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：	ChiCTR2600124058
最近更新日期： Date of Last Refreshed on：	2026-05-06 18:19:40
注册时间： Date of Registration：	2026-05-06 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	注射用维迪西妥单抗联合恩扎卢胺一线治疗HER2表达的转移性去势抵抗性前列腺癌中安全性和疗效的II期临床研究
Public title：	Phase II Clinical Study to Evaluate the Safety and Efficacy of Disitamab Vedotin for Injection in Combination with Enzalutamide as First-Line Treatment for HER2-Expressing Metastatic Castration-Resistant Prostate Cancer
注册题目简写：
English Acronym：
研究课题的正式科学名称：	注射用维迪西妥单抗联合恩扎卢胺一线治疗HER2表达的转移性去势抵抗性前列腺癌中安全性和疗效的II期临床研究
Scientific title：	Phase II Clinical Study to Evaluate the Safety and Efficacy of Disitamab Vedotin for Injection in Combination with Enzalutamide as First-Line Treatment for HER2-Expressing Metastatic Castration-Resistant Prostate 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：	张智宇	研究负责人：	张智宇
Applicant：	Zhiyu Zhang	Study leader：	Zhiyu Zhang
申请注册联系人电话： Applicant telephone：	+86 535 669 1999	研究负责人电话： Study leader's telephone：	+86 535 669 1999
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：	yyyiitzzy0213@163.com	研究负责人电子邮件： Study leader's E-mail：	yyyiitzzy0213@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：	山东烟台芝罘区毓璜顶东路20号	研究负责人通讯地址：	山东烟台芝罘区毓璜顶东路20号
Applicant address：	No.20, Yuhuangdingdong Road, Zhifu District, Yantai, Shandong, China	Study leader's address：	No.20, Yuhuangdingdong Road, Zhifu District, Yantai, 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：	烟台毓璜顶医院
Applicant's institution：	Yantai Yuhuangding Hospital
研究负责人所在单位：	烟台毓璜顶医院
Affiliation of the Leader：	Yantai Yuhuangding Hospital

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：	YYYIRB-IIT[2026]048	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：	烟台毓璜顶医院临床研究伦理委员会
Name of the ethic committee：	Yantai Yuhuangding Hospital Clinical Research Institutional Review Board
伦理委员会批准日期： Date of approved by ethic committee：	2026-03-23 00:00:00
伦理委员会联系人：	李康琪
Contact Name of the ethic committee：	Li Kangqi
伦理委员会联系地址：	山东烟台芝罘区毓璜顶东路20号
Contact Address of the ethic committee：	No.20, Yuhuangdingdong Road, Zhifu District, Yantai, Shandong, China
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 535 6691999	伦理委员会联系人邮箱： Contact email of the ethic committee：	likangqiyt@163.com

研究实施负责（组长）单位：

烟台毓璜顶医院

Primary sponsor：

Yantai Yuhuangding Hospital

研究实施负责（组长）单位地址：

山东烟台芝罘区毓璜顶东路20号

Primary sponsor's address：

No.20, Yuhuangdingdong Road, Zhifu District, Yantai, 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)：	山东省	市(区县)：
Country：	China	Province：	Shandong	City：
单位(医院)：	烟台毓璜顶医院	具体地址：	山东烟台芝罘区毓璜顶东路20号
Institution hospital：	Yantai Yuhuangding Hospital	Address：	No.20, Yuhuangdingdong Road, Zhifu District, Yantai, Shandong, China

经费或物资来源：

荣昌生物制药（烟台）股份有限公司

Source(s) of funding：

Rongchang Bio-Pharmaceutical (Yantai) Co., LTD

研究疾病：

转移性去势抵抗性前列腺癌（mCRPC）

Target disease：

Metastatic castration-resistant prostate cancer (mCRPC)

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：

本研究的依据是评估在恩扎卢胺的基础上加用维迪西妥单抗是否可以延缓疾病进程，从而增加 mCRPC 期间针对恩扎卢胺的临床获益持续时间。这项研究旨在证明维迪西妥单抗 + 恩扎卢胺在 mCRPC 研究参与者中的临床获益。

Objectives of Study：

The basis of this study is to evaluate whether the addition of vedoximab to enzalutamide can delay the disease progression and thereby increase the duration of clinical benefits against enzalutamide during mCRPC. This study aims to demonstrate the clinical benefits of vedotinumab + enzalutamide in participants of the mCRPC study.

