ChiCTR2500106402 版本V1.0 版本创建时间2025/07/23 11:08:40 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：

 ChiCTR2500106402 

最近更新日期：

Date of Last Refreshed on：

 2025-07-23 11:08:25 

注册时间：

Date of Registration：

 2025-07-23 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

局部进展期HER2不表达胃肝样腺癌围手术期治疗的前瞻性、单臂、单中心Ⅱ期临床研究

Public title：

Perioperative Treatment for Locally Advanced HER2-Negative Hepatoid Adenocarcinoma of the Stomach: A Prospective, Single-Arm, Single-Center Phase II Clinical Study

注册题目简写：

English Acronym：

研究课题的正式科学名称：

局部进展期HER2不表达胃肝样腺癌围手术期治疗的前瞻性、单臂、单中心Ⅱ期临床研究

Scientific title：

Perioperative Treatment for Locally Advanced HER2-Negative Hepatoid Adenocarcinoma of the Stomach: A Prospective, Single-Arm, Single-Center 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：

王安强 

研究负责人：

王安强 

Applicant：

Anqiang Wang 

Study leader：

Anqiang Wang 

申请注册联系人电话：

Applicant telephone：

 +86 10 88196970

研究负责人电话：

Study leader's
telephone：

+86 10 88196970

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：

 wanganqiang0902@163.com

研究负责人电子邮件：

Study leader's E-mail：

 wanganqiang0902@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：

北京市海淀区阜成路52号

研究负责人通讯地址：

北京市海淀区阜成路52号

Applicant address：

No. 52 Fucheng Road , Haidian District, Beijing

Study leader's address：

No. 52 Fucheng Road , Haidian District, Beijing

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：

北京大学肿瘤医院

Applicant's institution：

Peking University Cancer Hospital

研究负责人所在单位：

北京肿瘤医院（北京大学肿瘤医院）

Affiliation of the Leader：

Beijing 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：

 2025YJZ50

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：

北京肿瘤医院医学伦理委员会

Name of the ethic committee：

Medical Ethics Committee of Beijing Cancer Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

 2025-07-10 00:00:00

伦理委员会联系人：

廖红舞

Contact Name of the ethic committee：

Liao Hongwu

伦理委员会联系地址：

北京市海淀区阜成路52号

Contact Address of the ethic committee：

No. 52 Fucheng Road , Haidian District, Beijing

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 10 88196391

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 liaohongwu2015@163.com

研究实施负责（组长）单位：

北京肿瘤医院

Primary sponsor：

Beijing Cancer Hospital

研究实施负责（组长）单位地址：

北京市海淀区阜成路52号

Primary sponsor's address：

No. 52 Fucheng Road , Haidian District, Beijing

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

北京市

市(区县)：

Country：

China

Province：

Beijing

City：

单位(医院)：

北京肿瘤医院

具体地址：

北京市海淀区阜成路52号

Institution
hospital：

Beijing Cancer Hospital

Address：

No. 52 Fucheng Road , Haidian District, Beijing

经费或物资来源：

北京大学肿瘤医院临床研究青年基金

Source(s) of funding：

Youth Foundation for Clinical Research of Peking University Cancer Hospital

研究疾病：

胃肝样腺癌  

Target disease：

Hepatoid adenocarcinoma of stomach

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：

本研究主要目的为评估SOX联合白蛋白紫杉醇和信迪利单抗方案用于局部进展期HER2不表达胃肝样腺癌围手术期治疗的有效性。次要研究目的为评估SOX联合白蛋白紫杉醇和信迪利单抗方案用于局部进展期HER2不表达胃肝样腺癌围手术期治疗的安全性和长期获。  

Objectives of Study：

The primary objective of this study is to evaluate the efficacy of the SOX regimen combined with nab-paclitaxel and sintilimab in the perioperative treatment of locally advanced HER2-negative hepatoid adenocarcinoma of the stomach. The secondary objectives are to assess the safety and long-term benefits of the SOX regimen combined with nab-paclitaxel and sintilimab in the perioperative treatment of locally advanced HER2-negative hepatoid adenocarcinoma of the stomach.

