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：	ChiCTR2400085460
最近更新日期： Date of Last Refreshed on：	2024-06-07 14:39:49
注册时间： Date of Registration：	2024-06-07 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	单药卡培他滨对比奥沙利铂联合卡培他滨应用于高危Ⅱ期-Ⅲ期且MRD阴性老年结直肠癌患者术后辅助化疗的有效性与安全性：一项单中心、平行设计、非劣效的随机对照临床研究
Public title：	The efficacy and safety of capecitabine monotherapy versus oxaliplatin combined with capecitabine in postoperative adjuvant chemotherapy in high-risk stage II and stage III elderly colorectal cancer patients with negative MRD: a single-center, parallel-designed, non-inferior, randomized controlled clinical study
注册题目简写：
English Acronym：
研究课题的正式科学名称：	单药卡培他滨对比奥沙利铂联合卡培他滨应用于高危Ⅱ期-Ⅲ期且MRD阴性老年结直肠癌患者术后辅助化疗的有效性与安全性：一项单中心、平行设计、非劣效的随机对照临床研究
Scientific title：	The efficacy and safety of capecitabine monotherapy versus oxaliplatin combined with capecitabine in postoperative adjuvant chemotherapy in high-risk stage II and stage III elderly colorectal cancer patients with negative MRD: a single-center, parallel-designed, non-inferior, randomized controlled clinical study
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：	翟嘉伟	研究负责人：	周才进
Applicant：	Zhai Jiawei	Study leader：	Zhou Caijin
申请注册联系人电话： Applicant telephone：	+86 151 8990 8715	研究负责人电话： Study leader's telephone：	+86 138 2254 9914
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：	1299309142@qq.com	研究负责人电子邮件： Study leader's E-mail：	zhoucaipingren@163.com
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：	广东省湛江市霞山区工农街道人民大道南57号广东医科大学附属医院	研究负责人通讯地址：	广东省湛江市霞山区工农街道人民大道南57号广东医科大学附属医院
Applicant address：	Affiliated Hospital of Guangdong Medical University, No. 57 South Renmin Avenue, Gongnong Street, Xiashan District, Zhanjiang City, Guangdong Province	Study leader's address：	Affiliated Hospital of Guangdong Medical University, No. 57 South Renmin Avenue, Gongnong Street, Xiashan District, Zhanjiang City, Guangdong Province
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：	广东医科大学附属医院
Applicant's institution：	Affiliated Hospital of Guangdong Medical University
研究负责人所在单位：	广东医科大学附属医院
Affiliation of the Leader：	Affiliated Hospital of Guangdong 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：	PJKT2024-063	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：	广东医科大学附属医院临床科研伦理委员会
Name of the ethic committee：	Clinical Research Ethics Committee, Affiliated Hospital of Guangdong Medical University
伦理委员会批准日期： Date of approved by ethic committee：	2024-04-22 00:00:00
伦理委员会联系人：	梁政
Contact Name of the ethic committee：	Liang Zheng
伦理委员会联系地址：	广东省湛江市人民大道南 57 号
Contact Address of the ethic committee：	No. 57 South Renmin Avenue, Zhanjiang City, Guangdong Province
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 2386971	伦理委员会联系人邮箱： Contact email of the ethic committee：	fyllwyh@126.com

研究实施负责（组长）单位：

广东医科大学附属医院

Primary sponsor：

Affiliated Hospital of Guangdong Medical University

研究实施负责（组长）单位地址：

广东省湛江市霞山区工农街道人民大道南57号广东医科大学附属医院

Primary sponsor's address：

Affiliated Hospital of Guangdong Medical University, No. 57 South Renmin Avenue, Gongnong Street, Xiashan District, Zhanjiang City, Guangdong 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)：	湛江	市(区县)：	湛江
Country：	China	Province：	Guangdong	City：	Zhanjiang
单位(医院)：	广东医科大学附属医院	具体地址：	广东省湛江市霞山区工农街道人民大道南57号广东医科大学附属医院
Institution hospital：	Affiliated Hospital of Guangdong Medical University	Address：	Affiliated Hospital of Guangdong Medical University, No. 57 South Renmin Avenue, Gongnong Street, Xiashan District, Zhanjiang City, Guangdong Province

经费或物资来源：

广东医科大学附属医院

Source(s) of funding：

Affiliated Hospital of Guangdong Medical University

研究疾病：

结直肠癌

Target disease：

colorectal 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：

随机平行对照

Study design：

Parallel

研究目的：

在直接接受手术后且术后分期为高危Ⅱ期-Ⅲ期以及术后MRD检测为阴性的老年结直肠癌患者中，对比单药卡培他滨组的3年无病生存率是否非劣于奥沙利铂联合卡培他滨（CAPOX）方案辅助化疗组。

Objectives of Study：

In elderly colorectal cancer patients with high-risk stage II and stage III and postoperative negative MRD after direct surgery, the 3-year disease-free survival rate of the capecitabine monotherapy group was compared with that of the oxaliplatin combined with capecitabine (CAPOX) adjuvant chemotherapy group.

