ChiCTR2500105112 版本V1.0 版本创建时间2025/06/30 09:11:27 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

ChiCTR2500105112 

最近更新日期：

Date of Last Refreshed on：

2025-06-30 09:11:21 

注册时间：

Date of Registration：

2025-06-30 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

伊立替康脂质体（II）和奥沙利铂联合替吉奥对比联合5-氟尿嘧啶/亚叶酸钙围术期治疗临界可切除胰腺癌的前瞻性、多中心、随机、双队列临床研究

Public title：

Prospective, Multicenter, Randomized, Dual-Cohort Clinical Study of Irinotecan Liposome (II) Plus Oxaliplatin Combined with Tegafur-Gimeracil-Oteracil Potassium (SOX) versus 5-Fluorouracil/Leucovorin (5-FU/LV) in Perioperative Treatment of Borderline Resectable Pancreatic Cancer

注册题目简写：

English Acronym：

研究课题的正式科学名称：

伊立替康脂质体（II）和奥沙利铂联合替吉奥对比联合5-氟尿嘧啶/亚叶酸钙围术期治疗临界可切除胰腺癌的前瞻性、多中心、随机、双队列临床研究

Scientific title：

Prospective, Multicenter, Randomized, Dual-Cohort Clinical Study of Irinotecan Liposome (II) Plus Oxaliplatin Combined with Tegafur-Gimeracil-Oteracil Potassium (SOX) versus 5-Fluorouracil/Leucovorin (5-FU/LV) in Perioperative Treatment of Borderline Resectable 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：

温晨磊 

研究负责人：

沈柏用 

Applicant：

Chenlei Wen 

Study leader：

Baiyong Shen 

申请注册联系人电话：

Applicant telephone：

+86 19945678374

研究负责人电话：

Study leader's telephone：

+86 13901943778

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：

wcl12161@rjh.com.cn

研究负责人电子邮件：

Study leader's E-mail：

shenby@shsmu.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：

上海市黄浦区瑞金二路197号

研究负责人通讯地址：

上海市黄浦区瑞金二路197号

Applicant address：

No. 197, Ruijin 2nd Road, Huangpu District, Shanghai

Study leader's address：

No. 197, Ruijin 2nd Road, Huangpu District, Shanghai

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

研究负责人所在单位：

上海交通大学医学院附属瑞金医院

Affiliation of the Leader：

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

（2025）临伦审第（331）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涉及人体的临床与科研项目伦理委员会

Name of the ethic committee：

Ruijin Hospital Ethics Committee, Shanghai JiaoTong University School of Medicine

伦理委员会批准日期：

Date of approved by ethic committee：

2025-06-12 00:00:00

伦理委员会联系人：

赵彦琳

Contact Name of the ethic committee：

Zhao Yanlin

伦理委员会联系地址：

上海市黄浦区瑞金二路197号

Contact Address of the ethic committee：

No. 197, Ruijin 2nd Road, Huangpu District, Shanghai

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 21 80585870

伦理委员会联系人邮箱：

Contact email of the ethic committee：

zyl02d86@rjh.com.cn

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, Shanghai Jiao Tong University School of Medicine

研究实施负责（组长）单位地址：

上海市黄浦区瑞金二路197号

Primary sponsor's address：

No. 197, Ruijin 2nd Road, Huangpu District, Shanghai

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

上海

市(区县)：

Country：

China

Province：

Shanghai

City：

单位(医院)：

上海交通大学医学院附属瑞金医院

具体地址：

上海市黄浦区瑞金二路197号

Institution
hospital：

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Address：

No. 197, Ruijin 2nd Road, Huangpu District, Shanghai

经费或物资来源：

无

Source(s) of funding：

N/A

Target disease：

Boarderline resectable pancreatic cancer

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 其它 

Study phase：

N/A

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

探索伊立替康脂质体（II）和奥沙利铂联合替吉奥（NASOX）或5-FU/LV（NALIRIFOX）围术期治疗临界可切除胰腺癌的有效性和安全性。  

Objectives of Study：

Exploring the efficacy and safety of perioperative treatment with irinotecan liposome (II) combined with oxaliplatin and tegafur-gimeracil-oteracil potassium (NASOX) or 5-FU/LV (NALIRIFOX) for borderline resectable pancreatic cancer.

