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：	ChiCTR2500098868
最近更新日期： Date of Last Refreshed on：	2025-03-14 12:00:58
注册时间： Date of Registration：	2025-03-14 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	外周血肿瘤相关TCR评分用于免疫检查点抑制剂疗效监测的单中心、前瞻性、观察性临床研究
Public title：	Study on the Use of Peripheral Blood Tumor-Associated TCR Scoring for Monitoring the Efficacy of Immune Checkpoint Inhibitors: A Single-Center, Prospective, Observational Clinical Study
注册题目简写：	肿瘤相关TCR评分用于免疫检查点抑制剂疗效监测
English Acronym：	Tumor-Associated TCR Scoring for Monitoring the Efficacy of Immune Checkpoint Inhibitors
研究课题的正式科学名称：	外周血肿瘤相关TCR评分用于免疫检查点抑制剂疗效监测的单中心、前瞻性、观察性临床研究
Scientific title：	Study on the Use of Peripheral Blood Tumor-Associated TCR Scoring for Monitoring the Efficacy of Immune Checkpoint Inhibitors: A Single-Center, Prospective, Observational 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：	纪洪辰	研究负责人：	纪洪辰
Applicant：	Hongchen Ji	Study leader：	Hongchen Ji
申请注册联系人电话： Applicant telephone：	+86 159 2989 4706	研究负责人电话： Study leader's telephone：	+86 159 2989 4706
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：	jhca.xyt@163.com	研究负责人电子邮件： Study leader's E-mail：	jhca.xyt@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：	陕西省西安市新城区长乐西路127号	研究负责人通讯地址：	陕西省西安市新城区长乐西路127号西京医院
Applicant address：	127 Changle West Road, Xincheng District, Xi'an, Shaanxi Province, China.	Study leader's address：	Xijing Hospital, 127 Changle West Road, Xincheng District, Xi'an, Shaanxi Province, China.
申请注册联系人邮政编码： Applicant postcode：	710032	研究负责人邮政编码： Study leader's postcode：	710032
申请人所在单位：	第四军医大学第一附属医院肿瘤科
Applicant's institution：	Department of Oncology, First Affiliated Hospital of Fourth Military Medical University.
研究负责人所在单位：	第四军医大学第一附属医院肿瘤科
Affiliation of the Leader：	Department of Oncology, First Affiliated Hospital of Fourth Military 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：	KY20252069-F-1	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：	中国人民解放军第四军医大学（空军军医大学）第一附属医院医学伦理委员会
Name of the ethic committee：	The Medical Ethics Committee, First Affiliated Hospital of the Fourth Military Medical University of the People's Liberation Army of China.
伦理委员会批准日期： Date of approved by ethic committee：	2025-02-27 00:00:00
伦理委员会联系人：	张红梅
Contact Name of the ethic committee：	Hong-Mei Zhang
伦理委员会联系地址：	陕西省西安市新城区长乐西路127号
Contact Address of the ethic committee：	127 Changle West Road, Xincheng District, Xi'an, Shaanxi Province, China.
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 29 8477 5412	伦理委员会联系人邮箱： Contact email of the ethic committee：	zhm@fmmu.edu.cn

研究实施负责（组长）单位：

第四军医大学第一附属医院

Primary sponsor：

Department of Oncology, First Affiliated Hospital of Fourth Military Medical University.

研究实施负责（组长）单位地址：

陕西省西安市新城区长乐西路127号

Primary sponsor's address：

127 Changle West Road, Xincheng District, Xi'an, Shaanxi Province, China.

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：	中国	省(直辖市)：	陕西	市(区县)：	西安
Country：	China	Province：	Shaanxi	City：	Xi'an
单位(医院)：	第四军医大学第一附属医院	具体地址：	陕西省西安市新城区长乐西路127号
Institution hospital：	First Affiliated Hospital of the Air Force Medical University of the People's Liberation Army of China	Address：	127 Changle West Road, Xincheng District, Xi'an, Shaanxi Province, China.

经费或物资来源：

第四军医大学第一附属医院

Source(s) of funding：

Department of Oncology, First Affiliated Hospital of Fourth Military Medical University

研究疾病：

实体肿瘤

Target disease：

Solid tumor

研究疾病代码：

Target disease code：

研究类型：

观察性研究

Study type：

Observational study

研究所处阶段：

其它

Study phase：

N/A

研究设计：

连续入组

Study design：

Sequential

研究目的：

验证一种基于外周血肿瘤特异性TCR谱的免疫治疗疗效评估方法，提升免疫治疗的个体化管理水平，提高疗效监测的准确性。

Objectives of Study：

To validate a method for evaluating the efficacy of immunotherapy based on peripheral blood tumor-specific TCR profiling, aiming to enhance the level of personalized management in immunotherapy and improve the accuracy of efficacy monitoring.

