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：	ChiCTR2500109825
最近更新日期： Date of Last Refreshed on：	2025-09-25 14:58:36
注册时间： Date of Registration：	2025-09-25 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	一项评估HLX22（重组人源化抗HER2单克隆抗体注射液）联合曲妥珠单抗和化疗一线治疗HER2阳性胰腺癌有效性和安全性的II期临床研究
Public title：	A Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX22 (Recombinant Humanized Anti-HER2 Monoclonal Antibody Injection) in Combination with Trastuzumab and Chemotherapy for the First-Line Treatment of HER2-Positive Pancreatic Ductal Adenocarcinoma
注册题目简写：
English Acronym：
研究课题的正式科学名称：	一项评估HLX22（重组人源化抗HER2单克隆抗体注射液）联合曲妥珠单抗和化疗一线治疗HER2阳性胰腺癌有效性和安全性的II期临床研究
Scientific title：	A Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX22 (Recombinant Humanized Anti-HER2 Monoclonal Antibody Injection) in Combination with Trastuzumab and Chemotherapy for the First-Line Treatment of HER2-Positive Pancreatic Ductal Adenocarcinoma
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：	刘亮	研究负责人：	刘亮
Applicant：	Liang Liu	Study leader：	Liang Liu
申请注册联系人电话： Applicant telephone：	+86 180 1731 7395	研究负责人电话： Study leader's telephone：	+86 180 1731 7395
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：	liu.liang@zs-hospital.sh.cn	研究负责人电子邮件： Study leader's E-mail：	liu.liang@zs-hospital.sh.cn
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：	上海市徐汇区枫林路180号	研究负责人通讯地址：	上海市徐汇区枫林路180号
Applicant address：	No. 180 Fenglin Road, Xuhui District, Shanghai	Study leader's address：	No. 180 Fenglin Road, Xuhui 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：	复旦大学附属中山医院
Applicant's institution：	ZHONGSHAN HOSPITAL
研究负责人所在单位：	复旦大学附属中山医院
Affiliation of the Leader：	ZHONGSHAN 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：	B2025-511R	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：	复旦大学附属中山医院医学伦理委员会
Name of the ethic committee：	Zhongshan Hospital, Fudan University Medical Ethics Committee
伦理委员会批准日期： Date of approved by ethic committee：	2025-09-04 00:00:00
伦理委员会联系人：	李雪宁
Contact Name of the ethic committee：	Xuening Li
伦理委员会联系地址：	枫林路180号复旦大学附属中山医院 5号楼411机构办公室
Contact Address of the ethic committee：	No. 180 Fenglin Road, Zhongshan Hospital, Fudan University, Building 5, Room 411, Institutional Office
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 180 1731 7395	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：

复旦大学附属中山医院

Primary sponsor：

ZHONGSHAN HOSPITAL

研究实施负责（组长）单位地址：

上海市徐汇区枫林路180号

Primary sponsor's address：

No. 180 Fenglin Road, Xuhui 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)：
Country：	China	Province：	Shanghai	City：
单位(医院)：	复旦大学附属中山医院	具体地址：	上海市徐汇区枫林路180号
Institution hospital：	ZHONGSHAN HOSPITAL	Address：	No. 180 Fenglin Road, Xuhui District, Shanghai

经费或物资来源：

HLX22来自上海复宏汉霖生物制药股份有限公司

Source(s) of funding：

HLX22 is provided by Shanghai Henlius Biopharmaceutical Inc.

研究疾病：

胰腺癌

Target disease：

Pancreatic Cancer

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：

评估HLX22联合曲妥珠单抗和化疗一线治疗HER2阳性胰腺癌的疗效

Objectives of Study：

To evaluate the efficacy of HLX22 in combination with trastuzumab and chemotherapy as first-line treatment for HER2-positive pancreatic cancer.