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.受试者自愿加入本研究，能完成知情同意书的签署，且依从性良好；
2.年龄18-75岁（签署知情同意书时），男女不限；
3.经组织学确诊的胃肝样腺癌，根据AJCC第8版标准诊断局部进展期（即根据超声内镜或增强CT/MRI扫描临床分期诊断为II-III期的患者），且同意接受根治性手术治疗，研究者评估病灶可切除；既往未接受过针对当前疾病的系统性治疗，包括抗肿瘤放化疗/免疫治疗等；
4.HER2检测IHC 0；
5.ECOG评分0-1分；
6.预计生存期≥6个月；
7.主要器官功能良好，可耐受化疗、免疫治疗及手术；
8.有生育能力的受试者在本研究期间和研究结束后3月内，必须采用医学认可的有效的避孕措施（包括物理避孕、手术避孕、禁欲等），在研究入组前的 7 天内血清妊娠试验阴性，且必须为非哺乳期受试者；

Inclusion criteria

1.The subjects voluntarily participated in this study, are able to sign the informed consent form and have good compliance.
2.Age: 18 - 75 years old (at the time of signing the informed consent form), gender not limited.
3.Patients with histologically confirmed hepatoid adenocarcinoma of the stomach, with imaging findings indicating locally advanced disease (clinically staged as II-III according to the 8th edition of AJCC), and who consent to receive radical surgical treatment, and whose lesions are deemed resectable by the investigators; those who have not received systemic treatment for the current disease, including anti-tumor radiotherapy and chemotherapy/immunotherapy, etc. in the past.
4.The immunohistochemical result of HER2 detection was 0.
5.ECOG score ranging from 0 to 1 point.
6.Expected survival period ≥ 6 months.
7.The main organs function well and can tolerate chemotherapy, immunotherapy and surgery.
8.During the study period and within 3 months after the study concludes, fertile subjects must adopt medically approved and effective contraceptive measures (including physical contraception, surgical contraception, abstinence, etc.), have negative serum pregnancy test results within 7 days before being enrolled in the study, and must be non-lactating subjects.

