ChiCTR2100052693 版本V1.5 版本创建时间2022/08/08 21:14:22 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：

ChiCTR2100052693 

最近更新日期：

Date of Last Refreshed on：

2022-05-16 21:49:15 

注册时间：

Date of Registration：

2021-11-03 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

卡瑞利珠单抗联合替吉奥或5-氟尿嘧啶一线治疗老年晚期/转移性食管鳞癌的单臂、探索性研究

Public title：

A single-arm, exploratory study of camrelizumab combined with S-1 or 5-fluorouracil in the first-line therapy of elderly patients with advanced/metastatic esophageal squamous cell carcinoma

注册题目简写：

English Acronym：

研究课题的正式科学名称：

卡瑞利珠单抗联合替吉奥或5-氟尿嘧啶一线治疗老年晚期/转移性食管鳞癌的单臂、探索性研究

Scientific title：

A single-arm, exploratory study of camrelizumab combined with S-1 or 5-fluorouracil in the first-line therapy of elderly patients with advanced/metastatic esophageal squamous cell carcinoma

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：

许曦予 

研究负责人：

陈勇 

Applicant：

Xu Xiyu 

Study leader：

Chen Yong 

申请注册联系人电话：

Applicant telephone：

+86 18360688022

研究负责人电话：

Study leader's telephone：

+86 18051062926

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：

18360688022@163.com

研究负责人电子邮件：

Study leader's E-mail：

29008315@qq.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：

江苏省南京市鼓楼区中央路19号

研究负责人通讯地址：

江苏省扬州市邗江中路368号

Applicant address：

19 Zhongyang Road, Gulou District, Nanjing, Jiangsu, China

Study leader's address：

368 Hanjiang Middle Road, Yangzhou, Jiangsu

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：

江苏恒瑞医药股份有限公司

Applicant's institution：

Jiangsu Hengrui Pharmaceutical Co. LTD

研究负责人所在单位：

扬州大学附属医院

Affiliation of the Leader：

Affiliated Hospital of Yangzhou University

是否获伦理委员会批准：

否/No

Approved by ethic committee：

No

伦理委员会批件文号：

Approved No. of ethic committee：

伦理委员会批件附件：

Approved file of Ethical Committee：

批准本研究的伦理委员会名称：

Name of the ethic committee：

伦理委员会批准日期：

Date of approved by ethic committee：

2013-08-26 00:00:00

伦理委员会联系人：

Contact Name of the ethic committee：

伦理委员会联系地址：

Contact Address of the ethic committee：

伦理委员会联系人电话：

Contact phone of the ethic committee：

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：

扬州大学附属医院

Primary sponsor：

Affiliated Hospital of Yangzhou University

研究实施负责（组长）单位地址：

江苏省扬州市邗江中路368号

Primary sponsor's address：

368 Hanjiang Middle Road, Yangzhou, Jiangsu

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

江苏

市(区县)：

扬州

Country：

China

Province：

Jiangsu

City：

Yangzhou

单位(医院)：

扬州大学附属医院

具体地址：

邗江中路368号

Institution
hospital：

Affiliated Hospital of Yangzhou University

Address：

368 Hanjiang Middle Road

经费或物资来源：

江苏恒瑞医药股份有限公司

Source(s) of funding：

Jiangsu Hengrui Medicine Co.,Ltd.

Target disease：

esophageal squamous cell carcinoma

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：

主要目的：评估卡瑞利珠单抗联合替吉奥或5-氟尿嘧啶一线治疗老年晚期/转移性食管鳞癌的有效性及安全性。  

Objectives of Study：

Main purpose: To evaluate the efficacy and safety of carrelizumab in combination with first-line treatment of ticio or 5-fluorouracil in elderly patients with advanced/metastatic esophageal squamous cell carcinoma.

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≥75岁的受试者；
2.组织学证实的原发性食管鳞状细胞癌，病理学和影像学确诊的不能切除的局部晚期/远处转移食管癌，Ⅳ期；
3.至少有1处可测量病灶，根据RECIST 1.1 标准；
4.既往未接受过除手术之外针对原发性食管鳞癌的局部和全身系统性治疗。
5.体力状况评分（ECOG PS评分）：0-1分；
6.预计生存期≥ 6个月；
7.主要脏器功能良好，即入组前14天内相关检查指标满足以下要求：
(1)红蛋白 ≥ 90 g/L（14天内未输血）；
(2)中性粒细胞计数> 1.5×10^9/L；
(3)血小板计数≥ 100×10^9/L；
(4)总胆红素 ≤ 1.5×ULN（正常值上限）；
(5)血谷丙转氨酶（ALT）或血谷草转氨酶（AST） ≤ 2.5×ULN；
(6)如有肝转移，则ALT或AST ≤ 5×ULN；
(7)内生肌酐清除率 ≥ 60 mL/min（Cockcroft-Gault公式）；
(8)心脏多普勒超声评估：左室射血分数 (LVEF) ≥ 50%。
8.甲状腺功能指标：促甲状腺激素（TSH）、游离甲状腺素（FT3/FT4）在正常范围或轻微且无临床意义的异常；
9.
(1)非手术绝育或育龄期女性受试者，需要在研究治疗期间和研究治疗期结束后 3 个月内采用一种经医学认可的避孕措施（如宫内节育器，避孕药或避孕套）；
(2)非手术绝育的育龄期女性受试者在研究入组前的 7 天内血清或尿HCG检查必须为阴性，而且必须为非哺乳期；
(3)非手术绝育或育龄期男性受试者，需要同意与其配偶在研究治疗期间和研究治疗期结束后 3 个月内采用一种经医学认可的避孕措施。
10.受试者自愿加入本研究，依从性好，配合安全性和生存期随访。

