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Clinical study for paclitaxel (albumin-binding) for injection plus gemcitabine combined with neoadjuvant radiotherapy and chemotherapy for unresectable locally advanced pancreatic cancer
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注册号:

Registration number:

ChiCTR1900022684 

最近更新日期:

Date of Last Refreshed on:

2019-04-21 

注册时间:

Date of Registration:

2019-04-21 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

注射用紫杉醇(白蛋白结合型)+吉西他滨方案联合同步放化疗新辅助治疗不可切除局部进展期胰腺癌的临床研究 

Public title:

Clinical study for paclitaxel (albumin-binding) for injection plus gemcitabine combined with neoadjuvant radiotherapy and chemotherapy for unresectable locally advanced pancreatic cancer  

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

注射用紫杉醇(白蛋白结合型)+吉西他滨方案联合同步放化疗新辅助治疗不可切除局部进展期胰腺癌的临床研究 

Scientific title:

Clinical study for paclitaxel (albumin-binding) for injection plus gemcitabine combined with neoadjuvant radiotherapy and chemotherapy for unresectable locally advanced pancreatic 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:

段华新 

研究负责人:

段华新 

Applicant:

Huaxin Duan 

Study leader:

Huaxin Duan 

申请注册联系人电话:

Applicant telephone:

+86 13347315509 

研究负责人电话:

Study leader's telephone:

+86 13347315509 

申请注册联系人传真 :

Applicant Fax:

+86 0731-82278012 

研究负责人传真:

Study leader's fax:

+86 0731-82278012 

申请注册联系人电子邮件:

Applicant E-mail:

317102912@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

317102912@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:

湖南省长沙市解放西路61号 

研究负责人通讯地址:

湖南省长沙市解放西路61号 

Applicant address:

61 Jiefang Road West, Changsha, Hu'nan, China 

Study leader's address:

61 Jiefang Road West, Changsha, Hu'nan, China 

申请注册联系人邮政编码:

Applicant postcode:

410006 

研究负责人邮政编码:

Study leader's postcode:

410006 

申请人所在单位:

湖南省人民医院 

Applicant's institution:

Hu'nan Provincial People's Hospital  

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:

[2019]-06 

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:

湖南省人民医院医学伦理委员会 

Name of the ethic committee:

Hunan Provincial People's Hospital Ethics Committee  

伦理委员会批准日期:

Date of approved by ethic committee:

2019-03-21 

伦理委员会联系人:

李璟 

Contact Name of the ethic committee:

Li Jing 

伦理委员会联系地址:

湖南省长沙市解放西路61号湖南省人民医院  

Contact Address of the ethic committee:

Hunan Province Hunan Provincial People's Hospital, 61 Jiefang Road West, Changsha, Hu'nan, China  

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 0731-83929085 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

lunlikyb@163.com 

研究实施负责(组长)单位:

湖南省人民医院 

Primary sponsor:

Hu'nan Provincial People's Hospital  

研究实施负责(组长)单位地址:

湖南省长沙市解放西路61号 

Primary sponsor's address:

61 Jiefang Road West, Changsha, 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

市(区县):

长沙

Country:

China

Province:

Hu'nan

City:

Changsha

单位(医院):

湖南省人民医院

具体地址:

湖南省长沙市解放西路61号

Institution
hospital:

Hu'nan Provincial People's Hospital

Address:

61 Jiefang Road West, Changsha, Hu'nan, China

经费或物资来源:

石药集团欧意药业有限公司 

Source(s) of funding:

Stone Pharmaceutical Group Ouyi Pharmaceutical Co., Ltd.  

研究疾病:

胰腺癌 

Target disease:

pancreatic cancer 

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:

探索性研究/预试验 

Study phase:

研究目的:

评估局部进展期胰腺癌患者接受白蛋白结合型紫杉醇联合吉西他滨方案进行诱导化疗,之后予以吉西他滨为基础的同步放化疗的疗效和安全性。 

Objectives of Study:

To evaluate the efficacy and safety of induction chemotherapy with albumin-bound paclitaxel combined with gemcitabine in patients with locally advanced pancreatic cancer, followed by gemcitabine-based concurrent radiotherapy and chemotherapy.  