药物成份或治疗方案详述：

Description for medicine or protocol of treatment in detail：

纳入标准：

1.签署知情同意书时年龄 18 周岁以上，男性。
2.东部肿瘤协作组（ECOG）体能状态评分为 0 或 1，且经研究者评估预期生存期≥6个月。
3.组织学或细胞学检查证实的前列腺腺癌（小细胞特征除外），HER2表达（HER 2表达定义为 HER2免疫组织化学检查结果为 1+、2+或 3+）的转移性去势抵抗性 前列腺癌，需同时满足如下标准： 
1) 持续的黄体生成素释放激素类似物（LHRHa）治疗（药物去势）或既往接受 过双侧睾丸切除术（手术去势）；未接受双侧睾丸切除术的受试者必须计划在整个 研究期间维持有效的 LHRHa 治疗； 
2) 筛选时睾酮处于去势水平（＜50ng/dl 或 1.7nmol/L）； 
3) 骨扫描结果表明骨骼中有转移病灶，或者 CT/MRI 扫描结果表明软组织中有 转移病灶。 
a. 如果不存在可评估的骨病灶（根据 PCWG3标准），则需要存在可测量的软组织疾病（根据 RECIST V1.1）。如果骨扫描显示骨骼中存在强烈对称的骨 代谢活性（称为超级影像），则被视为不可评估。 
b. 对于只有可测量的软组织病灶的研究参与者，仅有区域性淋巴结病灶（即主动 脉分叉以下的淋巴结病灶）不符合参加研究的资格。
4.在随机化之前，任何既往治疗的急性影响的严重程度必须消退至基线水平或 CTCAE ≤ 1 级（据研究者判定不构成安全性风险的 AE 除外，比如脱发和周围 神经病）。
5.计划或既往已经稳定口服恩扎卢胺的患者。
6. 伴侣为育龄妇女的男性受试者均须从签署知情同意书开始直到试验用药品末次 给药后3个月内采取高效的避孕措施。
7.重要器官功能符合以下标准（首次用药前 14 天内未使用任何血液成分、细胞 生长因子进行纠正治疗），检查结果需在首次研究治疗前 14 天内完成： - 中性粒细胞计数（ANC）≥1.5×10^9 /L（1,500/mm^3）； - 血小板≥80×10^9 /L（100,000/mm^3）； - 血红蛋白（Hgb）≥9.0 g/dL（90 g/L）； - 白蛋白水平≥3.0 g/dL； - 总胆红素≤1.5×ULN - ALT 和 AST≤2.5×ULN（肝转移患者，ALT 和 AST≤5×ULN）； - 血清肌酐≤1.5×ULN 或肌酐清除率≥40 mL/min/ 1.73 m2（采用慢性肾脏病-流行 病学 公式[CKD-EPI]基于血清肌酐计算） - 凝血酶原时间和部分凝血活酶时间≤1.5×ULN； - 心电图检查：Fridericia 公式校正 QT 间期（QTcF）≤470 ms；
8.自愿签署书面知情同意书，依从性良好。