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.Voluntary enrollment with signed written informed consent;
2.Age >= 18 years;
3.Histologically or cytologically confirmed solid malignant tumors with documented metastasis to solid organs via imaging or pathology;
4.ECOG (Eastern Cooperative Oncology Group) performance status score of 0-1;
5.No indications for local treatment (surgical resection, radiofrequency ablation, interventional therapy, etc.) at the time of enrollment;
6.At least one measurable lesion confirmed by imaging according to the RECIST 1.1 criteria; metastatic lesions at the site of previously treated local lesions may be considered measurable if progression is confirmed;
7.Eligible for treatment with immune checkpoint inhibitors based on guidelines, clinical studies, or investigator judgment, and consent to the treatment plan;
8.Expected survival of >= 6 months;
9.Adequate organ function, defined by the following criteria (without receiving any blood components or growth factors within 14 days prior to enrollment):
 (1). Neutrophils >= 2.0 × 10^9/L;
 (2). White blood cells >= 3.0 × 10^9/L;
 (3). Platelets >= 100 × 10^9/L;
 (4). Hemoglobin >= 90 g/L;
 (5). Total bilirubin <= 1.5 × ULN;
 (6). AST and ALT <= 2.5 × ULN;
 (7). INR <= 1.5 × ULN and APTT <= 1.5 × ULN (patients on stable doses of anticoagulants such as low molecular weight heparin or warfarin with INR within the expected therapeutic range may be included);
 (8). Cardiac echocardiogram: LVEF (left ventricular ejection fraction) >= 50%.
10.Women of childbearing potential must have a negative serum pregnancy test within 3 days prior to enrollment and agree to use appropriate contraception during the treatment period and for 6 months after treatment. Male participants must be surgically sterilized or agree to use appropriate contraception during the study and for 3 months after treatment;
11.Voluntary participation in this study with signed informed consent;
12.Good compliance and agreement to cooperate with survival follow-up.

排除标准：

1) 未经组织病理或细胞病理明确为恶性肿瘤，或实体脏器不存在经病理学或影像学证实的可评估病灶； 2) 无法遵循研究方案接受治疗或按期随访； 3) 入组前4周内接受过其它任何临床研究药物治疗，除非是观察性（非干预性）临床研究或者干预性临床研究随访。 4) 严重的胃肠功能紊乱（有出血、梗阻；＞2级的炎症；＞1级的腹泻）。 5) 已知有间质性肺病，仅影像学显示的间质性改变除外。 6) 已知的周围神经病变（CTCAE≥2级）。 7) 入组前4周内发生过严重感染（CTCAE＞2级），如需要住院治疗的严重肺炎、菌血症、感染并发症等；入组前2周内存在感染的症状和体征需要静脉使用抗生素治疗（预防性使用抗生素的情况除外）。 8) 凝血功能严重异常、具有出血倾向或正在接受溶栓或抗凝治疗。允许预防性使用小剂量阿司匹林（≤100mg/天）、低分子肝素（依诺肝素40mg/天及其等效剂量下的其他低分子肝素）。 9) 有未能良好控制的心脏临床症状或疾病，包括但不限于： a) NYHA 3级及以上心力衰竭。 b) 不稳定型心绞痛。 c) 6个月内发生过心肌梗死。 10) 其他研究者认为不适用免疫检查点抑制剂的情形。 11) 入组前5年内患有其他肿瘤，除外经充分治疗的宫颈原位癌、皮肤基底细胞或鳞状上皮细胞癌。 12) 已知有获得性免疫缺陷综合征（艾滋病）或HIV检测阳性者，活动性梅毒感染者。 13) 既往有明确的神经或精神障碍史，包括癫痫或痴呆。 14) 计划怀孕者、妊娠期及哺乳期妇女。 15) 经研究者判断，受试者有其他可能导致其被迫中途终止研究的因素，如不依从方案、患有其他严重疾病需要合并治疗，具有临床意义的实验室检查值严重异常，家庭或社会因素，可能影响到受试者安全或试验资料收集的情况等。

