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：	ChiCTR2500101912
最近更新日期： Date of Last Refreshed on：	2025-05-06 08:48:06
注册时间： Date of Registration：	2025-05-06 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	限制精氨酸饮食用于实体瘤患者的安全性和有效性研究
Public title：	A Study on the Safety and Efficacy of Arginine-Restricted Diet in Patients with Solid Tumors
注册题目简写：
English Acronym：
研究课题的正式科学名称：	限制精氨酸饮食用于实体瘤患者的安全性和有效性研究
Scientific title：	A Study on the Safety and Efficacy of Arginine-Restricted Diet in Patients with Solid Tumors
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：	谭可芹	研究负责人：	马学磊
Applicant：	Keqin Tan	Study leader：	Xuelein Ma
申请注册联系人电话： Applicant telephone：	+86 152 8417 0585	研究负责人电话： Study leader's telephone：	+86 134 0841 0416
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：	tankeqin1130@163.com	研究负责人电子邮件： Study leader's E-mail：	drmaxuelei@gmail.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：	四川省成都市武侯区国学巷37号	研究负责人通讯地址：	四川省成都市武侯区国学巷37号
Applicant address：	No. 37, Guoxue Lane, Wuhou District, Chengdu City, Sichuan Province	Study leader's address：	No. 37, Guoxue Lane, Wuhou District, Chengdu City, Sichuan 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：	四川大学华西医院
Applicant's institution：	West China Hospital, Sichuan University
研究负责人所在单位：	四川大学华西医院
Affiliation of the Leader：	West China Hospital, Sichuan University

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年审(383)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：	四川大学华西医院生物医学伦理审查委员会
Name of the ethic committee：	Biomedical Ethics Review Committee of West China Hospital, Sichuan University
伦理委员会批准日期： Date of approved by ethic committee：	2025-04-01 00:00:00
伦理委员会联系人：	邓绍林
Contact Name of the ethic committee：	Shaolin Deng
伦理委员会联系地址：	四川省成都市武侯区国学巷37号八角亭2105
Contact Address of the ethic committee：	Room 2105, Bajiaoting Building, No. 37, Guoxue Lane, Wuhou District, Chengdu City, Sichuan Province
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 28 8542 2654	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：

四川大学华西医院

Primary sponsor：

West China Hospital, Sichuan University

研究实施负责（组长）单位地址：

四川省成都市武侯区国学巷37号

Primary sponsor's address：

No. 37, Guoxue Lane, Wuhou District, Chengdu City, Sichuan 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)：	四川省	市(区县)：
Country：	China	Province：	Sichuan	City：
单位(医院)：	四川大学华西医院	具体地址：	四川省成都市武侯区国学巷37号
Institution hospital：	West China Hospital, Sichuan University	Address：	No. 37, Guoxue Lane, Wuhou District, Chengdu City, Sichuan Province

经费或物资来源：

SCI经费

Source(s) of funding：

Funding for SCI (Science Citation Index) papers

研究疾病：

实体瘤

Target disease：

solid tumors

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：

探索性研究/预试验

Study phase：

0

研究设计：

单臂

Study design：

Single arm

研究目的：

主要研究目的：评估限制精氨酸饮食（-Arg饮食）用于实体瘤患者的安全性和耐受性；次要研究目的：评估限制精氨酸饮食用于实体瘤患者的客观缓解率（Objective Response Rate, ORR）、疾病控制率（Disease Control Rate, DCR）、缓解持续时间（Duration of Response, DoR）。探索性目的：评价限制精氨酸饮食的营养充足性；评价限制精氨酸饮食的对实体瘤患者生活质量的营养；评估限制精氨酸饮食用于实体瘤患者对患者氨基酸代谢、免疫情况的影响，并进一步研究与初步疗效的相关性。

Objectives of Study：

Primary research objective: To evaluate the safety and tolerability of an arginine-restricted diet (-Arg diet) in patients with solid tumors. Secondary research objectives: To evaluate the Objective Response Rate (ORR), Disease Control Rate (DCR), and Duration of Response (DoR) of an arginine-restricted diet in patients with solid tumors. Exploratory objectives: To assess the nutritional adequacy of an arginine-restricted diet; To evaluate the impact of an arginine-restricted diet on the nutrition related to the quality of life of patients with solid tumors; To assess the effects of an arginine-restricted diet on the amino acid metabolism and immune status of patients with solid tumors, and to further investigate its correlation with the preliminary therapeutic efficacy.