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. Before performing any procedures related to the study protocol other than routine care, a voluntary signed and dated informed consent must be obtained from the subject in accordance with regulations and institutional guidelines. 
2. Age 65-85. 
3. Confirmed histological evidence of colorectal adenocarcinoma. 
4.ECOG physical status score is 0-1. 
5. TNM staging was performed by spiral or multi-slice CT to confirm that there was no distant metastasis. 
6. Did not receive any treatment before surgery (including chemoradiotherapy, molecular targeted therapy and immunotherapy). 
7. The patient underwent radical surgery (R0) resection, and the postoperative pathological stage was high-risk stage II or III. 
8. Randomization must be within 8 weeks after surgery. 
9. Appropriate organ function based on the following laboratory test values obtained within 7 days prior to treatment: Hemoglobin ≥90g/L, neutrophil count ≥1.5×109/L, platelet count ≥75×109/L. Serum total bilirubin ≤1.5× upper limit of normal (UNL), aspartate transferase ≤2×UNL. Alanine transferase ≤3×UNL, serum creatinine ≤1.5×UNL. 
10. Willing and able to follow research procedures and visit plans.

排除标准：

1) 全身CT、MR或PET-CT（至少包括胸部全腹部和盆腔）证实有远处转移（M1）。 2) 患者术后合并梗阻或活动性出血。 3) 既往或同时存在其他活动性恶性肿瘤（曾接受治愈性治疗且超过 5 年无发病的恶性肿瘤或可通过充分治疗治愈的原位癌除外）。 4) 术后至开始辅助治疗的时间已超过8周。 5) 接受新辅助治疗的患者。 6) 参加研究前12个月内有活动性冠状动脉疾病，严重/不稳定性心绞痛或新确诊的心绞痛或心肌梗塞。 7) 既往6个月内发生血栓或栓塞事件，例如脑血管意外（包括一过性脑缺血发作）、肺栓塞、深静脉血栓。 8) 纽约心脏学会（NYHA）II级或以上充血性心力衰竭。 9) 已知存在人免疫缺陷病毒（HIV）感染或获得性免疫缺陷综合症（AIDS）相关性疾病。 10) 存在活动性炎症性肠病或导致慢性腹泻的其他结直肠疾病。 11) 已知或怀疑对研究中使用的任何相关药物过敏的病史。 12) 妊娠或哺乳期妇女。 13) 未使用或拒绝使用有效的非激素避孕手段的育龄期妇女（末次月经后< 2 年）或有生育可能的男性。 14) 不稳定或会影响患者安全及其研究依从性的任何医学状况。

Exclusion criteria：

1) Whole-body CT, MR Or PET-CT (including at least the whole abdomen and pelvis of the chest) confirms distant metastases (M1). 2) Patients with postoperative obstruction or active bleeding. 3) Other active malignancies are present in the past or at the same time (except malignancies that have been treated with curative therapy and have been free of disease for more than 5 years or cancers in situ that can be cured with adequate treatment). 4) The time between the operation and the start of adjuvant therapy has exceeded 8 weeks. 5) Patients receiving neoadjuvant therapy. 6) Active coronary artery disease, severe/unstable angina pectoris or newly diagnosed angina pectoris or myocardial infarction in the 12 months prior to study participation. 7) Thrombotic or embolic events occurred within the past 6 months, such as cerebrovascular accidents (including transient ischemic attacks), pulmonary embolism, and deep vein thrombosis. 8) New York Heart Society (NYHA) Grade II or above congestive heart failure. 9) There are known diseases associated with human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS). 10) The presence of active inflammatory bowel disease or other colorectal disease that causes chronic diarrhea. 11) A known or suspected history of allergy to any of the relevant drugs used in the study. 12) Pregnant or lactating women. 13) Women of reproductive age who do not use or refuse to use effective non-hormonal contraception (< 2 years after the last menstrual period) or men who are likely to have children. 14) Any medical condition that is unstable or could affect patient safety and their compliance with the study.

