今天是:2019-11-20 星期三

一项分析mXELOXIRI进展后再引入对比mFOLFOX6序贯FOLFIRI联合分子靶向药物一线治疗初始不可切除转移性结直肠癌的随机对照临床研究(TRICAP 2)
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注册号:

Registration number:

ChiCTR1900026529 

最近更新日期:

Date of Last Refreshed on:

2019-11-11 

注册时间:

Date of Registration:

1990-01-01 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

一项分析mXELOXIRI进展后再引入对比mFOLFOX6序贯FOLFIRI联合分子靶向药物一线治疗初始不可切除转移性结直肠癌的随机对照临床研究(TRICAP 2) 

Public title:

mXELOXIRI followed by re-introduction versus mFOLFOX6 followed by FOLFIRI after disease progression in combination with molecularly targeted first-line therapy for initially unresectable metastatic colorectal cancer 

注册题目简写:

TRICAP 2 

English Acronym:

TRICAP 2 

研究课题的正式科学名称:

一项分析mXELOXIRI进展后再引入对比mFOLFOX6序贯FOLFIRI联合分子靶向药物一线治疗初始不可切除转移性结直肠癌的随机对照临床研究(TRICAP 2) 

Scientific title:

mXELOXIRI followed by re-introduction versus mFOLFOX6 followed by FOLFIRI after disease progression in combination with molecularly targeted first-line therapy for initially unresectable metastatic colorectal 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:

蒋微琴 

研究负责人:

蒋微琴 

Applicant:

Weiqin Jiang 

Study leader:

Weiqin Jiang 

申请注册联系人电话:

Applicant telephone:

+86 15068117618 

研究负责人电话:

Study leader's telephone:

+86 15068117618 

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:

1312028@zju.edu.cn 

研究负责人电子邮件:

Study leader's E-mail:

1312028@zju.edu.cn 

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:

浙江杭州市庆春路79号 

研究负责人通讯地址:

浙江杭州市庆春路79号 

Applicant address:

79 Qingchun Road, Hangzhou, Zhejiang, China 

Study leader's address:

79 Qingchun Road, Hangzhou, Zhejiang, 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:

浙江大学医学院附属第一医院 

Applicant's institution:

The First Affiliated Hospital, Zhejiang University School of Medicine 

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:

浙江大学医学院附属第一医院 

Primary sponsor:

The First Affiliated Hospital, Zhejiang University School of Medicine 

研究实施负责(组长)单位地址:

浙江省杭州市庆春路79号 

Primary sponsor's address:

79 Qingchun Road, Hangzhou, Zhejiang, 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):

浙江省

市(区县):

Country:

China

Province:

Zhejiang

City:

单位(医院):

浙江大学医学院附属第一医院

具体地址:

杭州市庆春路79号

Institution
hospital:

The First Affiliated Hospital, Zhejiang University School of Medicine

Address:

79 Qingchun Road, Hangzhou

经费或物资来源:

自筹 

Source(s) of funding:

self-raised 

研究疾病:

初始不可切除转移性结直肠癌 

Target disease:

Initially Unresectable Metastatic Colorectal Cancer 

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:

研究目的:

本研究旨在通过单中心、前瞻性、随机对照试验,研究mXELOXIRI进展后再引入对比mFOLFOX序贯FOLFIRI联合分子靶向药物一线治疗初始不可切除转移性结直肠癌的有效性及其安全性。 

Objectives of Study:

We designed an investigator-initiated, single institution, prospective, randomized controlled clinical study to evaluate the effective and safety of mXELOXIRI followed by re-introduction versus mFOLFOX6 followed by FOLFIRI after disease progression combined with molecular targeting drug as first-line treatment in patients with initially unresectable metastatic colorectal 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:

随机平行对照 

Study design:

Parallel 

纳入标准:

(1)男性或女性,年龄≥18岁,≤75岁; (2)经组织学确诊的转移性结直肠腺癌(mCRC),MDT讨论初始评估为初始不可切除性mCRC,为避免选择性偏移,符合以下任何一条标准者定义为初始不可切除:1) 转移病灶≥5个,可累犯一个或多个脏器;2) 无法行R0切除术;3) 切除术后预计残留肝脏体积不足;4) 切除后3根肝静脉均不能保留,不能保证残留肝进出肝的血流及胆管均能保留,不能保留相邻2个肝段。 (3)ECOG体能状态为0到1; (4)预期寿命至少为12周; (5)血液学检查绝对中性粒细胞计数(ANC)>3.0×10^9/L,血红蛋白> 8g/dL且血小板>100×10^9/L(以临床试验中心正常值为准); (6)凝血酶原时间(PT)<正常值上限的1.5倍和正常凝血活酶时间(APTT)<正常值上限的1.5倍; (7)实验室检查,血清肌酐小于或等于正常值参考范围上限的1.5倍 (如果血清肌酐升高,必须收集24小时尿液,24小时肌酐清除率> 50ml/min者除外); (8)无肝转移时,ALT或AST小于或等于正常值参考范围上限的2.5倍,血清总胆红素小于或等于正常值参考范围上限的1.5倍;对于有肝转移的患者ALT或AST小于或等于正常值参考范围上限的5倍,血清总胆红素小于或等于正常值参考范围上限的3倍; (9)育龄女性必须愿意在研究药物治疗期间采用充分避孕措施; (10)已签署知情同意书。 