药物成份或治疗方案详述:

白蛋白紫杉醇 125mg/m2 ,d1、8 吉西他滨 1000mg/m2 ,d1、8 每3周为1周期,共2周期后,予以吉西他滨为基础的同步放化疗,放疗总剂量为50.4Gy,1.8-2.0Gy/次,每周照射5次,吉西他滨的剂量为400mg/m2 每周一次。治疗结束后4周,进行重新评估,MDT讨论后,确定为可切除患者和不可切除患者(包括远处转移患者)。可切除患者接受手术治疗及后续的辅助治疗。不可切除患者或远处转移患者参照晚期胰腺癌治疗原则。 

Description for medicine or protocol of treatment in detail:

Albumin paclitaxel 125mg/m2, d1, 8 Gemcitabine 1000mg/m2, d1, 8 Gemcitabine-based concurrent chemoradiotherapy was given every 3 weeks for a period of 2 cycles. The total dose of radiotherapy was 50.4 Gy, 1.8-2.0 Gy/time, five times a week, and the dose of gemcitabine was 400 mg/m2 once a week. Four weeks after treatment, the patients were reassessessed. After MDT discussion, the patients were identified as resectable and unresectable (including those with distant metastasis). Resectable patients received surgical treatment and subsequent adjuvant treatment. Non-resectable patients or patients with distant metastasis refer to the treatment principle of advanced pancreatic cancer.  

研究设计:

单臂 

Study design:

Single arm 

纳入标准:

(1) 穿刺病理活检确诊为胰腺腺癌; (2) 根据NCCN指南(2018.V1),影像学检查确定为不可切除局部进展期胰腺癌: A. 动脉: 胰头/钩突:a.肿瘤侵犯肠系膜上动脉超过 180° b.肿瘤侵犯腹腔干超过180° c.肿瘤侵犯肠系膜上动脉第一空肠支 胰体尾部:a.肿瘤侵犯肠系膜上动脉或腹腔干超过 180° b.肿瘤侵犯腹腔干和腹主动脉 B. 静脉: 胰头/钩突:a.肿瘤侵犯或栓塞(瘤栓或血栓)导致肠系膜上静脉或门静脉不可切除重建 b.肿瘤侵犯大部分肠系膜上静脉的近侧端空肠引流支 胰体尾部:肿瘤侵犯或栓塞(瘤栓或血栓)导致肠系膜上静脉或门静脉不可切除重建 (3) 有可测量病灶; (4) 一线治疗; (5) 年龄≥18岁且≤75岁,性别不限; (6) 体力状况评分ECOG 0~1; (7) 血常规:中性粒细胞≥1.5×109/L,血小板≥100×109/L,血红蛋白≥90g/L; (8) 血生化指标:转氨酶≤2.5倍正常上限值,总胆红素≤2mg/dl(胆道引流患者小于3.0mg/dl),肌酐正常范围内; (9) 无严重的血液系统、心、肺功能异常和免疫缺陷(参照各自标准); (10) 自愿参加并签署知情同意书 ; (11) 能依从研究访视计划和其它方案要求。 

Inclusion criteria

1. Puncture biopsy confirmed pancreatic adenocarcinoma; 2. According to the NCCN Guidelines (2018.V1), radiological examinations identified unresectable locally advanced pancreatic cancer: (1) artery: Head/uncinate process of pancreas: 1) Tumors invade superior mesenteric artery more than 180 degrees; 2) Tumors invade abdominal trunk more than 180 degrees; 3) Invasion of the first jejunal branch of superior mesenteric artery by tumors. (2) Pancreatic body and tail: 1) Tumors invade superior mesenteric artery or celiac trunk more than 180 degrees; 2) Tumors invade the abdominal trunk and aorta; (3) vein: Head/uncinate process of pancreas: 1) Invasion or embolization of tumors (thrombus or thrombus) leading to unresectable reconstruction of superior mesenteric vein or portal vein; 2) The proximal jejunal drainage branch of most superior mesenteric veins invaded by tumors. Pancreatic body and tail: Invasion or embolization of tumors (thrombus or thrombus) leading to unresectable reconstruction of superior mesenteric vein or portal vein. 3. There are measurable lesions; 4. First-line treatment; 5. Aged 18 to 75 years old male and female; 6. Physical condition score ECOG 0-1; 7. Blood routine: neutrophils (>1.5 *10^9/L), platelets (>100 *10^9/L) and hemoglobin (>90 g/L); 8. Blood biochemical indicators: transaminase < 2.5 times the normal upper limit, total bilirubin < 2 mg/dl (less than 3.0 mg/dl in patients with biliary drainage), creatinine within the normal range; 9. There were no serious abnormalities of blood system, heart and lung function and immune deficiency (refer to their respective standards); 10. Voluntary participation and signing of informed consent; 11. Ability to comply with research visits and other program requirements. 