排除标准：

1.首次给药前5年内诊断为胃癌之外的其他恶性疾病（不包括经过根治的皮肤基底细胞癌、皮肤鳞状上皮癌、和/或经过根治性切除的原位癌）；
2.肿瘤病灶具有出血倾向（如存在活动性溃疡肿瘤病灶且粪便潜血试验阳性、签署知情同意书前2个月内呕血或黑便病史、经研究者判断存在消化道大出血危险等）；
3.dMMR/MSIH胃癌患者；
4.无法口服药物；
5.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；
6.首次给药前2周内接受过具有抗肿瘤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，除外为控制胸水局部使用）系统性全身治疗；
7.首次给药前2年内发生过需要全身性治疗（例如使用缓解疾病药物、糖皮质激素或免疫抑制剂）的活动性自身性免疫疾病。替代疗法（例如甲状腺素、胰岛素或者用于肾上腺或垂体机能不全的生理性糖皮质激素等）不视为全身性治疗；
8.研究首次给药前7天内正在接受全身性糖皮质激素治疗（不包括喷鼻、吸入性或其他途径的局部糖皮质激素）或任何其他形式的免疫抑制疗法；注：允许使用生理剂量的糖皮质激素（≤10mg/天的泼尼松或等效药物）；首次给药前2周内接受过具有抗肿瘤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）系统性全身治疗；
9.已知异体器官移植（角膜移植除外）或异体造血干细胞移植；
10.已知对本研究中使用药物过敏者；
11.周围神经病变≥2级；
12.已知人类免疫缺陷病毒（HIV）感染史（即HIV1/2抗体阳性）；
13.活动性乙型肝炎或丙型肝炎受试者（HBsAg阳性同时检测到HBV DNA滴度高于正常值上限；HCVAb阳性同时检测到HCVRNA滴度高于正常值上限）；
14.首次给药之前（第1周期，第1天）30天内接种过活疫苗；（注：允许首次给药前30天内接受针对季节性流感的注射用灭活病毒疫苗；但是不允许接受鼻内用药的减毒活流感疫苗。）；
15.妊娠或哺乳期妇女；
16.存在任何严重或不能控制的全身性疾病，例如 a) 静息心电图在节律、传导或形态上出现有重大且症状严重难以控制的异常，如完全性左束支传导阻滞，Ⅱ度以上心脏传导阻滞，室性心律失常或心房颤动； b) 不稳定型心绞痛，充血性心力衰竭，纽约心脏病协会（NYHA）分级 ≥ 2 级的慢性心衰； c) 在入选治疗前 6 个月内发生过任何动脉血栓、栓塞或缺血，如心肌梗死、不稳定型心绞痛、脑血管意外或一过性脑缺血发作等； d) 血压控制不理想（收缩压＞140 mmHg，舒张压＞90 mmHg）； e) 首次给药前 1 年内存在需要糖皮质激素治疗的非感染性肺炎病史， 或当前存在临床活动性间质性肺病； f) 活动性肺结核； g) 存在需要全身性治疗的活动性或未能控制的感染； h) 存在临床活动性憩室炎、腹腔脓肿、胃肠道梗阻； i) 肝脏疾病如肝硬化、失代偿性肝病、急性或慢性活动性肝炎； j) 糖尿病控制不佳（空腹血糖（FBG）＞10mmol/L）； k) 尿常规提示尿蛋白≥++，且证实 24 小时尿蛋白定量＞1.0 g 者； l) 存在精神障碍且无法配合治疗的患者;
17: 有可能干扰试验结果、妨碍受试者全程参与研究的病史或疾病证据、治疗或实验室检查值异常，或研究者认为其他不适合入组的情况， 研究者认为存在其他潜在风险不适合参加本研究；