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）在实施任何试验相关流程之前，签署书面知情同意；
（2）男性或女性，18-75岁；
（3）病理组织活检诊断为实体瘤；
（4）根据RECIST v1.1（Response Evaluation Criteria in Solid Tumors Version 1.1）标准，至少有1个可测量病灶（既往接受过放疗等局部治疗的病灶不能视为可测量病灶）；
（5）ECOG（Eastern Cooperative Oncology Group Performance Status）评分0-1分；
（6）NRS-2002（Nutritional Risk Screening 2002）评分＜3分；
（7）BMI（Body Mass Index） >= 18.5（可根据实际情况适当调整）；
（8）能经口进食或经营养管进食的患者，能够耐受肠内营养；
（9）足够器官功能，受试者需满足如下实验室指标：
1) 近14天未使用粒细胞集落刺激因子的情况下，中性粒细胞绝对值≥1.5×10^9/L；
2) 血小板≥75×10^9/L；
3) 近7天内无输血或使用促红细胞生成素的情况下，血红蛋白≥8g/dL；
4) 血清白蛋白≥3.0g/dL；
5) 总胆红素≤1.5×正常值上限（ULN, Upper Limit of Normal）；
6) 天门冬氨酸转氨酶（Aspartate Aminotransferase, AST）、丙氨酸转氨酶（Alanine Aminotransferase, ALT）在≤2.5×ULN；如有肝转移，ALT和/或AST ≤5 × ULN，总胆红素≤ 3× ULN；如有肝转移或骨转移，碱性磷酸酶（Alkaline Phosphatase, AKP）≤5 × ULN；
7) 肌酐清除率≥ 50 mL/min（根据Cockcroft-Gault公式计算）或血清肌酐≤ 1.5× ULN；
8) 国际标准化比值（International Normalized Ratio, INR）≤ 1.5×ULN，凝血酶原时间（Prothrombin Time, PT）和活化部分凝血活酶时间（Activated Partial Thromboplastin Time, APTT）≤ 1.5×ULN；
9）尿蛋白< 2+（如尿蛋白≥2+，可进行24小时尿蛋白定量，24小时尿蛋白定量< 2.0 g的受试者可入组）；
（10）有生育能力的女性必须同意从签署知情同意书至研究药物末次给药后至少6个月内避免性交（避免异性性交）或使用可靠有效的避孕方法。此外，研究治疗开始前3天内血清HCG (Human Chorionic Gonadotropin) 检测必须为阴性，且受试者必须处于非哺乳期。女性患者如已绝经，尚未达到绝经后状态（非月经期≥连续12个月，且除绝经外未发现其他原因），且未接受绝育手术（如子宫切除术、双侧输卵管结扎术或双侧卵巢切除术），则认为具有生育能力。
（11）如存在受孕风险，所有受试者（不论男性或女性）均需在整个治疗期间直至治疗末次研究药物给药后120天（或末次化疗药物给药后180天）内采用年失败率低于1%的避孕措施。