Inclusion criteria

1. Aged 18 to 75 years; 2. Diagnosis of metastatic colorectal cancer (mCRC), and assessed as initially unresectable mCRC by MDT. Initially unresectable mCRC is defined by meeting any of the following criteria: 1) Metastatic sites >=5, and number of visceral organ >=1; 2) Unable to perform R0 resection; 3) The residual liver volume is expected to be insufficient after resection; 4) After the resection, all three hepatic veins could not be preserved, and the blood flow and bile duct of the residual liver could not be preserved, and the adjacent two liver segments could not be preserved; 3. ECOG status 0 to 1; 4. Expected survival >=12 weeks; 5. Absolute neutrophil count (ANC) >=3.0 x10^9/L, Hemoglobin (Hb) >=8g/dL, Platelet count >=100 x 10^9/L (subject to the normal values from clinical trials center); 6. Prothrombin time (PT) or activated partial thrombin time (APTT) <=1.5 ULN; 7. Laboratory test values must meet the following standards: Serum creatinine <=1.5 ULN (If the value of serum creatinine is elevated, 24 hours urine must be collected, and patients with creatinine clearance>=50 mL/min will be excluded); 8. AST and ALT<=2.5 ULN, serum total bilirubin <=1.5 ULN; ALT and AST <=5 ULN, Serum total bilirubin <=3 ULN in patients with liver metastasis; 9. Women of reproductive age must agree to use effective contraceptive measures during the study drug use; 10. Fully understand the study and sign informed consent voluntarily. 

排除标准:

(1)既往接受过针对局部晚期或转移性病灶的化疗(辅助治疗和/或新辅助治疗结束时与首次复发/转移之间的间隔超过12个月患者可以入选); (2)MDT评估为初始可切除的mCRC; (3)3周之内接受过手术(除诊断性活检术)和放疗; (4)在开始研究治疗前4周内接受过任何试验性治疗,如参加了另一个临床研究; (5)同时接受研究方案中不包括的免疫治疗、化疗、放疗(姑息性放疗除外)或激素治疗; (6)已知或怀疑脑转移; (7)妊娠期或哺乳妇女; (8)严重的未能控制的全身性疾病,例如严重的活动性感染; (9)已知对任何研究药物过敏; (10)任何指标显示有化疗禁忌症; (11)过去5年内的其他恶性肿瘤,原位宫颈癌或皮肤基底细胞癌除外; (12)研究者判定因医学、社会因素或心理状态原因无法完成研究或无法签署有效知情同意的患者; (13)需要接受免疫抑制剂治疗的器官移植者; (14)已知有人免疫缺陷病毒(HIV)感染或者已知HIV血清阳性。 

Exclusion criteria:

(1) Previously received chemotherapy for locally advanced or metastatic cancer focus (patients who have previously received adjuvant therapy and/or neoadjuvant therapy, if the interval between the end of therapy and first recurrence/metastasis is more than 12 months, can be included); (2) Assessed as initially resectable mCRC by MDT; (3) Have received surgery (except diagnostic biopsy) and radiotherapy within 3 weeks; (4) Have received any experimental therapy (such as take part in another clinical study) within 4 weeks before treatment; (5) Have received immunotherapy, chemotherapy, radiotherapy (except palliative radiotherapy), or hormonotherapy, which are not included in study protocol; (6) Known or suspected brain metastases; (7) Pregnant and nursing women; (8) Severe uncontrolled systemic disease, for example, severe uncontrolled active infection; (9) Known allergy to any study drug; (10) Any indication of contraindications to chemotherapy; (11) Have had other malignant tumors within the past 5 years, cervical carcinoma in situ or basal cell carcinoma of the skin are excluded; (12) The investigator judges that patients can not finish the clinical study due to medical, social, or psychological reasons, or can not sign a valid informed consent; (13) Patients with parenchymal organ transplantation who need to receive immunosuppressive therapy; (14) Known human immunodeficiency virus (HIV) infection, or known to be HIV seropositive. 

研究实施时间:

Study execute time:

From2019-10-01To 2023-01-31 

干预措施:

Interventions:

组别:

试验组

样本量:

54

Group:

Experimental group

Sample size:

干预措施:

mXELOXIRI进展后再引入联合分子靶向药物

干预措施代码:

Intervention:

mXELOXIRI followed by re-introduction combined with molecular targeting drug

Intervention code:

组别:

对照组

样本量:

54

Group:

Control group

Sample size:

干预措施:

mFOLFOX序贯FOLFIRI联合分子靶向药物

干预措施代码:

Intervention:

mFOLFOX6 followed by FOLFIRI after disease progression combined with molecular targeting drug

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

浙江省 

市(区县):

 

Country:

China 

Province:

Zhejiang 

City:

 

单位(医院):

浙江大学医学院附属第一医院 

单位级别:

三甲 

Institution
hospital:

The First Affiliated Hospital, Zhejiang University School of Medicine  

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:

Objective response 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:

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:

R0切除率

指标类型:

次要指标 

Outcome:

R0 resection rate

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

总体生存期

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:

采集人体标本:

Collecting sample(s)
from participants:

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):

随机治疗分配方案由统计人员运用SPSS统计软件,采用完全随机化的方法生成随机分配序列,将合格的研究对象按纳入顺序编号并且分为试验组和对照组。

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

Randomization will be conducted by statisticians using SPSS statistical software. Qualified subjects are numbered in the order of inclusion and divided into experimental and control groups according to the random assignment sequences generated by a completely randomized method.

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):

原始数据公开时间:

The time of sharing IPD:

试验完成后6个月内公开/Within six months after the trial complete

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):

试验完成后6个月内以论文形式公开数据结果

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

Data results were published in a paper within 6 months after the experiment

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:

电子采集和管理系统

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

Electronic Data Capture, EDC

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 1990-01-01
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