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Trial search Nation, Province(City) Code of disease Primary sponsor(s) Secondary sponsor(s) Funding source Recruiting status Register status Measure Ethical committee Study type

Camrelizumab combine with gemcitabine and apatinib in the treatment of advanced PD-L1 positive Biliary tract cancer: A Single-arm, open, exploratory clinical study

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注册号：

Registration number：

ChiCTR2000040181 

最近更新日期：

Date of Last Refreshed on：

2021-02-19 07:02:31 

注册时间：

Date of Registration：

2020-11-24 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

卡瑞利珠单抗联合吉西他滨、甲磺酸阿帕替尼治疗进展期PD-L1阳性胆道恶性肿瘤的单臂、开放、探索性临床研究

Public title：

Camrelizumab combine with gemcitabine and apatinib in the treatment of advanced PD-L1 positive Biliary tract cancer: A Single-arm, open, exploratory clinical study

注册题目简写：

English Acronym：

研究课题的正式科学名称：

卡瑞利珠单抗联合吉西他滨、甲磺酸阿帕替尼治疗进展期PD-L1阳性胆道恶性肿瘤的单臂、开放、探索性临床研究

Scientific title：

Camrelizumab combine with gemcitabine and apatinib in the treatment of advanced PD-L1 positive Biliary tract cancer: A Single-arm, open, exploratory 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：

许曦予 

研究负责人：

陈晓锋 

Applicant：

Xiyu Xu 

Study leader：

Xiaofeng Chen 

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 13585172066

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：

Xiaofengch198019@126.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号金峰大厦11楼

研究负责人通讯地址：

江苏省南京市广州路300号

Applicant address：

11th Floor, Jinfeng Building, 19 Zhongzhong Road, Gulou District, Nanjing, Jiangsu, China

Study leader's address：

300 Guangzhou Road, Nanjing, Jiangsu, 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：

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：

江苏省人民医院

Affiliation of the Leader：

Jiangsu Provincial People's 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：

2020-SR301

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：

南京医科大学第一附属医院伦理委员会

Name of the ethic committee：

Affiliated First Hospital of Nanjing Medical University Ethics Committee

伦理委员会批准日期：

Date of approved by ethic committee：

2020-09-29 00:00:00

伦理委员会联系人：

张馥敏

Contact Name of the ethic committee：

Zhang Fuming

伦理委员会联系地址：

江苏省南京市广州路300号

Contact Address of the ethic committee：

300 Guangzhou Road, Nanjing, Jiangsu, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 25 68306360

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：

江苏省人民医院

Primary sponsor：

Jiangsu Provincial People's Hospital

研究实施负责（组长）单位地址：

江苏省南京市广州路300号

Primary sponsor's address：

300 Guangzhou Road, Nanjing, Jiangsu, China

试验主办单位(项目批准或申办者)：

Secondary sponsor：

经费或物资来源：

无

Source(s) of funding：

NA

Target disease：

Biliary tract cancer

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 探索性研究/预试验 

Study phase：

0

研究设计：

单臂 

Study design：

Single arm 

研究目的：

观察和评价卡瑞利珠单抗联合吉西他滨、甲磺酸阿帕替尼治疗晚期胆道恶性肿瘤（BTC）患者的有效性和安全性  

Objectives of Study：

observe and evaluate the efficacy and safety of camrelizumab combined with gemcitabine and apatinib in the treatment of patients with advanced BTC.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

a. 病理学证实的胆道恶性肿瘤，包括肝内胆管癌，肝外胆管癌，胆囊癌，且免疫组化提示PD-L1阳性 (TPS ≥1% 或IPS ≥1%)；
b. 年龄18-75岁，性别不限；
c. 预计生存期≥3个月；
d. ECOG 评分0-1分；
e. 有至少1处可测量病灶，根据RECIST 1.1 标准。
f. 既往没有接受过甲磺酸阿帕替尼、吉西他滨以及PD-1/PD-L1单抗的治疗。既往接受过吉西他滨术后辅助化疗结束6个月以上复发，或接受铂类／替吉奥／卡培他滨等药物作为一线治疗失败的患者可以入选，既往晚期治疗线数不超过1线。
g. 主要器官功能良好，即入组前14天内相关检查指标满足以下要求：
血红蛋白 ≥ 90 g/L（14天内未输血）；
中性粒细胞计数> 1.5×109/L；
血小板计数≥ 100×109/L；
总胆红素 ≤ 1.5×ULN（正常值上限）；
血谷丙转氨酶（ALT）或血谷草转氨酶（AST） ≤ 2.5×ULN；如有肝转移，则ALT或AST ≤ 5×ULN；
内生肌酐清除率 ≥ 60 ml/min（Cockcroft-Gault公式）；
心脏多普勒超声评估：左室射血分数 (LVEF) ≥ 50%。
h. 签署知情同意书且依从性好，家属同意配合接受生存随访。

Inclusion criteria

1. Pathologically confirmed biliary malignancies, including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder cancer, with immunohistochemical findings indicating positive PD-L1 (TPS >=1% or IPS >=1%);
2. Aged 18 to 75 years;
3. Expected survival >=3 months;
4. ECOG score 0-1;
5. At least 1 measurable lesion, according to RECIST 1.1;
6. No prior treatment with apatinib mesylate, gemcitabine and PD-1/PD-L1 monoab.Patients who had relapsed at least 6 months after the end of postoperative adjuvant chemotherapy with gemcitabine, or who had failed first-line treatment with platinum/tecio/capecitabine, etc., could be included. The number of previous advanced treatment lines was no more than 1 line;
7. The function of major organs is good, that is, the relevant examination indicators within 14 days before enrollment meet the following requirements:
Hemoglobin >=90 g/L (no blood transfusion within 14 days);
Neutrophil count & GT; 1.5x10^9/L;
Platelet count >=100x10^9/L;
Total bilirubin <=1.5 ULN;
ALT or AST <=2.5 ULN; ALT or AST <=5 ULN in case of liver metastasis;
Endogenous creatinine clearance >=60 ml/min (Cockcroft-Gault formula);
Cardiac Doppler ultrasound assessment: Left ventricular ejection fraction (LVEF) >=50%;
8. The informed consent was signed and the compliance was good. The family members agreed to cooperate with the survival follow-up.

