ChiCTR2400088196 版本V1.0 版本创建时间2024/08/13 11:36:31 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：

ChiCTR2400088196 

最近更新日期：

Date of Last Refreshed on：

2024-08-13 11:36:11 

注册时间：

Date of Registration：

2024-08-13 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

甲磺酸阿帕替尼和卡瑞利珠单抗联合Capox新辅助化疗治疗局部进展期胃、胃食管结合部腺癌的单臂、单中心、探索性临床研究

Public title：

A Single-Arm, Single-Center, Exploratory Clinical Study of Apatinib Mesylate Combined with Camrelizumab and Capox Chemotherapy as Neoadjuvant Therapy for Locally Advanced Gastric and Gastroesophageal Junction Adenocarcinoma

注册题目简写：

English Acronym：

研究课题的正式科学名称：

甲磺酸阿帕替尼和卡瑞利珠单抗联合Capox新辅助化疗治疗局部进展期胃、胃食管结合部腺癌的单臂、单中心、探索性临床研究

Scientific title：

A Single-Arm, Single-Center, Exploratory Clinical Study of Apatinib Mesylate Combined with Camrelizumab and Capox Chemotherapy as Neoadjuvant Therapy for Locally Advanced Gastric and 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：

谢思军 

研究负责人：

任亦星 

Applicant：

Xie si jun 

Study leader：

Ren yi xing 

申请注册联系人电话：

Applicant telephone：

+86 180 8104 0601

研究负责人电话：

Study leader's telephone：

+86 139 9078 3731

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：

2569194347@qq.com

研究负责人电子邮件：

Study leader's E-mail：

cra009@163.con

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：

四川省南充市顺庆区茂源南路1号

研究负责人通讯地址：

四川省南充市顺庆区茂源南路1号

Applicant address：

No. 1, South Maoyuan Road, Shunqing District, Nanchong City, Sichuan Province

Study leader's address：

No. 1, South Maoyuan Road, Shunqing District, Nanchong City, Sichuan 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：

川北医学院附属医院

Applicant's institution：

Affiliated Hospital of North Sichuan Medical College

研究负责人所在单位：

川北医学院附属医院

Affiliation of the Leader：

Affiliated Hospital of North Sichuan Medical College

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

2024ER437-1

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：

川北医学院附属医院医学伦理委员会

Name of the ethic committee：

Medical Ethics Committee of Affiliated Hospital of North Sichuan Medical College

伦理委员会批准日期：

Date of approved by ethic committee：

2024-07-18 00:00:00

伦理委员会联系人：

张全波

Contact Name of the ethic committee：

Zhang quan bo

伦理委员会联系地址：

四川省南充市顺庆区茂源南路1号

Contact Address of the ethic committee：

No. 1, South Maoyuan Road, Shunqing District, Nanchong City, Sichuan Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 817 226 2124

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：

川北医学院附属医院

Primary sponsor：

Affiliated Hospital of North Sichuan Medical College

研究实施负责（组长）单位地址：

四川省南充市顺庆区茂源南路1号

Primary sponsor's address：

No. 1, South Maoyuan Road, Shunqing District, Nanchong City, Sichuan 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)：

四川省

市(区县)：

南充市

Country：

China

Province：

Sichuan Province

City：

Nanchong City

单位(医院)：

川北医学院附属医院

具体地址：

四川省南充市顺庆区茂源南路1号

Institution
hospital：

Affiliated Hospital of North Sichuan Medical College

Address：

No. 1, South Maoyuan Road, Shunqing District, Nanchong City, Sichuan Province

经费或物资来源：

江苏恒瑞股份有限公司

Source(s) of funding：

Jiangsu Hengrui Pharmaceutical Co., LTD

Target disease：

Locally Advanced Gastric and Gastroesophageal Junction Adenocarcinoma

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 上市后药物 

Study phase：

4

研究设计：

单臂 

Study design：

Single arm 

研究目的：

探索甲磺酸阿帕替尼和卡瑞利珠单抗联合Capox新辅助化疗治疗局部进展期胃、胃食管结合部腺癌的疗效。  

Objectives of Study：

To explore the efficacy of Apatinib Mesylate Combined with Camrelizumab and Capox neoadjuvant chemotherapy in the treatment of locally advanced gastric and gastroesophageal junction adenocarcinoma

