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：	ChiCTR2500099983
最近更新日期： Date of Last Refreshed on：	2025-04-01 14:38:32
注册时间： Date of Registration：	2025-04-01 00:00:00
注册号状态：	补注册
Registration Status：	Retrospective registration
注册题目：	磷酸腺嘌呤用于预防和治疗晚期结肠癌患者化疗过程中白细胞减少及其对患者免疫功能的影响
Public title：	Adenosine phosphate is used for the prevention and treatment of leukopenia during chemotherapy in patients with advanced colon cancer and its impact on the patient's immune function
注册题目简写：
English Acronym：
研究课题的正式科学名称：	磷酸腺嘌呤用于预防和治疗晚期结肠癌患者化疗过程中白细胞减少及其对患者免疫功能的影响
Scientific title：	Adenosine phosphate is used for the prevention and treatment of leukopenia during chemotherapy in patients with advanced colon cancer and its impact on the patient's immune function
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：	张思琪	研究负责人：	康欣梅
Applicant：	Zhang Siqi	Study leader：	Kang Xinmei
申请注册联系人电话： Applicant telephone：	+86 158 8333 5268	研究负责人电话： Study leader's telephone：	+86 137 2087 9248
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：	24520231154719@stu.xmu.edu.cn	研究负责人电子邮件： Study leader's E-mail：	kangxm28@xmu.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：	厦门市翔安区翔安东路2000号	研究负责人通讯地址：	厦门市翔安区翔安东路2000号
Applicant address：	No. 2000 Xiang'an East Road, Xiang'an District, Xiamen City	Study leader's address：	No. 2000 Xiang'an East Road, Xiang'an District, Xiamen City
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：	厦门大学医学院
Applicant's institution：	Xiamen University Medical College
研究负责人所在单位：	厦门大学附属翔安医院
Affiliation of the Leader：	Xiamen University Affiliated Xiang'an Hospital

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：	XAHLL2024031	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：	厦门大学附属翔安医院伦理委员会
Name of the ethic committee：	Ethics Committee of Xiamen University Affiliated Xiang'an Hospital
伦理委员会批准日期： Date of approved by ethic committee：	2024-07-27 00:00:00
伦理委员会联系人：	郑俊艺
Contact Name of the ethic committee：	Zheng Junyi
伦理委员会联系地址：	厦门市翔安区翔安东路2000号
Contact Address of the ethic committee：	No. 2000 Xiang'an East Road, Xiang'an District, Xiamen City
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 592 288 9233	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：

厦门大学附属翔安医院

Primary sponsor：

Xiamen University Affiliated Xiang'an Hospital

研究实施负责（组长）单位地址：

厦门市翔安区翔安东路2000号

Primary sponsor's address：

No. 2000 Xiang'an East Road, Xiang'an District, Xiamen 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)：	福建省	市(区县)：	厦门市
Country：	China	Province：	Fujian Province	City：	Xiamen
单位(医院)：	厦门大学附属翔安医院	具体地址：	厦门市翔安区翔安东路2000号
Institution hospital：	Xiamen University Affiliated Xiang'an Hospital	Address：	No. 2000 Xiang'an East Road, Xiang'an District, Xiamen City

经费或物资来源：

自筹

Source(s) of funding：

Self-funded

研究疾病：

结肠癌

Target disease：

Colon cancer

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：

非随机对照试验

Study design：

Non randomized control

研究目的：

评价磷酸腺嘌呤用于预防和治疗晚期结直肠癌患者化疗过程中白细胞减少的效果；研究磷酸腺嘌呤对患者免疫功能的影响和分子机制。

Objectives of Study：

Evaluate the efficacy of adenine phosphate in preventing and treating leukopenia during chemotherapy in patients with advanced colorectal cancer; Study the effects and molecular mechanisms of adenine phosphate on patients' immune function.