Inclusion criteria

1. Male, over 18 years old at the time of signing the informed consent form.
2. The Eastern Cooperative Oncology Group (ECOG) performance status score was 0 or 1, and the expected survival period was evaluated by the researchers as ≥6 months.
3. Metastatic castration-resistant prostate cancer confirmed by histological or cytological examination to be prostatic adenocarcinoma (excluding small cell features) with HER2 expression (HER2 expression is defined as a HER2 immunohistochemical result of 1+, 2+, or 3+), which must simultaneously meet the following criteria: 
1) Continuous treatment with a luteinizing hormone-releasing hormone agonist (LHRHa) (medical castration) or prior bilateral orchiectomy (surgical castration); subjects who have not undergone bilateral orchiectomy must plan to maintain effective LHRHa treatment throughout the study period; 
2) Serum testosterone is at castrate levels at screening (<50 ng/dl or 1.7 nmol/L); 
3) Bone scan results demonstrate metastatic lesions in bone, or CT/MRI scan results demonstrate metastatic lesions in soft tissue. 
a. If there are no evaluable bone lesions (per PCWG3 criteria), measurable soft tissue disease (per RECIST V1.1) is required. A bone scan showing intense symmetric osseous metabolic activity in the skeleton (referred to as a superscan) is considered non-evaluable. 
b. For study participants with only measurable soft tissue lesions, the presence of only regional lymph node lesions (i.e., lymph node lesions below the aortic bifurcation) does not meet eligibility for study participation.
4. Prior to randomization, the severity of any acute effects of prior treatment must have resolved to baseline level or CTCAE Grade <= 1, except for adverse events (AEs) that, in the investigator's judgment, do not pose a safety risk, such as alopecia and peripheral neuropathy.
5. Patients who are planned to take or have been taking stable oral enzalutamide.
6. Male subjects whose partners are women of childbearing age must adopt highly effective contraceptive measures from the signing of the informed consent form until 3 months after the last administration of the investigational product.
7. The functions of vital organs meet the following criteria (no corrective treatment with any blood components, cytokines, or growth factors was administered within 14 days prior to the first dose), and the test results must be completed within 14 days before the first study treatment: - Absolute neutrophil count (ANC) >= 1.5×10⁹/L (1,500/mm³); - Platelets >= 80×10⁹/L (100,000/mm³); - Hemoglobin (Hgb) >= 9.0 g/dL (90 g/L); - Albumin level >= 3.0 g/dL; - Total bilirubin <= 1.5×ULN; - ALT and AST <= 2.5×ULN (for patients with liver metastases, ALT and AST <= 5×ULN); - Serum creatinine <= 1.5×ULN or creatinine clearance >= 40 mL/min/1.73 m² (calculated from serum creatinine using the Chronic Kidney Disease Epidemiology Collaboration equation [CKD-EPI]); - Prothrombin time and activated partial thromboplastin time <= 1.5×ULN; - Electrocardiogram: QT interval corrected by Fridericia formula (QTcF) <= 470 ms;
8. Voluntarily sign a written informed consent form and demonstrate good compliance.

排除标准：

1.首次给药前4周内接种减毒活疫苗，或预计在研究期间需要接种减毒活疫苗。
2.筛选前4周内接受过严重手术或在严重手术恢复期。
3.已知严重的脑内疾病或脑转移。
4.在过去2年内确诊过任何骨髓增生异常综合征、急性髓系白血病或任何其他既往恶性肿瘤病史（已根治性治疗的非黑色素瘤性皮肤癌或浅表尿路上皮癌除外）。
5.患有重大心血管疾病，包括以下任何一种疾病：入组研究前 6 个月内发生心肌梗死；入组研究前 3 个月内发生未受控心绞痛；筛选期超声波心动图或 MUGA 检查，结果显示左心室射血分数＜45%；具有临床意义的室性心律失常史（如室性心动过速、室颤、尖端扭转型室性心动过速）；
6.首次用药前14天内需要全身抗生素治疗的活动性感染；
7.间质性肺病病史、活动性感染、未控制的高血压/糖尿病；
8.对维迪西妥单抗、恩扎卢胺或辅料过敏者；
9.既往使用过抗HER2靶向药物（曲妥珠单抗、T-DM1、维迪西妥单抗等）；
10.既往 30天内或正在参与其他临床研究的患者；
11.mCRPC患者在入组首次给药前4周内，使用过可能降低PSA水平的植物药（如锯棕榈）或类固醇全身治疗（用于预防或治疗过敏的临时性的类固醇类药物除外），或计划本试验期间使用这类药物；
12.入组首次给药前1周内，接受过抗肿瘤中药方剂或中成药、首次给药前2周内接受过输血或血液制品、造血刺激因子和其他药物纠正血细胞数；
13.存在原因不明的发热> 38.5°C（肿瘤性发热受试者由研究者判断是否可以参加本研究）、持续的或活动性感染；HIV抗体阳性、HBsAg阳性且HBVDNA拷贝数 ≥所在研究中心ULN、HBV感染经治疗后HBsAg（-）HBcAb（+）且HBVDNA拷贝数≥所在研究中心ULN、HCV抗体阳性且HCV RNA≥所在研究中心ULN、梅毒活动性感染者（既往梅毒感染如经过系统性治疗，目前已证实处于治愈或者稳定的情况除外）；
14.存在纽约心脏病协会（NYHA）功能分类为Ⅲ/Ⅳ级的充血性心力衰竭，或经治疗干预仍无法有效控制的心律失常，具有QT间期延长风险或正在使用已知可能引起QT间期延长的药物，难治性高血压（使用药物将血压控制在140/90mmHg以下的高血压患者除外）；
15.入组首次给药前6个月内发生过临床严重的血管疾病，包括急性的动静脉栓塞、急性栓塞性动脉炎、血栓性静脉炎、急性肺栓塞、急性冠脉综合症（包括心肌梗塞、不稳定性心绞痛等）、急性脑血管疾病、弥漫性血管内凝血等；
16.肿瘤转移灶明显入侵大动脉导致具有较高的出血风险患者；
17.存在需要治疗的间质性肺炎或肺纤维化等严重的肺部疾病等，入组首次给药前 3周内存在咯血（每次咯血量≥2.5ml）；
18.入组首次给药前6个月内有接受治疗的胃肠道活动性溃疡、穿孔和/或瘘管病史，入组首次给药前3个月内活动性胃肠道出血（如呕血、便血或黑便）且无痊愈的内镜或结肠镜检查证据；
19.存在控制不佳的其他伴随疾病（CTCAE 5.0分级≥2级），如糖尿病等；
20.存在CTCAE（5.0版）规定的≥2级周围神经病变、既往癫痫、精神性疾病病史，入组首次给药前6个月内药物滥用史或3个月内酗酒史；酗酒定义为每周饮酒多于14单位，1单位=285 mL啤酒=25 mL白酒=80 mL葡萄酒；
21.存在自身免疫病、免疫缺陷病和器官移植史；
22.根据研究者的判断，存在可能混淆试验结果、干扰受试者参与全程试验或不符合受试者参加试验最佳利益的任何疾病、治疗或实验室异常的病史或当前证据。