排除标准:

(1) 远处转移; (2) 伴有其它系统恶性肿瘤; (3) 入组前进行过抗肿瘤治疗,包括消融、放疗、化疗、分子靶向治疗等; (4) 入组前5周内使用过任何其它研究药物; (5) 中枢神经系统疾病、精神疾病、不稳定型心绞痛、充血性心衰、严重心律失常及其它无法控制的严重疾病; (6) 有对研究药物或类似结构药物过敏史; (7) 妊娠、哺乳期妇女; (8) 有可能损害患者安全或研究数据完整性的任何状况,包括严重医学危险因素、医学状况、及实验室异常; (9) 患者不愿或不能依从研究程序,或在研究治疗期间可能脱离观察1个疗程或以上;  

Exclusion criteria:

1. Distant metastasis; 2. Complicated with other malignant tumors of the system; 3. Anti-cancer therapy including ablation, radiotherapy, chemotherapy and molecular targeted therapy was performed before admission; 4. Any other research drugs were used within 5 weeks before admission; 5. Central nervous system diseases, psychiatric disorders, unstable angina pectoris, congestive heart failure, severe arrhythmia and other serious uncontrollable diseases; 6. Have a history of drug allergy to research drugs or similar structures; 7. Pregnant and lactating women; 8. Any condition that may impair patient safety or integrity of research data, including serious medical risk factors, medical conditions, and laboratory abnormalities; 9. The patient is unwilling or unable to follow the research procedure, or may be separated from the observation for one course or more during the course of the study.  

研究实施时间:

Study execute time:

From2019-05-01To 2020-05-01 

干预措施:

Interventions:

组别:

Group 1

样本量:

30

Group:

Group 1

Sample size:

干预措施:

注射用紫杉醇(白蛋白结合型)+吉西他滨方案联合同步放化疗新辅助治疗

干预措施代码:

Intervention:

Paclitaxel for injection (albumin-binding) +gemcitabine regimen combined with neoadjuvant radiotherapy and chemotherapy

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):

长沙 

Country:

China 

Province:

Hu'nan 

City:

Changsha 

单位(医院):

湖南省人民医院 

单位级别:

三级甲等 

Institution
hospital:

Hunan Provincial People's Hospital  

Level of the institution:

Tertiary A hospital  

测量指标:

Outcomes:

指标中文名:

手术切除率

指标类型:

主要指标 

Outcome:

Surgical resection rate

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

R0切除率

指标类型:

主要指标 

Outcome:

R0 resection rate

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

疗效评估(RECIST评价标准)

指标类型:

次要指标 

Outcome:

Therapeutic evaluation (RECIST criteria)

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

无进展生存期

指标类型:

次要指标 

Outcome:

Progression-free survival

Type:

Secondary indicator 

测量时间点:

测量方法:

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:

Overall survival

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

化疗药物安全性和耐受性(CTCAE)

指标类型:

次要指标 

Outcome:

Safety and Tolerance of Chemotherapeutic Drugs (CTCAE)

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

治疗前后CA-199变化

指标类型:

次要指标 

Outcome:

Changes of CA-199 before and after treatment

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:

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 75 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):

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

N/A

盲法:

N/A

Blinding:

N/A

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

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):

发表文章;借助中国临床试验注册中心公布数据( http://www.chictr.org.cn/index.aspx)

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

Published articles; with China clinical trial registration center data released( http://www.chictr.org.cn/index.aspx)

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:

1.病例记录表;2.电子采集和管理系统,如ResMan

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

1.Case Record Form, CRF;2.Electronic Data Capture, EDC,such as ResMan

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2019-04-21
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