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：	ChiCTR2600124959
最近更新日期： Date of Last Refreshed on：	2026-05-19 17:06:53
注册时间： Date of Registration：	2026-05-19 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	基于类器官培养药敏结果用于指导转移性尿路上皮癌患者二线治疗的临床研究
Public title：	A Clinical Study of Organoid-Guided Drug Sensitivity Testing for Second-Line Therapy in Metastatic Urothelial Carcinoma
注册题目简写：
English Acronym：
研究课题的正式科学名称：	基于类器官培养药敏结果用于指导转移性尿路上皮癌患者二线治疗的临床研究
Scientific title：	A Clinical Study of Organoid-Guided Drug Sensitivity Testing for Second-Line Therapy in Metastatic Urothelial Carcinoma
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：	蒋军辉	研究负责人：	蒋军辉
Applicant：	Jiang Junhui	Study leader：	Jiang Junhui
申请注册联系人电话： Applicant telephone：	+86 574 87085111	研究负责人电话： Study leader's telephone：	+86 574 87085111
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：	jiangjh200509@126.com	研究负责人电子邮件： Study leader's E-mail：	Jiangjh200509@126.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：	浙江省宁波市海曙区柳汀街59号	研究负责人通讯地址：	浙江省宁波市海曙区柳汀街59号
Applicant address：	59 Liuting Street, Haishu District, Ningbo City, Zhejiang Province	Study leader's address：	59 Liuting Street, Haishu District, Ningbo City, Zhejiang 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：	宁波大学附属第一医院
Applicant's institution：	The First Affiliated Hospital of Ningbo University
研究负责人所在单位：	宁波大学附属第一医院
Affiliation of the Leader：	The First Affiliated Hospital of Ningbo 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：	宁波大学附属第一医院伦审2026研第104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：	宁波大学附属第一医院医学伦理委员会
Name of the ethic committee：	First Affiliated Hospital of Ningbo University Clinical Trial Ethics Committee for Drugs and Medical Devices
伦理委员会批准日期： Date of approved by ethic committee：	2026-04-14 00:00:00
伦理委员会联系人：	陈少莹
Contact Name of the ethic committee：	Chen ShaoYing
伦理委员会联系地址：	浙江省宁波市海曙区柳汀街59号
Contact Address of the ethic committee：	59 Liuting Street, Haishu District, Ningbo City, Zhejiang Province
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 574 87085233	伦理委员会联系人邮箱： Contact email of the ethic committee：	sychenjy@163.com

研究实施负责（组长）单位：

宁波大学附属第一医院

Primary sponsor：

The First Affiliated Hospital of Ningbo University

研究实施负责（组长）单位地址：

浙江省宁波市海曙区柳汀街59号

Primary sponsor's address：

59 Liuting Street, Haishu District, Ningbo City, Zhejiang 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)：	浙江省	市(区县)：
Country：	China	Province：	Zhejiang	City：
单位(医院)：	宁波大学附属第一医院	具体地址：	浙江省宁波市海曙区柳汀街59号
Institution hospital：	The First Affiliated Hospital of Ningbo University	Address：	59 Liuting Street, Haishu District, Ningbo City, Zhejiang Province

经费或物资来源：

自选课题（自筹）

Source(s) of funding：

Self-funded

研究疾病：

转移性尿路上皮癌

Target disease：

Metastatic urothelial 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：

探索性研究/预试验

Study phase：

0

研究设计：

单臂

Study design：

Single arm

研究目的：

本研究拟对转移性尿路上皮癌患者进行类器官构建，通过局部诊断性手术切除、软组织病灶穿刺取样等方式，获取肿瘤患者的新鲜肿瘤组织进行类器官培养。对构建的类器官进行临床治疗药物敏感性分析；根据药敏结果针对性使用敏感治疗方案，通过统计病人预后情况评价类器官药敏分析结果指导转移性尿路上皮癌治疗的可行性。

Objectives of Study：

This study intends to construct organoids from patients with metastatic urothelial carcinoma. Fresh tumor tissue from tumor patients will be obtained through local diagnostic surgical resection, soft tissue lesion puncture sampling, and other methods for organoid culture. The constructed organoids will undergo clinical drug sensitivity analysis. Based on the drug sensitivity results, targeted treatment plans will be implemented. The feasibility of using organoid drug sensitivity analysis results to guide the treatment of metastatic urothelial carcinoma will be evaluated by analyzing patient outcomes.

