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：	ChiCTR2400085653
最近更新日期： Date of Last Refreshed on：	2024-06-14 15:00:43
注册时间： Date of Registration：	2024-06-14 00:00:00
注册号状态：	补注册
Registration Status：	Retrospective registration
注册题目：	一项在适宜肌层浸润性膀胱癌患者中的保膀胱单臂临床研究
Public title：	A single arm study of bladder preservation in suitable patients with muscule invasive bladder cancer
注册题目简写：
English Acronym：
研究课题的正式科学名称：	最大化经尿道膀胱肿瘤电切术联合化疗和免疫治疗的保膀胱模式在适宜肌层浸润性膀胱癌病患中的临床研究
Scientific title：	The bladder-sparing pattern of maximizing transurethral bladder tumor resection combined with chemotherapy and immunotherapy in suitable patients with muscule invasive bladder cancer
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：	徐耀宗	研究负责人：	徐耀宗
Applicant：	Yaozong Xu	Study leader：	Yaozong Xu
申请注册联系人电话： Applicant telephone：	+86 180 4975 9866	研究负责人电话： Study leader's telephone：	+86 180 4975 9866
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：	yaozong_x@163.com	研究负责人电子邮件： Study leader's E-mail：	yaozong_x@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：	上海市闵行区鹤庆路801号	研究负责人通讯地址：	上海市闵行区鹤庆路801号
Applicant address：	No.801,Heqing Road,Minhang District,Shanghai	Study leader's address：	No.801,Heqing Road,Minhang District,Shanghai
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：	复旦大学附属上海市第五人民医院
Applicant's institution：	The Fifth People's Hospital of Shanghai,Fudan University
研究负责人所在单位：	复旦大学附属上海市第五人民医院
Affiliation of the Leader：	The Fifth People's Hospital of Shanghai,Fudan 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：	2023062	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：	复旦大学附属上海市第五人民医院医学伦理委员会
Name of the ethic committee：	Medical Ethics Committee of Shanghai Fifth People's Hospital affiliated to Fudan University
伦理委员会批准日期： Date of approved by ethic committee：	2023-03-23 00:00:00
伦理委员会联系人：	钱少霞
Contact Name of the ethic committee：	Shaoxia Qian
伦理委员会联系地址：	上海市闵行区鹤庆路801号
Contact Address of the ethic committee：	No.801,Heqing Road,Minhang District,Shanghai
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 21 2428 9446	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：

复旦大学附属上海市第五人民医院

Primary sponsor：

The Fifth People's Hospital of Shanghai,Fudan University

研究实施负责（组长）单位地址：

上海市闵行区鹤庆路801号

Primary sponsor's address：

No.801,Heqing Road,Minhang District,Shanghai

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：	中国	省(直辖市)：	上海	市(区县)：	闵行区
Country：	China	Province：	Shanghai	City：	Minhang District
单位(医院)：	复旦大学附属上海市第五人民医院	具体地址：	上海市闵行区鹤庆路801号
Institution hospital：	The Fifth People's Hospital of Shanghai,Fudan University	Address：	No.801,Heqing Road,Minhang District,Shanghai

经费或物资来源：

院级项目

Source(s) of funding：

Hospital-level project

研究疾病：

肌层浸润性膀胱癌

Target disease：

Muscle invasive bladder cancer

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：

治疗新技术临床试验

Study phase：

New Treatment Measure Clinical Study

研究设计：

单臂

Study design：

Single arm

研究目的：

该研究探讨最大化经尿道膀胱肿瘤切除联合化疗和免疫治疗对合适的肌肉浸润性膀胱癌患者的效果，并为临床膀胱保存方案提供了新的证据

Objectives of Study：

The study explores the effect of maximizing transurethral bladder tumor resection combined with chemotherapy and immunotherapy in suitable patients with muscule invasive bladder cancer, and provides a new model for clinical bladder preservation protocols

