ChiCTR2100050489 版本V1.4 版本创建时间2021/12/25 03:34:51 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：

ChiCTR2100050489 

最近更新日期：

Date of Last Refreshed on：

2021-11-13 10:58:33 

注册时间：

Date of Registration：

2021-08-28 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

尼妥珠单抗联合AG方案新辅助化疗及免疫检查点抑制剂转化治疗局部进展期胰腺癌患者的临床研究

Public title：

Clinical study of nituzumab combined with a AG regimen of neoadjuvant chemotherapy and immunocheckpoint inhibitor transformation in patients with locally progressive pancreatic cancer

注册题目简写：

English Acronym：

研究课题的正式科学名称：

尼妥珠单抗联合AG方案新辅助化疗及免疫检查点抑制剂转化治疗局部进展期胰腺癌患者的临床研究

Scientific title：

Clinical study of nituzumab combined with a AG regimen of neoadjuvant chemotherapy and immunocheckpoint inhibitor transformation in patients with locally progressive pancreatic 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：

张松岩 

研究负责人：

张松岩 

Applicant：

Zhang Songyan 

Study leader：

Zhang Songyan 

申请注册联系人电话：

Applicant telephone：

18846437566

研究负责人电话：

Study leader's telephone：

18846437566

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：

zhangsong-yan@163.com

研究负责人电子邮件：

Study leader's E-mail：

zhangsong-yan@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：

黑龙江省哈尔滨市南岗区哈平路150号

研究负责人通讯地址：

黑龙江省哈尔滨市南岗区哈平路150号

Applicant address：

150 Haping Road, Nangang District, Harbin, Heilongjiang, China

Study leader's address：

150 Haping Road, Nangang District, Harbin, Heilongjiang, 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：

哈尔滨医科大学附属肿瘤医院

Applicant's institution：

Harbin Medical University Affiliated Tumor Hospital

研究负责人所在单位：

哈尔滨医科大学附属肿瘤医院

Affiliation of the Leader：

Harbin Medical University Affiliated Tumor Hospital

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：

ChiECRCT20210473

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：

中国注册临床试验伦理委员会

Name of the ethic committee：

Chinese Ethics Committee of Registering Clinical Trials

伦理委员会批准日期：

Date of approved by ethic committee：

2021-10-13 00:00:00

伦理委员会联系人：

吴莼

Contact Name of the ethic committee：

Wu Chun

伦理委员会联系地址：

中国香港特别行政区九龙浸会大学道中国临床试验注册中心香港中心

Contact Address of the ethic committee：

Chinese Clinical trial Hong Kong Centre, Baptist University Road, Kowloon Tong, Hong Kong SAR, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 18980604562

伦理委员会联系人邮箱：

Contact email of the ethic committee：

chictr001@chictr.org.cn

研究实施负责（组长）单位：

哈尔滨医科大学附属肿瘤医院

Primary sponsor：

Harbin Medical University Affiliated Tumor Hospital

研究实施负责（组长）单位地址：

黑龙江省哈尔滨市南岗区哈平路150号

Primary sponsor's address：

150 Haping Road, Nangang District, Harbin, Heilongjiang, 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)：

黑龙江

市(区县)：

哈尔滨

Country：

China

Province：

Heilongjiang

City：

Harbin

单位(医院)：

哈尔滨医科大学附属肿瘤医院

具体地址：

南岗区哈平路150号

Institution
hospital：

Harbin Medical University Affiliated Tumor Hospital

Address：

150 Haping Road, Nan'gang District

经费或物资来源：

企业资助

Source(s) of funding：

Enterprise financing

Target disease：

pancreatic cancer

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 I期临床试验 

Study phase：

1

研究设计：

横断面 

Study design：

Cross-sectional 

研究目的：

本研究旨在探索尼妥珠单抗联合AG方案新辅助化疗及免疫检查点抑制剂同步化疗治疗局进展期胰腺癌的有效性及安全性。  

Objectives of Study：

This study was designed to explore the efficacy and safety of nituzumab combined with the AG regimen of neoadjuvant chemotherapy and immune checkpoint inhibitor synchronous chemotherapy for the treatment of progressive 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：

