中国临床试验注册中心 - 世界卫生组织国际临床试验注册平台一级注册机构

注册号： Registration number：	ChiCTR2600130141
最近更新日期： Date of Last Refreshed on：	2026-08-16 11:35:16
注册时间： Date of Registration：	2026-08-16 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	肝脏减瘤术治疗神经内分泌肿瘤肝转移预后因素的探索研究
Public title：	Study on Prognostic Factors of Liver Metastasis from Neuroendocrine Tumors Treated by liver debulking surgery
注册题目简写：
English Acronym：
研究课题的正式科学名称：	肝脏减瘤术治疗神经内分泌肿瘤肝转移预后因素的探索研究
Scientific title：	Study on Prognostic Factors of Liver Metastasis from Neuroendocrine Tumors Treated by liver debulking surgery
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：	周嘉敏	研究负责人：	王鲁, 陈洁
Applicant：	Zhou Jiamin	Study leader：	Wang Lu, Chen Jie
申请注册联系人电话： Applicant telephone：	+86 13764061286	研究负责人电话： Study leader's telephone：	+86 21 64175590
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：	zhoujiamin0514@163.com	研究负责人电子邮件： Study leader's E-mail：	zhoujiamin0514@163.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：	上海市徐汇区东安路270号	研究负责人通讯地址：	上海市徐汇区东安路270号
Applicant address：	No. 270, Dong'an Road, Xuhui District, Shanghai	Study leader's address：	No. 270, Dong'an Road, Xuhui 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：	复旦大学附属肿瘤医院
Applicant's institution：	Fudan University Shanghai Cancer Center
研究负责人所在单位：	复旦大学附属肿瘤医院
Affiliation of the Leader：	Fudan University Shanghai Cancer Center

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：	2603-Exp397	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：	复旦大学附属肿瘤医院医学伦理委员会
Name of the ethic committee：	Shanghai Cancer Center Institutional Review Board, SCCIRB
伦理委员会批准日期： Date of approved by ethic committee：	2026-07-07 00:00:00
伦理委员会联系人：	张玮静
Contact Name of the ethic committee：	Zhang Weijing
伦理委员会联系地址：	上海市徐汇区东安路270号
Contact Address of the ethic committee：	No. 270, Dong'an Road, Xuhui District, Shanghai
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 21 64175590	伦理委员会联系人邮箱： Contact email of the ethic committee：	andwater@163.com

研究实施负责（组长）单位：

复旦大学附属肿瘤医院

Primary sponsor：

Fudan University Shanghai Cancer Center

研究实施负责（组长）单位地址：

上海市徐汇区东安路270号

Primary sponsor's address：

No. 270, Dong'an Road, Xuhui 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	市(区县)：
Country：	China	Province：	Shanghai	City：
单位(医院)：	复旦大学附属肿瘤医院	具体地址：	上海市徐汇区东安路270号
Institution hospital：	Fudan University Shanghai Cancer Center	Address：	No. 270, Dong'an Road, Xuhui District, Shanghai

经费或物资来源：

国家自然科学基金

Source(s) of funding：

National Natural Science Foundation of China

研究疾病：

神经内分泌肿瘤

Target disease：

neuroendocrine tumor

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：

其它

Study phase：

N/A

研究设计：

连续入组

Study design：

Sequential

研究目的：

主要研究目的：探索影响肝脏减瘤术治疗神经内分泌肿瘤肝转移患者预后的主要因素; 次要研究目的：评价肝脏减瘤术治疗神经内分泌肿瘤肝转移的安全性。

Objectives of Study：

Primary objective: To explore the factors influencing the prognosis of patients with liver metastases from neuroendocrine tumors treated by liver debulking surgery; Secondary objective: To evaluate the safety of liver debulking surgery in the treatment of liver metastases from neuroendocrine tumors.