Exclusion criteria：

1. Not confirmed as malignant tumors by histopathology or cytopathology, or absence of assessable lesions in solid organs confirmed by pathology or imaging; 2. Unable to adhere to the study protocol for treatment or follow-up; 3. Received any other clinical trial drug treatment within 4 weeks prior to enrollment, except for observational (non-interventional) clinical studies or interventional clinical studies for follow-up; 4. Severe gastrointestinal dysfunction (e.g., bleeding, obstruction; > grade 2 inflammation; > grade 1 diarrhea); 5. Known interstitial lung disease, except for interstitial changes shown only by imaging; 6. Known peripheral neuropathy (CTCAE >= grade 2); 7. Experienced a severe infection (CTCAE > grade 2) within 4 weeks prior to enrollment, such as severe pneumonia requiring hospitalization, bacteremia, or infectious complications; symptoms and signs of infection requiring intravenous antibiotic treatment within 2 weeks prior to enrollment (excluding prophylactic antibiotic use); 8. Severe coagulation dysfunction, bleeding tendency, or currently receiving thrombolytic or anticoagulant therapy. Prophylactic use of low-dose aspirin (<= 100 mg/day) and low molecular weight heparin (e.g., enoxaparin 40 mg/day and equivalent doses of other low molecular weight heparins) is permitted; 9. Uncontrolled cardiac clinical symptoms or diseases, including but not limited to: (1). NYHA class 3 or higher heart failure; (2).Unstable angina; (3) Myocardial infarction within the past 6 months; 10. Other conditions deemed unsuitable for immune checkpoint inhibitor therapy by the investigator; 11. History of other tumors within 5 years prior to enrollment, except for adequately treated cervical carcinoma in situ, basal cell carcinoma, or squamous cell carcinoma of the skin; 12. Known acquired immunodeficiency syndrome (AIDS) or positive HIV test, or active syphilis infection; 13. History of significant neurological or psychiatric disorders, including epilepsy or dementia; 14. Individuals planning to become pregnant, pregnant women, or breastfeeding women; 15. At the investigator's discretion, the subject has other factors that may lead to premature termination of the study, such as non-compliance with the protocol, other serious illnesses requiring concurrent treatment, clinically significant laboratory values that are severely abnormal, or family or social factors that may affect the subject's safety or the collection of trial data.

研究实施时间：

Study execute time：

从 From 2025-02-01 00:00:00至 To 2028-12-31 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2025-03-14 00:00:00 至 To 2028-03-14 00:00:00

干预措施：

Interventions：

组别：	观察组	样本量：	200
Group：	Observation group	Sample size：	200
干预措施：	无	干预措施代码：
Intervention：	None	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	中国	省(直辖市)：	陕西	市(区县)：	西安
Country：	China	Province：	Shaanxi	City：	Xi'an
单位(医院)：	第四军医大学第一附属医院	单位级别：	三甲
Institution hospital：	Department of Oncology, First Affiliated Hospital of Fourth Military Medical University	Level of the institution：	Tertiary A

测量指标：

Outcomes：

指标中文名：	总生存期	指标类型：	主要指标
Outcome：	overall survival	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	一年总生存率	指标类型：	次要指标
Outcome：	1-year overall survival rate	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	18	岁 years
最大 Max age	80	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	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）：	如发表公开论文，临床数据将作为论文附件共享，TCR测序数据将提交至VJDdb数据库（https://vdjdb.cdr3.net/）共享。数据共享时将隐去全部受试者隐私信息。
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	If a public paper is published, the clinical data will be shared as an appendix to the paper, and the TCR sequencing data will be submitted to the VJDdb database (https://vdjdb.cdr3.net/) for sharing. All participant privacy information will be removed during data sharing.
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：	本次研究采用电子化数据采集系统。研究者对每位受试者在试验中的相关资料均应及时、真实地记录在研究病历中；研究者或其授权人员在规定的时间内将相关资料及时、真实填写在电子病例报告表中。保证录入的内容与源数据一致。为保证患者的隐私权，患者姓名使用代码。数据录入人员或研究者核实数据后可对数据进行修改，修改的数据需填写修改理由。研究者对最终所有数据具有审核权限。数据库中的数据都已经监查员和数据管理员核查清理无疑问后，由数据管理员对数据进行冻结，此时数据不可再修改，主要研究者对冻结的数据确认其真实性和完整性，并进行电子签名。
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	This study employs an electronic data collection system. The investigator is responsible for timely and accurately recording all relevant information about each subject in the study medical records. The investigator or authorized personnel must complete the electronic case report forms with timely and accurate information within the stipulated timeframe, ensuring that the entered content is consistent with the source data. To protect patient privacy, patient names will be replaced with codes. Data entry personnel or the investigator can modify the data after verification, and any modifications must include a reason for the change. The investigator has the authority to review all final data. The data in the database are verified and cleaned by monitors and data administrators; once this process is completed without any questions, the data will be frozen by the data administrator, making it unmodifiable. The principal investigator will confirm the authenticity and completeness of the frozen data and provide an electronic signature.
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：	2025-03-14 12:00:38