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：	ChiCTR2600117708
最近更新日期： Date of Last Refreshed on：	2026-01-28 08:37:05
注册时间： Date of Registration：	2026-01-28 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	糖代谢调节联合抗肿瘤方案治疗复发或转移晚期癌症的有效性和安全性研究
Public title：	Study on the Efficacy and Safety of a Glucose Metabolism Regulation-Combined Antitumor Regimen for Recurrent or Metastatic Advanced Cancer
注册题目简写：
English Acronym：
研究课题的正式科学名称：	糖代谢调节联合抗肿瘤方案治疗复发或转移晚期癌症的有效性和安全性研究
Scientific title：	Study on the Efficacy and Safety of a Glucose Metabolism Regulation-Combined Antitumor Regimen for Recurrent or Metastatic Advanced 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：	宋斌斌	研究负责人：	宋斌斌
Applicant：	Song Binbin	Study leader：	Song Binbin
申请注册联系人电话： Applicant telephone：	+86 15024363171	研究负责人电话： Study leader's telephone：	+86 150 2436 3171
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：	sbbwy2005@163.com	研究负责人电子邮件： Study leader's E-mail：	15024363171@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：	浙江省嘉兴市中环南路1882号	研究负责人通讯地址：	浙江省嘉兴市中环南路1882号
Applicant address：	1882 Zhonghuan South Road, Jiaxing City, Zhejiang Province	Study leader's address：	1882 Zhonghuan South Road, Jiaxing City, Zhejiang Province
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：	嘉兴市第一医院
Applicant's institution：	The First Hospital of Jiaxing
研究负责人所在单位：	嘉兴市第一医院
Affiliation of the Leader：	The First Hospital of Jiaxing

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：	2025-LP-741	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：	嘉兴市第一医院医学伦理委员会
Name of the ethic committee：	Medical Ethics Committee of the First Hospital of Jiaxing
伦理委员会批准日期： Date of approved by ethic committee：	2025-10-09 00:00:00
伦理委员会联系人：	许文
Contact Name of the ethic committee：	Wen Xu
伦理委员会联系地址：	浙江省嘉兴市中环南路1882号
Contact Address of the ethic committee：	1882 Zhonghuan South Road, Jiaxing City, Zhejiang Province
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 573 89976378	伦理委员会联系人邮箱： Contact email of the ethic committee：	xwkikimi@163.com

研究实施负责（组长）单位：

嘉兴市第一医院

Primary sponsor：

The First Hospital of Jiaxing

研究实施负责（组长）单位地址：

浙江省嘉兴市中环南路1882号

Primary sponsor's address：

1882 Zhonghuan South Road, Jiaxing City, Zhejiang Province

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)：	嘉兴市第一医院	具体地址：	浙江省嘉兴市中环南路1882号
Institution hospital：	The First Hospital of Jiaxing	Address：	1882 Zhonghuan South Road, Jiaxing City, Zhejiang Province

经费或物资来源：

自选课题（自筹）

Source(s) of funding：

Self-initiated Research Project

研究疾病：

复发或转移晚期癌症

Target disease：

Recurrent or Metastatic Advanced 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：

其它

Study phase：

N/A

研究设计：

单臂

Study design：

Single arm

研究目的：

本临床研究主要是针对复发或转移晚期癌症难以控制，针对该难题，引入糖代谢调节联合化疗、免疫、靶向治疗等抗肿瘤方案，来达到控制肿瘤进展的目的。联合治疗前后观察病人症状改善状态及生存期及相关实验室指标的变化，重点解决用药前后实验数据的变化的相关问题，以推动临床的实际应用。

Objectives of Study：

This clinical study mainly targets the difficulty of controlling recurrent or metastatic advanced cancer. To address this challenge, anti-tumor strategies such as combining regulation of glucose metabolism with chemotherapy, immunotherapy, and targeted therapy are introduced to achieve tumor progression control. The study observes changes in patient symptom improvement, survival, and related laboratory indicators before and after combination therapy, with a focus on addressing issues related to changes in experimental data before and after treatment, in order to promote practical clinical application.

