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：	ChiCTR2600123501
最近更新日期： Date of Last Refreshed on：	2026-04-27 15:27:51
注册时间： Date of Registration：	2026-04-27 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	评价艾帕洛利托沃瑞利单抗联合白蛋白紫杉醇治疗既往接受过含铂化疗和/ 或 PD-1/PD-L1 抑制剂的尿路上皮癌患者的疗效和安全性：一项前瞻性、单臂、 II 期临床研究
Public title：	Evaluation of the Efficacy and Safety of Ipatrolitol plus Tovorilimab in Combination with Albumin-Bound Paclitaxel for the Treatment of Urothelial Carcinoma Patients Previously Treated with Platinum-Based Chemotherapy and/or PD-1/PD-L1 Inhibitors: A Prospective, Single-Arm, Phase II Clinical Study
注册题目简写：
English Acronym：
研究课题的正式科学名称：	评价艾帕洛利托沃瑞利单抗联合白蛋白紫杉醇治疗既往接受过含铂化疗和/ 或 PD-1/PD-L1 抑制剂的尿路上皮癌患者的疗效和安全性：一项前瞻性、单臂、 II 期临床研究
Scientific title：	Evaluation of the Efficacy and Safety of Ipatrolitol plus Tovorilimab in Combination with Albumin-Bound Paclitaxel for the Treatment of Urothelial Carcinoma Patients Previously Treated with Platinum-Based Chemotherapy and/or PD-1/PD-L1 Inhibitors: A Prospective, Single-Arm, Phase II 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：	张慧	研究负责人：	张慧;邹本奎
Applicant：	Hui Zhang	Study leader：	Hui Zhang; Benkui Zou
申请注册联系人电话： Applicant telephone：	+86 531 67626409	研究负责人电话： Study leader's telephone：	+86 15854168073
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：	hui8942615@163.com	研究负责人电子邮件： Study leader's E-mail：	hui8942615@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：	中国山东省济南市槐荫区济兖路440号	研究负责人通讯地址：	中国山东省济南市槐荫区济兖路440号
Applicant address：	No. 440, Jiyan Road, Huaiyin District, Jinan, Shandong, China	Study leader's address：	No. 440, Jiyan Road, Huaiyin District, Jinan, Shandong, 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：	山东第一医科大学附属肿瘤医院（山东省肿瘤医院、山东省肿瘤防治研究院)
Applicant's institution：	Shandong First Medical University and Shandong Academy of Medical Sciences (Shandong Cancer Hospital &Institute)
研究负责人所在单位：	山东第一医科大学附属肿瘤医院（山东省肿瘤防治研究院、山东省肿瘤医院）
Affiliation of the Leader：	Shandong First Medical University and Shandong Academy of Medical Sciences (Shandong Cancer Hospital ＆Institute)

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：	SDZLEC2026-024-002	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：	山东第一医科大学附属肿瘤医院伦理委员会
Name of the ethic committee：	Ethics Committee of the Affiliated Cancer Hospital of Shandong First Medical University
伦理委员会批准日期： Date of approved by ethic committee：	2026-04-07 00:00:00
伦理委员会联系人：	李朝伟
Contact Name of the ethic committee：	Li Chaowei
伦理委员会联系地址：	中国山东省济南市槐荫区济兖路440号
Contact Address of the ethic committee：	No. 440, Jiyan Road, Huaiyin District, Jinan, Shandong, China
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 531 67627162	伦理委员会联系人邮箱： Contact email of the ethic committee：	sdzlllh803@126.com

研究实施负责（组长）单位：

山东第一医科大学附属肿瘤医院（山东省肿瘤防治研究院、山东省肿瘤医院）

Primary sponsor：

Shandong First Medical University and Shandong Academy of Medical Sciences (Shandong Cancer Hospital ＆Institute)

研究实施负责（组长）单位地址：

中国山东省济南市槐荫区济兖路440号

Primary sponsor's address：

No. 440, Jiyan Road, Huaiyin District, Jinan, Shandong, 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)：	山东	市(区县)：
Country：	China	Province：	Shandong	City：
单位(医院)：	山东第一医科大学附属肿瘤医院（山东省肿瘤防治研究院、山东省肿瘤医院）	具体地址：	中国山东省济南市槐荫区济兖路440号
Institution hospital：	Shandong First Medical University and Shandong Academy of Medical Sciences (Shandong Cancer Hospital ＆Institute)	Address：	No. 440, Jiyan Road, Huaiyin District, Jinan, Shandong, China

经费或物资来源：

自选课题（自筹）

Source(s) of funding：

Self-selected research topic (self-funded)

