery-hepatic vein and it is not easy to embolize and seal; 8) Those who are allergic to iodine or cannot improve enhanced CT or MRI for other reasons; 9) those with currently active gastrointestinal bleeding, or those with a history of gastrointestinal bleeding in the last 2 weeks; 10) Patients with combination of other malignant tumors; 11) Application of other modern Chinese medicinal preparations with indications for the treatment of hepatocellular carcinoma (including but not limited to: Kang Lai Te injection/soft capsule, Aidi injection, Kang Ai injection, Eleutherococcus injection, Huazhuazin capsule, Hepatoflex, Sophora ear granules, etc.); 12) Not signing the informed consent form; 13) Other conditions that the investigator considers unsuitable for participation in the study.

研究实施时间：

Study execute time：

从 From 2024-01-09 00:00:00至 To 2025-12-31 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2024-02-19 00:00:00 至 To 2025-12-31 00:00:00

干预措施：

Interventions：

组别：	槲芪癥消方+西医治疗组	样本量：	172
Group：	the Huqizhengxiao (HQZX) formula plus Western Medicine Treatment Group	Sample size：	172
干预措施：	在单纯西医治疗基础上，根据肝癌患者不同阶段的证候特点，给予槲芪癥消方或个体化辩证加减治疗	干预措施代码：
Intervention：	Besides of Western medical treatment, the Huqizhengxiao (HQZX) formula will be given to the patients according to the symptoms and characteristics of HCC patients at different stages.	Intervention code：

组别：	单纯西医治疗组	样本量：	172
Group：	Western Medicine Treatment Group	Sample size：	172
干预措施：	根据指南进行单纯西医治疗	干预措施代码：
Intervention：	Western medical treatment will be given to the HCC patients according to the HCC guideline.	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	中国	省(直辖市)：	北京	市(区县)：
Country：	China	Province：	Beijing	City：
单位(医院)：	首都医科大学附属北京佑安医院	单位级别：	三甲
Institution hospital：	Beijing Youan Hospital, Capital Medical University	Level of the institution：	Tertiary A

测量指标：

Outcomes：

指标中文名：	1年生存率	指标类型：	主要指标
Outcome：	1-year survival 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：	生活质量评分	指标类型：	主要指标
Outcome：	Quality of life scores	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	中医症状评分	指标类型：	主要指标
Outcome：	Chinese Medicine Symptom Score	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	总生存期	指标类型：	次要指标
Outcome：	overall survival, 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：	无进展生存期	指标类型：	次要指标
Outcome：	progression-free survival, PFS	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	缓解持续时间	指标类型：	次要指标
Outcome：	Duration of Response, DOR	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	疾病进展时间	指标类型：	次要指标
Outcome：	time-to-progression, TTP	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：

正在进行

Recruiting

年龄范围：

Participant age：

最小 Min age	18	岁 years
最大 Max age	75	岁 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）：

使用区组随机分组的方法，将尚未确定的344位病人按1:1的比例随机分入两个组(治疗组和对照组)，选择区组的大小为4，应用EXCEL表格生成344个随机数字，在一个密封不透光的信封里面保存分组信息，按患者入组顺序拆开相应编号的随机信封，根据信封里的分配方案来决定某个患者的分组，进行相应的干预措施。

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

Using the method of zone randomization grouping, 344 patients who have not yet been identified were randomly assigned to two groups (treatment and control) in a ratio of 1:1, the size of the selected zone group was 4, and an EXCEL form was applied to generate 344 random numbers. Save the grouping information inside a sealed and impermeable envelope. The corresponding numbered randomized envelopes were opened in the order of patients' enrollment in the groups, and the allocation scheme in the envelopes was used to decide the grouping of a particular patient for the appropriate intervention.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：	无
Blinding：	None
试验完成后的统计结果（上传文件）：	点击下载
Calculated Results after the Study Completed(upload file)：	download

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）：	专利注册完成后18月将考虑公开，共享方式: 向研究者联系索取。
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	18 months after the completion of the patent, it will be considered to be open to the public. Sharing method: contact the researcher to obtain
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：	有病历记录表和电子表
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	There are medical records and electronic forms
数据与安全监察委员会： Data and Safety Monitoring Committee：	有/Yes
注册人： Name of Registration：	2024-02-19 15:43:16