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. Age 18 to 80 years old, both male and  female are eligible.
2. Histologically or cytologically confirmed recurrent or metastatic malignant tumors.
3. No previous systemic anti-tumor treatment for advanced or metastatic solid tumors, and planned to receive intravenous infusion of anti-tumor drugs (including chemotherapy, immunotherapy, chemotherapy combined with immunotherapy, and chemotherapy combined with targeted therapy). The following situations are allowed to be included: subjects who have received adjuvant or neoadjuvant anti-tumor treatment (including chemotherapy, immunotherapy, and targeted therapy), with at least 6 months between the last dose of adjuvant or neoadjuvant anti-tumor treatment and disease recurrence.
4. According to RECIST v1.1, there must be at least one measurable lesion. Lesions that have received radiotherapy cannot be selected as target lesions, unless the radiotherapy lesion is the only measurable lesion and is clearly progressing based on imaging, it can be considered as a target lesion. The basic criteria for including target lesions are: the long diameter of the tumor lesion >= 10mm or the short diameter of the pathological lymph node >= 15mm. The sum of the long diameter of the tumor target lesion and the short diameter of the pathological lymph node target lesion is used as the basis for quantitative assessment. The selection criteria for non-target lesions are: the long diameter of the tumor lesion <= 10mm or the short diameter of the lymph node >= 10mm and < 15mm or truly unmeasurable lesions. Lesions within the same organ that meet the measurement criteria but exceed the total number of included lesions are defined as unmeasurable lesions.
5. ECOG 0-2 within 7 days before the first administration of the study drug.
6. Expected survival >= 12 weeks.
7. The functions of important organs meet the following requirements: absolute neutrophil count (ANC) >= 1.5×10^9/L; platelets >= 100×10^9/L; total bilirubin <= 1.5 × ULN, ALT, AST and/or ALP <= 2.5 × ULN; if there is liver metastasis, ALT and/or AST <= 5 × ULN; if there is liver or bone metastasis, ALP <= 5 × ULN; serum creatinine <= 1.5 × ULN or creatinine clearance rate > 60 mL/min (calculated by Cockcroft-Gault formula); activated partial thromboplastin time (APTT), international normalized ratio (INR), and prothrombin time (PT) <= 1.5 × ULN.
8. For female subjects of childbearing age, the blood pregnancy test must be negative within 7 days before the first administration of the study drug, and for male subjects whose partners are of childbearing age, at least one medically approved contraceptive measure (such as intrauterine device, contraceptive pills, or condoms) must be used during the study treatment period.
9. The expected intravenous infusion time of the anti-tumor drug does not exceed 1.5 hours.
10. The subject voluntarily participates in this study, fully understands the study, signs the informed consent form, has good compliance, and cooperates with follow-up.

排除标准：

1.4个治疗周期后进展的患者（含超进展）；
2.存在消化道梗阻且无法经口或鼻饲肠内营养的患者；
3.随机前 2 周内需要静脉或口服给予抗生素﹥7天治疗的全身性感染或其他严重感染（包括不限于肺部感染、肠道感染、败血症等），或在筛选期间、入组前出现原因不明的发热>38.5 ℃（经研究者判断，受试者因肿瘤原因导致的发热除外）；
4.存在脑干、脑膜转移、脊髓转移或压迫或活动性出血；
5.已知有活动性中枢神经系统（CNS）转移癌和/或癌性脑膜炎。既往接受过治疗的脑转移受试者如果在首次给药前临床稳定至少2周，无新发或扩大脑部转移的证据，并且在研究药物给药前3天停用类固醇，则可以参加研究。根据这一定义，应在研究药物首次给药前确定脑部转移的稳定性。已知有未经治疗的无症状脑部转移（即无神经系统症状，无需皮质类固醇治疗，无或仅轻微的周围水肿）的受试者可以参加研究，但需要定期对脑部进行影像学检查，以评估转移情况；
6.有活动性的自身免疫性疾病、自身免疫性疾病史（如间质性肺炎、结肠炎、肝炎、垂体炎、血管炎、肾炎、甲状腺功能亢进症、甲状腺功能减退症，包括但不限于这些疾病或综合症）；除外白癜风或已痊愈的童年时代哮喘/过敏，成人后无需任何干预的患者；使用稳定剂量的甲状腺替代激素治疗的自身免疫介导的甲状腺功能减退症；使用稳定剂量的胰岛素的I型糖尿病；
7.有免疫缺陷病史，包括HIV抗体检测阳性，或患有其他获得性、先天性免疫缺陷疾病，或有器官移植史和异基因骨髓移植史；
8.受试者具有未能良好控制的心血管临床症状或疾病，包括但不限于：如：（1）NYHA II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未经临床干预或临床干预后仍控制不佳；
9.受试者存在已知活动性或可疑自身免疫病。允许入组处于稳定状态，不需要全身免疫抑制剂治疗的受试者；
10.乙肝表面抗原HBsAg（+）和/或乙肝核心抗体（HBcAb）（+）的受试者，入组时HBV-DNA ≥500 IU/mL或2500拷贝/mL。对于高于该标准，除非首先接受抗病毒治疗，并要求下降至正常范围至少2周，且必须在研究期间全程继续接受抗病毒治疗方可入组。对于既往需要接受或筛选时正在接受抗病毒治疗的受试者，即使HBV-DNA符合入组条件，必须在研究期间全程继续接受抗病毒治疗方可纳入研究。丙型肝炎（HCV抗体检查呈阳性，且HCV-RNA阳性）；
11.妊娠期或哺乳期妇女；
12.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，如患有其他严重疾病（含精神疾病）需要合并治疗，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。