研究疾病：

既往一线系统治疗（包括一线后维持治疗）失败的局部晚期或晚期尿路上皮癌

Target disease：

Locally advanced or advanced urothelial carcinoma that has progressed on or after prior first-line systemic therapy (including post-first-line maintenance therapy)

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：

主要目的：评价艾帕洛利托沃瑞利单抗注射液联合白蛋白紫杉醇治疗既往一线治疗失败的尿路上皮癌的无进展生存期（PFS）；次要目的：评价艾帕洛利托沃瑞利单抗联合白蛋白紫杉醇治疗既往一线治疗失败的尿路上皮癌的疗效，包括客观缓解率（ORR）、疾病控制率（DCR）、缓解持续时间（DoR）、疾病进展时间（TTP）、总生存期（OS）；评价艾帕洛利托沃瑞利单抗联合白蛋白紫杉醇治疗既往一线治疗失败的尿路上皮癌的安全性；评价艾帕洛利托沃瑞利单抗联合白蛋白紫杉醇治疗对既往一线治疗失败的尿路上皮癌患者健康相关生活质量（QoL）的影响；构建类器官，研究药物耐药机制。

Objectives of Study：

Primary Objective: To evaluate the progression‑free survival (PFS) of Iparomlimab and Tuvonralimab Injection combined with nab‑paclitaxel in the treatment of urothelial carcinoma that has failed first‑line therapy. Secondary Objectives: To evaluate the efficacy of Iparomlimab and Tuvonralimab Injection combined with nab‑paclitaxel in the treatment of urothelial carcinoma that has failed first‑line therapy, including objective response rate (ORR), disease control rate (DCR), duration of response (DoR), time to progression (TTP), and overall survival (OS). To evaluate the safety of Iparomlimab and Tuvonralimab Injection combined with nab‑paclitaxel in the treatment of urothelial carcinoma that has failed first‑line therapy. To evaluate the impact of Iparomlimab and Tuvonralimab Injection combined with nab‑paclitaxel on health‑related quality of life (QoL) in patients with urothelial carcinoma that has failed first‑line therapy. To establish organoids for investigating mechanisms of drug resistance.

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.At the time of voluntarily signing the informed consent form, the subject must be aged ≥18 years, of any gender, and judged by the investigator as having good compliance.
2.Histopathologically confirmed urothelial carcinoma of the bladder or upper urinary tract. If other heterologous components (such as squamous cell carcinoma, adenocarcinoma, small cell carcinoma, etc.) are present, the transitional cell component must be predominant (>50%).
3.Prior first-line systemic therapy (including maintenance therapy after first-line) for unresectable locally advanced or advanced urothelial carcinoma has failed, meeting any of the following criteria:  Disease progression or recurrence following first-line platinum‑based regimen (e.g., cisplatin or carboplatin in combination with gemcitabine, methotrexate, vinblastine, doxorubicin, etc.) for unresectable locally advanced or advanced urothelial carcinoma. Platinum‑based therapy is permitted to include combination with a PD‑1 or PD‑L1 inhibitor.  Disease progression or recurrence following first‑line PD‑1 or PD‑L1 inhibitor therapy for unresectable locally advanced or advanced urothelial carcinoma.
4.There is at least one measurable lesion according to RECIST v1.1 criteria.
5.Eastern Cooperative Oncology Group (ECOG, Appendix 1) performance status score of 0-1.
6.Estimated life expectancy >=3 months.
7.Adequate organ function meeting the protocol‑specified laboratory criteria: hemoglobin >=90 g/L; hematological parameters: white blood cell count >=3×10^9/L, absolute neutrophil count >=1.5×10^9/L, platelet count >=100×10^9/L.
8.No organ dysfunction: total bilirubin (T-BIL) <=1.5 × upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <=2.5 × ULN, or <=5 × ULN in the presence of liver metastases; serum creatinine <=1.5 × ULN; creatinine clearance>=30 mL/min (Appendix 2).
9.Male patients and female patients of childbearing potential must take adequate contraceptive measures from the time of signing the informed consent form until 6 months after the last dose of study treatment; female patients of childbearing potential must have a negative pregnancy test within 7 days prior to the first treatment.

