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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

Phase II Clinical Study for Anlotinib Combined with Gemcitabine in the Treatment of Recurrent or Metastatic Advanced Cervical Cancer

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注册号：

Registration number：

ChiCTR1900020912 

最近更新日期：

Date of Last Refreshed on：

2019-01-22 13:16:56 

注册时间：

Date of Registration：

2019-01-22 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

安罗替尼联合吉西他滨对比单药吉西他滨二线治疗复发或转移性晚期宫颈癌的Ⅱ期临床研究

Public title：

Phase II Clinical Study for Anlotinib Combined with Gemcitabine in the Treatment of Recurrent or Metastatic Advanced Cervical Cancer

注册题目简写：

English Acronym：

研究课题的正式科学名称：

安罗替尼联合吉西他滨对比单药吉西他滨二线治疗复发或转移性晚期宫颈癌的Ⅱ期临床研究

Scientific title：

Phase II Clinical Study for Anlotinib Combined with Gemcitabine in the Treatment of Recurrent or Metastatic Advanced 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：

谢王踢 

研究负责人：

文芳 

Applicant：

Xie Wangti 

Study leader：

Wen Fang 

申请注册联系人电话：

Applicant telephone：

+86 18773006437

研究负责人电话：

Study leader's telephone：

+86 18673013969

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：

xiewangti@163.com

研究负责人电子邮件：

Study leader's E-mail：

6479512@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：

岳阳楼区东茅岭路39号

研究负责人通讯地址：

岳阳楼区东茅岭路39号

Applicant address：

39 Dongmaoling Road, Yueyanglou District, Hu'nan, China

Study leader's address：

39 Dongmaoling Road, Yueyanglou District, Hu'nan, 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：

岳阳市一人民医院

Applicant's institution：

The First people's Hospital of Yueyang

研究负责人所在单位：

岳阳市一人民医院

Affiliation of the Leader：

The First people's Hospital of Yueyang

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：

岳阳市一人民医院

Primary sponsor：

The First People's Hospital of Yueyang

研究实施负责（组长）单位地址：

岳阳楼区东茅岭路39号

Primary sponsor's address：

39 Dongmaoling Road, Yueyanglou District, Hu'nan, 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)：

湖南省

市(区县)：

岳阳市

Country：

China

Province：

Hu'nan

City：

YueYang

单位(医院)：

岳阳市一人民医院

具体地址：

岳阳楼区东茅岭路39号

Institution
hospital：

The First people's Hospital of Yueyang

Address：

39 Dongmaoling Road, Yueyanglou District, Hu'nan, China

经费或物资来源：

自筹

Source(s) of funding：

raise independently

Target disease：

cervical cancer

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：

随机平行对照 

Study design：

Parallel 

研究目的：

本研究拟设计一项前瞻性、开放、随机对照Ⅱ期临床研究，评估安罗替尼联合吉西他滨治疗对比单纯吉西他滨二线治疗复发或转移性晚期宫颈癌的安全性及有效性。  

Objectives of Study：

This study intends to design a prospective, open, randomized controlled phase II clinical study to evaluate the safety and efficacy of combination of gemcitabine and anlotinib in the treatment of recurrent or metastatic advanced cervical cancer compared with gemcitabine alone.

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岁；②经病理学及影像学确诊的复发或转移性晚期宫颈癌患者；③既往接受系统一线化疗后进展的复发或转移性晚期宫颈癌患者；④ECOG体力状况评分：0-1分；⑤预计生存期≥3个月；⑥主要器官功能良好，无严重高血压、糖尿病及心脏病。即随机前14天内相关检查指标满足以下要求：a)血常规检查：i.血红蛋白≥90 g/L（14天内未输血）；ii.中性粒细胞计数>1.5×109/L；iii血小板计数≥ 100×109/L； b) 生化检查：i.总胆红素≤1.5×ULN（正常值上限）；ii.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；iii.内生肌酐清除率≥60ml/min（Cockcroft-Gault公式）；c)心脏多普勒超声评估：左室射血分数 (LVEF)≥ 50%；d)血糖控制在空腹血糖?<7.2mmol/L，非空腹血糖?<10mmol/L，糖化血红蛋白<7%。⑦签署知情同意书；⑧依从性好，家属同意配合接受生存随访。

