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：	ChiCTR2600126897
最近更新日期： Date of Last Refreshed on：	2026-06-18 14:26:34
注册时间： Date of Registration：	2026-06-18 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	基于多组学预测瑞康曲妥珠单抗联合卡瑞利珠单抗围手术期治疗HER2 阳性肌层浸润性尿路上皮癌疗效的Ⅱ 期临床研究
Public title：	Phase Ⅱ Clinical Study on Predicting Perioperative Efficacy of Trastuzumab Rezetecan Combined with Camrelizumab in HER2-Positive Muscle-Invasive Urothelial Carcinoma Based on Multi-Omics
注册题目简写：
English Acronym：
研究课题的正式科学名称：	基于多组学预测瑞康曲妥珠单抗联合卡瑞利珠单抗围手术期治疗HER2 阳性肌层浸润性尿路上皮癌疗效的Ⅱ 期临床研究
Scientific title：	Phase Ⅱ Clinical Study on Predicting Perioperative Efficacy of Trastuzumab Rezetecan Combined with Camrelizumab in HER2-Positive Muscle-Invasive Urothelial Carcinoma Based on Multi-Omics
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：	邰胜;徐汉江	研究负责人：	邰胜
Applicant：	Tai Sheng;Xu Hanjiang	Study leader：	Sheng Tai
申请注册联系人电话： Applicant telephone：	+86 551 62922234	研究负责人电话： Study leader's telephone：	+86 18355159268
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：	taisheng@ahmu.edu.cn	研究负责人电子邮件： Study leader's E-mail：	taishengwk@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：	中国安徽省合肥市蜀山区绩溪路218号	研究负责人通讯地址：	安徽省合肥市蜀山区绩溪路218号
Applicant address：	218 Jixi Road, Shushan District, Hefei, Anhui, China	Study leader's address：	218 Jixi Road, Hefei City, Anhui Province, China
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：	安徽医科大学第一附属医院
Applicant's institution：	The First Affiliated Hospital of Anhui Medical University
研究负责人所在单位：	安徽医科大学第一附属医院
Affiliation of the Leader：	The first affiliated hospital of anhui 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：	KY2026-04-47 (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：	安徽医科大学第一附属医院临床研究伦理委员会
Name of the ethic committee：	Clinical Research Ethics Committee of the First Affiliated Hospital of Anhui Medical University
伦理委员会批准日期： Date of approved by ethic committee：	2026-05-18 00:00:00
伦理委员会联系人：	丁佳翔
Contact Name of the ethic committee：	Jiaxiang Ding
伦理委员会联系地址：	安徽省合肥市蜀山区绩溪路218号
Contact Address of the ethic committee：	218 Jixi Road, Hefei City, Anhui Province, China
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 551 62923004	伦理委员会联系人邮箱： Contact email of the ethic committee：	ayfyllbgs@88.com

研究实施负责（组长）单位：

安徽医科大学第一附属医院

Primary sponsor：

The first affiliated hospital of anhui medical university

研究实施负责（组长）单位地址：

安徽省合肥市蜀山区绩溪路218号

Primary sponsor's address：

218 Jixi Road, Hefei City, Anhui 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)：	安徽省	市(区县)：
Country：	China	Province：	Anhui	City：
单位(医院)：	安徽医科大学第一附属医院	具体地址：	安徽省合肥市蜀山区绩溪路218号
Institution hospital：	The first affiliated hospital of anhui medical university	Address：	218 Jixi Road, Hefei City, Anhui Province, China

经费或物资来源：

自选课题（自筹）

Source(s) of funding：

Self-funded

研究疾病：

HER2 表达阳性肌层浸润性尿路上皮癌患者

Target disease：

Patients with HER2-positive muscle-invasive 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：

II期临床试验

Study phase：

2

研究设计：

单臂

Study design：

Single arm

研究目的：

基于多组学预测瑞康曲妥珠单抗联合卡瑞利珠单抗围手术期治疗HER2 阳性肌层浸润性尿路上皮癌患者的疗效和安全性。

Objectives of Study：

Predicting the efficacy and safety of perioperative treatment with Trastuzumab Rezetecan combined with camrelizumab in patients with HER2-positive muscle-invasive urothelial carcinoma based on multi-omics.