药物成份或治疗方案详述：

Description for medicine or protocol of treatment in detail：

纳入标准：

Inclusion criteria

1.Sign a written informed consent form before enrollment;
2.Aged over 18 years old, male or female;
3.Liver metastasis of neuroendocrine tumor confirmed by histology;
4.Surgical resection is mandatory;
5.ECOG PS score: 0-1;
6.It is expected that the enrolled patients will be able to tolerate surgical treatment and have a survival period of more than 6 months;
7.The functions of vital organs meet the following requirements (excluding the use of any blood components and cell growth factors within 14 days) :
(1) Blood routine: Neutrophils >= 1,500/mm3; Platelet count >= 100,000/mm3; hemoglobin >= 9g/dL; 
(2) Liver and kidney function: 
Serum creatinine (SCr) <= 1.5 times the upper limit of normal value (ULN) or creatinine clearance rate >= 50 ml/min (Cockcroft-Gault formula); 
Total bilirubin (TBIL) <= 2 times the upper limit of the normal value (ULN); The level of aspartate aminotransferase (AST) or alanine aminotransferase (ALT) is <= 3 times the upper limit of the normal value (ULN). 
Urine protein < 2+; If the urine protein is >= 2+, the 24-hour urine protein quantification shows that the protein must be <=1g. Adequate surgical biliary drainage with no signs of infection;
8.The coagulation function is normal, with no active bleeding or thrombotic diseases. 
(1) The international normalized ratio INR <= 1.5×ULN; 
(2) Partial thromboplastin time (APTT) <= 1.5×ULN; 
(3) Prothrombin time PT <= 1.5ULN;
9.The subjects voluntarily joined this study with good compliance and cooperated with the safety and survival follow-up.

排除标准：

1.患者依从性不佳，失访； 2.肝转移单纯接受射频消融的患者； 3.肝脏减瘤术未能达到70%的减瘤阈值； 4.有临床症状的腹水或胸腔积液，需要治疗性的穿刺或引流； 5.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）1年内发生过心肌梗死; （4）有临床意义的室上性或室性心律失常需要治疗或干预的患者； 6.凝血功能异常（PT>16s、APTT>43s、TT>21s、Fbg>2g/L），具有出血倾向或正在接受溶栓或抗凝治疗； 7.受试者有活动性感染或在筛选期间、首次给药前发生原因不明发热>38.5度（经研究者判断，受试者因肿瘤产生的发热可以入组）； 8.既往和目前有肺纤维化史、间质性肺炎、尘肺、放射性肺炎、药物相关肺炎、肺功能严重受损等的客观证据的患者； 9.受试者先天或后天免疫功能缺陷，如HIV感染者，或活动性肝炎（转氨酶不符合入选标准，乙肝参考： HBV DNA ≥ 10^3/ml；丙肝参考: HCV RNA ≥10^3/ml）；慢性乙型肝炎病毒携带者，HBV DNA＜2000 IU/ml（<10^4拷贝/ml），试验期间必须同时接受抗病毒治疗才可以入组； 10.受试者正在参加其他相关临床研究或距离前一项临床研究结束不足1个月；受试者在研究期间可能会接受其他全身抗肿瘤治疗； 11.研究用药前不足4周内或可能于研究期间接种活疫苗； 12.受试者已知有精神类药物滥用、酗酒或吸毒史； 13.受试者无法或不同意负担自费部分的检查和治疗费用； 14.具有明显影响口服药物吸收的因素，如无法吞咽、慢性腹泻和肠梗阻； 15.受试者正在使用免疫抑制剂、或全身、或可吸收的局部激素治疗以达到免疫抑制目的（剂量>10mg/天泼尼松或其他等疗效激素），并在入组前2周内仍在继续使用的； 16.研究者认为应排除在本研究之外，例如经研究者判断，受试者有其他可能导致本研究被迫中途终止的因素，如，其他的严重疾病（含精神疾病）需要合并治疗，有严重的实验室检查异常，伴有家庭或社会等因素，会影响到受试者的安全，或资料及样品的收集。

