中国临床试验注册中心 - 世界卫生组织国际临床试验注册平台一级注册机构

注册号： Registration number：	ChiCTR2100049404
最近更新日期： Date of Last Refreshed on：	2022-04-08 07:53:20
注册时间： Date of Registration：	2021-08-02 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	卡瑞利珠单抗联合白蛋白紫杉醇、吉西他滨及顺铂用于晚期胆道系统肿瘤的临床研究
Public title：	The clinical study of carrelizumab combined with albumin paclitaxel, gemcitabine and cisplatin for advanced biliary system tumors
注册题目简写：
English Acronym：
研究课题的正式科学名称：	卡瑞利珠单抗联合白蛋白紫杉醇、吉西他滨及顺铂用于晚期胆道系统肿瘤的临床研究
Scientific title：	The clinical study of carrelizumab combined with albumin paclitaxel, gemcitabine and cisplatin for advanced biliary system tumors
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：	周迪	研究负责人：	全志伟
Applicant：	Zhou Di	Study leader：	Quan Zhiwei
申请注册联系人电话： Applicant telephone：	+86 21 25077905	研究负责人电话： Study leader's telephone：	+86 21 25077905
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：	zhiwquan@163.com	研究负责人电子邮件： Study leader's E-mail：	zhiwquan@163.com
申请单位网址(自愿提供)： Applicant website(voluntary supply)：	上海交通大学医学院附属新华医院普外科	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：	上海市杨浦区控江路1665号	研究负责人通讯地址：	上海市杨浦区控江路1665号新华医院
Applicant address：	1665 Kongjiang Road, Yangpu District, Shanghai, China	Study leader's address：	1665 Kongjiang Road, Yangpu District, Shanghai, China
申请注册联系人邮政编码： Applicant postcode：	200092	研究负责人邮政编码： Study leader's postcode：	200092
申请人所在单位：	上海交通大学医学院附属新华医院
Applicant's institution：	Xinhua Hospital affiliated to Shanghai JiaoTong University
研究负责人所在单位：	上海交通大学医学院附属新华医院
Affiliation of the Leader：	Xinhua Hospital affiliated to Shanghai JiaoTong University

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：	XHEC-C-2021-051-2	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：	上海交通大学医学院附属新华医院医学伦理委员会
Name of the ethic committee：	Medical Ethics Committee of Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
伦理委员会批准日期： Date of approved by ethic committee：	2021-07-29 00:00:00
伦理委员会联系人：	施敏
Contact Name of the ethic committee：	Shi Min
伦理委员会联系地址：	上海市杨浦区控江路1665号新华医院
Contact Address of the ethic committee：	1665 Kongjiang Road, Yangpu District, Shanghai, China
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 21 25078922	伦理委员会联系人邮箱： Contact email of the ethic committee：	xinhuahospitalec@163.com

研究实施负责（组长）单位：

上海交通大学医学院附属新华医院

Primary sponsor：

Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine

研究实施负责（组长）单位地址：

上海市杨浦区控江路1665号新华医院

Primary sponsor's address：

1665 Kongjiang Road, Yangpu District, Shanghai, 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)：	上海	市(区县)：
Country：	China	Province：	Shanghai	City：
单位(医院)：	上海交通大学医学院附属新华医院	具体地址：	杨浦区控江路1665号
Institution hospital：	Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine	Address：	1665 Kongjiang Road, Yangpu District

经费或物资来源：

企业

Source(s) of funding：

enterprise

研究疾病：

胆道系统恶性肿瘤

Target disease：

Malignant Tumor of Biliary System

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：观察和评价卡瑞利珠单抗联合白蛋白紫杉醇、吉西他滨及顺铂用于晚期胆道系统恶性肿瘤的有效性和安全性。

Objectives of Study：

Main purpose: To observe and evaluate the efficacy and safety of carrelizumab combined with albumin paclitaxel, gemcitabine and cisplatin for advanced malignant tumors of the biliary system.

药物成份或治疗方案详述：

Description for medicine or protocol of treatment in detail：

纳入标准：

Inclusion criteria

1. Aged 18 to 80 years, male or female;
2. Patients with untreated primary advanced biliary malignancies (BTC) diagnosed by histopathology or cytology, including intrahepatic cholangiocarcinoma (ICC), extrahepatic cholangiocarcinoma (ECC), gallbladder cancer ( GBC); or untreated recurrent biliary tract tumors (surgery, adjuvant/neoadjuvant chemotherapy allowed in the past, recurrence >=3 months after the end of adjuvant chemotherapy, adjuvant/neoadjuvant chemotherapy regimen excluding PD-1/L1 monotherapy anti, gemcitabine, nab-paclitaxel, and cisplatin)
3. Physical condition ECOG PS score: 0-1 points;
4. Expected survival period >= 3 months;
5. According to RECIST 1.1 criteria, at least one measurable target lesion that can be examined by CT or MRI;
6. Laboratory inspection indicators meet the following requirements:
(1) Bone marrow function: hemoglobin (Hb) >= 90g/L; white blood cell count (WBC) >= lower limit of normal; absolute neutrophil value (ANC) >= 1.5x10^9/L; platelet count >=100x10^9/L ;
(2) Renal function: Cr<=UNL (upper limit of normal)x1.5, endogenous creatinine clearance rate (Ccr)>=55 ml/min;
(3) Liver function: total bilirubin<=ULNx1.5; ALT and AST<=ULNx2.5; (in the case of intrahepatic cholangiocarcinoma or liver metastasis, total bilirubin is not higher than 3 times the upper limit of normal, transaminases are not 5 times higher than the upper limit of normal)
(4) Coagulation function: the international normalized ratio of prothrombin time is less than or equal to ULNx1.5, and the partial thromboplastin time is within the normal range;
7. Have not received any anti-tumor therapy for advanced biliary tract tumors in the past, including chemotherapy, radiotherapy, targeted, hormone or immunotherapy; patients after R2 resection are allowed to be enrolled;
8. Females of childbearing age agree to contraception during the study period and within 6 months after the end of the study; serum or urine pregnancy test is negative within 7 days before the study is enrolled, and non-lactating patients; males agree to use contraception during the study period and within 6 months after the end of the study contraceptive patients;
9. Those who have not participated in clinical trials of other drugs within 4 weeks before enrollment;
10. The subjects can understand the research situation and voluntarily sign the informed consent.
11. No serious complications such as active gastrointestinal bleeding, perforation, jaundice, gastrointestinal obstruction, non-cancerous fever >38 degree;
12. Those who are expected to have good compliance can follow up the curative effect and adverse reactions according to the program requirements.

