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：	ChiCTR2500111613
最近更新日期： Date of Last Refreshed on：	2026-01-06 16:27:13
注册时间： Date of Registration：	2025-11-03 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	高剂量维生素C联合双硫仑治疗晚期非小细胞肺癌的疗效和安全性研究
Public title：	The Efficacy and Safety of High-Dose Vitamin C in Combination with Disulfiram for the Treatment of Advanced Non-Small Cell Lung Cancer
注册题目简写：
English Acronym：
研究课题的正式科学名称：	高剂量维生素C联合双硫仑治疗晚期非小细胞肺癌的疗效和安全性研究
Scientific title：	The Efficacy and Safety of High-Dose Vitamin C in Combination with Disulfiram for the Treatment of Advanced Non-Small Cell Lung 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：	曾灏	研究负责人：	田攀文
Applicant：	Zeng Hao	Study leader：	Tian Panwen
申请注册联系人电话： Applicant telephone：	+86 28 8542 3660	研究负责人电话： Study leader's telephone：	+86 28 8542 3660
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：	1659098993@qq.com	研究负责人电子邮件： Study leader's E-mail：	mrascend@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：	四川省成都市国学巷37号	研究负责人通讯地址：	四川省成都市国学巷37号
Applicant address：	No. 37, Guoxue Lane, Chengdu City, Sichuan Province	Study leader's address：	No. 37, Guoxue Lane, 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 of 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 of 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：	20251472	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：	The Ethics Committee of West China Hospital of Sichuan University
伦理委员会批准日期： Date of approved by ethic committee：	2025-09-09 00:00:00
伦理委员会联系人：	李娜
Contact Name of the ethic committee：	Li Na
伦理委员会联系地址：	四川省成都市国学巷37号
Contact Address of the ethic committee：	No. 37, Guoxue Lane, 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 of Sichuan University

研究实施负责（组长）单位地址：

四川省成都市国学巷37号

Primary sponsor's address：

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

经费或物资来源：

四川省重点研发项目

Source(s) of funding：

Key Projects in Sichuan Province

研究疾病：

晚期非小细胞肺癌

Target disease：

Advanced Non-Small Cell Lung 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：

I期+II期

Study phase：

1-2

研究设计：

单臂

Study design：

Single arm

研究目的：

1. 主要目的：观察高剂量维生素C联合双硫仑治疗不适合含铂双药化疗的晚期NSCLC的主要疗效。 2. 次要目的：观察高剂量维生素C联合双硫仑治疗不适合含铂双药化疗的晚期NSCLC的安全性。

Objectives of Study：

1. Main objective: To observe the main efficacy of high-dose vitamin C combined with disulfiram in the treatment of advanced NSCLC that is not suitable for platinum based dual drug chemotherapy. 2. Secondary objective: To observe the safety of high-dose vitamin C combined with disulfiram in the treatment of advanced NSCLC that is not suitable for platinum based dual drug chemotherapy.

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. The subjects voluntarily joined this study, signed the informed consent form, had good compliance and cooperated with the follow-up.
2. At the time of signing the informed consent form, the age should be no less than 18 years old, with no gender restrictions.
3. Platinum-based dual-drug chemotherapy is not suitable for the following reasons: ECOG PS of 2-3, or age >=70 years old, with severe comorbidities or contraindications to chemotherapy; If the ECOG PS is 0-1 and the researcher assesses that the subject is suitable for platinum-based chemotherapy, but the subject refuses chemotherapy, they can also be enrolled.
4. No variations in driver genes such as EGFR, ALK, ROS1, and RET;
5. The expected survival period is no less than 8 weeks;
6. Male and female patients of childbearing age all agreed to use reliable contraceptive methods before entering the trial, during the study process, and within 8 weeks after drug withdrawal.
7. According to the solid tumor efficacy evaluation criteria RECIST 1.1, there is at least one measurable lesion;
8. Histologically or cell-confirmed, locally advanced or metastatic stage IIIB/IIIC/IV NSCLC (according to the ninth Edition of the TNM staging system of the American Joint Committee on Cancer);
9. Wild type of KEAP1 gene;
10. Allow newly diagnosed or previously treated patients who have received systemic anti-tumor therapy to be enrolled in the group;
11. Allow patients with asymptomatic brain metastases to be enrolled;
Women of childbearing age (15 to 49 years old) must undergo a urine pregnancy test within 7 days before the start of treatment and the result must be negative.
13. Normal functions of major organs should meet the following criteria:
• Blood routine test criteria (no blood transfusion or blood products within 14 days, and no correction using G-CSF and other hematopoietic stimulating factors) :
Hemoglobin (HB) >=90g/L
b) The absolute value of neutrophils (ANC) is >=1.5×10^9/L
c) Platelet count (PLT) >=80×10^9/L;
Biochemical tests must meet the following indicators:
a) Total bilirubin (TBIL) <=1.5 times the upper limit of the normal value (ULN);
b) Alanine aminotransferase (ALT) and aspartate aminotransferase AST<=2.5×ULN; If liver metastasis exists, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) should be less than or equal to 5×ULN
c) Serum creatinine (Cr) ≤ 1.5×ULN or creatinine clearance rate (CCr) >=50ml/min.
For patients who have not received anticoagulant therapy, the International normalized ratio of prothrombin time (INR) is less than or equal to 1.5, and the partial thromboplastin time (APTT) is less than or equal to 1.5 times the upper limit of the normal value. Patients who receive full-dose or parenteral anticoagulant drug treatment can enter clinical trials as long as the dosage of anticoagulant drugs is stable for at least 2 weeks before entering clinical research and the results of coagulation tests are within the range restricted by local treatment.
• Urine protein <2+.