Exclusion criteria：

1.The patient had poor compliance and was lost to follow-up; 2.Patients with liver metastasis who only receive radiofrequency ablation; 3.Liver cytoreductive surgery failed to reach the 70% cytoreductive threshold; 4.Ascites or pleural effusion with clinical symptoms requires therapeutic puncture or drainage; 5.Patients with poorly controlled clinical symptoms or diseases of the heart, such as: (1) NYHA grade 2 or above heart failure; (2) unstable angina pectoris; (3) those who have experienced myocardial infarction within one year; (4) Patients with clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention; 6.Abnormal coagulation function (PT>16s, APTT>43s, TT>21s, Fbg>2g/L), with bleeding tendency or currently receiving thrombolytic or anticoagulant therapy; 7.Subjects with active infection or unexplained fever > 38.5 degrees Celsius during the screening period or before the first administration (as determined by the researchers, subjects with fever caused by tumors can be enrolled); 8.Patients with objective evidence of a history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, and severe impairment of lung function, both in the past and at present; 9.The subjects have congenital or acquired immune deficits, such as HIV-infected individuals, or active hepatitis (transaminase does not meet the inclusion criteria; for hepatitis B, reference: HBV DNA>=10^3/ml; for hepatitis C, reference: HCV RNA >=10^3/ml); Chronic hepatitis B virus carriers, with HBV DNA < 2000 IU/ml (<10^4 copies /ml), must receive antiviral treatment simultaneously during the trial period to be enrolled; 10.The subject is participating in other relevant clinical studies or has less than one month until the end of the previous clinical study; The subjects may receive other systemic anti-tumor treatments during the study period; 11.Live vaccines were administered less than 4 weeks before the study or may have been administered during the study period; 12.The subjects are known to have a history of psychotropic substance abuse, alcoholism or drug abuse; 13.The subjects are unable or unwilling to bear the self-funded portion of the examination and treatment costs; 14.There are significant factors that affect the absorption of oral drugs, such as inability to swallow, chronic diarrhea and intestinal obstruction; 15.The subjects were using immunosuppressants, or systemic, or absorbable local hormone therapy to achieve immunosuppressive purposes (dose >10mg/ day prednisone or other therapeutic hormones), and were still using them within 2 weeks before enrollment; 16.The researchers believe that the subjects should be excluded from this study. For instance, if the researchers determine that the subjects have other factors that may lead to the forced termination of this study, such as other serious diseases (including mental disorders) requiring combined treatment, severe laboratory test abnormalities, accompanied by family or social factors that may affect the safety of the subjects, or the collection of data and samples.

研究实施时间：

Study execute time：

从 From 2026-08-01 00:00:00至 To 2026-12-31 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2026-08-18 00:00:00 至 To 2026-12-31 00:00:00

干预措施：

Interventions：

组别：	case series	样本量：	116
Group：	case series	Sample size：	116
干预措施：	无	干预措施代码：
Intervention：	None	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	市(区县)：
Country：	China	Province：	Shanghai	City：
单位(医院)：	复旦大学附属肿瘤医院	单位级别：	三级甲等
Institution hospital：	Fudan University Shanghai Cancer Center	Level of the institution：	Tertiary A

测量指标：

Outcomes：

指标中文名：	无进展生存	指标类型：	主要指标
Outcome：	Progression‑free survival (PFS)	Type：	Primary indicator
测量时间点：	随访时间	测量方法：	随访
Measure time point of outcome：	follow-up period	Measure method：	follow-up

指标中文名：	2年无进展生存率	指标类型：	次要指标
Outcome：	2‑year progression‑free survival 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：	总生存期	指标类型：	次要指标
Outcome：	Overall survival (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：	不良事件	指标类型：	次要指标
Outcome：	Adverse Events	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：	无	组织：
Sample Name：	None	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	85	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）：

无

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

None

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：	无
Blinding：	None

是否共享原始数据： IPD sharing	否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）：	不共享
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	None
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：	病历记录表
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	Case Record Form
数据与安全监察委员会： Data and Safety Monitoring Committee：	有/Yes
注册人： Name of Registration：	2026-08-16 11:35:07