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

1.Voluntarily join this study and sign an informed consent form;
2.Age range: 18-85 years old;
3.Diagnosed with advanced colorectal cancer stage IV (AJCC TNM staging 8th edition.by pathology, systemic chemotherapy was performed;
4.According to the RECISST1.1 solid tumor efficacy evaluation criteria, there must be at least one measurable lesion;
5.ECOG score: 0-1 points;
6.Expected survival period exceeding 3 months;
7.No obvious contraindications for immunotherapy, targeted therapy, or chemotherapy;
8.The patient has no cognitive impairment or mental illness;
9.The patient is able to complete the survey form;
10.Patients can correctly understand and cooperate with the medication guidance of medical staff;
11.The patient did not receive any experimental drug treatment within 28 days prior to enrollment in the study;
12.The main organ function is normal, which meets the following criteria:
(1)The blood routine test standards must meet the following criteria: no blood transfusion or blood products have been administered within the previous 14 days, and no correction has been made using G-CSF or other hematopoietic stimulating factors; Hemoglobin (HB)>= 90 g/L; Absolute neutrophil count (ANC)>= 1.5 × 10 ^ 9/L (1500/m3); Platelet count (PLT)>= 80 × 10 ^ 9/L;
(2)Biochemical testing standards must comply with: total bilirubin (TBiL)<= 1.5ULN; ALT and AST <= 2.5 ULN, for liver metastasis subjects, ALT and AST <= 5 ULN; Serum creatinine (Cr)<= 1.5ULN or endogenous creatinine clearance rate (CrCl)>= 50 ml/min (Cockcroft Gault formula);
(3)The New York Heart Association cardiac function classification is 0-1, with no unstable angina or myocardial infarction, no symptomatic arrhythmias that cannot be controlled by drug therapy, and no clinically active other heart diseases within the 6 months prior to enrollment; Doppler ultrasound evaluation: Left ventricular ejection fraction (LVEF)>= lower limit of normal (50%).

排除标准：

1）存在严重活动性自身免疫病； 2）患有先天或后天免疫功能缺陷（如HIV感染）、活动性乙肝（HBV-DNA>104拷贝数/ml）或丙肝（丙肝抗体阳性，且HCR-RNA高于分析方法的检测下限）患者； 3）已知对研究药物或其任何辅料成分过敏； 4）未受控制的高血压； 5）首次使用研究药物前4周内接种过活疫苗，允许接受针对季节性流感，注射灭活病毒疫苗，减毒疫苗不予以纳入； 6）妊娠或哺乳期； 7）冠状动脉临床上显著的动脉病变或近12个月心肌梗死的先例或未控制的心律失常或心脏未控制性功能不全的高风险，肺梗阻性慢性病，在过去12个月中需要住院3次或更多次； 8）存在一种心理或医疗疾病，可能妨碍患者完成研究或在知情同意书上授予其签名； 9）怀疑或确有吸毒、药物滥用、酗酒者； 10）在进入研究前30天内进行任何实验治疗； 11）不管严重程度如何，存在任何出血体质迹象或病史的患者；在分组前4周内出现任何出血或流血事件的患者，存在未愈合创口、溃疡或骨折； 12）具有出血倾向或正在接受溶栓或抗凝治疗；注：在凝血酶病的病史时间国际标准化比值（INR）≤1.5的前提下，允许以预防目的使用小剂量肝素（成人每日用量为0.6万~1.2万U）或小剂量阿司匹林（每日用量≤100 mg）

