注册号: Registration number: |
ChiCTR1900024552 |
最近更新日期: Date of Last Refreshed on: |
2019-07-16 |
注册时间: Date of Registration: |
2019-07-16 |
注册号状态: |
补注册 |
Registration Status: |
Retrospective registration |
注册题目: |
新辅助化疗(NAC)与经腔镜腹腔内温热化疗(L-HIPEC)联合R0胃癌根治术治疗浆膜浸润局部进展期胃癌(cT4-LAGC)的多中心随机对照研究 |
Public title: |
Combined neoadjuvant chemotherapy (NAC) and laparoscopic intraperitoneal hyperthermic chemotherapy (L-HIPEC) followed by R0 gastrectomy for locally advanced gastric cancer with serosal invasion (cT4-LAGC): A multicentric randomized controlled trial |
注册题目简写: |
|
English Acronym: |
|
研究课题的正式科学名称: |
新辅助化疗(NAC)与经腔镜腹腔内温热化疗(L-HIPEC)联合R0胃癌根治术治疗浆膜浸润局部进展期胃癌(cT4-LAGC)的多中心随机对照研究 |
Scientific title: |
Combined neoadjuvant chemotherapy (NAC) and laparoscopic intraperitoneal hyperthermic chemotherapy (L-HIPEC) followed by R0 gastrectomy for locally advanced gastric cancer with serosal invasion (cT4-LAGC): A multicentric randomized controlled trial |
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: |
倪震天 |
研究负责人: |
朱正纲 |
Applicant: |
Ni Zhentian |
Study leader: |
Zhu Zhenggang |
申请注册联系人电话: Applicant telephone: |
+86 13482508978 |
研究负责人电话: Study leader's telephone: |
+86 18917762000 |
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: |
351775759@qq.com |
研究负责人电子邮件: Study leader's E-mail: |
zzg1954@hotmail.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: |
上海市瑞金二路197号 |
研究负责人通讯地址: |
上海市瑞金二路197号 |
Applicant address: |
197 Second Ruijin Road, Huangpu District, Shanghai, China |
Study leader's address: |
197 Second Ruijin Road, Huangpu District, Shanghai, 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: |
上海交通大学医学院附属瑞金医院 |
||
Applicant's institution: |
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine |
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)临伦审第(71)号 |
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: |
上海交通大学医学院附属瑞金医院伦理委员会 |
||
Name of the ethic committee: |
Ethics committee of Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine |
||
伦理委员会批准日期: Date of approved by ethic committee: |
2019-04-30 | ||
伦理委员会联系人: |
杨伟国 |
||
Contact Name of the ethic committee: |
Yang Weiguo |
||
伦理委员会联系地址: |
上海市瑞金二路197号 |
||
Contact Address of the ethic committee: |
197 Second Ruijin Road, Huangpu District, Shanghai, China |
||
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: |
上海交通大学医学院附属瑞金医院 |
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Primary sponsor: |
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine |
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
研究实施负责(组长)单位地址: |
上海市瑞金二路197号 |
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Primary sponsor's address: |
197 Second Ruijin Road, Huangpu District, Shanghai, China |
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
试验主办单位(项目批准或申办者): Secondary sponsor: |
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
经费或物资来源: |
上海交通大学医学院附属瑞金医院临床研究课题 |
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Source(s) of funding: |
Clinical research project of Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine |
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
研究疾病: |
胃癌 |
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Target disease: |
Gastric 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: |
III期临床试验 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Study phase: |
3 |
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
研究目的: |
研究主要目的:有效预防局部进展期胃癌(cT4-LAGC)腹膜转移,提高患者生存率 研究次要目的: a. 评价L-HIPEC+NAC+手术与直接手术两种疗法对预防胃癌腹膜转移的客观有效率 b. 评价两种疗法的R0手术切除率 c. 评价两种疗法的手术并发症发生率 |