Inclusion criteria

1. Aged at least 18 years old;
2. Recurrent or metastatic advanced cervical cancer patients confirmed by pathology and imaging;
3. Recurrent or metastatic advanced cervical cancer patients who had received systemic first-line chemotherapy;
4. ECOG physical condition score: 0-1 points;
5. predicted survival period (> 3 months);
6. good function of main organs, no severe hypertension, diabetes and heart disease. Within the first 14 days of randomization, the relevant examination indicators meet the following requirements:
(1) blood routine examination: hemoglobin (> 90 g/L) (no blood transfusion within 14 days); neutrophil count > 1.5 x 10^9/L; I I I platelet count (> 100 x 10^9/L);
(2) biochemical examination: total bilirubin (< 1.5 x ULN) (upper limit of normal value); ALT or AST (< 2.5 x ULN); if there is any For liver metastasis, ALT or AST were less than 5 *ULN; Creatinine clearance rate was more than 60 ml/min (Cockcroft-Gault formula);
(3) Doppler echocardiography evaluation: left ventricular ejection fraction (LVEF) was more than 50%;
(4) blood glucose was controlled at fasting < 7.2 mmol/L, non-fasting < 10 mmol/L, and glycosylated hemoglobin < 7%. Sign the informed consent;
Compliance is good, family members agree to cooperate with survival follow-up.