Exclusion criteria：

1. Patients who progress after 4 treatment cycles (including hyperprogression);
2. Patients with gastrointestinal obstruction and unable to receive enteral nutrition through the mouth or nasogastric tube;
3. Patients with systemic infection or other severe infections (including but not limited to pulmonary infection, intestinal infection, sepsis, etc.) requiring intravenous or oral antibiotics for more than 7 days within 2 weeks before randomization, or with unexplained fever > 38.5 ℃ during the screening period or before enrollment (excluding fever caused by tumor as judged by the investigator);
4. Patients with brainstem, leptomeningeal, spinal cord metastases or compression or active bleeding;
5. Patients with known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Patients with previously treated brain metastases who have been clinically stable for at least 2 weeks before the first dose, with no evidence of new or enlarged brain metastases, and have discontinued steroids for at least 3 days before the study drug administration can be included in the study. According to this definition, the stability of brain metastases should be determined before the first dose of the study drug. Patients with known untreated asymptomatic brain metastases (i.e., no neurological symptoms, no need for corticosteroid treatment, and no or only mild perifocal edema) can be included in the study, but regular brain imaging is required to assess the metastases;
6. Patients with active autoimmune diseases or a history of autoimmune diseases (such as interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to these diseases or syndromes); except for patients with vitiligo or childhood asthma/allergy that has been cured and does not require any intervention in adulthood; patients with autoimmune-mediated hypothyroidism treated with a stable dose of thyroid replacement hormones; patients with type 1 diabetes treated with a stable dose of insulin;
7. Patients with a history of immunodeficiency, including positive HIV antibody test, or with other acquired or congenital immunodeficiency diseases, or with a history of organ transplantation and allogeneic bone marrow transplantation;
8. Patients with uncontrolled cardiovascular clinical symptoms or diseases, including but not limited to: (1) NYHA class II or above heart failure; (2) unstable angina; (3) myocardial infarction within 6 months; (4) clinically significant supraventricular or ventricular arrhythmias that have not been clinically intervened or remain uncontrolled after clinical intervention;
9. Patients with known active or suspected autoimmune diseases. Patients in a stable state who do not require systemic immunosuppressive therapy are allowed to be included;
10. Patients with positive hepatitis B surface antigen (HBsAg) and/or hepatitis B core antibody (HBcAb), and HBV-DNA ≥ 500 IU/mL or 2500 copies/mL at the time of enrollment. For those above this standard, they must first receive antiviral treatment and the HBV-DNA must be reduced to the normal range for at least 2 weeks before enrollment, and must continue antiviral treatment throughout the study. For patients who have previously required or are currently receiving antiviral treatment at the time of screening, even if the HBV-DNA meets the inclusion criteria, they must continue antiviral treatment throughout the study to be included. Patients with positive hepatitis C antibody and positive HCV-RNA;
11. Pregnant or lactating women;
12. Patients with other factors that may cause them to be forced to terminate the study prematurely, as judged by the investigator, such as other serious diseases (including mental illness) requiring combined treatment, severely abnormal laboratory test values, family or social factors that may affect the safety of the patient or the collection of study data.

研究实施时间：

Study execute time：

从 From 2025-11-01 00:00:00至 To 2028-10-31 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2026-01-31 00:00:00 至 To 2028-10-31 00:00:00

干预措施：

Interventions：

组别：	试验组	样本量：	100
Group：	Experimental group	Sample size：	100
干预措施：	糖代谢调节联合抗肿瘤方案	干预措施代码：
Intervention：	Glucose Metabolism Regulation Combined with Anti-Tumor Regimen	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)：	嘉兴市第一医院	单位级别：	三级甲等
Institution hospital：	The First Hospital Of Jiaxing	Level of the institution：	Tertiary A

测量指标：

Outcomes：

指标中文名：	无进展生存期（PFS）	指标类型：	主要指标
Outcome：	Progression-free survival (PFS)	Type：	Primary indicator
测量时间点：	每2疗程评估一次	测量方法：	用药开始后，每2疗程（±7天）评估一次，根据计算机断层扫描或核磁共振成像【CT或MRI（颈部、胸部、腹部、盆腔以及其他任何怀疑有肿瘤病灶的部位）】检查结果，根据RECIST v1.1标准对肿瘤影像学情况进行评估（肿瘤评估可由研究者根据临床需要增加评估次数）。因除疾病进展以外的原因停止用药的受试者，尽量按照既定的时间继续进行影像学评估，直至疾病进展、开始新的抗肿瘤治疗、撤回知情同意、死亡或本研究结束
Measure time point of outcome：	Assessed every two treatment cycles	Measure method：	After the initiation of treatment, the assessment will be conducted every 2 cycles (±7 days). The imaging of the tumor will be evaluated based on the results of computed tomography or magnetic resonance imaging (CT or MRI of the neck, chest, abdomen, pelvis, and any other sites suspected of having tumor lesions) in accordance with RECIST v1.1 criteria. The frequency of tumor assessment can be increased by the investigator as clinically necessary. For subjects who discontinue treatment for reason

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：	大便	组织：
Sample Name：	stool	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	18	岁 years
最大 Max age	80	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：
Blinding：	Double blind

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）：	无
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：	电子采集和管理
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	Electronic Data Capture
数据与安全监察委员会： Data and Safety Monitoring Committee：	无/No
注册人： Name of Registration：	2026-01-28 08:36:48