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.≥ 18-year-old male or female;
2.People who are willing to protect their bladder;
3.ECOG PS: 0 to 2 points;
4.Subjects undergo TURBT and imaging diagnosis, which the researchers judged to be muscle-invasive bladder urothelial carcinoma (receiving histological variations, not receiving diffuse CIS lesions), simple or mixed (urinary intestinal carcinoma ≥ 50%)
5.Accept maximized TURBT
6.Clinical stages T2, N0, M0
7.Na?ve populations that have not received systemic chemotherapy or immunotherapy
8.Cisplatin tolerates people
9.Normal functioning of the main organs (14 days before enlistment) i.e. complies with the following criteria:
(1) The blood routine examination criteria should be met (no blood transfusion and no granulocyte colony stimulator treatment within 14 days before admission):
HB≥90 g/L
ANC≥1.5×109 /L
PLT≥100×109 /L
(2) Non-functional organic diseases, which must meet the following standards:
T-BIL≤ 1.5 × ULN (upper limit of normal value);
ALT and AST ≤ 2.5 × ULN; If liver metastases, ALT and AST ≤ 5× ULN;
Estimated glomerular filtration rate (eGFR) >60 ml/min (MdRD formula);
International Normalized Ratio (INR), Activated Partial Thromboplastin Time (aPTT): ≤ 1.5× ULN (this criterion applies only to patients who have not received anticoagulation; Patients receiving anticoagulation should keep the anticoagulant within the limits of the therapeutic requirements);
10.Men with reproductive capacity or women with the possibility of becoming pregnant must use highly effective contraceptive methods (e.g., oral contraceptives, intrauterine devices, libido abstinence or barrier contraception in combination with spermicide) during the trial and continue contraception for 12 months after the end of treatment;
11.Participants voluntarily joined the study, signed informed consent forms, had good compliance, and cooperated with follow-up.

排除标准：

1. 既往接受过抗PD-1、抗PD-L1、抗PD-L2治疗； 2. 已知对重组人源化抗PD-1单克隆抗体药物及其组分过敏者； 3. 研究治疗开始前4周内接受过其他抗肿瘤治疗（包括但不限于皮质类固醇治疗、免疫治疗）或参与其他临床研究的，或尚未从上次毒性中恢复的（除外2度脱发及1度神经毒性）； 4. 妊娠或哺乳期妇女，以及有生育意愿的女性（盆腔放疗可能使卵巢功能早衰）； 5. HIV检测结果阳性； 6. 活动性乙型肝炎或丙型肝炎患者 7. HBsAg或HBcAb阳性者同时检测到HBV DNA拷贝数阳性（定量检测限为500IU/ml，或达到研究中心检测的拷贝数阳性值）；这类患者研究筛查时必须检测 HBV DNA； 8. HCV抗体检测结果阳性的患者，仅当HCV RNA的PCR检测结果为阴性时，方可入选本研究。 9. 有明确活动性结核病史； 10. 有在过去2年内需要系统治疗的活动性自身免疫性疾病（如使用疾病调节药物、皮质类固醇或免疫抑制药物），允许相关的替代治疗（如甲状腺素、胰岛素，或肾或垂体机能不全的生理性皮质类固醇替代治疗）； 11. 其他可能影响方案依从性或干扰结果解释的严重的、无法控制的伴随疾病，包括活动性机会性感染或进展期（严重）感染、不能控制的糖尿病、心血管疾病（纽约心脏病协会分级定义的Ⅲ级或Ⅳ级心衰、Ⅱ度以上心脏传导阻滞、过去6个月内发生心肌梗塞、不稳定性心律失常或不稳定性心绞痛、3个月内发生脑梗塞等）或肺部疾病（间质性肺炎、阻塞性肺病和有症状的支气管痉挛病史）； 12. 治疗开始前4周内接受了活疫苗接种的； 13. 既往接受过异体造血干细胞移•植或实体器官移植； 14. 具有精神类药物滥用史且无法戒除者或有精神障碍史者； 15. 伴有临床症状或需要对症处理的大量胸水或腹水； 16. 过去5年曾患有其他恶性肿瘤未愈，但不包括已明显得到治愈的恶性肿瘤、或者可治愈癌症，如基底皮肤癌或鳞状细胞皮肤癌、局限性低危前列腺癌、宫颈原位癌或乳腺原位癌；备注：局限性低危前列腺癌（定义为阶段≤T2a、格里森评分≤6分和前列腺癌诊断时PSA≤10ng/mL（如测量）的患者接受过根治性手术且无前列腺特异性抗原（PSA）生化复发者可参与本研究）； 17. 既往有盆腔放疗史； 18. 合并UTUC； 19. 根据研究者的观点，可能会增加参加研究相关的风险、或者可能干扰研究结果的解释的其它重度、急性或慢性医学疾病或精神疾病或实验室异常。