(1) 年龄18-75岁，含18岁和75岁；
(2) ECOG PS评分0-2；
(3) 经过病理组织学或细胞学确诊的Ⅲ-Ⅳ期胰腺癌患者。如患者本人拒绝穿刺或胰腺病理穿刺困难，则需有PET-CT、核磁、肿瘤标记物（CA199，CA125，CEA）等相关证据支持。（按照2020年CSCO胰腺肿瘤诊疗指南）。
(4) 影像学评估无远处转移
(5) 影像学评估病灶侵犯肠系膜上动脉或肠系膜上静脉，侵犯范围≤180度；
(6) 根据RECIST 1.1版评价标准，至少具有一处可测量病灶；
(7) 适合接受以根治为目的转化治疗及外科手术治疗。
(8) 预期存活时间≥ 12个月；
(9) 血液学指标基本正常：白细胞计数≥4×109/L；中性粒细胞绝对计数≥1.5×109/L；血小板≥100×109/L；血红蛋白≥90 g/L；
(10) 肾功能基本正常：血清肌酐≤1.2mg/dL或肌酐清除率≥60mL/min
(11) 肝功能基本正常：血清总胆红素≤1.5×ULN （如有肝转移，则血清总胆红素应≤3.0×ULN）； 谷草转氨酶（AST）和谷丙转氨酶（ALT）≤2.5×ULN（≤5.0×ULN，如果有肝转移）。
(12) 签署书面知情同意书。

Inclusion criteria

(1) Age 18 – 75 years, including 18 and 75 years;
(2) ECOG PS score of 0-2;
(3) Patients with stage-stage pancreatic cancer diagnosed by pathological histology or cytology. If the patient himself refuses to puncture or has pancreatic pathological puncture, relevant evidence of PET-CT, nuclear magnet, tumor markers (CA 199,CA 125,CEA).(According to the 2020 CSCO Pancreatic Tumor Diagnosis and Treatment Guidelines).
(4) Imaging was assessed without distant transfer
(5) Imaging evaluation of lesions invaded the superior mesenteric artery or superior mesenteric vein, with the invasion range ≤ 180 degrees;
(6) At least one measurable lesion according to RECIST 1.1 evaluation criteria;
(7) Suitable for transformation treatment and surgical treatment for the purpose of radical cure.
(8) Expected survival time of ≥ for 12 months;
(9) Hematology indicators were basically normal: leukocyte count ≥ 4 × 109/ L; Neutrophil absolute counts of ≥ 1.5 × 109/ L; platelet ≥ 100 × 109/ L; Hemoglobin ≥ 90 g/L;
(10) Renal function is basically normal: serum creatinine ≤ 1.2mg/dL or creatinine clearance rate ≥ 60mL/min
(11) Liver function is basically normal: serum total bilirubin ≤ 1.5 ×ULN (if liver metastasis, serum total bilirubin should be ≤ 3.0 ×ULN); glutamatase (AST) and glutaminase (ALT) ≤ 2.5 ×ULN (≤ 5.0 ×ULN, if there is liver metastasis).
(12) Sign a written informed consent form.
.21 Exclusion criteria
(1) Those who have received radiotherapy, chemotherapy, monoclonal antibody and oral EGFR-TKI treatment, antiangiogenic drugs, and immunosuppressive agents within six months;
(2) Participated in other interventional clinical trials within 30 days prior to the screening;
(3) Patients with distant metastases;
(4) With a history of other malignant tumors (except for cured cervical carcinoma in situ or skin basal cell carcinoma and other malignancies that have been cured for more than 5 years);
(5) There are poorly controlled concurrent diseases (e. g., heart failure, diabetes, hypertension, thyroid disease, mental illness, etc.);
(6) Known infection with HIV virus or active viral hepatitis;
(7) Is receiving chronic steroid hormone treatment for more than 6 months (e. g., a prednisone dose of> for 10 mg/ days or equivalent);
(8) Those allergic to the drugs or their ingredients used in this protocol;
(9) ≥ grade 2 peripheral neurological disease or hearing loss according to the criteria for common adverse event terms (NCI CTCAE V5.0);
(10) Pregnancy (confirmed by blood or urine HCG testing) or women lactating, or childbearing age subjects were unwilling or unable to take effective contraception (for both male and female subjects) until at least 6 months after the last trial treatment;
(11) The investigator does not consider it appropriate to participate in the investigator;
(12) Those who were unwilling to participate in this study or were unable to sign the informed consent form.