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. Aged 18 years or older, no restriction on gender;
2. Voluntarily participate in the study, sign a written informed consent form, and maintain good compliance
3. Confirmed as urothelial carcinoma of the bladder by histopathology (presence of squamous or glandular components is permitted, provided urothelial carcinoma constitutes the predominant component);
4. Patients are diagnosed with muscle-invasive bladder cancer (MIBC) via imaging or clinical assessment: cT2–T4a, N0–1, M0 (staged per AJCC/UICC criteria; imaging evaluations must be completed within the specified time window prior to enrollment, e.g., within 28 days);
5. Positive HER2 expression in tumor: IHC 1+, 2+ or 3+ (tested on tumor tissue specimens obtained prior to enrollment; central laboratory/designated laboratory testing may be specified);
6. ECOG performance status of 0–1;
7. Eligibility for radical surgical treatment: Radical cystectomy (RC) is expected to be feasible; and investigators assess that subsequent TURBT can be performed in line with the study protocol;
8. Major organ functions meet the treatment criteria (threshold values are recommended as exemplified below): Blood routine: ANC >=1.5×10^9/L, PLT >=100×10^9/L, Hb >=90 g/L; Liver function: ALT/AST <=2.5×ULN, TBil <=1.5×ULN; Renal function: creatinine clearance >=50 mL/min (calculated via Cockcroft–Gault or MDRD formula); Satisfactory cardiac function: echocardiographic LVEF >=50% (or threshold set per local hospital standards or clinical guidelines) with no obvious heart failure symptoms (due to trastuzumab-containing regimen);
9. Subjects of childbearing age agree to use effective contraception during the study period and within the specified time after the last dose administration.

排除标准：

1.存在远处转移（M1）或不可切除/不适合手术者；或合并其他需要系统治疗的活动性肿瘤负荷（按研究者判断）。
2.既往接受过针对本次肿瘤的系统抗肿瘤治疗（如新辅助/辅助/转移期化疗、免疫治疗、抗HER2治疗等）；或既往接受过 PD-1/PD-L1 抑制剂、抗HER2单抗/ADC 且研究者认为影响疗效/安全性评估。
3.既往盆腔放疗或近期重大手术/严重创伤未恢复（可按时间窗规定）。
4.活动性自身免疫性疾病或需系统性免疫抑制治疗者（如长期激素 >10 mg 泼尼松/日或等效剂量；允许局部/吸入/短程）。
5.活动性感染或严重感染未控制；活动性结核。病毒感染：HBsAg 阳性且 HBV DNA 高于阈值/未规范抗病毒；HCV RNA 阳性且未控制；HIV 感染（可按中心要求）。具有临床意义的心血管疾病：充血性心力衰竭、近期心肌梗死、不稳定心绞痛、难以控制的心律失常；LVEF <50% 或研究者认为不适合接受曲妥珠单抗者。
6.既往或当前间质性肺病/非感染性肺炎，或影像学提示明显肺间质改变且研究者判断风险高（免疫相关肺炎风险）。
7.已知对研究药物（曲妥珠单抗、卡瑞利珠单抗）或其辅料严重过敏。妊娠或哺乳期；计划在研究期间妊娠者。
8.伴有严重精神/认知障碍、药物滥用等导致无法完成随访或评估者。
9.研究者认为不适合入组的其他情况（如严重合并症、预期生存期过短等）。

Exclusion criteria：

1. Patients with distant metastasis (M1) or unresectable/inoperable disease; or those complicated with other active tumor burdens requiring systemic treatment (as judged by the investigator); 2. Prior receipt of systematic anti-tumor therapy for the current malignancy (such as neoadjuvant/adjuvant/metastatic-phase chemotherapy, immunotherapy, anti-HER2 therapy, etc.); or prior treatment with PD-1/PD-L1 inhibitors, anti-HER2 monoclonal antibodies/ADCs, which the investigator deems capable of affecting efficacy or safety assessment; 3. Prior pelvic radiotherapy or unrecovered major surgery/severe trauma in the recent period (subject to specified time limits); 4. Individuals with active autoimmune diseases or those requiring systemic immunosuppressive therapy (e.g., long-term hormone treatment with prednisone >10 mg per day or equivalent dosage; topical, inhaled or short-course medication is permitted); 5. Uncontrolled active or severe infection; active tuberculosis. Viral infections: positive HBsAg with HBV DNA above the threshold or without standardized antiviral treatment; positive HCV RNA with uncontrolled disease; HIV infection (subject to the requirements of the study center). Clinically significant cardiovascular diseases: congestive heart failure, recent myocardial infarction, unstable angina pectoris, refractory arrhythmia; LVEF <50% or subjects deemed inappropriate for trastuzumab administration by the investigator; 6. Previous or current interstitial lung disease/non-infectious pneumonia, or significant interstitial lung abnormalities on imaging assessed by the investigator to carry a high risk (risk of immune-related pneumonia); 7. Known severe hypersensitivity to the investigational medicinal products (trastuzumab, camrelizumab) or their excipients; pregnant or breastfeeding patients; those planning to become pregnant during the study period; 8. Those complicated with severe mental/cognitive disorders, substance abuse or other conditions that prevent completion of follow-up or assessment; 9. Other conditions deemed ineligible for enrollment by the investigators (such as severe comorbidities, too short expected survival time, etc.).