排除标准：

a. 以往或同时患有其它恶性肿瘤，但是已治愈的皮肤基底细胞癌和宫颈原位癌除外；患者合并的微小的胃间质瘤等肿瘤，以及其他早期肿瘤经根治性治疗后，经研究者判断短期内不影响患者生命的其他肿瘤可除外。
b. 四周内参加过其他药物临床试验；
c. 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患者。对于临床疑似中枢神经系统转移的患者，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；
d. 具有不稳定型心绞痛病史者；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；
e. 尿常规提示尿蛋白≥++且证实24小时尿蛋白定量>1.0 g；
f. 对于女性受试者：应为手术绝育、绝经后的患者，或同意在研究治疗期间和研究治疗期结束后6个月内采用一种经医学认可的避孕措施；在研究入组前的7天内血清或尿妊娠试验必须为阴性，且必须为非哺乳期。男性受试者：应为手术绝育，或同意在研究治疗期间和研究治疗期结束后6个月内采用一种经医学认可的避孕措施的患者；
g. 曾使用过免疫靶向治疗药物；
h. 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；
i. 感染性肺炎、非感染性肺炎、间质性肺炎及其他需要使用皮质类固醇激素患者；
j. 有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；活动性乙肝、丙肝病史以及HIV感染患者；
k. 对人源或鼠源单克隆抗体有高敏反应患者；
l. 具有精神类药物滥用史且无法戒除者或有精神障碍的；
m. 有临床症状，需要临床干预的胸腔积液或腹腔积液；
n. 根据研究者的判断，有严重的危害患者安全或影响患者完成研究的伴随疾病；

Exclusion criteria：

1. Previous or concurrent malignancies, except basal cell carcinoma of the skin and carcinoma in situ of the cervix, which have been cured; The exceptions were microscopic gastric stromal tumors, other early tumors after radical treatment, and other tumors that the researchers determined did not affect the patient's life in the short term.
2. Participated in other drug clinical trials within 4 weeks;
3. Patients with known CNS metastasis or a history of CNS metastasis before screening. For patients clinically suspected of central nervous system metastasis, CT or MRI examination must be performed within 28 days before enrollment to exclude central nervous system metastasis;
4. A history of unstable angina pectoris; Screening for newly diagnosed angina within 3 months or myocardial infarction within 6 months prior to screening; Arrhythmias (including QTcF: >=450 ms for men and >=470 ms for women) require long-term use of anti-arrhythmias and New York Heart Association grade >=II cardiac dysfunction;
5. Urine routine indicated urinary protein >=++ and confirmed 24-hour urinary protein quantification>1.0 g;
6. For female subjects: for surgical sterilization, postmenopausal patients, or consent to use a medically approved contraceptive method during the study treatment period and for a period of 6 months after the end of the study treatment period; The serum or urine pregnancy test must be negative within 7 days prior to study inclusion and must be non-lactating. For male subjects: patients who should be surgically sterilized or who have agreed to use a medically approved contraceptive method during the study treatment period and for a period of 6 months after the end of the study treatment period;
7. Immunological and antiangiogenic drugs have been used;
8. A history of immunodeficiency, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation;
9. Patients with infectious pneumonia, non-infectious pneumonia, interstitial pneumonia and other conditions requiring corticosteroid use;
10. History of chronic autoimmune diseases, such as systemic lupus erythematosus; History of inflammatory bowel diseases such as ulcerative enteritis and Crohn's disease, and History of chronic diarrheal diseases such as irritable bowel syndrome; History of sarcoidosis or tuberculosis; History of active hepatitis B and C and HIV infection;
11. Patients with high sensitivity to human or mouse monoclonal antibodies;
12. Has a history of substance abuse and is unable to quit or has a mental disorder;
13. Pleural effusion or peritoneal effusion with clinical symptoms requiring clinical intervention;
14. Concomitant disease that, in the investigator's judgment, would seriously endanger the patient's safety or affect the patient's completion of the study.

研究实施时间：

Study execute time：

从 From 2020-12-01 00:00:00至 To 2023-06-01 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2020-12-01 00:00:00 至 To 2022-12-31 00:00:00  

干预措施：

Interventions：

组别：

实验组

样本量：

20

Group：

The experimental group

Sample size：

干预措施：

卡瑞利珠单抗

干预措施代码：

Intervention：

Camrelizumab

Intervention code：

组别：

实验组

样本量：

20

Group：

The experimental grou

Sample size：

干预措施：

吉西他滨

干预措施代码：

Intervention：

gemcitabine

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

测量指标：

Outcomes：

指标中文名：

OS

指标类型：

主要指标

Outcome：

OS

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）：

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：

N/A

Blinding：

N/A

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）：

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, CRF

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2020-11-24 19:39:20
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