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

Patients must meet all of the following criteria to be enrolled in this study:

Voluntarily participate in the clinical study; fully understand and be informed about the study and sign the informed consent form (ICF); willing to comply with and capable of completing all trial procedures.
No gender restrictions; age >= 18 years and <= 75 years at the time of signing the ICF.
Histologically or cytologically confirmed metastatic pancreatic cancer.
No prior systemic anti-tumor therapy for metastatic pancreatic cancer. Note: Patients who have received the first cycle of chemotherapy (nab-paclitaxel combined with gemcitabine) as subsequent treatment for newly diagnosed PDAC are allowed. For subjects who have received prior neoadjuvant/adjuvant therapy, the interval from the last treatment to progression must exceed 6 months, and any treatment-related adverse events (AEs) must have recovered to NCI-CTCAE <=  Grade 1 (except alopecia) before the first dose.
Measurable lesions per Response Evaluation Criteria in Solid Tumors (RECIST v1.1), as assessed by the investigator. Target lesions cannot be solely bone metastases.
HER2-positive status. Defined as immunohistochemistry (IHC) 3+ in primary or metastatic lesions, or IHC 2+ with positive in situ hybridization (ISH/FISH), according to the ASCO/CAP HER2 testing guidelines for gastric cancer. A maximum of 15 subjects with IHC 2+ and ISH/FISH-positive status will be enrolled.
ECOG performance status of 0 or 1 within 7 days prior to the first dose.
Expected survival >= 3 months.
Hepatitis B surface antigen (HBsAg) (-) and hepatitis B core antibody (HBcAb) (-). If HBsAg (+) or HBcAb (+), HBV-DNA must be < 2500 copies/mL or 500 IU/mL or within the normal range at the study center.
HCV antibody (-); if HCV antibody (+), HCV-RNA must be negative for enrollment. Subjects with co-infection of hepatitis B and hepatitis C (positive HBsAg or HBcAb, and positive HCV antibody) are excluded.
HIV antibody (-).
Adequate organ function.
Female subjects of childbearing potential must have a negative blood pregnancy test within 7 days prior to the first dose. Female subjects of childbearing potential and male subjects with partners of childbearing potential must use a medically approved contraceptive method (e.g., intrauterine device, oral contraceptives, or condoms) during the study treatment and for at least 7 months after the last dose.

排除标准：

符合下列任意一项排除标准的患者，将不得进入本研究：首次用药前2年内患有其他恶性肿瘤的患者。已治愈的局限性肿瘤，如皮肤基底细胞癌、皮肤鳞状细胞癌、浅表性膀胱癌、前列腺原位癌、宫颈原位癌、乳腺原位癌和甲状腺癌可以入组。既往使用多柔比星体内浓度> 360 mg/m2 （或当量）；注意：等效药物包括表柔比星> 720 mg/m2、米托蒽醌>120 mg/m2、伊达比星>90 mg/m2、超过360mg/m2多柔比星当量的阿霉素脂质体或其他蒽环类抗生素。如果使用了一种以上蒽环类抗生素，则累积剂量不得超过360mg/m2多柔比星当量。既往接受过任何HER2靶向治疗。活动性胃肠道出血（根据美国国家癌症研究所（NCI）常见不良事件评价标准（CTCAE）第5.0版评估为≥2级毒性反应）存在中枢神经系统（CNS）和/或软脑膜转移。距首次用药前半年内发生过脑血管意外、心肌梗塞、不稳定心绞痛、控制不良的心律失常（包括QTc间期男性 ≥ 450 ms、女性 ≥ 470 ms）（QTc间期以Fridericia公式计算）。按照美国纽约心脏病学会（NYHA）标准III-Ⅳ级心功能不全，或心脏彩超检查：LVEF（左室射血分数）< 55%。既往或目前合并间质性肺疾病；需要系统性治疗的活动性感染或活动性肺结核患者。首次用药前28天内接受过减毒活疫苗的治疗；用于季节性流感或新型冠状肺炎灭活病毒疫苗除外。研究药物首次用药前28天内，接受过重大手术。首次用药前28天内接受过根治性放疗。正在参加其他临床研究，或在本研究首次用药前28天内使用过其他临床研究类药物或医疗器械。已知对任何单克隆抗体或研究药物辅料有严重过敏史。已知有精神类药物滥用或吸毒史。妊娠期或哺乳期妇女。经研究者判断，受试者有其他可能导致其被迫中途终止研究的因素，如患有其他严重疾病（含精神疾病）需要合并治疗，实验室检查值严重异常，家庭或社会因素，可能影响到受试者安全或试验资料收集的情况。