Exclusion criteria：

1: Within five years prior to the first administration, other malignant diseases were diagnosed except for gastric cancer (excluding skin basal cell carcinoma and/or squamous cell carcinoma that have undergone radical cure, and/or carcinoma in situ that has undergone radical resection); 2: The tumor lesion has a tendency to bleed (such as when there is an active ulcerative tumor lesion and the fecal occult blood test is positive, when there is a history of hematemesis or melena within 2 months before signing the informed consent form, or when the researcher judges that there is a risk of major gastrointestinal bleeding, etc.); 3: Patients with dMMR/MSIH gastric cancer; 4: Unable to take oral medication; 5: Currently participating in an interventional clinical trial for treatment, or having received other investigational drugs or used investigational devices within 4 weeks prior to the first administration of the current drug; 6: Within 2 weeks prior to the first administration, received systemic and systemic treatment with traditional Chinese medicine or drugs with immunomodulatory effects (including thymosin, interferon, interleukin, excluding those used locally for controlling pleural effusion) with anti-tumor indications; 7: Within two years prior to the first administration, there has been a history of active autoimmune diseases requiring systemic treatment (such as the use of disease-modifying drugs, glucocorticoids or immunosuppressants). Therapies that are alternative to systemic treatment (such as thyroid hormone, insulin or physiological glucocorticoids for adrenal or pituitary insufficiency) are not regarded as systemic treatment; 8: The study excluded subjects who were receiving systemic glucocorticoid therapy (excluding nasal spray, inhalation or other local glucocorticoid routes) or any other form of immunosuppressive therapy within 7 days before the first administration; Note: Physiological doses of glucocorticoids (<=10 mg/day of prednisone or equivalent drugs) were allowed; Subjects who had received systemic treatment with traditional Chinese medicine or immunomodulatory drugs (including thymosin, interferon, interleukin) with anti-tumor indications within 2 weeks before the first administration were also excluded; 9: allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation has been carried out; 10: Those who are known to have drug allergies to the drugs used in this study; 11: Peripheral neuropathy grade >= 2; 12: It is known that the history of human immunodeficiency virus (HIV) infection (i.e., positive for HIV 1/2 antibodies); 13: Subjects with active hepatitis B or hepatitis C (HBsAg positive and HBV DNA detected with a titer higher than the upper limit of normal value; HCVAb positive and HCV RNA detected with a titer higher than the upper limit of normal value); 14: Before the first administration (during the 1st cycle, on the 1st day), received live vaccines within 30 days prior to the first administration; (Note: Live attenuated influenza vaccines for seasonal influenza can be administered within 30 days before the first administration; however, inactivated virus vaccines for seasonal influenza injection are not allowed. Reduced-dose live influenza vaccines administered by nasal route are not permitted.); 15: Pregnant or lactating women; 16: There are any serious or uncontrollable systemic diseases, such as a) significant and severe abnormal rhythms, conduction or morphology in the resting electrocardiogram, like complete left bundle branch block, second-degree or above cardiac conduction block, ventricular arrhythmia or atrial fibrillation; b) unstable angina pectoris, congestive heart failure, chronic heart failure with NYHA classification >= 2; c) any arterial thrombosis, embolism or ischemia within 6 months before the inclusion for treatment, such as myocardial infarction, unstable angina pectoris, cerebrovascular accident or transient ischemic attack; d) poor blood pressure control (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg); e) history of non-infectious pneumonia requiring glucocorticoid treatment within 1 year before the first administration, or current clinical active interstitial lung disease; f) active pulmonary tuberculosis; g) active or uncontrolled infections requiring systemic treatment; h) active diverticulitis, abdominal abscess, or gastrointestinal obstruction; i) liver diseases such as cirrhosis, decompensated liver disease, acute or chronic active hepatitis; j) poor control of diabetes (fasting blood glucose (FBG) > 10 mmol/L); k) urine protein >= ++ as indicated by urine routine test and confirmed 24-hour urine protein quantification > 1.0 g; l) patients with mental disorders who cannot cooperate with treatment; 17: There may be medical history or disease evidence, abnormal values of treatment or laboratory tests, or other circumstances that interfere with the test results and prevent the participants from fully participating in the research. For instance, if the researcher deems that there are other potential risks that make the participants unsuitable for inclusion in this study;

研究实施时间：

Study execute time：

从 From 2025-07-15 00:00:00至 To 2028-08-15 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2025-08-15 00:00:00 至 To 2028-08-15 00:00:00

干预措施：

Interventions：

组别：

试验组

样本量：

 30

Group：

Experimental group

Sample size：

干预措施：

1.新辅助治疗：白蛋白紫杉醇150mg/kg，静脉滴注，d1，每21天一个疗程；信迪利单抗200mg，静脉滴注，d1，每21天一个疗程；替吉奥（按体表面积给药：BSA<1.25m2，40mg；BSA≥1.25m2，<1.5m2，50mg；BSA≥1.5m2，60mg），口服，每天2次，d1-14，每21天一个疗程；奥沙利铂85mg/m2，静脉滴注，d1，每21天一个疗程。新辅助治疗共4周期。 2.新辅助治疗结束后4-6周内进行根治手术治疗。 3.辅助治疗：手术后4-6周内开始辅助治疗。白蛋白紫杉醇125mg/kg，静脉滴注，d1、d8，每21天一个疗程；信迪利单抗200mg，静脉滴注，d1，每21天一个疗程；替吉奥（按体表面积给药：BSA<1.25m2，40mg;BSA≥1.25m2，<1.5m2，50mg；BSA≥1.5m2，60mg），口服，每天2次，d1-14，每21天一个疗程。辅助治疗共4周期。