排除标准：

1.妊娠或计划妊娠或哺乳期女性； 2.对研究药物或其任何辅料存在过敏史； 3.5年内合并其它原发恶性肿瘤（经充分治疗并且疾病稳定的基底细胞癌、鳞状皮肤细胞癌、宫颈原位癌等除外）者； 4.研究治疗开始前4周内发生的严重感染，包括但不限于因感染、菌血症或者严重肺炎的并发症住院治疗； 5.有免疫缺陷的诊断或预期在研究治疗期间需要使用系统性免疫抑制药物治疗或首次治疗前使用过系统性糖皮质激素或其他免疫抑制药物，注：不包括喷鼻、吸入性或其他途径的局部糖皮质激素或生理剂量的系统性糖皮质激素（即不超过10mg/天泼尼松或等效剂量的其他糖皮质激素）、允许因治疗慢性阻塞性肺疾病等疾病的呼吸困难症状、预防过敏临时使用糖皮质激素； 6.存在活动性自身免疫性疾病或自身免疫性疾病病史，包括但不限于间质性肺炎、葡萄膜炎、炎症性肠病、肝炎、垂体炎症、血管炎、系统性红斑狼疮等，注：无症状或仅需要稳定剂量的激素替代治疗达到稳定的甲状腺功能减退（由自身免疫性甲状腺炎引起的）以及仅需要稳定剂量的胰岛素替代治疗的 I型糖尿病除外； 7.具有临床意义的心血管疾病：脑卒中（入组前＜6个月）、心肌梗死（入组前＜6个月）、不稳定型心绞痛、充血性心力衰竭（≥纽约心脏病学会心功能分级II级）或需药物治疗的严重心律失常； 8.首次治疗前合并以下症状或疾病，且经最佳治疗后仍控制不佳：（1）合并未控制的高血糖（血糖控制定义为空腹血糖7mmol/L以下、正在接受稳定的口服降糖药方案、专科医生评价血糖控制稳定）；（2）合并控制不良的高血压（两种或两种以上降压药联合治疗后，收缩压>150 mmHg和/或舒张压>100mmHg）及既往具有高血压危象或高血压脑病史者；（3）经干预后仍控制不佳的恶性胸腔积液、腹腔积液或心包积液（控制不佳指积液抽取2周内增长明显，伴有明显症状需再次进行穿刺或其它干预）； 9.已知人类免疫缺陷病毒（HIV 1/2抗体）感染史的患者； 10.活动性乙型肝炎或丙型肝炎感染者； 11.存在其他经研究者评估可能影响研究安全性和有效性评估的严重的和/或未控制的合并疾病或研究者认为具有不适合入选的其他情况。

Exclusion criteria：

1.Women who are pregnant, planning to become pregnant, or breastfeeding. 2.History of allergy to the study drug or any of its excipients; 3.Patients with other primary malignancies within 5 years (excluding adequately treated and stable basal cell carcinoma, squamous cell skin carcinoma, cervical carcinoma in situ, etc.); 4.Severe infection occurring within 4 weeks prior to the start of study treatment, including but not limited to hospitalization due to complications of infection, bacteremia, or severe pneumonia; 5.Diagnosis of immunodeficiency, or anticipated need for systemic immunosuppressive therapy during the study treatment period, or use of systemic corticosteroids or other immunosuppressive drugs prior to the first treatment. Note: Intranasal, inhaled, or other topical corticosteroids, as well as physiological doses of systemic corticosteroids (i.e., no more than 10 mg/day of prednisone or equivalent) are not excluded. Temporary use of corticosteroids for dyspnea symptoms due to chronic obstructive pulmonary disease (COPD) or other conditions, or for allergy prophylaxis, is permitted. 6.Presence of active autoimmune disease or history of autoimmune disease, including but not limited to interstitial pneumonia, uveitis, inflammatory bowel disease, hepatitis, hypophysitis, vasculitis, systemic lupus erythematosus, etc. Note: Asymptomatic or stable hypothyroidism requiring only stable doses of hormone replacement therapy (caused by autoimmune thyroiditis) and type I diabetes mellitus requiring only stable doses of insulin replacement therapy are excluded. 7.Clinically significant cardiovascular disease: stroke (<6 months prior to enrollment), myocardial infarction (<6 months prior to enrollment), unstable angina, congestive heart failure (>= New York Heart Association functional class II), or severe arrhythmia requiring medical therapy. 8. The following symptoms or diseases were present before the initial treatment and poorly controlled with the best treatment: (1) uncontrolled hyperglycemia (glycemic control was defined as fasting blood glucose less than 7mmol/L, current treatment with stable oral antidiabetic drugs, and stable glycemic control as assessed by a specialist); (2) patients with uncontrolled hypertension (systolic blood pressure >150 mmHg and/or diastolic blood pressure >100mmHg after combined treatment of two or more antihypertensive drugs) and a history of hypertensive crisis or hypertensive encephalopathy; (3) poorly controlled malignant pleural effusion, peritoneal effusion or pericardial effusion (poorly controlled means that the volume of pleural effusion increased significantly within 2 weeks after extraction, accompanied by obvious symptoms requiring repeat puncture or other interventions); 9.Patients with a known history of human immunodeficiency virus (HIV 1/2 antibody) infection. 10.Patients with active hepatitis B or hepatitis C infection. 11.Presence of other severe and/or uncontrolled comorbidities that, in the investigator's assessment, may affect the evaluation of study safety and efficacy, or other conditions that, in the investigator's opinion, make the subject unsuitable for enrollment.