研究实施时间：

Study execute time：

从 From 2024-07-01 00:00:00至 To 2029-07-01 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2024-07-01 00:00:00 至 To 2026-07-01 00:00:00

干预措施：

Interventions：

组别：	单药卡培他滨组	样本量：	290
Group：	Capecitabine monotherapy group	Sample size：	290
干预措施：	单药卡培他滨方案×8疗程（单药卡培他滨方案：卡培他滨 1250mg/m2 早晚口服各一次，第 1-14 天，每3周重复一次。）	干预措施代码：
Intervention：	Capecitabine monotherapy ×8 courses (Capecitabine monotherapy: capecitabine 1250mg/m2 orally once in the morning and once in the evening, on days 1-14, repeated every 3 weeks.)	Intervention code：

组别：	CapOx联合化疗组	样本量：	290
Group：	CapOx chemotherapy group	Sample size：	290
干预措施：	CapOx 方案× 8 疗程（CapOx 方案：奥沙利铂130mg/m2 静脉滴注2小时，第1天；卡培他滨1250mg/m2早晚口服各一次，第1-14天，每3周重复1次）	干预措施代码：
Intervention：	CapOx regimen × 8 courses (CapOx regimen: oxaliplatin 130mg/m2 intravenous infusion for 2 hours, day 1; Capecitabine 1250mg/m2 is taken orally once in the morning and once in the evening, on days 1-14, and repeated every 3 weeks.	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	中国	省(直辖市)：	广东	市(区县)：
Country：	China	Province：	Guangdong	City：
单位(医院)：	广东医科大学附属医院	单位级别：	三甲
Institution hospital：	Affiliated Hospital of Guangdong Medical University	Level of the institution：	Tertiary A

测量指标：

Outcomes：

指标中文名：	3年无病生存率	指标类型：	主要指标
Outcome：	3-year disease-free 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：	3年总体生存率	指标类型：	次要指标
Outcome：	3-year overall survival 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：	3年无局部复发生存率	指标类型：	次要指标
Outcome：	3-year local recurrence-free survival 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：	无远处转移生存时间	指标类型：	次要指标
Outcome：	Survival time without distant metastasis	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	安全性	指标类型：	次要指标
Outcome：	Safety	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	生活质量	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：

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：

尚未开始

Not yet recruiting

年龄范围：

Participant age：

最小 Min age	65	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）：

本研究采用分层随机法进行分组，即根据临床分期进行分层，再在每个层内进行多亚组随机分组，将研究对象平均分配到两组中。操作步骤：（1）先将入组的580例患者按术后临床分期分层；（2）再按性别进行分组；（3）再在男性和女性中，按照年龄（＜75岁与≥75岁）分组（4）再按BMI＜18.5、BMI≥18.5进行分组（5）最后在16个亚组中各按1：1的比例随机分组至试验组与对照组中

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

In this study, stratified randomization method was used for grouping, that is, stratification was conducted according to clinical stages, and multi-subgroup randomization was conducted within each layer, and the subjects were evenly allocated to the two groups. Procedure: (1) 580 enrolled patients were stratified according to postoperative clinical stage; (2) Grouping by gender; (3) Men and women were grouped according to age (< 75 years and ≥75 years); (4) BMI < 18.5, BMI≥18.5 were divided into groups; (5) Finally, the 16 subgroups were randomly divided into the experimental group and the control group at a ratio of 1:1.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：	对评估者设盲
Blinding：	Blinding evaluators

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）：	无
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	None
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：	研究数据将通过病例报告表（CRF）进行记录，由研究中心将其从纸质原始文件转录到CRF上。研究监查员将依据药品临床试验质量管理规范（GCP）对照研究者的记录核查并交互核对CRF（原始文件核查），以确保数据收集的准确性及可靠性。每个参与中心的所有被观察患者都将接受原始文件核查。将相应地生成差异报告并提供给研究中心，供研究者进行解析。此外，CRF数据将持续接受审查，以确保在医学及科学方面的合理性。电子采集和管理系统：本研究采用广东医科大学附属医院全病种大数据平台进行定期数据录入与更新。
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	The study data will be recorded via a case report Form (CRF), which will be transcribed from the paper original file to the CRF by the research Center. The study monitor will check the investigator's records against the GCP and cross-check the CRF (Original Document Check) to ensure the accuracy and reliability of the data collection. All observed patients at each participating center will undergo original documentation verification. Discrepancy reports will be generated accordingly and provided to the research Center for analysis by researchers. In addition, CRF data will be continuously reviewed to ensure medical and scientific soundness. Electronic collection and management system: This study adopted the big data platform of the Affiliated Hospital of Guangdong Medical University for regular data entry and update.
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：	2024-06-07 14:39:46