排除标准：

①四周内参加过其他药物临床试验，既往应用过阿帕替尼、吉西他滨及贝伐单抗；②具有影响口服药物的多种因素（比如无法吞咽、慢性腹泻和肠梗阻等）；③有出血病史，筛选前4周内发生任何严重分级达到CTCAE4.0中3度或以上的出血事件；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患者。对于临床疑似中枢神经系统转移的患者，随机化前28天内必须进行CT或MRI检查，排除中枢神经系统转移；⑤患有高血压且经单一降压药物治疗无法获得良好控制者（收缩压>140mmHg，舒张压>90mmHg）；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≥450ms，女性≥470ms）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尿常规提示尿蛋白≥++且证实24小时尿蛋白定量>1.0 g；⑦长期未愈合的伤口或愈合不全的骨折；⑧影像学显示肿瘤已侵犯重要血管周或经研究者判断患者肿瘤在治疗期间有极高可能侵袭重要血管而引起致命大出血的情况；⑨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患者；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（1mg口服，每日一次）或小剂量阿司匹林（每日用量不超过100 mg）；⑩筛选前6个月内发生过动/静脉血栓事件，如脑血管意外（包括暂时性缺血性发作）、深静脉血栓（因前期化疗行静脉置管引发静脉血栓经研究者判断已痊愈者除外）及肺栓塞等；?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。?既往存在甲状腺功能异常，即使在药物治疗的情况下，甲状腺功能仍不能维持在正常范围内；?具有精神类药物滥用史且无法戒除者或有精神障碍的；?有临床症状，需要临床干预的胸腔积液或腹腔积液；?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；?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. Participated in clinical trials of other drugs within four weeks, and used Apatinib, gemcitabine and bevacizumab in the past;
2. had multiple factors affecting oral drugs (such as inability to swallow, chronic diarrhea and intestinal obstruction);
3. had a history of bleeding, and any bleeding events with a severe grade of 3 or more in CTCAE 4.0 occurred within the first four weeks of screening;
4. Central nervous system was known before screening. Patients with systemic metastasis or a history of central nervous system metastasis. For patients with suspected clinical central nervous system metastasis, CT or MRI examination must be performed within 28 days before randomization to exclude the central nervous system metastasis;
5. those with hypertension who cannot be well controlled by a single antihypertensive drug therapy (systolic pressure > 140 mmHg, diastolic pressure > 90 mmHg); those with a history of unstable angina pectoris; those newly diagnosed as angina pectoris screened or screened within the first three months. Myocardial infarction occurred in the first six months; arrhythmia (including QTcF: men (> 450 ms) and women (> 470 ms) required long-term use of antiarrhythmic drugs and New York Heart Association grade (> II) cardiac insufficiency; Urinary Routine indicated that urinary protein (++) and confirmed 24-hour urinary protein quantification > 1.0 g; long-term union wounds or union incomplete fractures; imaging showed that tumors had already occurred. Invasion of important perivascular or judged by researchers that patients with tumors are highly likely to invade important blood vessels during treatment and cause fatal massive hemorrhage;
Coagulation dysfunction, with a tendency to bleed (14 days before randomization must be satisfied: INR is within the normal range without anticoagulant); application of anticoagulants or vitamin K antagonists such as warfarin, heparin or their kind Patients treated with analogue therapy; on the premise that the international standardized ratio of prothrombin time (INR) is less than 1.5, low-dose warfarin (1 mg orally, once a day) or aspirin (less than 100 mg daily) is allowed for preventive purposes; _Arteriovenous thrombosis events such as cerebrovascular accident (including temporary ischemic attack) and deep thrombosis occurred within the first six months of screening. Venous thrombosis (venous thrombosis caused by intravenous catheterization due to pre-chemotherapy, except those who have been judged to be cured by researchers) and pulmonary embolism;
Should be surgical sterilization, postmenopausal patients, or agree to use a medically approved contraceptive measure during the period of study treatment and within 6 months after the end of the study period; serum or urine pregnancy test must be negative within 7 days before the study group. And must be non-lactating period;
6. Thyroid dysfunction has existed in the past, even in the case of drug treatment, the thyroid function can not be maintained within the normal range;
7. those who have a history of psychotropic drug abuse and can not be withdrawn or have mental disorders;
8. pleural effusion or peritoneal effusion with clinical symptoms requiring clinical intervention;
9. history of immunodeficiency or other acquired or congenital immunodeficiency. Disease, or history of organ transplantation; _According to the judgement of researchers, there are concomitant diseases that seriously endanger the safety of patients or affect the completion of research.

研究实施时间：

Study execute time：

从 From 2019-06-01 00:00:00至 To 2021-06-01 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2019-06-01 00:00:00 至 To 2020-06-30 00:00:00  

干预措施：

Interventions：

组别：

试验组

样本量：

20

Group：

Group 1

Sample size：

干预措施：

安罗替尼联合注射用吉西他滨

干预措施代码：

Intervention：

Anlotinib combined with Gemcitabine

Intervention code：

组别：

对照组

样本量：

20

Group：

Group 2

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：

国家：

 中国

省(直辖市)：

 湖南省 

市(区县)：

 岳阳市 

Country：

China 

Province：

Hu'nan 

City：

YueYang 

单位(医院)：

岳阳市一人民医院 

单位级别：

三甲医院 

Institution
hospital：

The First People's Hospital of Yueyang

Level of the institution：

Tertiary A Hospital

测量指标：

Outcomes：

指标中文名：

客观缓解率

指标类型：

主要指标

Outcome：

ORR

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

局部控制率

指标类型：

主要指标

Outcome：

DCR

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

无疾病生存率

指标类型：

次要指标

Outcome：

PFS

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

毒副反应

指标类型：

次要指标

Outcome：

AEs

Type：

Secondary 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：

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 岁 years
最大 Max age 70 岁 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）：

电脑进行SPSS随机分组

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

Computer SPSS generated random number sequence

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：

未说明

Blinding：

Not stated

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）：

通过ResMan提供原始数据查询

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

IPD will be public accessable via ResMan

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

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

CRF

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2019-01-22 13:16:56
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