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 18-75 岁； 2. 根据胰腺癌 NCCN 临床实践指南(2024.V1 版)，临床病理与影像学评估符合 NCCN 指南定义的临界可切除胰腺癌、研究者评估为潜在可切除的局部进展期胰腺癌和高危可切除胰腺癌。 3. 临界可切除的定义包括： （1）无远处转移。 （2）动脉： 1）胰头/钩突：肿瘤与肝总动脉接触，没有延伸到腹腔动脉或肝动脉分叉，能够安全完整的切除和重建；肿瘤与肠系膜上动脉接触<=180°；肿瘤接触变异的动脉（如副肝右动脉，替代肝右动脉、替代肝总动脉或替代/副动脉起始部等），但可完整切除并安全重建。 2）胰头/钩突：肿瘤接触腹腔动脉<=180°。 （3）静脉：肿瘤接触肠系膜上静脉或门静脉＞180°，或接触≤180°合并静脉轮廓不规则或静脉血栓，在受累部位的近端和远端有合适的血管能够完全完整的切除和重建；肿瘤接触下腔静脉。高危可切除胰腺癌定义（符合其中一项即可）：影像学提示门静脉或肠系膜上静脉管腔狭窄；影像学分期 T>=3 或 N>=1；血清 CA19-9>=1000U/ml（黄疸解除后）；区域淋巴结转移明确；体重明显降低或重度疼痛。 4. 至少有一个可测量病灶作为靶病灶（根据 RECISTv1.1 标准）； 5. 未接受过任何抗肿瘤治疗（包括放疗、消融、化疗、靶向、免疫治疗等）、研究性药物治疗； 6. ECOG：0～1； 7. 预期生存期>=3 个月； 8. 主要器官功能良好，即符合以下标准（开始治疗前 14 天内未接受任何血液成分、细胞生长因子的情况下）： （1）中性粒细胞>=1.5*10^9/L；血小板>=80*10^9/L；血红蛋白>=9g/dl；血清白蛋白>=3g/dl； （2）总胆红素<=正常值上限 2 倍（胆道梗阻允许胆道引流）；ALT 和 AST<=正常值上限 3倍 （3）血清肌酐<=正常值上限 1.5 倍，肌酐清除率≥60ml/min； （4）INR<=正常值上限 1.5 倍且 APTT<=正常值上限 1.5 倍（对于使用稳定剂量的抗凝治疗如低分子肝素或者华法林且 INR 在抗凝血剂的预期治疗范围内可以筛选）； （5）心电图：QTcF<=450ms(男)，≤,=470ms(女)； （6）心脏彩超：LVEF（左室射血分数）>=50% 9. 育龄妇女必须在开始治疗前 3 天内进行血妊娠试验，且结果为阴性，并且愿意在试验期间和治疗结束后 6 个月内采取适当的方法避孕。对于男性，应为手术绝育，或同意在研究期间和治疗结束后 3 个月内采用适当的方法避孕； 10. 受试者自愿加入本研究，签署知情同意书。

Inclusion criteria

1. Age 18-75 years old; 2. According to the NCCN Clinical Practice Guideline for pancreatic Cancer (2024.V1), the clinicopathological and imaging evaluation met the NCCN guideline definition of borderline resectable pancreatic cancer, investigator's assessment of potentially resectable locally advanced pancreatic cancer, and high-risk resectable pancreatic cancer. 3. The definition of borderline resectable includes: (1) No distant metastasis. (2) Arteries: 1) Pancreatic head/uncinate process: the tumor was in contact with the common hepatic artery and did not extend to the celiac artery or the bifurcation of the hepatic artery, which could be safely and completely resected and reconstructed; The contact between tumor and superior mesenteric artery was less than 180°. The tumor touches the aberrant artery (such as accessory right hepatic artery, alternative right hepatic artery, alternative common hepatic artery, or alternative/accessory artery origin), but it can be completely resected and safely reconstructed. 2) pancreatic head/uncinate process: tumor contact with celiac artery <=180°. (3) Veins: if the tumor contact with superior mesenteric vein or portal vein > 180°, or contact ≤180° with irregular venous contour or venous thrombosis, there are suitable vessels at the proximal and distal end of the involved site for complete resection and reconstruction; The tumor contacted the inferior vena cava. The definition of high-risk resectable pancreatic cancer (meeting one of these criteria) : stenosis of the lumen of the portal vein or superior mesenteric vein on imaging; Imaging staging T>=3 or N>=1; Serum CA19-9>=1000U/ml (after jaundice relief); Regional lymph node metastasis was clear. Significant weight loss or severe pain. 4. At least one measurable lesion was used as the target lesion (according to RECISTv1.1 criteria); 5. Have not received any anti-tumor therapy (including radiotherapy, ablation, chemotherapy, targeted therapy, immunotherapy, etc.) and investigational drug treatment; 6. ECOG: 0-1; 7. Expected survival time >=3 months; 8. Good major organ function, that is, meeting the following criteria (without receiving any blood components, cell growth factors within 14 days before starting treatment) : (1) Neutrophil count >=1.5*10^9/L; Platelet >=80*10^9/L; Hemoglobin >=9g/dl; Serum albumin >=3g/dl; (2) Total bilirubin <= 2 times the upper limit of normal (biliary obstruction allows biliary drainage); ALT and AST<= 3 times the upper limit of normal (3) Serum creatinine <= 1.5 times the upper limit of normal, creatinine clearance ≥60ml/min; (4) INR<= 1.5 times the upper limit of normal range and APTT<= 1.5 times the upper limit of normal range (if using stable doses of anticoagulant therapy such as low molecular weight heparin or warfarin and INR within the expected range of anticoagulant therapy can be screened); (5) ECG: QTcF<=450ms(male), ≤,=470ms(female); (6) Echocardiography: left ventricular ejection fraction >=50% 9. Women of reproductive age must have a negative blood pregnancy test within 3 days before starting treatment and be willing to use an appropriate method of contraception during the test and for 6 months after completion of treatment. For men, surgical sterilization or consent to use an appropriate method of contraception during the study and for 3 months after the end of treatment; 10. All subjects voluntarily participated in this study and signed an informed consent form.

