今天是:2019-03-26 星期二

信迪利单抗治疗持续性、复发性、转移性宫颈癌的有效性和安全性的单中心、单臂、前瞻性II期临床研究
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注册号:

Registration number:

ChiCTR1900021908 

最近更新日期:

Date of Last Refreshed on:

2019-03-15 

注册时间:

Date of Registration:

2019-03-15 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

信迪利单抗治疗持续性、复发性、转移性宫颈癌的有效性和安全性的单中心、单臂、前瞻性II期临床研究 

Public title:

Single-center, one-arm, prospective phase II clinical study of the efficacy and safety of sintilimab in the treatment of persistent, recurrent, and metastatic cervical cancer 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

信迪利单抗治疗持续性、复发性、转移性宫颈癌的有效性和安全性的单中心、单臂、前瞻性II期临床研究 

Scientific title:

Single-center, single-arm, prospective phase II clinical study of the efficacy and safety of sintilimab in the treatment of persistent, recurrent, and metastatic cervical 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:

徐沁 

研究负责人:

徐沁 

Applicant:

Xu Qin 

Study leader:

Xu Qin 

申请注册联系人电话:

Applicant telephone:

+86 13950419396 

研究负责人电话:

Study leader's telephone:

+86 13950419396 

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:

1379423879@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

1379423879@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:

福建省福州市晋安区福马路420号 

研究负责人通讯地址:

福建省福州市晋安区福马路420号 

Applicant address:

420 Fuma Road, Jinan District, Fuzhou, Fujian 

Study leader's address:

420 Fuma Road, Jinan District, Fuzhou, Fujian 

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:

福建省肿瘤医院 

Applicant's institution:

Fujian Provincial Cancer Hospital 

是否获伦理委员会批准:

否 

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 

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:

福建省肿瘤医院 

Primary sponsor:

Fujian Provincial Cancer Hospital 

研究实施负责(组长)单位地址:

福建省福州市晋安区福马路420号 

Primary sponsor's address:

420 Fuma Road, Jinan District, Fuzhou, Fujian 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

福建省

市(区县):

福州

Country:

China

Province:

Fujian

City:

Fuzhou

单位(医院):

福建省肿瘤医院

具体地址:

福建省福州市晋安区福马路420号

Institution
hospital:

Fujian Provincial Cancer Hospital

Address:

420 Fuma Road, Jinan District

经费或物资来源:

吴阶平医学基金会临床科研专项资助基金 

Source(s) of funding:

Wu Jieping Medical Foundation Clinical research special fund 

研究疾病:

宫颈癌 

Target disease:

Cervical Carcinoma 

研究疾病代码:

 

Target disease code:

 

研究类型:

观察性研究 

Study type:

Observational study 

研究所处阶段:

II期临床试验 

Study phase:

研究目的:

在真实世界背景下,评价估信迪利单抗治疗复发宫颈癌患者的疗效及安全性。 

Objectives of Study:

In the real world context, the evaluation of the efficacy and safety of sintilimab in the treatment of patients with recurrent cervical cancer. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

单臂 

Study design:

Single arm 

纳入标准:

1) 受试者自愿加入本研究,并签署知情同意书; 2) 年龄18岁以上; 3) 患者必须有持续性,复发性或转移性鳞状细胞癌,腺鳞癌或子宫颈腺癌,并且有疾病进展记录(疾病不能通过治愈性治疗来修复); 注意:通过病理报告需要原始原发肿瘤的组织学确认; 4) 不适合手术或放疗; 5) 患者必须接受过一种方案的全身化疗,用于治疗复发性、转移性宫颈癌,包括:紫杉醇/铂类,紫杉醇/铂类/贝伐单抗。放疗期间施行的同步化疗不作为全身化疗方案。完成放射治疗(或同时化疗和放射治疗)后给予的辅助化疗不计入全身化疗方案(例如紫杉醇和卡铂,最多4个周期); 注意:接受过一种以上治疗方案的患者不符合资格。 6) PD-1表达阳性(>1%); 7) 患者必须具有RECIST1.1标准定义的可测量病灶; 8) ECOG身体状态评分为0或1; 9) 良好的器官功能: A. 中性粒细胞计数 ≥1500/ul B. 血小板 ≥100,000/ul C. 血红蛋白 ≥10g/dl D. 血清肌酐 ≤1.5倍正常值上限或肌酐清除率≥60ml/min E. 总胆红素≤1.5倍正常值上限或直接胆红素≤1.0倍正常值上限 F. AST及ALT ≤2.5倍正常值上限,肝转移存在时必须≤5倍正常值上限 10) 有能力依从方案; 11) 任何既往化疗的毒副反应已恢复至≤CTCAE1级或基线水平; 12) 预期生存时间大于3个月。 

