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进展期胃癌患者应用替吉奥胶囊联合注射用奥沙利铂方案(SOX)新辅助化疗不同时长疗程的前瞻性、多中心、随机、对照III期临床研究
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注册号:

Registration number:

ChiCTR1900023293 

最近更新日期:

Date of Last Refreshed on:

2019-05-21 

注册时间:

Date of Registration:

2019-05-21 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

进展期胃癌患者应用替吉奥胶囊联合注射用奥沙利铂方案(SOX)新辅助化疗不同时长疗程的前瞻性、多中心、随机、对照III期临床研究 

Public title:

A prospective multicenter, randomized, controlled phase III study of oxaliplatin combined with S-1(SOX) neoadjuvant chemotherapy for different cycles in patients with locally advanced gastric adenocarcinoma 

注册题目简写:

 

English Acronym:

RESONANCE-2 study 

研究课题的正式科学名称:

进展期胃癌患者应用替吉奥胶囊联合注射用奥沙利铂方案(SOX)新辅助化疗不同时长疗程的前瞻性、多中心、随机、对照III期临床研究 

Scientific title:

A prospective multicenter, randomized, controlled phase III study of oxaliplatin combined with S-1(SOX) neoadjuvant chemotherapy for different cycles in patients with locally advanced gastric adenocarcinoma 

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:

王鑫鑫 

研究负责人:

陈凛 

Applicant:

Wang Xinxin 

Study leader:

Chen Lin 

申请注册联系人电话:

Applicant telephone:

+86 13811858199 

研究负责人电话:

Study leader's telephone:

+86 13801290395 

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:

plaghgs4@sina.com 

研究负责人电子邮件:

Study leader's E-mail:

plaghgs4@sina.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:

北京市海淀区复兴路28号 

研究负责人通讯地址:

北京市海淀区复兴路28号 

Applicant address:

28 Fuxing Road, Haidian District, Beijing, China 

Study leader's address:

28 Fuxing Road, Haidian District, Beijing, 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:

中国人民解放军总医院第一医学中心 

Applicant's institution:

the first Medical Center of Chinese PLA General 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:

中国人民解放军总医院第一医学中心 

Primary sponsor:

the first Medical Center of Chinese PLA General Hospital 

研究实施负责(组长)单位地址:

北京市海淀区复兴路28号 

Primary sponsor's address:

28 Fuxing Road, Haidian District, Beijing, 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):

北京

市(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

中国人民解放军总医院

具体地址:

北京市海淀区复兴路28号

Institution
hospital:

Chinese PLA General Hospital

Address:

28 Fuxing Road, Haidian District, Beijing, China

经费或物资来源:

自筹 

Source(s) of funding:

self-raising 

研究疾病:

局部进展期胃癌 

Target disease:

locally advanced gastric adenocarcinoma 

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:

III期临床试验 

Study phase:

研究目的:

主要目的: 证明对于局部进展期胃腺癌(cT4a-4bN0-3M0,AJCC第八版胃癌分期)患者,以奥沙利铂联合替吉奥胶囊(SOX)方案新辅助化疗5周期后行D2根治手术的病理缓解率(pCR%)优于SOX新辅助化疗3周期组。 次要目的: 比较SOX新辅助化疗5周期组与3周期组的R0切除率; 比较SOX新辅助化疗5周期组与3周期组分别接受D2根治手术的3年无复发生存率; 比较SOX新辅助化疗5周期组与3周期组分别接受D2根治手术的5年总生存率; 比较SOX新辅助化疗5周期组与3周期组的安全性及不良反应率 

Objectives of Study:

Main objective: To prove that for patients with locally advanced gastric adenocarcinoma (cT4a-4bN0-3M0, AJCC eighth edition of gastric cancer staging), the pathological remission rate (pCR) of D2 radical surgery after 5 cycles of neoadjuvant chemotherapy with oxaliplatin combined with S-1 (SOX) was better than that of 3 cycles of neoadjuvant chemotherapy with SOX. Secondary objectives: To compare the R0 resection rate, 3-year DFS, 5-year OS, safety and adverse reaction rates of D2 radical surgery after 5 cycles of neoadjuvant chemotherapy with oxaliplatin combined with S-1 (SOX) and that of 3 cycles of neoadjuvant chemotherapy with SOX. 

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). 非卧床患者,年龄≥18岁,≤70岁; (2). ECOG体力状况评分为0-1分; (3). 术前组织病理学确认为胃腺癌; (4). 术前完成增强CT/MRI和超声胃镜检查(必要时完成诊断性腹腔镜探查术)进行临床分期,为cT4a-4bN0-3M0(8th AJCC TNM); (5). 研究中心及术者能够完成标准的D2根治手术,且术前判断受试者可能完成根治性手术; (6). 受试者满足如下实验室检查标准: ① 血红蛋白≥90g/L;② 中性粒细胞绝对计数(ANC)≥3*109/L;③ 血小板≥100*109/L;④ 谷丙转氨酶和谷草转氨酶≤2.5倍正常值上限(ULN);⑤ 总胆红素≤1.5 ULN;⑥ 血肌酐≤1 ULN;⑦血清白蛋白≥30g/L (7). 超声心动图提示左心室射血分数≥50%,同时术前4周心电图基本正常,无明显临床症状的心脏疾病; (8). 无严重的使预期生存期<5年的基础疾病; (9). 签署知情同意书。 