排除标准：

(1) 半年内接受过放射治疗、化疗、单克隆抗体及口服EGFR-TKI治疗、抗血管生成药物、免疫抑制剂者；
(2) 筛选前30天内参加过其它干预性临床试验；
(3) 远处转移的患者；
(4) 具有其他恶性肿瘤史（已治愈的宫颈原位癌或皮肤基底细胞癌以及已治愈5年以上的其他恶性肿瘤除外）；
(5) 存在控制不佳的并发疾病(如心衰、糖尿病、高血压、甲状腺疾病、精神疾病等)；
(6) 已知感染HIV病毒或活动性病毒性肝炎；
(7) 正接受慢性类固醇激素治疗超过6个月（如泼尼松剂量> 10 mg/天或同等剂量）；
(8) 对本方案中使用药物或其成分过敏者；
(9) 根据常见不良事件术语（NCI CTCAE V5.0）的标准，≥2级外周神经疾病或听力丧失；
(10) 妊娠（经血或尿HCG检测确认）或哺乳期妇女，或育龄期受试者不愿或不能采取有效的避孕措施（既适用于男性也适用于女性受试者）直到末次试验治疗后至少6个月；
(11) 研究者认为不适宜参加本研究者；
(12) 不愿参加本研究或无法签署知情同意书者。

Exclusion criteria：

(1) Those who have received radiotherapy, chemotherapy, monoclonal antibody and oral EGFR-TKI treatment, antiangiogenic drugs, and immunosuppressive agents within six months;
(2) Participated in other interventional clinical trials within 30 days prior to the screening;
(3) Patients with distant metastases;
(4) With a history of other malignant tumors (except for cured cervical carcinoma in situ or skin basal cell carcinoma and other malignancies that have been cured for more than 5 years);
(5) There are poorly controlled concurrent diseases (e. g., heart failure, diabetes, hypertension, thyroid disease, mental illness, etc.);
(6) Known infection with HIV virus or active viral hepatitis;
(7) Is receiving chronic steroid hormone treatment for more than 6 months (e. g., a prednisone dose of> for 10 mg/ days or equivalent);
(8) Those allergic to the drugs or their ingredients used in this protocol;
(9) ≥ grade 2 peripheral neurological disease or hearing loss according to the criteria for common adverse event terms (NCI CTCAE V5.0);
(10) Pregnancy (confirmed by blood or urine HCG testing) or women lactating, or childbearing age subjects were unwilling or unable to take effective contraception (for both male and female subjects) until at least 6 months after the last trial treatment;
(11) The investigator does not consider it appropriate to participate in the investigator;
(12) Those who were unwilling to participate in this study or were unable to sign the informed consent form.

研究实施时间：

Study execute time：

从 From 2021-10-01 00:00:00至 To 2023-10-31 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2021-10-01 00:00:00 至 To 2023-08-25 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：

尼妥珠单抗联合AG方案新辅助化疗转化治疗

干预措施代码：

Intervention：

Nituzumab combined with AG regimen for neoadjuvant chemotherapy transformation therapy

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 黑龙江 

市(区县)：

 哈尔滨 

Country：

China 

Province：

Heilongjiang 

City：

Harbin 

单位(医院)：

哈尔滨医科大学附属肿瘤医院 

单位级别：

三甲 

Institution
hospital：

Harbin Medical University Affiliated Tumor Hospital

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

肿瘤完全缓解率

指标类型：

主要指标

Outcome：

Tumor 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：

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：

指标中文名：

疾病控制率

指标类型：

主要指标

Outcome：

Disease control 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 岁 years
最大 Max age 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）：

双臂、开放性临床试验设计

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

Double-arm, open clinical trial design

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

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）：

不确定

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

Not sure yet

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：

病例报告表

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

Case Report Form

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2021-08-28 11:47:00