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

受试者必须符合以下所有标准，才可入组本试验： 1.签署知情同意书，自愿加入本研究； 2.组织学病理学确诊为胃腺癌或胃食管结合部腺癌； 3.经CT和腹腔镜确定临床分期为cT4a/bN+M0（根据AJCC第8版分期）胃/胃食管结合部腺癌； 4.既往未接受过抗肿瘤治疗； 5.计划在新辅助治疗完成后接受手术治疗； 6.年龄18-75岁，男女不限； 7.ECOG-PS评分0-1分； 8.预计生存期≥3个月； 9.育龄妇女必须在首次用药前7天内进行血清妊娠研究，且结果为阴性。育龄妇女受试者和伴侣为育龄妇女的男性受试者必须同意自签署知情同意书至末次给予研究药物后24周内避孕； 10.首剂研究药物前，实验室检查值满足以下条件： （1）血常规（筛查前 14 天内未输血、未使用造血刺激因子类药物纠正）：白细胞计数（white blood cell, WBC）≥3.0 × 109/L；绝对中性粒细胞计数（absolute neutrophil count, ANC）≥1.5 × 109/L；血小板（platelet, PLT）≥100 × 109/L；血红蛋白含量（hemoglobin, HGB）≥9.0 g/dL； （2）肝功能：受试者天门冬氨酸氨基转移酶（aspartate transferase, AST）≤2.5 x ULN；丙氨酸肝氨基转移酶（alanine aminotransferase, ALT）≤2.5 x ULN；血清总胆红素（total bilirubin, TBIL）≤1.5 x ULN (除外Gilbert 综合征总胆红素≤3.0 mg/dL) ； （3）肾功能：血清肌酐≤1.5 x ULN 或 肌酐清除率 (creatinine clearance rate, CrCl) ≥50 mL/minute (使用 Cockcroft/Gault 公式) ； （4）凝血功能：国际标准化比率（international normalized ratio, INR）≤1.5 x ULN，活化部分凝血活酶时间（activated partial thromboplastin time, APTT）≤1.5 x ULN（仅适用于目前没有接受抗凝治疗的患者，对于目前正在接受抗凝治疗的患者应接受稳定剂量的抗凝剂治疗）； （5）其他：脂肪酶≤1.5 x ULN（若脂肪酶>1.5 x ULN无临床或影像学证实胰腺炎的情况可以入组）；淀粉酶 ≤1.5 x ULN（若淀粉酶>1.5 x ULN 无临床或影像学证实胰腺炎的情况可以入组）；碱性磷酸酶（alkaline phosphatase, ALP）≤2.5ULN