Exclusion criteria：

1. Live attenuated vaccine should be administered within 4 weeks before the first dose, or it is expected that live attenuated vaccine will be needed during the study period. 2. Those who have undergone severe surgery or are in the recovery period of severe surgery within 4 weeks prior to screening. 3. Known serious brain diseases or brain metastases. 4. Has been diagnosed with any myelodysplastic syndrome, acute myeloid leukemia or any other history of previous malignant tumors within the past two years (except for non-melanoma skin cancer or superficial urothelial carcinoma that has been radical treated). 5. Suffering from a major cardiovascular disease, including any of the following conditions: myocardial infarction occurring within 6 months prior to study enrollment; uncontrolled angina pectoris occurring within 3 months prior to study enrollment; left ventricular ejection fraction <45% shown by echocardiogram or MUGA scan during the screening period; a history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, torsades de pointes); 6. Active infection requiring systemic antibiotic therapy within 14 days prior to the first administration of the medication; 7. History of interstitial lung disease, active infection, uncontrolled hypertension/diabetes; 8. Individuals with hypersensitivity to disitamab, enzalutamide, or any of the excipients; 9. Previous use of anti-HER2 targeted agents (trastuzumab, T-DM1, vedicizumab, etc.); 10. Patients who have participated in other clinical studies within the past 30 days or are currently participating in such studies; 11. Patients with mCRPC have used herbal medicines that may reduce PSA levels (such as saw palmetto) or systemic steroid therapy (excluding temporary steroids used for the prevention or treatment of allergies) within 4 weeks prior to the first dose of enrollment, or plan to use such drugs during this trial; 12. Within 1 week prior to the first dose of study treatment, having received traditional Chinese medicine prescriptions or Chinese patent medicines for anti-tumor purposes; having received blood transfusions or blood products, hematopoietic stimulating factors, or other medications to correct blood cell counts within 2 weeks prior to the first dose. 13. Unexplained fever > 38.5°C (for subjects with neoplastic fever, the investigator shall determine eligibility for this study), persistent or active infection; positive HIV antibody, positive HBsAg with HBVDNA copy number >= ULN of the local study center, HBV infection after treatment with HBsAg(-) HBcAb(+) and HBVDNA copy number >= ULN of the local study center, positive HCV antibody with HCV RNA >= ULN of the local study center, or active syphilis infection (excluding previous syphilis infection that has been systematically treated and is currently confirmed to be cured or stable); 14. Having congestive heart failure with New York Heart Association (NYHA) functional Class Ⅲ/Ⅳ, or arrhythmia that cannot be effectively controlled despite therapeutic interventions, being at risk of QT interval prolongation or using medications known to potentially cause QT interval prolongation, or having refractory hypertension (excluding hypertensive patients whose blood pressure is controlled below 140/90 mmHg with medication); 15. Clinically severe vascular diseases that occurred within 6 months prior to the first dose of study enrollment, including acute arteriovenous embolism, acute embolic arteritis, thrombophlebitis, acute pulmonary embolism, acute coronary syndrome (including myocardial infarction, unstable angina, etc.), acute cerebrovascular disease, disseminated intravascular coagulation, etc.; 16. Patients with tumor metastases that have significantly invaded the large arteries, resulting in a high risk of bleeding; 17. Suffering from severe pulmonary diseases such as interstitial pneumonia or pulmonary fibrosis that require treatment; having hemoptysis (with a volume of >=2.5 ml each time) within 3 weeks prior to the first dose of administration in the group. 18. History of active gastrointestinal ulcers, perforation and/or fistula treated within 6 months prior to the first dose of enrollment, or active gastrointestinal bleeding (e.g., hematemesis, hematochezia or melena) within 3 months prior to the first dose of enrollment without endoscopic or colonoscopic evidence of recovery; 19. Presence of other comorbidities with poor control (CTCAE 5.0 grade >= 2), such as diabetes mellitus; 20. Have a history of peripheral neuropathy of Grade >=2 as defined by CTCAE (Version 5.0), prior epilepsy, or psychiatric disorders; a history of drug abuse within 6 months prior to the first dose of enrollment, or a history of alcohol abuse within 3 months; alcohol abuse is defined as consuming more than 14 units of alcohol per week, with 1 unit equivalent to 285 mL of beer, 25 mL of liquor, or 80 mL of wine. 21. Having a history of autoimmune diseases, immunodeficiency diseases, and organ transplantation; 22. According to the investigator's judgment, there is any medical history or current evidence of diseases, treatments, or laboratory abnormalities that may potentially confound the trial results, interfere with the subject's participation in the entire trial, or are not in the best interests of the subject to participate in the trial.