排除标准：

1. 起源于非胰腺导管上皮的胰腺癌，包括胰腺神经内分泌癌、胰腺腺泡细胞癌、胰母细胞瘤、实性-假乳头状肿瘤患者； 2. 已知有中枢神经系统转移的患者； 3. 严重的胃肠功能紊乱（有出血、梗阻；大于 2 级的炎症；大于 1 级的腹泻）； 4. 开始治疗前 2 周内存在除腹水外无法达到稳定状态（拔除引流管后无需干预治疗）的第三间隙积液（如大量胸水）； 5. 有临床症状的腹水，需要穿刺、引流者或既往 3 个月内接受过腹水引流的患者（仅影像学显示少量腹水且可控制，但不伴有临床症状者除外）； 6. 已知有间质性肺病，仅影像学显示的间质性改变除外； 7. 已知的周围神经病变（CTCAE>=3 级）； 8. 已知二氢嘧啶脱氢酶（活性低）或缺乏； 9. 开始治疗前 4 周内发生过严重感染（CTCAE＞2 级），如需要住院治疗的严重肺炎、菌血症、感染并发症等；开始治疗前 2 周内存在感染的症状和体征需要静脉使用抗生素治疗（预防性使用抗生素的情况除外）； 10. 接受过以下任何治疗： （1）开始治疗前 2 周内伴随用药中含有 CYP3A4、CYP2C8 强抑制剂/强诱导剂或 UGT1A1强抑制剂； （2）开始治疗前 2 周内接受过放射治疗； （3）开始治疗前 4 周内接受大型手术（如开胸手术、开腹手术等）； （4）开始治疗前 4 周内接受过其它任何临床研究药物治疗，除非是观察性（非干预性）临床研究或者干预性临床研究随访。 11. 凝血功能异常、具有出血倾向或正在接受溶栓或抗凝治疗。允许预防性使用小剂量阿司匹林（<=100mg/天）、低分子肝素（依诺肝素 40mg/天及其等效剂量下的其他低分子肝素）； 12. 有未能良好控制的心脏临床症状或疾病，如：（1）NYHA2 级以上心力衰竭；（2）不稳定型心绞痛；（3）6 个月内发生过心肌梗死；（4）有临床意义的室上性或室性心律失常且需要治疗或干预的患者； 13. 开始治疗前 5 年内患有胰腺癌以外的恶性肿瘤，除外经充分治疗的宫颈原位癌、皮肤基底细胞或鳞状上皮细胞癌； 14. 已知对伊立替康脂质体 II、其他脂质体产品、奥沙利铂、5-FU、亚叶酸钙及上述产品中任何成分过敏者； 15. 已知有获得性免疫缺陷综合征（艾滋病）或 HIV 检测阳性者，活动性梅毒感染者； 16. 既往有明确的神经或精神障碍史，包括癫痫或痴呆； 17. 经研究者判断，受试者有其他可能导致其被迫中途终止研究的因素，如不依从方案、患有其他严重疾病（含精神疾病）需要合并治疗，具有临床意义的实验室检查值严重异常，家庭或社会因素，可能影响到受试者安全或试验资料收集的情况等