Exclusion criteria：

1.Serious active autoimmune disease exists; 2.Patients with congenital or acquired immune deficiency (such as HIV infection), active hepatitis B (HBV-DNA>104 copies/ml)or hepatitis C (hepatitis C antibody is positive, and HCR-RNA is higher than the detection limit of the analytical method); 3.Known to be allergic to the investigational drug or any of its excipients; 4.Uncontrolled hypertension; 5.Vaccination with live vaccine within 4 weeks prior to the first use of the investigational drug is allowed, and vaccination with inactivated virus vaccine for seasonal influenza is allowed. Attenuated vaccines are not included; 6.Pregnancy or lactation period; 7.Significant coronary artery disease in clinical practice or a history of myocardial infarction in the past 12 months, or a high risk of uncontrolled arrhythmia or uncontrolled cardiac dysfunction, chronic obstructive pulmonary disease requiring hospitalization three or more times in the past 12 months; 8.There is a psychological or medical condition that may hinder the patient from completing the study or granting their signature on the informed consent form; 9.Suspected or confirmed drug use, substance abuse, or alcoholism; 10.Conduct any experimental treatment within 30 days prior to entering the study; 11.Patients with any signs or medical history of bleeding, regardless of the severity; Patients who experience any bleeding or bleeding events within the first 4 weeks of grouping, with unhealed wounds, ulcers, or fractures; 12.Having a tendency to bleed or undergoing thrombolytic or anticoagulant therapy; Note: Under the premise that the international normalized ratio (INR)of the medical history time of thrombin disease is <= 1.5, the use of low-dose heparin (adult daily dose of 6000-12000 U.or low-dose aspirin (daily dose <= 100 mg)for preventive purposes is allowed.

研究实施时间：

Study execute time：

从 From 2024-08-01 00:00:00至 To 2025-08-01 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2024-08-06 00:00:00 至 To 2025-08-01 00:00:00

干预措施：

Interventions：

组别：	实验组	样本量：	15
Group：	Experimental group	Sample size：	15
干预措施：	常规治疗+治疗开始后口服磷酸腺嘌呤20mg每日三次。	干预措施代码：
Intervention：	Conventional treatment +Oral adenine phosphate 20 mg three times a day after the start of treatment.	Intervention code：

组别：	对照组	样本量：	15
Group：	Control group	Sample size：	15
干预措施：	常规治疗	干预措施代码：
Intervention：	Conventional treatment	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	中国	省(直辖市)：	福建省	市(区县)：	厦门市
Country：	China	Province：	Fujian Province	City：	Xiamen
单位(医院)：	福建省厦门市厦门大学附属翔安医院	单位级别：	三甲
Institution hospital：	Xiamen University Affiliated Xiang'an Hospital	Level of the institution：	Tertiary A

测量指标：

Outcomes：

指标中文名：	白细胞计数	指标类型：	主要指标
Outcome：	White blood cell count	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	血浆中细胞因子和免疫指标	指标类型：	主要指标
Outcome：	Cytokines and immune markers in plasma	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	接受治疗后影像学评估患者病灶变化情况（符合RECIST评价标准）	指标类型：	次要指标
Outcome：	Imaging assessment of changes in the patient's lesion after treatment (meets RECIST evaluation criteria)	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	安全及患者耐受情况	指标类型：	次要指标
Outcome：	Safety and patient tolerance	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	85	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）：

无

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

None

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	否No
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）：	论文发表后一年内，http://www.medresman.org.cn/login.aspx。
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	Within one year of the publication of the paper, http://www.medresman.org.cn/login.aspx.
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：	1)数据收集计划数据采集的持续时间是从患者签署知情同意之后至化疗后28天，将所有不良事件记录在CRF中。每名患者将接受计划的访视，并且将在访视的不同时间点记录特定的数据。 2) 研究期访视研究治疗结束：随访至治疗后3个月。提前退出访视：随访至患者接受其他治疗结束后3个月。
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	1.Data Collection Plan The duration of data collection is from the patient's signing of informed consent to 28 days after chemotherapy, and all adverse events are recorded in the CRF. Each patient will undergo a planned visit and specific data will be recorded at different time points during the visit. 2.Visit during the research period End of study treatment: Follow up until 3 months after treatment. Early withdrawal from visit: Follow up until 3 months after the patient receives other treatments.
数据与安全监察委员会： Data and Safety Monitoring Committee：	暂未确定/Not yet
注册人： Name of Registration：	2025-04-01 14:38:20