排除标准：

1.既往5年内已诊断其它恶性肿瘤（原位癌、基底细胞癌等除外）；
2.已知有中枢神经系统转移者（经放疗或手术 4 周后疾病控制稳定且无症状者除外）或癌性脑膜炎证据者；
3.患有精神或神经系统疾患，不能配合者；
4.既往接受过本研究用药方案（PD-1/L1单抗、白蛋白结合型紫杉醇、吉西他滨、顺铂）的患者；
5.准备进行或既往接受过器官或骨髓移植的患者；
6.患有任何活动性自身免疫病或自身免疫病史；
7.首次给药前30天内接种过活疫苗（允许使用注射型季节性流感疫苗，因该疫苗为灭活疫苗）；
8.患有未能控制的心脏临床症状或疾病；
9.有活动性感染或发热（明确的肿瘤热除外）；
10.间质性肺病或活动性非感染性肺炎病史或证据；
11.患其他疾病不适合入组者，如免疫功能缺陷、活动性肺结核、乙肝（经治疗后乙肝病毒滴度HBV-DNA<500IU/ml，且肝功能正常则可入组）、丙肝病毒检测阳性、无法纠正的电解质紊乱、不可控制的心包积液、胸腔积液及腹腔积液等；
12.对本方案中任何药物过敏者；
13.入组前14天内使用免疫抑制药物或皮质类固醇>10mg/天泼尼松疗效剂量者；
14.入组前4周内接受过放疗、化疗、靶向治疗或免疫治疗者；
15.妊娠期或哺乳期妇女；
16.研究者认为不适合入组者。

Exclusion criteria：

1. Other malignant tumors (except for carcinoma in situ, basal cell carcinoma, etc.) have been diagnosed within the past 5 years;
2. Those with known central nervous system metastasis (except those with stable disease control and asymptomatic 4 weeks after radiotherapy or surgery) or evidence of cancerous meningitis;
3. People who suffer from mental or nervous system disorders and cannot cooperate;
4. Patients who have previously received the medication regimen of this study (PD-1/L1 monoclonal antibody, albumin-bound paclitaxel, gemcitabine, cisplatin);
5. Patients who are planning to undergo or have previously received organ or bone marrow transplantation;
6. Suffer from any active autoimmune disease or autoimmune disease history;
7. Live vaccine has been vaccinated within 30 days before the first administration (injectable seasonal influenza vaccine is allowed because the vaccine is an inactivated vaccine);
8. Suffer from uncontrolled clinical symptoms or diseases of the heart;
9. Active infection or fever (except for clear tumor fever);
10. History or evidence of interstitial lung disease or active non-infectious pneumonia;
11. Those who suffer from other diseases are not suitable for entry, such as immunodeficiency, active tuberculosis, hepatitis B (hepatitis B virus titer HBV-DNA <500IU/ml after treatment, and normal liver function can be included in the group), hepatitis C virus detection Positive, uncorrectable electrolyte disturbances, uncontrollable pericardial effusion, pleural effusion and ascites effusion, etc.;
12. Those who are allergic to any of the drugs in this program;
13. Those who have used immunosuppressive drugs or corticosteroids> 10 mg/day of prednisone therapeutic effect within 14 days before enrollment;
14. Those who have received radiotherapy, chemotherapy, targeted therapy or immunotherapy within 4 weeks before enrollment;
15. Women during pregnancy or lactation;
The researcher believes that it is not suitable for enrollment.

研究实施时间：

Study execute time：

从 From 2021-08-01 00:00:00至 To 2023-07-31 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2021-08-01 00:00:00 至 To 2022-07-31 00:00:00

干预措施：

Interventions：

组别：	Case series	样本量：	218
Group：	Case series	Sample size：	218
干预措施：	无	干预措施代码：
Intervention：	No	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	中国	省(直辖市)：	上海	市(区县)：
Country：	China	Province：	Shanghai	City：
单位(医院)：	上海交通大学医学院附属新华医院	单位级别：	三级甲等
Institution hospital：	Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine	Level of the institution：	Tertiary 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	80	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）：

N/A

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

N/A

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：	N/A
Blinding：	N/A
试验完成后的统计结果（上传文件）：	点击下载
Calculated Results after the Study Completed(upload file)：	download

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）：	N/A
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	N/A
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+EDC
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	CRF+EDC
数据与安全监察委员会： Data and Safety Monitoring Committee：	有/Yes
注册人： Name of Registration：	2021-08-02 00:43:58