Inclusion criteria

Participants must meet all of the following criteria to be enrolled in this study: 1. Sign informed consent and join the study voluntarily; 2. Histological diagnosis of gastric adenocarcinoma or gastroesophageal junction adenocarcinoma; 3. The clinical stage was determined by CT and laparoscopy as cT4a/bN+M0 (according to AJCC 8th edition staging) gastric/gastroesophageal junction adenocarcinoma; 4. Have not received anti-tumor therapy before; 5. Plan to undergo surgical treatment after the completion of neoadjuvant therapy; 6. Age 18-75 years old, male or female; 7.ECOG-PS score 0-1; 8. Expected survival ≥3 months; 9. Women of childbearing age must have a serum pregnancy study done within 7 days before the first medication, and the result is negative. Female subjects of reproductive age and male subjects whose partners are women of reproductive age must consent to contraception within 24 weeks from the date of signing the informed consent to the last administration of the study drug; 10. Before the first dose of the investigational drug, the laboratory test value meets the following conditions: (1) blood routine (no blood transfusion within 14 days before screening, no hematopoietic stimulating drug correction) : white blood cell count (WBC) ≥3.0 × 109/L; absolute neutrophil count (ANC) ≥1.5 × 109/L; platelet (PLT) ≥100 × 109/L; hemoglobin content (hemoglobin, HGB) ≥9.0 g/dL; (2) Liver function: aspartate transferase (AST) ≤2.5 x ULN; alanine aminotransferase (ALT) ≤2.5 x ULN; Serum total bilirubin (TBIL) ≤1.5 x ULN (except Gilbert syndrome total bilirubin ≤3.0 mg/dL); (3) Renal function: serum creatinine ≤1.5 x ULN or creatinine clearance rate (CrCl) ≥50 mL/minute (using Cockcroft/Gault formula); (4) Coagulation function: international normalized ratio (INR) ≤1.5 x ULN, activated partial thromboplastin time (APTT) ≤1.5 x ULN (only for patients who are not currently receiving anticoagulant therapy, patients who are currently receiving anticoagulant therapy should receive a steady dose of anticoagulant therapy); (5) Others: Lipase ≤1.5 x ULN (Lipase >1.5 x ULN without clinical or imaging evidence of pancreatitis can be included in the group); Amylase ≤1.5 x ULN (if amylase >1.5 x ULN has no clinical or imaging evidence of pancreatitis, it can be included in the group); alkaline phosphatase (ALP) ≤2.5ULN

排除标准：

符合以下任意一项的受试者均将从本试验中排除： 1.首剂用药前≤5年并发其他恶性肿瘤； 2.活动性、已知或怀疑自身免疫性疾病包括但不仅限于重症肌无力、自身免疫性肝炎、系统性红斑狼疮类风湿性关节炎、炎性肠病等。 3.既往接受过任何T细胞共刺激或免疫检查点治疗，包括但不限于细胞毒性T淋巴细胞相关抗原-4（cytotoxic T lymphocyte-associated antigen-4，CTLA-4）抑制剂、PD-1抑制剂、PD-L1/2抑制剂或其他靶向T细胞的药物； 4.首剂研究药物前≤14天内使用皮质类固醇激素（＞10 mg/天强的松或等效剂量）或其他免疫抑制剂。没有活动性自身免疫疾病的情况下允许吸入或局部使用类固醇和肾上腺替代类固醇； 5.HBsAg阳性且HBV DNA拷贝数大于所在研究中心检验科正常值上限（1000拷贝数/ml或500IU/ml?），或HCV阳性（HCV RNA或HCV Ab检测提示急慢性感染）；已知HIV阳性病史或已知的获得性免疫缺陷综合征（Acquired Immune Deficiency Syndrome, AIDS）； 6.入组时存在重度感染，包括但不仅限于需住院治疗的感染并发症、菌血症、重症肺炎等； 7.在入组前28天内接受过大型手术，或计划在研究期间接受其他大型手术； 8.入组前28天内使用减毒活疫苗，或预计研究期间需要使用此种减毒活疫苗（入组前4周、治疗期间以及研究药物末次给药后5个月内患者不允许接种流感减毒活疫苗）； 9.有严重的心血管疾病，如纽约心脏病协会（New York Heart Association, NYHA）2级以上心力衰竭、不稳定型心绞痛、不稳定性心律失常、入组前3个月内发生的心肌梗死或脑血管意外； 10.既往接受过同种异体骨髓移植或实体器官移植的患者； 11.已知对研究药物或辅料过敏，已知对任何一种单抗发生严重过敏反应； 12.签署ICF前4周内曾接受其它任何试验药物治疗或参加过另一项干预性临床研究； 13.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，不依从方案、其他的严重疾病（含精神疾病）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。