Exclusion criteria：

1. Previous treatment against PD-1, anti-PD-L1, and anti-PD-L2;
2. Those who are known to be allergic to recombinant humanized anti-PD-1 monoclonal antibody drugs and their components;
3. Those who have received other anti-tumor therapy (including but not limited to corticosteroid therapy, immunotherapy) or participated in other clinical studies within 4 weeks prior to the start of the study treatment, or have not recovered from the previous toxicity (except for 2 degree hair loss and 1 degree neurotoxicity);
4. Pregnant or lactating women, as well as women who wish to have children (pelvic radiation therapy may cause premature ovarian failure);
5. Positive HIV test result;
6. Patients with active hepatitis B or C
7. HBsAg or HBcAb positive also detects positive HBV DNA copies (quantitative test limit is 500 IU/ml, or the copy number positive value detected by the research center is reached); HBV DNA must be detected for study screening in such patients;
8. Patients with positive HCV antibody test results should only be included in this study if the PCR test for HCV RNA is negative.
9. Have a clear history of active tuberculosis;
10. Have an active autoimmune disorder that requires systemic therapy within the past 2 years (e.g., using disease-modifying drugs, corticosteroids, or immunosuppressive drugs) that allows for associated alternative therapy (e.g., thyroxine, insulin, or phytologenetic corticosteroid replacement therapy for renal or pituitary insufficiency);
11. Other serious, uncontrollable concomitant diseases that may affect protocol adherence or interfere with the interpretation of outcomes, including active opportunistic or advanced (severe) infections, uncontrollable diabetes mellitus, cardiovascular disease (Grade III or IV heart failure as defined by the New York Heart Association, heart block above degree II,myocardial infarction within the past 6 months, unstable arrhythmias or unstable angina, cerebral infarction within 3 months, etc.) or lung disease (interstitial pneumonia, history of obstructive pulmonary disease and symptomatic bronchospasm);
12. Those who received live vaccination within 4 weeks prior to the start of treatment;
13. Previously received allogeneic hematopoietic stem cell transplantation, graft or solid organ transplantation;
14. Persons with a history of psychotropic substance abuse who cannot be rehabilitated or who have a history of mental disorders;
15. Substantial pleural or ascites with clinical symptoms or requiring symptomatic treatment;
16. Have had other malignancies that have not healed in the past 5 years, but do not include malignancies that have been clearly cured, or that can be cured, such as basal skin cancer or squamous cell skin cancer, localized low-risk prostate cancer, cervical carcinoma in situ or breast carcinoma in situ; Note: Patients with localized low-risk prostate cancer (defined as stage ≤ T2a, Gleason score of ≤6, and PSA ≤10 ng/mL (as measured) at prostate cancer diagnosis who underwent radical surgery and no biochemical recurrence of prostate-specific antigen (PSA) may participate in this study);
17. Previous history of pelvic radiotherapy;
18. Merger of UTUC;
19. Depending on the investigator's opinion, there may be an increased risk associated with participating in the study, or other severe, acute or chronic medical illness or psychiatric disorder or laboratory abnormalities that may interfere with the interpretation of the findings.

研究实施时间：

Study execute time：

从 From 2023-02-06 00:00:00至 To 2026-02-06 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2023-02-16 00:00:00 至 To 2025-12-31 00:00:00

干预措施：

Interventions：

组别：	实验组：研究保膀胱方案	样本量：	20
Group：	Experimental group: Investigate bladder-preserving regimens	Sample size：	20
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)：	上海	市(区县)：
Country：	China	Province：	Shanghai	City：
单位(医院)：	复旦大学附属上海市第五人民医院	单位级别：	三级
Institution hospital：	The Fifth People's Hospital of Shanghai,Fudan University	Level of the institution：	Tertiary

测量指标：

Outcomes：

指标中文名：	一年的膀胱完整的无病生存率	指标类型：	主要指标
Outcome：	One-year disease-free survival rate for intact bladder	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	12周临床完全缓解率（cT0）	指标类型：	次要指标
Outcome：	12-week clinical complete response rate (cT0)	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	非肌层浸润性膀胱癌复发率	指标类型：	次要指标
Outcome：	Non-Muscular invasive bladder cancer recurrence 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：	两年的无转移生存率	指标类型：	次要指标
Outcome：	Metastasis-Free survival at two year	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	两年的膀胱完整无病生存率	指标类型：	次要指标
Outcome：	Bladder intact disease-free survival at two year	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：	尿液	组织：
Sample Name：	Urine	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	100	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）：

单臂

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

Single arm

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：
Blinding：
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）：	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)：	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：	http://www.medresman.org.cn/login.aspx
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	http://www.medresman.org.cn/login.aspx
数据与安全监察委员会： Data and Safety Monitoring Committee：	无/No
注册人： Name of Registration：	2024-06-14 15:00:38