ChiCTR2500102628 版本V1.1 版本创建时间2025/05/16 16:37:22 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

 ChiCTR2500102628 

最近更新日期：

Date of Last Refreshed on：

 2025-05-16 16:36:56 

注册时间：

Date of Registration：

 2025-05-16 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

维迪西妥单抗联合XELOX一线治疗HER2阳性晚期胃癌或胃食管结合部腺癌的前瞻性、单臂、II期临床研究

Public title：

Prospective, single arm, phase II clinical study of disitamab vedotin combined with XELOX as first-line treatment for HER2 positive advanced gastric cancer or gastroesophageal junction adenocarcinoma

注册题目简写：

English Acronym：

研究课题的正式科学名称：

维迪西妥单抗联合XELOX一线治疗HER2阳性晚期胃癌或胃食管结合部腺癌的前瞻性、单臂、II期临床研究

Scientific title：

Prospective, single arm, phase II clinical study of disitamab vedotin combined with XELOX as first-line treatment for HER2 positive advanced gastric cancer or gastroesophageal junction 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：

魏登文 

研究负责人：

魏登文 

Applicant：

dengwen wei 

Study leader：

dengwen wei 

申请注册联系人电话：

Applicant telephone：

 +86 139 1991 6710

研究负责人电话：

Study leader's
telephone：

+86 139 1991 6710

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：

 dengwen002@163.com

研究负责人电子邮件：

Study leader's E-mail：

 dengwen002@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：

甘肃省兰州市七里河区小西湖东街2号

研究负责人通讯地址：

甘肃省兰州市七里河区小西湖东街2号

Applicant address：

No.2 Xiaoxihu East Street, Qilihe District, Lanzhou City, Gansu Province

Study leader's address：

No.2 Xiaoxihu East Street, Qilihe District, Lanzhou City, Gansu Province

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：

甘肃省肿瘤医院

Applicant's institution：

Gansu Cancer Hospital

研究负责人所在单位：

甘肃省肿瘤医院

Affiliation of the Leader：

Gansu Cancer 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：

 A202501100001

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：

甘肃省肿瘤医院甘肃省医学科学院伦理委员会

Name of the ethic committee：

Ethics Committee of Gansu Cancer Hospital and Gansu Academy of Medical Sciences

伦理委员会批准日期：

Date of approved by ethic committee：

 2025-01-10 00:00:00

伦理委员会联系人：

郭楠

Contact Name of the ethic committee：

nan guo

伦理委员会联系地址：

甘肃省兰州市七里河区小西湖东街2号

Contact Address of the ethic committee：

No.2 Xiaoxihu East Street, Qilihe District, Lanzhou City, Gansu Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 189 1982 0525

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：

甘肃省肿瘤医院

Primary sponsor：

Gansu Cancer Hospital

研究实施负责（组长）单位地址：

甘肃省兰州市七里河区小西湖东街2号

Primary sponsor's address：

No.2 Xiaoxihu East Street, Qilihe District, Lanzhou City, Gansu Province

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

甘肃省

市(区县)：

兰州市

Country：

China

Province：

gansu province

City：

单位(医院)：

甘肃省肿瘤医院

具体地址：

甘肃省兰州市七里河区小西湖东街2号

Institution
hospital：

Gansu Cancer Hospital

Address：

No.2 Xiaoxihu East Street, Qilihe District, Lanzhou City, Gansu Province

经费或物资来源：

自筹经费

Source(s) of funding：

Self-funded

研究疾病：

胃/食管胃结合部腺癌  

Target disease：

Adenocarcinoma of stomach/esophagogastric junction

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 ? 由研究者根据RECIST 1.1版本评估的ORR，评估维迪西妥单抗联合XELOX治疗未接受系统治疗的 HER2 IHC 2+和3+ 晚期胃癌/胃食管结合部腺癌的疗效。 次要目的 ? 由研究者根据RECIST 1.1版本评估的DCR，DOR，PFS，OS。评估维迪西妥单抗联合XELOX治疗未接受系统治疗的 HER2IHC 2+和3+ 晚期胃癌/胃食管结合部腺癌的疗效。 ? 通过CTCAE 5.0版本中描述的AE和SAE，并按需结合相关体格检查、ECG和实验室检查，评估维迪西妥单抗联合XELOX治疗的安全性和耐受性。  