Inclusion criteria

(1) Sign a written informed consent before implementing any procedures related to the trial.
(2) Male or female, aged between 18 and 75 years old.
(3) Diagnosed with solid tumors by pathological tissue biopsy.
(4) According to the Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) criteria, there is at least 1 measurable lesion (lesions that have previously received local treatments such as radiotherapy cannot be regarded as measurable lesions).
(5) Eastern Cooperative Oncology Group Performance Status (ECOG) score of 0-1.
(6) Nutritional Risk Screening 2002 (NRS-2002) score < 3.
(7) Body Mass Index (BMI) >= 18.5 (which can be appropriately adjusted according to the actual situation).
(8) Patients who can eat orally or through a nutritional tube and are able to tolerate enteral nutrition.
(9) Sufficient organ function, and the subjects need to meet the following laboratory indicators:
1) Absolute neutrophil count >= 1.5×10⁹/L without the use of granulocyte colony-stimulating factor within the last 14 days.
2) Platelets >= 75×10⁹/L.
3) Hemoglobin >= 8 g/dL without blood transfusion or the use of erythropoietin within the last 7 days.
4) Serum albumin >= 3.0 g/dL.
5) Total bilirubin <= 1.5× Upper Limit of Normal (ULN).
6) Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) <= 2.5×ULN; in case of liver metastasis, ALT and/or AST <= 5×ULN, and total bilirubin <= 3×ULN; in case of liver or bone metastasis, Alkaline Phosphatase (AKP) <= 5×ULN.
7) Creatinine clearance rate >= 50 mL/min (calculated according to the Cockcroft-Gault formula) or serum creatinine <= 1.5×ULN.
8) International Normalized Ratio (INR) <=1.5×ULN, Prothrombin Time (PT) and Activated Partial Thromboplastin Time (APTT) <= 1.5×ULN.
9) Urine protein < 2+ (if urine protein >= 2+, 24-hour urine protein quantification can be performed, and subjects with a 24-hour urine protein quantification < 2.0 g can be enrolled).
(10) Women of childbearing potential must agree to avoid sexual intercourse (avoid heterosexual intercourse) or use a reliable and effective contraceptive method from the signing of the informed consent form until at least 6 months after the last administration of the study drug. In addition, the serum Human Chorionic Gonadotropin (HCG) test must be negative within 3 days before the start of the study treatment, and the subject must not be lactating. Female patients who are postmenopausal but have not reached the postmenopausal state (amenorrhea for >= 12 consecutive months and no other causes except menopause are found) and have not undergone sterilization surgery (such as hysterectomy, bilateral salpingectomy or bilateral oophorectomy) are considered to be of childbearing potential.
(11) If there is a risk of pregnancy, all subjects (both male and female) are required to use a contraceptive measure with an annual failure rate of less than 1% throughout the treatment period until 120 days after the last administration of the study drug (or 180 days after the last administration of the chemotherapy drug).

排除标准：

（1）认知功能障碍或心理疾病导致不能理解研究内容的患者；（2）中枢神经系统或脑膜转移患者；（3）有临床症状的中度或重度腹水患者（即在开始研究治疗前2周内需要治疗性穿刺引流，而影像学上仅显示少量腹水而无临床症状者可入组）；（4）未控制或中度或较严重的胸腔积液和心包积液；（5）严重腹泻、顽固性呕吐、严重吸收不良综合征、麻痹性和机械性肠梗阻的患者；气管食管瘘、胃肠道穿孔或胃肠道瘘、或腹腔脓肿；消化道外出血患者研究治疗开始前6个月内CTCAE (Common Terminology Criteria for Adverse Events) 3级或以上或3个月内CTCAE 2级或以上（如异常阴道出血、呕血）；（6）受试者的其他可能影响研究结果或导致被迫中止研究的因素（经研究者判断），如酗酒、滥用药物、其他需要联合治疗的严重疾病（包括精神疾病）、实验室检查值严重异常、家庭或社会因素以及其他可能影响受试者安全或研究数据收集的情况；（7）已知对本研究药物活性成分或辅料过敏者；（8）糖尿病血糖控制不佳的患者；（9）高血压控制不佳（常规降压治疗下收缩压≥140 mmHg和/或舒张压≥90 mmHg），既往有高血压危象或高血压脑病病史；（10）严重心脑血管疾病患者，包括脑血管意外（Cerebrovascular Accident, CVA）、短暂性脑缺血发作（Transient Ischemic Attack, TIA）、心肌梗死和重大血管疾病入组前6个月内（包括但不限于需要手术修复的主动脉瘤或近期动脉血栓形成）;临床症状或心脏疾病控制不佳的患者，如不稳定型心绞痛、NYHA心力衰竭（纽约心脏协会）II级或以上，彩色多普勒超声心动图检查左室射血分数< 50%，或药物治疗无法控制的严重心律失常；（11）妊娠或哺乳期妇女；（12）研究者认为其他不适合入组的情况。