Exclusion criteria：

1. Pancreatic cancer originating from non-ductal epithelium, including pancreatic neuroendocrine carcinoma, pancreatic acinar cell carcinoma, pancreatoblastoma, solid pseudopapillary tumor; 2. Patients with known central nervous system metastases; 3. Severe gastrointestinal dysfunction (bleeding, obstruction; > grade 2 inflammation; Grade 1 or greater diarrhea). 4. The presence of third-space effusion (e.g., massive pleural effusion) in addition to ascites that could not reach a stable state (no intervention after drainage tube removal) within 2 weeks before the start of treatment; 5. Patients with symptomatic ascites, requiring puncture or drainage, or patients with ascites drainage within the past 3 months (except those with small and controllable ascites on imaging, but without clinical symptoms); 6. Known interstitial lung disease, except interstitial changes on imaging; 7. Known peripheral neuropathy (CTCAE>= grade 3); 8. Known dihydropyrimidine dehydrogenase (low activity) or deficiency; 9. Severe infection (CTCAE > 2) occurred within 4 weeks before the initiation of treatment, such as severe pneumonia requiring hospitalization, bacteremia, and infectious complications; Signs and symptoms of infection requiring treatment with intravenous antibiotics within 2 weeks before the initiation of treatment (except for prophylactic antibiotics); 10. Received any of the following: (1) Concomitant medication containing a strong inhibitor/strong inducer of CYP3A4 or CYP2C8 or a strong inhibitor of UGT1A1 within 2 weeks before the initiation of treatment; (2) patients received radiotherapy within 2 weeks before treatment; (3) major surgery (e.g., thoracotomy, laparotomy, etc.) within 4 weeks before the initiation of treatment; (4) receiving any other investigational drug within 4 weeks before the initiation of treatment, unless it was an observational (noninterventional) clinical study or an interventional clinical study follow-up. 11. Abnormal coagulation function, bleeding tendency, or receiving thrombolytic or anticoagulant therapy. Prophylactic use of low-dose aspirin (<=100mg/ day), low-molecular-weight heparin (enoxaparin 40mg/ day and its equivalent dose of other low-molecular-weight heparin) was allowed. 12. Have uncontrolled cardiac symptoms or diseases, such as: (1) heart failure of NYHA2 or above; (2) unstable angina; (3) myocardial infarction within 6 months; (4) patients with clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention; 13. A malignant tumor other than pancreatic cancer within 5 years before the initiation of treatment, excluding adequately treated cervical carcinoma in situ, skin basal cell or squamous cell carcinoma; 14. Known to be allergic to irinotecan liposome II, other liposome products, oxaliplatin, 5-FU, leucovorin or any of the ingredients in the above products; 15. Active syphilis infection with known acquired immunodeficiency syndrome (AIDS) or HIV test positive; 15. 16. A definite previous history of a neurological or psychiatric disorder, including epilepsy or dementia; 17. According to the investigator's judgment, the subject has other factors that may lead to the forced termination of the study, such as non-compliance with the protocol, suffering from other serious diseases (including mental diseases) requiring combined treatment, serious abnormal laboratory test results of clinical significance, family or social factors, and conditions that may affect the safety of the subject or the collection of trial data.

研究实施时间：

Study execute time：

从 From 2025-07-01 00:00:00至 To 2030-05-31 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2025-07-01 00:00:00 至 To 2030-01-31 00:00:00  

干预措施：

Interventions：

组别：

试验组

样本量：

181

Group：

Experimental group

Sample size：

干预措施：

NASOX

干预措施代码：

Intervention：

NASOX

Intervention code：

组别：

对照组

样本量：

181

Group：

Control group

Sample size：

干预措施：

NALIRIFOX

干预措施代码：

Intervention：

NALIRIFOX

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 上海 

市(区县)：

  

Country：

China 

Province：

Shanghai 

City：

 

单位(医院)：

上海交通大学医学院附属瑞金医院 

单位级别：

三甲 

Institution
hospital：

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Level of the institution：

Tertiary A

国家：

 中国

省(直辖市)：

 上海 

市(区县)：

  

Country：

China 

Province：

Shanghai 

City：

 

单位(医院)：

上海交通大学医学院附属瑞金医院卢湾分院 

单位级别：

二甲 

Institution
hospital：

RuiJin Hospital LuWan Branch, Shanghai Jiaotong University School of Medicine

Level of the institution：

Secondary A

测量指标：

Outcomes：

指标中文名：

无事件生存期

指标类型：

主要指标

Outcome：

Event-free survival, EFS

Type：

Primary indicator

测量时间点：

受试者开始治疗之日到出现肿瘤进展导致不能手术、术后复发/转移或死亡之间的时间，以先发生者为准

测量方法：

Measure time point of outcome：

The time between the date the subject started treatment and the occurrence of tumor progression resulting in inoperable, postoperative recurrence/metastasis, or death, whichever occurred first

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

无

组织：

Sample Name：

N/A

Tissue：

人体标本去向

 其它  

说明

Fate of sample：

0thers  

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 75 岁 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）：

中央随机化系统（IWRS）

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

Central Randomization System (IWRS)

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：

开放标签

Blinding：

Open-label study

是否共享原始数据：

IPD sharing

No

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）：

无

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

N/A

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：

病例记录表

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

Case Record Form, CRF

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2025-06-30 09:11:21