Inclusion criteria

1) Subjects voluntarily joined the study and signed informed consent; 2) Aged >18 years; 3) Patients must have persistent, recurrent or metastatic squamous cell carcinoma, adenosquamous carcinoma or cervical adenocarcinoma, and have a history of disease progression (the disease cannot be repaired by curative treatment); Note: The pathological report passed requires histological confirmation of the original primary tumor. 4) Not suitable for surgery or radiotherapy; 5) Patients must have received a regimen of systemic chemotherapy for the treatment of recurrent, metastatic cervical cancer, including: paclitaxel/platinum, paclitaxel/platinum/bevacizumab. Synchronous chemotherapy administered during radiotherapy is not a systemic chemotherapy regimen. Adjuvant chemotherapy given after completion of radiation therapy (or concurrent chemotherapy and radiation therapy) is not counted in systemic chemotherapy regimens (eg, paclitaxel and carboplatin for up to 4 cycles); Note: Patients who have received more than one treatment regimen are not eligible. 6) PD-1 expression is positive (>1%); 7) Patients must have measurable lesions as defined by the RECIST 1.1 standard; 8) ECOG body status score is 0 or 1; 9) Good organ function; A. Neutrophil count ≥1500/ul B. Platelets ≥100,000/ul C. Hemoglobin ≥10g/dl D. Serum creatinine ≤ 1.5 times the upper limit of normal or creatinine clearance ≥ 60ml / min E. Total bilirubin ≤ 1.5 times the upper limit of normal value or direct bilirubin ≤ 1.0 times the upper limit of normal value F.AST and ALT ≤ 2.5 times the upper limit of normal value, liver transfer must be ≤ 5 times the upper limit of normal value 10) Ability to comply with the program; 11) The toxic side effects of any previous chemotherapy have been restored to ≤CTCAE1 level or baseline level; 12) Expected survival time is greater than 3 months. 

排除标准:

1) 病理类型为神经内分泌或小细胞癌; 2) 有脑转移史或脑转移征象的患者; 3) 入组前4周内接受抗肿瘤单克隆抗体或其他研究药物治疗;既往曾接受过其他抗PD-1抗体治疗或其他针对PD-1/PD-L1治疗; 4) 患者正在使用免疫抑制剂或全身激素治疗以达到免疫抑制目的(剂量大于10mg/天泼尼松或其他等效激素),并在入组前2周内仍在使用; 5) 患者存在任何活动性自身免疫病或有自身免疫病病史; 6) 有未能控制良好的心脏临床症状或疾病; 7) 患者先天或后天免疫功能缺陷; 8) 入组前2周内接受化疗、靶向治疗、放疗; 9) 怀疑患有其他原发癌的患者; 10) 已知对药物成分过敏者。 

Exclusion criteria:

1) The pathological type is neuroendocrine or small cell carcinoma; 2) Patients with a history of brain metastasis or signs of brain metastasis; 3) Receive anti-tumor monoclonal antibody or other research drugs within 4 weeks before enrollment; have received other anti-PD-1 antibody therapy or other treatment for PD-1/PD-L1; 4) The patient is using immunosuppressive or systemic hormonal therapy for immunosuppression purposes (dose greater than 10 mg/day of prednisone or other equivalent hormones) and is still in use 2 weeks prior to enrollment; 5) The patient has any active autoimmune disease or a history of autoimmune disease; 6) There are uncontrolled heart clinical symptoms or diseases; 7) Patients with congenital or acquired immune deficiency; 8) Receive chemotherapy, targeted therapy, radiotherapy within 2 weeks before enrollment; 9) Patients suspected of having other primary cancers; 10) Those who are known to be allergic to pharmaceutical ingredients. 

研究实施时间:

Study execute time:

From2019-05-01To 2022-12-01 

干预措施:

Interventions:

组别:

治疗组

样本量:

42

Group:

therapy group

Sample size:

干预措施:

信迪利单抗 200mg ivgtt q21d 2年

干预措施代码:

Intervention:

sintilimab 200mg ivgtt q21d 2 years

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

福建省 

市(区县):

 

Country:

China 

Province:

Fujian 

City:

 

单位(医院):

福建省肿瘤医院 

单位级别:

三级甲等医院 

Institution
hospital:

Fujian Provincial Cancer Hospital  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

总体反应率

指标类型:

主要指标 

Outcome:

ORR

Type:

Primary indicator 

测量时间点:

测量方法:

RECIST

Measure time point of outcome:

Measure method:

指标中文名:

肿瘤无进展生存期

指标类型:

次要指标 

Outcome:

PFS

Type:

Secondary indicator 

测量时间点:

测量方法:

RECIST

Measure time point of outcome:

Measure method:

指标中文名:

总生存期

指标类型:

次要指标 

Outcome:

OS

Type:

Secondary indicator 

测量时间点:

测量方法:

RECIST

Measure time point of outcome:

Measure method:

指标中文名:

反应持续时间

指标类型:

次要指标 

Outcome:

DOR

Type:

Secondary indicator 

测量时间点:

测量方法:

RECIST

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:

标本中文名:

尿液

组织:

Sample Name:

Urine

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 years
最大 Max age years

性别:

女性

Gender:

Female

随机方法(请说明由何人用什么方法产生随机序列):

不适用,单臂试验

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

NA,single arm study

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):

原始数据公开时间:

The time of sharing IPD:

即时公开/Real time access

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):

发表刊物

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

Publication

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 record form,CRF

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2019-03-15
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