干预措施代码：

Intervention：

1. Neoadjuvant therapy: albumin paclitaxel 150mg/kg, intravenous infusion, d1, every 21 days; sintilimab 200mg, intravenous infusion, d1, every 21 days; Tigio (administered by body surface area: BSA< 1.25m^2, 40mg; BSA>=1.25m2,<1.5m^2,50mg; BSA >=1.5m^2, 60mg), orally, twice a day, d1-14, every 21 days; oxaliplatin 85mg/m2, intravenous infusion, d1, every 21 days. There are 4 cycles of neoadjuvant therapy. 2. Radical surgery within 4-6 weeks after the end of neoadjuvant therapy. 3. Adjuvant therapy: start adjuvant therapy within 4-6 weeks after surgery. albumin paclitaxel 125mg/kg, intravenous infusion, d1, d8, every 21 days; sintilimab 200mg, intravenous infusion, d1, every 21 days; Tigio (administered by body surface area: BSA< 1.25m^2, 40mg; BSA>=1.25m^2,<1.5m2,50mg; BSA >=1.5m^2, 60mg), orally, twice a day, d1-14, every 21 days. There are 4 cycles of adjuvant therapy.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 北京市 

市(区县)：

  

Country：

China

Province：

Beijing

City：

单位(医院)：

 北京肿瘤医院 

单位级别：

 三级甲等 

Institution
hospital：

Beijing Cancer Hospital

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

不良事件

指标类型：

次要指标

Outcome：

Adverse event

Type：

Secondary indicator

测量时间点：

药物治疗期间和手术

测量方法：

临床观察

Measure time point of outcome：

During the period of drug treatment and during the surgery

Measure method：

Clinical observation

指标中文名：

客观缓解率

指标类型：

次要指标

Outcome：

Objective response rate

Type：

Secondary indicator

测量时间点：

术前治疗2周期和4周期后

测量方法：

CT影像

Measure time point of outcome：

After 2 cycles and 4 cycles of preoperative treatment

Measure method：

Computed Tomography (CT) imaging

指标中文名：

病理完全缓解率

指标类型：

主要指标

Outcome：

Completely pathological response rate

Type：

Primary indicator

测量时间点：

术后

测量方法：

组织病理学

Measure time point of outcome：

postoperative

Measure method：

pathology

指标中文名：

治疗疗效相关生物标志物及耐药机制探索

指标类型：

次要指标

Outcome：

Exploration of therapeutic efficacy-related biomarkers and mechanisms of drug resistance

Type：

Secondary indicator

测量时间点：

术后

测量方法：

包括全外显子和转录组在内的多项检测技术

Measure time point of outcome：

Postoperative

Measure method：

A variety of detection techniques including whole exome and transcriptome

指标中文名：

无疾病生存期

指标类型：

次要指标

Outcome：

Disease-free survival period

Type：

Secondary indicator

测量时间点：

手术、肿瘤复发

测量方法：

电话随访

Measure time point of outcome：

Operativetumor recurrence

Measure method：

Telephone follow-up

指标中文名：

主要病理缓解率

指标类型：

次要指标

Outcome：

Major pathological remission rate

Type：

Secondary indicator

测量时间点：

术后

测量方法：

组织病理学

Measure time point of outcome：

Postoperative

Measure method：

Pathology

指标中文名：

总生存期

指标类型：

次要指标

Outcome：

Overall survival

Type：

Secondary indicator

测量时间点：

确诊、死亡

测量方法：

电话随访

Measure time point of outcome：

DDiagnosedeath

Measure method：

Telephone follow-up

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：

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

Note：

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：

标本中文名：

粪便

组织：

Sample Name：

Feces

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:

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)：

NA

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：

CRF and EDC

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

CRF and EDC

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2025-07-23 11:08:25