研究实施时间：

Study execute time：

从 From 2026-04-01 00:00:00至 To 2028-12-31 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2026-06-18 00:00:00 至 To 2028-06-18 00:00:00

干预措施：

Interventions：

组别：	试验组	样本量：	44
Group：	Trial Group	Sample size：	44
干预措施：	瑞康曲妥珠单抗联合卡瑞利珠单抗围手术期治疗	干预措施代码：
Intervention：	Perioperative Treatment with Trastuzumab?Rezetecan Combined with Camrelizumab	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	中国	省(直辖市)：	安徽省	市(区县)：
Country：	China	Province：	Anhui	City：
单位(医院)：	安徽医科大学第一附属医院	单位级别：	三级甲等
Institution hospital：	The first affiliated hospital of anhui medical university	Level of the institution：	Tertiary A

测量指标：

Outcomes：

指标中文名：	总生存期（OS）	指标类型：	次要指标
Outcome：	Overall Survival (OS)	Type：	Secondary indicator
测量时间点：	自首次试验用药至任意原因死亡，最长随访12个月	测量方法：	门诊 / 电话随访记录患者生存状态，Kaplan-Meier 统计 OS 数据。
Measure time point of outcome：	The maximum follow-up period is 12 months from the first study drug administration to death from any	Measure method：	Survival status is collected via outpatient or telephone follow-up; all-cause death is defined as endpoint, OS is calculated with Kaplan-Meier method.

指标中文名：	无事件生存期（EFS）	指标类型：	次要指标
Outcome：	Event-Free Survival (EFS)	Type：	Secondary indicator
测量时间点：	自首次试验用药开始随访，直至出现疾病进展 / 死亡，最长随访 12 个月	测量方法：	定期影像学复查 + 临床随访，首次出现局部复发、远处转移、疾病进展或任何原因全因死亡记为终点事件，采用 Kaplan-Meier 法计算 EFS。
Measure time point of outcome：	From treatment start until disease progression/death, follow-up up to 12 months.	Measure method：	Regular imaging assessment and clinical follow-up; endpoint is defined as the first occurrence of local recurrence, distant metastasis, disease progression or all-cause death; EFS is analyzed via Kaplan-Meier method.

指标中文名：	术后病理降期至 T1 的患者比例	指标类型：	次要指标
Outcome：	Proportion of patients downstaged to pathological T1 stage	Type：	Secondary indicator
测量时间点：	根治性膀胱切除术后病理报告出具时	测量方法：	依据术后大体病理分期，统计术前 cT2-T4a 患者术后病理变为 pT1 的病例占比。
Measure time point of outcome：	Upon pathological report release after radical cystectomy.	Measure method：	Postoperative pathological staging is reviewed, and the percentage of patients with pathological downstaging to pT1 is calculated.

指标中文名：	病理完全缓解率（pCR）	指标类型：	主要指标
Outcome：	Pathological Complete Response Rate (pCR rate)	Type：	Primary indicator
测量时间点：	新辅助治疗完成后行根治性膀胱切除术时	测量方法：	术后手术标本病理取材，病理科按照膀胱癌病理判读标准评估原发灶及区域淋巴结，无残存浸润性尿路上皮癌即为 pCR，统计 pCR 病例占全部入组病例百分比
Measure time point of outcome：	At the time of radical cystectomy after completion of neoadjuvant treatment.	Measure method：	Postoperative surgical specimens are pathologically examined; pCR is defined as no residual invasive urothelial carcinoma in primary bladder lesion and regional lymph nodes, and pCR rate is calculated as the percentage of patients achieving pCR among all enrolled subjects.

指标中文名：	治疗安全性与耐受性	指标类型：	次要指标
Outcome：	Safety and Tolerability	Type：	Secondary indicator
测量时间点：	首次给药至末次用药后 30 天	测量方法：	全程记录不良事件，按照 CTCAE v6.0 分级，统计各类不良事件发生率、严重程度及药物相关性。
Measure time point of outcome：	From first study drug administration to 30 days after last study medication.	Measure method：	All adverse events are documented and graded by CTCAE version 6.0; incidence, severity and drug causality of AEs are summarized.

指标中文名：	多组学空间特征与新辅助疗效相关性	指标类型：	次要指标
Outcome：	Multiomics spatial biomarkers for neoadjuvant therapeutic response prediction	Type：	Secondary indicator
测量时间点：	新辅助前基线肿瘤活检取材 + 术后病理结果确定时	测量方法：	基线标本行 WES 全外显子测序、10x Xenium 空间转录组、PhenoCycler-Fusion 空间单细胞蛋白组检测，关联术后 pCR 等疗效结果，筛选疗效预测相关分子与空间病理特征。
Measure time point of outcome：	Baseline tumor biopsy before neoadjuvant therapy and after postoperative pathological confirmation.	Measure method：	Pre-treatment tumor samples are tested with WES, 10x Xenium spatial transcriptomics and PhenoCycler-Fusion spatial single-cell proteomics; multi-omics data are correlated with postoperative pathological response to screen predictive factors.

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		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	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）：	不涉及
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	N/A
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：	病例报告表
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	Case Report Form
数据与安全监察委员会： Data and Safety Monitoring Committee：	无/No
注册人： Name of Registration：	2026-06-18 14:25:45