Inclusion criteria

1. Subjects aged >= 75 years;
2. Histologically confirmed primary esophageal squamous cell carcinoma, unresectable locally advanced/distant metastatic esophageal cancer confirmed by pathology and imaging, stage IV;
3. At least one measurable lesion, according to RECIST 1.1 criteria;
4. Have not received local and systemic systemic therapy for primary esophageal squamous cell carcinoma other than surgery before.
5. Physical condition score (ECOG PS score): 0-1 points;
6. Expected survival period >= 6 months;
7. The function of main organs is good, that is, the relevant inspection indicators within 14 days before enrollment meet the following requirements:
(1) Hemoglobin >= 90 g/L (no blood transfusion within 14 days);
(2) Neutrophil count > 1.5x10^9/L;
(3) Platelet count >= 100x10^9/L;
(4) Total bilirubin <= 1.5xULN (upper limit of normal);
(5) Blood alanine aminotransferase (ALT) or blood aspartate aminotransferase (AST) <= 2.5xULN;
(6) If there is liver metastasis, ALT or AST <= 5xULN;
(7) Endogenous creatinine clearance >= 60 mL/min (Cockcroft-Gault formula);
(8) Cardiac Doppler ultrasound assessment: left ventricular ejection fraction (LVEF) >= 50%.
8. Thyroid function indicators: Thyroid-stimulating hormone (TSH), free thyroxine (FT3/FT4) in the normal range or mild and no clinically significant abnormalities;
9.
(1) Non-surgical sterilization or female subjects of childbearing age who need to use a medically approved contraceptive method (such as an intrauterine device, contraceptives or condoms during the study treatment period and within 3 months after the end of the study treatment period) );
(2) Non-surgical sterilized female subjects of childbearing age must have negative serum or urine HCG tests within 7 days before study enrollment, and must be non-lactating;
(3) Male subjects of non-surgical sterilization or of childbearing age need to agree to use a medically approved contraceptive method with their spouses during the study treatment period and within 3 months after the end of the study treatment period.
10. The subjects voluntarily joined the study, with good compliance, and with follow-up for safety and survival.

排除标准：

1.既往接受过针对原发性食管鳞癌放疗、化疗、靶向治疗及免疫治疗的受试者；
2.受试者既往或同时患有其它恶性肿瘤（已治愈的皮肤基底细胞癌和宫颈原位癌除外）；
3.四周内参加过其他药物临床试验；
4.筛选前已知有中枢神经系统转移或有中枢神经系统转移病史的受试者。对于临床疑似中枢神经系统转移的受试者，入组前28天内必须进行CT或MRI检查，排除中枢神经系统转移；
5.筛选前3个月内新诊断为心绞痛者或筛选前6个月内发生心肌梗塞事件；心律失常（包括QTcF： 男性≥450 ms，女性≥470 ms）需长期使用抗心律失常药物及纽约心脏病协会分级≥II级心功能不全；
6.受试者目前（3个月内）存在食道静脉曲张、胃及十二指肠活动性溃疡、溃疡性结肠炎、门脉高压等消化道疾病或未切除的肿瘤存在活动出血，或研究者判定的可能引起消化道出血、穿孔的其他状况；
7.有出血病史，筛选前 4 周内发生任何严重分级达到 CTCAE 5.0中 3 度或以上的出血事件；
8.凝血功能异常，具有出血倾向者（随机化前14天必须满足：在不使用抗凝剂的情况下INR在正常值范围内）；应用抗凝剂或维生素 K 拮抗剂如华法林、肝素或其类似物治疗的受试者；在凝血酶原时间国际标准化比值（INR）≤ 1.5的前提下，允许以预防目的使用小剂量华法林（1 mg口服，每日一次）或小剂量阿司匹林（每日用量不超过100 mg）；
9.有免疫缺陷病史，或患有其它获得性、先天性免疫缺陷疾病，或有器官移植史；
10.既往和目前有肺纤维化史、间质性肺炎、尘肺、放射性肺炎、药物相关肺炎、肺功能严重受损等的客观证据的受试者；
11.有严重的慢性自身免疫性疾病病史，如系统性红斑狼疮等；有溃疡性肠炎，克罗恩病等炎症性肠病病史，有肠易激综合征等慢性腹泻性疾病病史；有结节病病史或结核病病史；
12.对人源或鼠源单克隆抗体有高敏反应受试者；
13.具有精神类药物滥用史且无法戒除者或有精神障碍的；
14.有临床症状，需要临床干预的胸腔积液或腹腔积液；
15.不遵医嘱、不按规定用药，或资料不全等可影响疗效判断或安全判断的受试者；
16.根据研究者的判断，有严重的危害受试者安全或影响受试者完成研究的伴随疾病。