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. Patients aged 18 to 75, both male and female, are eligible;
2. Patients with urothelial carcinoma confirmed by histopathology and/or cytology, mainly including bladder cancer, ureteral cancer, and renal pelvis cancer; patients with mixed histological types (excluding small cell or neuroendocrine carcinoma), if urothelial carcinoma is the main tumor component, are eligible to participate in the study;
3. Patients with local or distant metastasis confirmed by imaging, and with measurable lesions according to RECIST 1.1 criteria;
4. Disease progression occurs after one systemic treatment (ADC combined with immunotherapy is considered as first-line treatment, and neoadjuvant/adjuvant therapy during the perioperative period is also considered as first-line treatment, provided that it has been more than one year since the end of the last medication);
5. Primary or metastatic lesions (such as soft tissue lesions, lymph nodes, etc.) can be resected or biopsied to obtain sufficient fresh tissue specimens for organoid establishment;
6. ECOG score is 0-2;
7. The estimated survival period is >= 3 months;
8. The patient voluntarily joined this study, signed the Informed Consent Form (ICF), exhibited good compliance, and cooperated with follow-up visits.

排除标准：

1.妊娠期、哺乳期妇女； 2.在过去12个月内患有临床上重要的（即活动的）心脏病（例如充血性心力衰竭，症状性冠状动脉病，心律不齐等）或心肌梗塞的患者；6个月内存在肾静脉血栓或非栓塞患者；或研究者判断患者具有显著临床意义的心血管疾病。 3.具有精神类药物滥用史且无法戒除者或有精神障碍的患者； 4.5年内患有其他恶性肿瘤的患者，已治愈的皮肤癌除外； 5.入组前4周内已知有未控制的活动性细菌、病毒、真菌、分枝杆菌、寄生虫感染或其他感染（不包括甲床皮肤真菌感染）或需要静脉抗生素治疗或住院的任何重大全身感染事件（肿瘤性发热除外）； 6.存在脑转移的患者； 7.相关不良反应未从一线治疗相关毒性中恢复的患者（≤1级）； 8.研究者认为不适合纳入的其他患者。

Exclusion criteria：

1. Women during pregnancy and lactation; 2. Patients who have had clinically significant (i.e., active) heart disease (such as congestive heart failure, symptomatic coronary artery disease, arrhythmias, etc.) or myocardial infarction within the past 12 months; patients who have had renal vein thrombosis or non-embolic conditions within the past 6 months; or patients with cardiovascular diseases that the investigator deems to have significant clinical implications. 3. Patients with a history of abuse of psychotropic drugs who are unable to quit or those with mental disorders; 4. Patients who have developed other malignant tumors within 5 years, except for cured skin cancer; 5. Within the 4 weeks prior to enrollment, there was known uncontrolled active bacterial, viral, fungal, mycobacterial, parasitic infection or other infections (excluding onychomycosis) or any significant systemic infection event requiring intravenous antibiotic treatment or hospitalization (excluding neoplastic fever); 6. Patients with brain metastasis; 7. Patients who have not recovered from the toxicity associated with first-line treatment (<=Grade 1); 8. Other patients deemed unsuitable for inclusion by the researchers.

研究实施时间：

Study execute time：

从 From 2026-04-30 00:00:00至 To 2028-04-30 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2026-05-31 00:00:00 至 To 2026-12-31 00:00:00

干预措施：

Interventions：

组别：	试验组	样本量：	19
Group：	Experimental group	Sample size：	19
干预措施：	参考类器官药敏结果，综合临床经验和患者状况，选择治疗方案。	干预措施代码：
Intervention：	Based on the drug sensitivity results of organoid models, combined with clinical experience and patient conditions, a treatment plan is selected.	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	中国	省(直辖市)：	浙江省	市(区县)：
Country：	China	Province：	Zhejiang	City：
单位(医院)：	宁波大学附属第一医院	单位级别：	三级甲等
Institution hospital：	The First Affiliated Hospital of Ningbo University	Level of the institution：	Tertiary A

测量指标：

Outcomes：

指标中文名：	持续缓解时间	指标类型：	次要指标
Outcome：	Duration of Response	Type：	Secondary indicator
测量时间点：		测量方法：	使用RECIST1.1标准评定
Measure time point of outcome：		Measure method：	Assessed using RECIST 1.1 criteria

指标中文名：	总生存期	指标类型：	次要指标
Outcome：	Overall Survival	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	客观响应率	指标类型：	主要指标
Outcome：	Objective response rate	Type：	Primary indicator
测量时间点：		测量方法：	使用RECIST1.1标准评定
Measure time point of outcome：		Measure method：	Assessed using RECIST 1.1 criteria

指标中文名：	无进展生存期	指标类型：	主要指标
Outcome：	Progression free survival	Type：	Primary 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：	肿瘤组织	组织：
Sample Name：	Tumor tissue	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	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）：

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:

不公开/Private

盲法：	无
Blinding：	None

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）：	临床试验公共管理平台IPD(http://www.medresman.org.cn)。实验结束后随文章发表
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	ResMan IPD (http://www.medresman.org. cn). After the end of the experiment, it will be published with the article
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：	病例记录表
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	Case Record Form
数据与安全监察委员会： Data and Safety Monitoring Committee：	有/Yes
注册人： Name of Registration：	2026-05-19 17:06:35