Exclusion criteria：

Patients who meet any of the following exclusion criteria will not be eligible for this study: Patients with other malignancies within 2 years prior to the first dose. Cured localized tumors such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the prostate, cervical carcinoma in situ, breast carcinoma in situ, and thyroid cancer may be enrolled. Prior cumulative doxorubicin exposure > 360 mg/m^2 (or equivalent). Note: Equivalent agents include epirubicin > 720 mg/m^2, mitoxantrone > 120 mg/m^2, idarubicin > 90 mg/m^2, liposomal doxorubicin exceeding 360 mg/m^2 doxorubicin equivalent, or other anthracyclines. If more than one anthracycline has been used, the cumulative dose must not exceed 360 mg/m^2 doxorubicin equivalent. Prior treatment with any HER2-targeted therapy. Active gastrointestinal bleeding (assessed as >= Grade 2 toxicity per NCI CTCAE v5.0). Presence of central nervous system (CNS) and/or leptomeningeal metastases. History of cerebrovascular accident, myocardial infarction, unstable angina, or poorly controlled arrhythmia (including QTc interval >= 450 ms for males or >= 470 ms for females) within 6 months prior to the first dose (QTc interval calculated using Fridericia’s formula). Grade III-IV cardiac dysfunction per New York Heart Association (NYHA) criteria, or left ventricular ejection fraction (LVEF) < 55% on echocardiography. History or current evidence of interstitial lung disease; active infection requiring systemic therapy or active tuberculosis. Treatment with live attenuated vaccines within 28 days prior to the first dose; except for inactivated vaccines for seasonal influenza or COVID-19. Major surgery within 28 days prior to the first dose of the study drug. Curative radiotherapy within 28 days prior to the first dose. Concurrent participation in other clinical studies, or use of other investigational drugs or medical devices within 28 days prior to the first dose in this study. Known history of severe allergy to any monoclonal antibody or excipients of the study drug. Known history of drug abuse or substance addiction. Pregnant or lactating women. Any other condition deemed by the investigator to potentially lead to premature termination of the study, including severe concomitant illnesses (including psychiatric disorders) requiring treatment, severe laboratory abnormalities, or familial/social factors that may compromise patient safety or data integrity.

研究实施时间：

Study execute time：

从 From 2025-09-30 00:00:00至 To 2027-03-05 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2025-09-30 00:00:00 至 To 2027-03-05 00:00:00

干预措施：

Interventions：

组别：	单臂试验组	样本量：	45
Group：	Single-Arm Trial	Sample size：	45
干预措施：	HLX22 + 曲妥珠单抗 + 化疗（白蛋白紫杉醇 + 吉西他滨）	干预措施代码：
Intervention：	HLX22 + Trastuzumab + Chemotherapy (Nab-Paclitaxel + Gemcitabine)	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)：	复旦大学附属中山医院	单位级别：	三甲
Institution hospital：	ZHONGSHAN HOSPITAL	Level of the institution：	Tertiary A

国家：	中国	省(直辖市)：	江苏	市(区县)：
Country：	China	Province：	Jiangsu	City：
单位(医院)：	南京鼓楼医院	单位级别：	三甲
Institution hospital：	Nanjing Drum Tower Hospital	Level of the institution：	Tertiary A

测量指标：

Outcomes：

指标中文名：	客观缓解率（ORR）（由研究者根据实体瘤疗效评价标准（RECIST）v1.1评估）	指标类型：	主要指标
Outcome：	Objective Response Rate (ORR) (assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1)	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	无进展生存期（PFS）（由研究者根据RECIST v1.1标准评估）	指标类型：	次要指标
Outcome：	Progression-Free Survival (PFS) (assessed by the investigator according to RECIST v1.1 criteria)	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

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：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	持续缓解时间（DOR）（由研究者根据RECIST v1.1标准评估）	指标类型：	次要指标
Outcome：	Duration of Response (DOR) (assessed by the investigator according to RECIST v1.1 criteria)	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	疾病控制率（DCR）（由研究者根据RECIST v1.1标准评估）	指标类型：	次要指标
Outcome：	Disease Control Rate (DCR) (assessed by the investigator according to RECIST v1.1 criteria)	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	不良事件（AE）及严重不良事件（SAE）的发生率	指标类型：	次要指标
Outcome：	Incidence of Adverse Events (AE) and Serious Adverse Events (SAE)	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：	肿瘤组织活检	组织：	肿瘤组织
Sample Name：	Tumor Tissue Biopsy	Tissue：	tumor 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:

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）：	Clinical Trials
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	Clinical Trials
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：	电子采集和管理系统
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	Electronic Data Capture, EDC
数据与安全监察委员会： Data and Safety Monitoring Committee：	暂未确定/Not yet
注册人： Name of Registration：	2025-09-25 14:58:29