Objectives of Study：

Main purpose Researchers evaluated the efficacy of vediximab combined with XELOX in the treatment of HER2 IHC 2+and 3+advanced gastric cancer/gastroesophageal junction adenocarcinoma that did not receive systemic therapy, based on the ORR assessed by RECIST version 1.1. Secondary purpose DCR evaluated by researchers based on RECIST version 1.1, DOR,PFS,OS. Evaluate the efficacy of vediximab combined with XELOX in the treatment of HER2IHC 2+and 3+advanced gastric cancer/gastroesophageal junction adenocarcinoma that has not received systemic therapy. Evaluate the safety and tolerability of vediximab combined with XELOX treatment through the AE and SAE described in CTCAE 5.0 version, combined with relevant physical examinations, ECG, and laboratory tests as needed.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

纳入标准： 1. 年龄18-75岁，性别不限； 2. 经病理学确诊的局部晚期不可手术或已发生远处转移的胃或胃食管结合部腺癌； 3. HER-2免疫组化检测为2+或3+； 4. 至少具有1个符合RECIST v1.1标准的可测量病灶； 5. 既往转移或复发阶段未接受过系统性治疗，或曾接受新辅助/辅助化疗，但在治疗结束后6个月以上出现疾病进展或复发； 6. ECOG PS：0-1分； 7. 足够的器官功能： 骨髓功能：血红蛋白≥80g/L； 中性粒细胞计数≥1.5×10 9/L； 白细胞计数≥3.5×10 9/L； 血小板≥100 ×10 9/L； 肝功能：血清总胆红素≤1.5 倍正常值上限（ULN） 丙氨酸氨基转移酶（ALT），门冬氨酸氨基转移酶（AST）和碱性磷酸酶（ALP）≤ 3× ULN，肝转移患者≤ 5× ULN 肾功能：血肌酐≤ 1.5×ULN，或 Cockcroft-Gault 公式法计算得肌酐清除率 （CrCl）≥60 mL/min 心脏功能：美国纽约心脏病学会（NYHA）分级＜3 级；左室射血分数≥50%。 8. 预计生存期≥3月； 9. 育龄妇女必须已经采取可靠的避孕措施或在入组前7天内进行妊娠试验（血清或尿液），且结果为阴性，并且愿意在试验期间和末次给予试验药物后8周采用适当的方法避孕。对于男性，须同意在试验期间和末次给予试验药物后8周采用适当的方法避孕； 10. 受试者自愿加入本研究，并签署知情同意书，依从性好， 配合随访。

Inclusion criteria

Inclusion criteria: 1. Age range: 18-75 years old, gender not limited; 2. Gastric or gastroesophageal junction adenocarcinoma diagnosed by pathology as locally advanced and inoperable, or with distant metastasis; 3. HER-2 immunohistochemistry detection shows 2+or 3+; 4. Have at least one measurable lesion that meets the RECIST v1.1 criteria; 5. Have not received systemic treatment in previous stages of metastasis or recurrence, or have received neoadjuvant/adjuvant chemotherapy, but have experienced disease progression or recurrence for more than 6 months after the end of treatment; 6. ECOG PS: 0-1 point; 7. Adequate organ function: Bone marrow function: hemoglobin >= 80g/L; Neutrophil count >= 1.5 × 10^9/L; White blood cell count >= 3.5 × 10^9/L; Platelets >= 100 × 10^9/L; Liver function: Serum total bilirubin <= 1.5 times the upper limit of normal (ULN) Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase (ALP) <= 3 × ULN, liver metastasis patients <= 5 × ULN Renal function: Blood creatinine <= 1.5 × ULN, or creatinine clearance rate (CrCl) calculated by Cockcroft Gault formula >= 60 mL/min Cardiac function: NYHA classification<3; Left ventricular ejection fraction >= 50%. 8. Expected survival period >= 3 months; 9. Women of childbearing age must have taken reliable contraceptive measures or undergone a pregnancy test (serum or urine) within 7 days prior to enrollment, with negative results, and be willing to use appropriate contraception methods during the trial period and 8 weeks after the last administration of the trial drug. For males, they must agree to use appropriate contraception methods during the trial period and 8 weeks after the last administration of the trial drug; 10. The subjects voluntarily joined this study and signed an informed consent form, with good compliance and cooperation with follow-up.