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Objectives of Study: |
Primary endpoint : to compare progress free survival(PFS ) between patients with L- HIPEC +NAC +D2 gastrectomy and patients with D2 gastrectomy alone in cT4- LAGC patients Secondary endpoints: 1. the overall survival (OS) and peritoneal metastasis rate (PMR) between L-HIPEC+NAC+D2 gatrectomy and D2 gastrectomy alone in cT4-LAGC patients; 2. to determine the rates of therapeutic toxicity and surgical complication in the two different treatment groups. |
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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) 18岁≤年龄≤75岁 2) ECOG评分≤2分 3) 美国麻醉协会分类I-III 4) 组织病理学检查证实为胃腺癌,无原发灶或转移灶切除史 5) MDCT, 内镜超声或腹腔镜检查证实浆膜浸润(T4) 6) 良好的骨髓、肝肾功能,各项实验室检查指标如下: ? 血清嗜中性粒细胞≥1.5 x 10 2/L ? 血小板≥100 x 109/L ? 血清总胆红素≤正常值上限(ULN)的1.5倍,丙氨酸转氨酶与天冬氨酸转氨酶≤ULN的2.5倍,肌酐清除率≥50 ml/min 7) 育龄女性病人尿或血清妊娠试验阴性 8) 预计生存期≥3个月 9) 本人愿意提供血液标本供药代学研究 10)本人签署知情同意书 |
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Inclusion criteria |
1. Age 18 years to 70 years; 2. World Health Organization (WHO)performance status 0 to 2; 3. American Society of Anesthesiologists classification I to III; 4. Biopsy proven adenocarcinoma of the stomach; 5. MDCTendoscopic ultrasound or laparoscopy proven serosal invasion (T4); 6. with P0/CY1 or P0/CY0; Adequate bone marrow, hepatic and renal function. Acceptable laboratory values at recruitment: Absolute neutrophil count greater than or equal to 1.5 x 10^2/L; Platelet count greater than or equal to 100 x 10^9/L; Serum bilirubin less than or equal to 1.5 times the upper limit of normal (ULN) and alanine transaminase and aspartate transaminase less than or equal to 2.5 ULN; Creatinine clearance greater than or equal to 50 ml/min (measured or calculated by Cockcroft-Gault formula); Negative pregnancy test (urine/serum) for female patients with childbearing potential; Life expectancy 3 months or greater; Able and willing to undergo blood sampling for pharmacokinetics; Written informed consent. |
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
排除标准: |
1)出现远处转移(如:肝转移、肺转移、腹主动脉旁淋巴结等转移) 2)肉眼可见的腹膜转移、卵巢转移或出现恶性腹水 3)胃癌复发 4)原发胃癌已作切除 5)妊娠或哺乳期妇女;拒绝采取避孕措施的育龄患者(包括男性) 6)严重的未控制的反复感染者,或HIV感染者 7)B或C型肝炎伴病毒复制者 8)临床上严重的(即活动的)心脏病,6个月内发生心肌梗塞或不稳定性心绞痛 9)未控制的糖尿病 10)存在可能或肯定会干扰研究过程的医疗状况(包括随访与遵从性) 11)对化疗药物或有关药剂过敏 |
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Exclusion criteria: |
1. Distant metastases (eg. Liver, lung metastasispara-aortic lymph node) and other distant metastasis; 2. Macroscopic peritoneal metastasis, ovarian metastasis or malignant ascites; 3. Recurrent gastric cancer; 4. Prior resection of the primary gastric cancer; 5. Pregnancy, breast feeding, active pregnancy ambition, or unreliable contraceptive methods; 6. Uncontrolled infectious disease or known infection with human immunodeficiency virus; 7. known history of hepatitis B or C with active viral replication; 8. Recent myocardial infarction (less than 6 months) or unstable angina; 9. Uncontrolled diabetes mellitus; 10. Any medical condition that is considered to possibly, probably, or definitely interfere with study procedures (including adequate follow-up and compliance) and/or would jeopardize safe treatment; 11. Known hypersensitivity for any of the applied chemotherapeutic agents and/or their solvents. |
研究实施时间: Study execute time: |
从From2019-06-01至To 2021-12-31 |
征募观察对象时间: Recruiting time: |
从From2019-06-01至To 2021-05-31 |
干预措施: Interventions: |
|
研究实施地点: Countries of recruitment and research settings: |
|
测量指标: Outcomes: |
|