Exclusion criteria：

Subjects who meet any of the following criteria will be excluded from this study: 1. Concurrent with other malignant tumors ≤5 years before the first dose; 2. Active, known or suspected autoimmune diseases include, but are not limited to, myasthenia gravis, autoimmune hepatitis, systemic lupus erythematosus rheumatoid arthritis, inflammatory bowel disease, etc. 3. Prior treatment with any T cell co-stimulation or immune checkpoint, including but not limited to cytotoxic T lymphocyte-associated antigen-4, CTLA-4) inhibitors, PD-1 inhibitors, PD-L1/2 inhibitors, or other drugs that target T cells; 4. Use of corticosteroids (> 10 mg/ day prednisone or equivalent dose) or other immunosuppressants within ≤14 days prior to the first dose of the study drug. Allowing inhaled or topical use of steroids and adrenal replacement steroids in the absence of active autoimmune disease; 5.HBsAg positive and HBV DNA copy number greater than the upper limit of normal value in the laboratory of the research center (1000 copy number /ml or 500IU/ml), or HCV positive (HCV RNA or HCV Ab test indicates acute or chronic infection); Known HIV positive history or known Acquired Immune Deficiency Syndrome (AIDS); 6. Severe infection at enrollment, including but not limited to infection complications requiring hospitalization, bacteremia, severe pneumonia, etc.; 7. Had undergone major surgery within 28 days prior to enrollment or planned to undergo other major surgery during the study period; 8. Use of live attenuated influenza vaccine within 28 days prior to enrollment, or anticipated use of such live attenuated influenza vaccine during the study period (patients are not allowed to receive live attenuated influenza vaccine 4 weeks prior to enrollment, during treatment, and within 5 months after the final administration of the study drug); 9. Severe cardiovascular disease, such as New York Heart Association (NYHA) grade 2 or higher heart failure, unstable angina, unstable arrhythmia, myocardial infarction or cerebrovascular accident within 3 months prior to enrollment; 10. Patients who have previously received allogeneic bone marrow transplantation or solid organ transplantation; 11. Known allergy to the investigational drug or excipient, known severe allergic reaction to any monoclonal antibody; 12. Received any other investigational drug treatment or participated in another interventional clinical study within 4 weeks prior to signing the ICF; 13. In the investigator's judgment, the subjects had other factors that might have led to the forced termination of the study, such as non-adherence to the protocol, other serious medical conditions (including mental illness) requiring combined treatment, serious laboratory abnormalities, family or social factors that would have affected the safety of the subjects, or the collection of data and samples.

研究实施时间：

Study execute time：

从 From 2024-09-01 00:00:00至 To 2027-08-31 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2024-09-01 00:00:00 至 To 2026-08-31 00:00:00  

干预措施：

Interventions：

组别：

试验组

样本量：

41

Group：

Experimental group

Sample size：

干预措施：

卡瑞利珠单抗+阿帕替尼+Capox新辅助化疗

干预措施代码：

Intervention：

Apatinib Mesylate Combined with Camrelizumab and Capox Chemotherapy as Neoadjuvant Therapy

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 四川省 

市(区县)：

  

Country：

China 

Province：

Sichuan Province 

City：

 

单位(医院)：

川北医学院附属医院 

单位级别：

三甲 

Institution
hospital：

Affiliated Hospital of North Sichuan Medical College

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

病理完全缓解率

指标类型：

主要指标

Outcome：

Pathological complete response rate

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

主要病理缓解

指标类型：

次要指标

Outcome：

MPR

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

客观缓解率

指标类型：

次要指标

Outcome：

ORR

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

R0切除率

指标类型：

次要指标

Outcome：

R0 resection rate

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：

胃

组织：

Sample Name：

stomach

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）：

Calculated Results after
the Study Completed(upload file)：

是否共享原始数据：

IPD sharing

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）：

发表文章后

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

After publishing the paper

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：

暂未确定/Not yet

注册人：

Name of Registration：

  2024-08-13 11:36:11