排除标准：

排除标准： 1. 对任何试验药物及其辅料过敏，或有严重过敏史，或为试验药物的禁忌症； 2. 有未能良好控制的心脑血管事件，如：a. NYHA 2级以上心力衰竭；b.不稳定型心绞痛；c. 1 年内发生过心肌梗死； d.有临床意义的室上性或室性心律失常需要治疗或干预；e. 脑出血和脑梗死（无症状且不需治疗的腔隙性脑梗除外）；f. 12个月内发生过严重的心脑血管事件; g.不能控制的高血压，即单药治疗后收缩压>140mmHg或舒张压>90mmHg；h.入选前6个月内有动脉血栓或深静脉血栓史，或入组前2个月内具有出血倾向证据或病史的患者，无论严重程度如何；i.入选前12个月内发生卒中事件或短暂性脑缺血发作； 3. 首次给药前 2 周内接受过具有抗胃癌适应症的中成药或免疫调节作用的药物（包括胸腺肽、干扰素、白介素，除外为控制腹水局部使用）系统性全身治疗； 4. 有间质性肺疾病、非传染性肺炎、肺纤维化、急性肺疾病，或控制不佳的全身性疾病病史（包括但不限于糖尿病、高血压等）； 5. 有活动性免疫缺陷或自身免疫性疾病病史，包括 HIV 检测阳性，或患有其他获得性、先天性免疫缺陷疾病，或有器官移植史、自身免疫性疾病； 6. 严重慢性或活动性感染，需要进行全身抗菌、抗真菌或抗病毒治疗，包括结核病感染等。在筛选前≥1 年曾有活动性结核感染病史的患者也应排除在外， 除非可以提供证明表明已经完成适当的治疗； 7. 存在脑转移或软脑膜转移； 8. 临床显著的胸腔积液、心包积液或腹水，需要在研究药物首次给药前 2 周内多次进行引流; 9. 入组时存在临床可检出的第二原发恶性肿瘤，或者在过去5年内出现过其它恶性肿瘤（已充分治疗的皮肤基底细胞癌或宫颈原位癌除外）； 10. 在首次研究药物给药前≤28 天进行过任何大型外科手术； 11. 既往进行过异基因干细胞移植或器官移植； 12. 目前有十二指肠溃疡、溃疡性结肠炎、肠梗阻等消化道疾病或研究者判定的可能引起消化道出血或者穿孔的其他状况；或者既往有肠穿孔、肠瘘史，而经手术治疗后未痊愈者； 13. 在研究药物首次用药前 4 周内（含）接种过活体疫苗；季节性注射的流感疫苗通常是灭活疫苗，因此允许使用；鼻内疫苗属于活体疫苗，所以不允许使用； 14. 经研究者判断，受试者有其他可能导致本研究被迫中途终止的因素，如其他的严重疾病（含心理、精神疾病）需要合并治疗，有严重的实验室检查异常，伴有家庭或社会等因素，会影响到受试者的安全，或资料及样品的收集； 15. 当前正在参与干预性临床研究治疗，或在首次给药前 4 周内接受过其他研究药物或使用过研究器械治疗； 16. 研究者认为其他不符合入组条件者。