Inclusion criteria

(1) Non-bedridden patients, aged 18 to 70 years old); (2) ECOG physical condition score was 0-1; (3) Gastric adenocarcinoma was confirmed by histopathology before operation; (4) Enhanced CT/MRI and ultrasonographic gastroscopy (diagnostic laparoscopic exploration if necessary) were performed before operation for clinical staging of cT4a-4bN0-3M0 (8th AJCC TNM); (5) The research center and the surgeon can complete the standard D2 radical operation, and preoperatively judge that the subjects may complete the radical operation; (6) Subjects met the following laboratory test criteria: (1) Hemoglobin (≥ 90g/L); Neutrophil absolute count (≥ 3*10^9/L); Platelet (≥ 100*109/L); Glutamic alanine aminotransferase and glutamic oxalate aminotransferase (≤ 2.5 ULN); Total bilirubin (≤ 1.5 ULN); Serum creatinine (≤ 1 ULN); Serum albumin (≥ 30 g/L); (7) Echocardiogram showed that the left ventricular ejection fraction was more than 50%. At the same time, the electrocardiogram was normal 4 weeks before operation, and there was no obvious clinical symptoms of heart disease; (8) There was no serious underlying disease that could lead to a life expectancy of less than 5 years; (9) Sign the informed consent. 

排除标准:

(1)妊娠或哺乳期女性; (2)育龄期女性妊娠试验阳性,绝经期女性停经至少12个月,可视为无怀孕可能; (3)受试者在研究期间不接受避孕要求者; (4)参与本研究前层接受过化疗、放疗或免疫治疗者; (5)近5年内曾患者其他恶性肿瘤病史,宫颈原位癌除外; (6)既往有未控制的中枢神经系统疾病,研究者判定会影响实验的整体提从性; (7)严重肝病(如肝硬化等)、肾病、呼吸道疾病或不能控制的糖尿病、高血压等慢性系统疾病;临床症状明显的心脏疾病,如:充血性心衰,症状明显的冠心病,药物难以控制的心律失常、高血压,或 6 个月内曾有心肌梗死发作,或心功能不全者; (8)伴有吞咽困难、完全或不全消化道梗阻、活动性消化道出血、穿孔者; (9)器官移植需长期免疫抑制治疗者。 

Exclusion criteria:

(1) Pregnant or lactating women; (2) Positive pregnancy test for women of childbearing age, menopausal women with menopause for at least 12 months, can be regarded as no possibility of pregnancy; (3) Subjects who did not accept contraceptive requirements during the study period; (4) Those who had received chemotherapy, radiotherapy or immunotherapy at the front of this study; (5) In the past five years, patients had other malignant tumors except cervical carcinoma in situ; (6) In the past, there were uncontrolled diseases of the central nervous system, which the researchers determined would affect the overall compliance of the experiment; (7) Severe liver diseases (such as cirrhosis of the liver, nephropathy, respiratory diseases or uncontrollable diabetes, hypertension and other chronic system diseases; cardiac diseases with obvious clinical symptoms, such as congestive heart failure, coronary heart disease with obvious symptoms, arrhythmia, hypertension difficult to control by drugs, or myocardial infarction attacks within 6 months, or cardiac insufficiency; (8) with dysphagia, complete or incomplete gastrointestinal obstruction, active gastrointestinal bleeding, perforation; (9) Organ transplantation requiring long-term immunosuppressive therapy. 

研究实施时间:

Study execute time:

From2020-01-01To 2026-12-31 

征募观察对象时间:

Recruiting time:

From2020-01-01To 2021-06-30 

干预措施:

Interventions:

组别:

A

样本量:

262

Group:

A

Sample size:

干预措施:

SOX方案术前化疗5周期

干预措施代码:

Intervention:

give SOX for 5 cycles before operation

Intervention code:

组别:

B

样本量:

262

Group:

B

Sample size:

干预措施:

SOX方案术前化疗3周期

干预措施代码:

Intervention:

give SOX for 3 cycles before operation

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

中国人民解放军总医院 

单位级别:

三级甲等医院 

Institution
hospital:

Chinese PLA General Hospital  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

病理缓解率

指标类型:

主要指标 

Outcome:

pCR%

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:

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:

3年无复发生存率

指标类型:

次要指标 

Outcome:

3-year DFS

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

5年总生存率

指标类型:

次要指标 

Outcome:

5-year OS

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

不良反应

指标类型:

次要指标 

Outcome:

side effects

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:

标本中文名:

粪便

组织:

Sample Name:

faeces

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 years
最大 Max age 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):

完成预入组登记之后,符合入组标准的受试者由各中心专员以随机数法按照1:1的比例随机分为A组或B组。

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

After completing the registration of pre-enrollment, the subjects who met the criteria of enrollment were randomly divided into group A or group B according to the ratio of 1:1 by the commissioners of each center.

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):

2026年12月,提前联系后可通过邮件发送

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

Dec. 2026,Send by e-mail after contact

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:

EDC

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2019-05-21
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