研究实施时间：

Study execute time：

从 From 2025-11-01 00:00:00至 To 2028-06-01 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2026-05-15 00:00:00 至 To 2027-06-01 00:00:00

干预措施：

Interventions：

组别：	试验组	样本量：	28
Group：	Experimental Group	Sample size：	28
干预措施：	艾帕洛利托沃瑞利单抗联合白蛋白紫杉醇	干预措施代码：
Intervention：	Iparomlimab and Tuvonralimab combined with nab-paclitaxel	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	中国	省(直辖市)：	山东	市(区县)：
Country：	China	Province：	Shandong	City：
单位(医院)：	山东第一医科大学附属肿瘤医院（山东省肿瘤防治研究院、山东省肿瘤医院）	单位级别：	三级甲等
Institution hospital：	Shandong First Medical University and Shandong Academy of Medical Sciences (Shandong Cancer Hospital ＆Institute)	Level of the institution：	Tertiary A

国家：	中国	省(直辖市)：	山东	市(区县)：
Country：	China	Province：	Shandong	City：
单位(医院)：	临沂市人民医院	单位级别：	三级甲等
Institution hospital：	Linyi People's Hospital	Level of the institution：	Tertiary A

国家：	中国	省(直辖市)：	山东	市(区县)：
Country：	China	Province：	Shandong	City：
单位(医院)：	青岛大学附属医院	单位级别：	三级甲等
Institution hospital：	Qingdao University Affiliated Hospital	Level of the institution：	Tertiary A

测量指标：

Outcomes：

指标中文名：	疾病进展时间（TTP）	指标类型：	次要指标
Outcome：	Time to Progression (TTP)	Type：	Secondary indicator
测量时间点：	首次影像学或临床确认疾病进展（依据 RECIST 1.1 标准）的日期。	测量方法：	根据影像学，判断疗效
Measure time point of outcome：	The date of first radiological or clinical confirmation of disease progression.	Measure method：	Based on imaging, assess the efficacy.

指标中文名：	客观缓解率（ORR）	指标类型：	次要指标
Outcome：	Objective Response Rate (ORR)	Type：	Secondary indicator
测量时间点：	首次复查评价疗效	测量方法：	根据影像学，判断疗效
Measure time point of outcome：	First follow-up efficacy assessment	Measure method：	Based on imaging, assess the efficacy.

指标中文名：	无进展生存时间（PFS）	指标类型：	主要指标
Outcome：	Progression-Free Survival (PFS)	Type：	Primary indicator
测量时间点：	从入组日期开始评估，直至首次记录的疾病进展日期或因任何原因导致的死亡日期，以先发生者为准。	测量方法：	计算疾病进展日期或生存期
Measure time point of outcome：	Assessed from the date of enrollment until the date of first documented disease progression or death	Measure method：	Calculation of Disease Progression Date and Survival Time

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：	从入组开始到因任何原因导致的死亡的时间间隔	测量方法：	计算生存期
Measure time point of outcome：	The time interval from enrollment to death from any cause.	Measure method：	Calculate survival time

指标中文名：	疾病控制率（DCR）	指标类型：	次要指标
Outcome：	Disease Control Rate (DCR	Type：	Secondary indicator
测量时间点：	首次复查评价疗效	测量方法：	根据影像学，判断疗效
Measure time point of outcome：	First follow-up efficacy assessment	Measure method：	Based on imaging, assess the efficacy.

指标中文名：	缓解持续时间（DoR）	指标类型：	次要指标
Outcome：	Duration of Response (DoR)	Type：	Secondary indicator
测量时间点：	首次满足缓解标准（CR 或 PR）的肿瘤评估日期至首次出现疾病进展（根据 RECIST 1.1 标准）或死亡的日期（以先发生者为准）	测量方法：	根据影像学，判断疗效
Measure time point of outcome：	From first CR/PR to PD or death, whichever occurs first.	Measure method：	Based on imaging, assess the efficacy.

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		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）：	无
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：	有/Yes
注册人： Name of Registration：	2026-04-27 15:27:42