Exclusion criteria：

Exclusion criteria: 1. Allergy to any investigational drug or its excipients, or a history of severe allergies, or contraindications to the investigational drug; 2. There are cardiovascular and cerebrovascular events that have not been well controlled, such as: a. NYHA grade 2 or above heart failure; b. Unstable angina pectoris; c. Have experienced myocardial infarction within one year; d. Clinically significant supraventricular or ventricular arrhythmias require treatment or intervention; e. Cerebral hemorrhage and infarction (excluding asymptomatic and untreated lacunar cerebral infarction); f. Serious cardiovascular and cerebrovascular events have occurred within the past 12 months; g. Uncontrollable hypertension, i.e. systolic blood pressure>140mmHg or diastolic blood pressure>90mmHg after monotherapy; h. Patients with a history of arterial or deep vein thrombosis within the first 6 months of enrollment, or with evidence or history of bleeding tendency within the first 2 months of enrollment, regardless of severity; i. Stroke events or transient ischemic attacks occurred within the 12 months prior to enrollment; 3. Within 2 weeks before the first administration, he has received systematic systemic treatment with traditional Chinese patent medicines and simple preparations with anti gastric cancer indications or drugs with immunomodulatory effects (including thymosin, interferon, interleukin, except for local use to control ascites); 4. Have a history of interstitial lung disease, non infectious pneumonia, pulmonary fibrosis, acute lung disease, or poorly controlled systemic diseases (including but not limited to diabetes, hypertension, etc.); 5. History of active immunodeficiency or autoimmune diseases, including HIV testing positive, or other acquired or congenital immunodeficiency diseases, or history of organ transplantation or autoimmune diseases; 6. Severe chronic or active infection requires systemic antibacterial, antifungal or antiviral treatment, including tuberculosis infection. Patients with a history of active tuberculosis infection for >= 1 year prior to screening should also be excluded, unless proof can be provided that appropriate treatment has been completed; 7. There is brain metastasis or leptomeningeal metastasis; 8. Clinically significant pleural effusion, pericardial effusion, or ascites require multiple drainage attempts within 2 weeks prior to the first administration of the study drug; 9. There is a clinically detectable second primary malignant tumor at the time of enrollment, or other malignant tumors have appeared in the past 5 years (excluding fully treated skin basal cell carcinoma or cervical carcinoma in situ); 10. Have undergone any major surgical procedures <= 28 days prior to the first study drug administration; 11. Have undergone allogeneic stem cell transplantation or organ transplantation in the past; 12. Currently, there are digestive tract diseases such as duodenal ulcer, ulcerative colitis, intestinal obstruction, or other conditions determined by researchers that may cause gastrointestinal bleeding or perforation; Or those who have a history of intestinal perforation or fistula and have not recovered after surgical treatment; 13. Have received a live vaccine within 4 weeks (inclusive) before the first use of the investigational drug; Seasonal flu vaccines are usually inactivated vaccines, so their use is allowed; Nasal vaccines belong to live vaccines, so their use is not allowed; 14. According to the researcher's assessment, there may be other factors that could lead to the forced termination of this study, such as other serious illnesses (including psychological and mental illnesses) that require concurrent treatment, serious laboratory test abnormalities, and family or social factors that may affect the safety of the subjects, or the collection of data and samples; 15. Currently participating in interventional clinical research treatment, or having received other investigational drugs or used investigational devices within 4 weeks prior to the first administration; 16. Researchers believe that there are other individuals who do not meet the inclusion criteria.

研究实施时间：

Study execute time：

从 From 2025-01-01 00:00:00至 To 2029-01-01 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2025-05-16 00:00:00 至 To 2028-12-01 00:00:00

干预措施：

Interventions：

组别：

试验组

样本量：

 30

Group：

test group

Sample size：

干预措施：

维迪西妥单抗：2.5mg/kg，D1，ivdrip，Q3W XELOX方案： 奥沙利铂：130mg/m2，静脉滴注，第1天给药，每21天一个治疗周期； 卡培他滨：1000mg/m2，口服，Bid, d1-14,每21天一个治疗周期； 每3周为一治疗周期，直至疾病进展或不可耐受的毒性

干预措施代码：

Intervention：

Vediximab: 2.5mg/kg, D1,ivdrip,Q3W XELOX solution: Oxaliplatin: 130mg/m2, intravenous infusion, administered on the first day, with one treatment cycle every 21 days; Capecitabine: 1000mg/m2, orally administered, Bid, d1-14, One treatment cycle every 21 days; Every 3 weeks is a treatment cycle until disease progression or intolerable toxicity occurs

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 甘肃省 

市(区县)：

  

Country：

China

Province：

gansu province

City：

单位(医院)：

 甘肃省肿瘤医院 

单位级别：

 三甲 

Institution
hospital：

Gansu Cancer Hospital

Level of the institution：

Grade III Grade A

测量指标：

Outcomes：

指标中文名：

客观缓解率

指标类型：

主要指标

Outcome：

Objective response rate

Type：

Primary 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：

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 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）：

本研究为单臂研究，因此无需随机

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

This study is a single arm study, therefore there is no need for randomization

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：

Blinding：

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）：

数据可不共享

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

raw data is not shared

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：

病例记录表

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

case record form

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2025-05-16 16:36:51