Exclusion criteria：

1. Subjects who have previously received radiotherapy, chemotherapy, targeted therapy, and immunotherapy for primary esophageal squamous cell carcinoma;
2. Subject has previous or co-existing malignancies (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix);
3. Participated in clinical trials of other drugs within 4 weeks;
4. Screening subjects with known CNS metastases or a history of CNS metastases.
For the subjects suspected of central nervous system metastasis, CT or MRI examination must be performed within 28 days before enrollment to exclude central nervous system metastasis.
5. Patients newly diagnosed with angina pectoris within 3 months prior to screening or patients with myocardial infarction within 6 months prior to screening;
Arrhythmias (including QTcF: >=450 ms for men and >=470 ms for women) requiring long-term use of antiarrhythmic drugs and New York Heart Association classification >=II cardiac insufficiency;
6. The subjects present (within 3 months) with esophageal varices, active gastric and duodenal ulcers, ulcerative colitis, portal hypertension and other gastrointestinal diseases, or with active bleeding from unresected tumors, or other conditions that may cause gastrointestinal bleeding or perforation as determined by the investigator;
7. There is a history of bleeding, and any bleeding event with severity grade 3 or above in CTCAE 5.0 occurred within 4 weeks prior to screening;
8. Patients with abnormal coagulation function and bleeding tendency (INR must be within the normal range without the use of anticoagulants 14 days before randomization);
Subjects treated with anticoagulants or vitamin K antagonists such as warfarin, heparin, or their analoges;
The use of low-dose warfarin (1 mg orally, once daily) or low-dose aspirin (not more than 100 mg daily) for preventive purposes is permitted if the international standardized ratio of prothrombin time (INR) <= 1.5;
9. A history of immunodeficiency, or other acquired or congenital immunodeficiency disease, or a history of organ transplantation;
10. Subjects with past or present objective evidence of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radioactive pneumonia, drug-related pneumonia, severely impaired lung function, etc.;
11. Have a history of severe chronic autoimmune diseases, such as systemic lupus erythematosus;
A history of ulcerative enteritis, Crohn's disease and other inflammatory bowel diseases, and a history of chronic diarrheal diseases such as irritable bowel syndrome;
A history of sarcoidosis or tuberculosis;
12. Subjects with high sensitivity to human or mouse monoclonal antibodies;
13. Those who have a history of psychotropic drug abuse and cannot get rid of it or have mental disorders;
14. Pleural or abdominal effusion with clinical symptoms requiring clinical intervention;
15. Subjects who do not follow the doctor's advice, do not follow the prescribed medication, or have incomplete information that may affect the judgment of efficacy or safety;
16. Concomitant diseases that, in the judgment of the investigator, seriously endanger the safety of the subject or affect the completion of the study.

研究实施时间：

Study execute time：

从 From 2021-12-01 00:00:00至 To 2023-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2021-12-01 00:00:00 至 To 2022-12-31 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：

卡瑞利珠单抗200mg+替吉奥或5-FU，Q3W，4-6周期后，卡瑞利珠单抗维持不超过2年

干预措施代码：

Intervention：

Camrelizumab 200mg+ S-1 or 5-Fu Q3W 4-6 cycles, Camrelizumab was maintained for no more than 2 years

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 江苏 

市(区县)：

  

Country：

China 

Province：

Jiangsu 

City：

 

单位(医院)：

扬州大学附属医院 

单位级别：

三级甲等 

Institution
hospital：

Affiliated Hospital of Yangzhou University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

无进展生存期

指标类型：

主要指标

Outcome：

Progression-free survival

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：

无

组织：

Sample Name：

None

Tissue：

人体标本去向

 其它  

说明

Fate of sample：

0thers  

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 75 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）：

无

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

NA

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）：

病例记录表

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

Case Record Form, CRF

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：

有/Yes

注册人：

Name of Registration：

  2021-11-03 20:37:23