研究实施时间：

Study execute time：

从 From 2026-03-30 00:00:00至 To 2028-06-01 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2026-05-07 00:00:00 至 To 2028-06-01 00:00:00

干预措施：

Interventions：

组别：	试验组	样本量：	30
Group：	Test group	Sample size：	30
干预措施：	维迪西妥单抗联合恩扎卢胺	干预措施代码：
Intervention：	Vedotinumab + Enzalutamide	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	中国	省(直辖市)：	山东省	市(区县)：
Country：	China	Province：	Shandong	City：
单位(医院)：	烟台毓璜顶医院	单位级别：	三级甲等
Institution hospital：	Yantai Yuhuangding Hospital	Level of the institution：	Tertiary A

测量指标：

Outcomes：

指标中文名：	主要指标：PSA50缓解率	指标类型：	主要指标
Outcome：	Main indicators: PSA50 response rate	Type：	Primary indicator
测量时间点：	治疗期间每4个治疗周期检查一次	测量方法：	进行血液学检测
Measure time point of outcome：	Check-ups should be conducted every four treatment cycles during the treatment period	Measure method：	Conduct hematological tests

指标中文名：	次要指标： ORR,PSA90缓解率，影像学无进展生存期	指标类型：	次要指标
Outcome：	Secondary indicators: ORR, PSA90 response rate, radiographic progression-free survival	Type：	Secondary indicator
测量时间点：	治疗期间每4个治疗周期检查一次	测量方法：	进行血液学检测
Measure time point of outcome：	Check-ups should be conducted every four treatment cycles during the treatment period	Measure method：	Conduct hematological tests

指标中文名：	安全指标：统计AE/SAE发生率及实验室检查变化	指标类型：	次要指标
Outcome：	Safety indicators: Statistics on the incidence of AE/SAE and changes in laboratory examinations	Type：	Secondary indicator
测量时间点：	治疗期间每个治疗周期检查一次	测量方法：	进行血液学检测
Measure time point of outcome：	Check-ups should be conducted every treatment cycles during the treatment period	Measure method：	Conduct hematological tests

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：	无	组织：
Sample Name：	NA	Tissue：
人体标本去向	其它	说明
Fate of sample：	0thers	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：

男性

Gender：

Male

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)：

Not Applicable

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）：	不适用
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	Not Applicable
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：	使用纸质病例记录表
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	Use paper case record forms
数据与安全监察委员会： Data and Safety Monitoring Committee：	无/No
注册人： Name of Registration：	2026-05-06 18:19:20