Exclusion criteria：

(1) Patients with cognitive impairment or mental disorders who are unable to understand the content of the study. (2) Patients with metastases to the central nervous system or meninges. (3) Patients with moderate or severe ascites accompanied by clinical symptoms (that is, those who require therapeutic puncture and drainage within 2 weeks before the start of the study treatment. Patients who only show a small amount of ascites on imaging and have no clinical symptoms can be enrolled). (4) Uncontrolled, moderate or severe pleural effusion and pericardial effusion. (5) Patients with severe diarrhea, intractable vomiting, severe malabsorption syndrome, paralytic or mechanical intestinal obstruction; patients with tracheoesophageal fistula, gastrointestinal perforation or gastrointestinal fistula, or intra-abdominal abscess; patients with extra-gastrointestinal bleeding who have a CTCAE (Common Terminology Criteria for Adverse Events) grade 3 or above within 6 months before the start of the study treatment or a CTCAE grade 2 or above within 3 months (such as abnormal vaginal bleeding, hematemesis). (6) Other factors of the subjects that may affect the study results or lead to the forced termination of the study (as judged by the researchers), such as alcohol abuse, drug abuse, other serious diseases requiring combined treatment (including mental diseases), severely abnormal laboratory test values, family or social factors, and other situations that may affect the safety of the subjects or the collection of study data. (7) Subjects known to be allergic to the active ingredients or excipients of the study drug. (8) Patients with poorly controlled blood glucose levels due to diabetes. (9) Poor control of hypertension (systolic blood pressure >= 140 mmHg and/or diastolic blood pressure >= 90 mmHg under conventional antihypertensive treatment), with a history of hypertensive crisis or hypertensive encephalopathy; (10) Patients with severe cardiovascular and cerebrovascular diseases, including Cerebrovascular Accident (CVA), Transient Ischemic Attack (TIA), myocardial infarction, and major vascular diseases within 6 months before enrollment (including but not limited to aortic aneurysm requiring surgical repair or recent arterial thrombosis); patients with poorly controlled clinical symptoms or heart diseases, such as unstable angina pectoris, New York Heart Association (NYHA) heart failure grade II or above, left ventricular ejection fraction < 50% as detected by color Doppler echocardiography, or severe arrhythmia that cannot be controlled by drug treatment. (11) Pregnant or lactating women. (12) Other situations deemed by the researchers as unsuitable for enrollment.

研究实施时间：

Study execute time：

从 From 2025-04-28 00:00:00至 To 2027-03-30 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2025-05-06 00:00:00 至 To 2026-12-30 00:00:00

干预措施：

Interventions：

组别：	试验组	样本量：	25
Group：	Test group	Sample size：	25
干预措施：	限制精氨酸饮食	干预措施代码：
Intervention：	Arginine-restricted diet(-Arg diet)	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	中国	省(直辖市)：	四川省	市(区县)：
Country：	China	Province：	Sichuan	City：
单位(医院)：	四川大学华西医院	单位级别：	三甲
Institution hospital：	West China Hospital, Sichuan University	Level of the institution：	Tertiary A

测量指标：

Outcomes：

指标中文名：	治疗相关不良事件	指标类型：	主要指标
Outcome：	Treatment - Emergent Adverse Event	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	客观缓解率	指标类型：	次要指标
Outcome：	Objective Response 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：	疾病控制率	指标类型：	次要指标
Outcome：	Disease Control Rate, DCR	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	缓解持续时间	指标类型：	次要指标
Outcome：	Duration of Response	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	限制精氨酸饮食的营养充足性	指标类型：	附加指标
Outcome：	The nutritional adequacy of an arginine-restricted diet	Type：	Additional indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	评价限制精氨酸饮食的对实体瘤患者生活质量的影响	指标类型：	附加指标
Outcome：	Evaluate the impact of an arginine-restricted diet on the quality of life of patients with solid tumors	Type：	Additional indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	评估限制精氨酸饮食用于实体瘤患者对患者氨基酸代谢、免疫情况的影响，并进一步研究与初步疗效的相关性	指标类型：	附加指标
Outcome：	Evaluate the effects of an arginine-restricted diet used in patients with solid tumors on the patients' amino acid metabolism and immune status, and further investigate its correlation with the preliminary therapeutic efficacy.	Type：	Additional 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：

征募研究对象情况：

Recruiting status：

正在进行

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）：

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:

公开/Public

盲法：
Blinding：
试验完成后的统计结果（上传文件）：	点击下载
Calculated Results after the Study Completed(upload file)：	download

是否共享原始数据： IPD sharing	是Yes
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）：	联系负责人邮箱
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	Contact the email of the person in charge
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, CRF
数据与安全监察委员会： Data and Safety Monitoring Committee：	暂未确定/Not yet
注册人： Name of Registration：	2025-05-06 08:47:44