排除标准：

1.大细胞癌及混合细胞肺癌 2.在筛查和先前的放射影像学评估期间，通过计算机断层扫描（CT）或磁共振成像（MRI）评估确定的活动性或未经治疗的中枢神经系统转移； 3.不受控制的肿瘤相关疼痛； 4.有肾结石病史； 5.当前使用维生素K拮抗剂治疗； 6.不受控制的胸腔积液、心包积液或腹水需要反复引流操作（每月一次或更频繁）； 7.严重的高钙血症（血清钙> 3.5 mmol/L ）； 8. 在本研究的治疗开始之前的五年内患有除 NSCLC 以外的其它癌症的患者。除外宫颈原位癌、已治愈的基底细胞癌、膀胱上皮肿瘤[包括Ta 和 Tis]； 9.葡萄糖-6-磷酸脱氢酶(G-6-PD)缺乏患者 10.对维生素C 过敏患者； 11.具有影响口服药物的多种因素（如：无法吞咽、慢性腹泻和肠梗阻等）的患者； 12. 存在任何重度和/或未能控制的疾病的患者，包括： a) 血压控制不理想（收缩压>=150 mmHg，舒张压>=100 mmHg）患者； b)患有I 级以上心肌缺血或者心肌梗塞、心律失常（包括QTc>=480ms）及>=2级充血性心功能衰竭（纽约心脏病协会（NYHA）分级）； c) 凝血功能异常（INR>1.5 或凝血酶原时间（PT）>ULN+4 秒或APTT >1.5 ULN），具有出血倾向或正在接受溶栓或抗凝治疗；注：在凝血酶原时间国际标准化比值（INR）<=1.5 的前提下，允许以预防目的使用小剂量肝素（成人每日用量为0.6 万~1.2 万U）或小剂量阿司匹林（每日用量<= 100 mg）; d) 活动性或未能控制的严重感染； e) 肝硬化、失代偿性肝病，活动性肝炎或慢性肝炎需要接受抗病毒治疗； f) 肾功能衰竭需要血液透析或者腹膜透析； g) 有免疫缺陷病史，包括HIV 阳性或患有其他获得性、先天性免疫缺陷疾病，或有器官移植史者； h) 糖尿病控制不佳（空腹血糖（FBG）＞10 mmol/L）； i) 尿常规提示尿蛋白>=++ ，且证实24 小时尿蛋白定量＞1.0g 者； j) 具有癫痫发作并需要治疗的患者； k) 长期未治愈的伤口或骨折等； l) 入组前2 周内出现临床显著的咯血（每日咯血大于50ml）；或显著临床意义的出血症状或具有明确的出血倾向，如消化道出血、出血性胃溃疡、基线期大便潜血++及以上，或患有脉管炎等；

Exclusion criteria：

1.Large cell carcinoma and mixed cell lung cancer 2. During screening and previous radiological imaging evaluations, active or untreated central nervous system metastases identified through computed tomography (CT) or magnetic resonance imaging (MRI) assessment; 3. Uncontrolled tumor-related pain; 4. Have a history of kidney stones; 5. Currently, vitamin K antagonists are used for treatment; 6. Uncontrolled pleural effusion, pericardial effusion or ascites requires repeated drainage operations (once a month or more frequently); 7. Severe hypercalcemia (serum calcium > 3.5 mmol/L); 8. Patients with cancers other than NSCLC within five years prior to the start of treatment in this study. Excluding cervical carcinoma in situ, cured basal cell carcinoma, and bladder epithelial tumors [including Ta and Tis]; Patients with glucose-6-phosphate dehydrogenase (G-6-PD) deficiency 10. Patients allergic to vitamin C; 11. Patients with multiple factors that affect oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction, etc.); 12. Patients with any severe and/or uncontrolled diseases, including: a) Patients with unsatisfactory blood pressure control (systolic blood pressure >=150 mmHg, diastolic blood pressure >=100 mmHg); b) Suffering from grade I or above myocardial ischemia or myocardial infarction, arrhythmia (including QTc>=480ms) and grade >=2 congestive heart failure (NYHA classification); c) Abnormal coagulation function (INR>1.5 or prothrombin time (PT) >ULN+4 seconds or APTT >1.5 ULN), with a bleeding tendency or currently receiving thrombolytic or anticoagulant therapy; Note: Under the premise that the International normalized ratio of prothrombin time (INR) is less than or equal to 1.5, low-dose heparin (daily dosage for adults is 6,000 to 12,000 U) or low-dose aspirin (daily dosage is less than or equal to 100 mg) may be used for preventive purposes. d) Active or uncontrolled severe infection; e) Antiviral treatment is required for liver cirrhosis, decompensated liver disease, active hepatitis or chronic hepatitis; f) Renal failure requires hemodialysis or peritoneal dialysis; g) Those with a history of immune deficiency, including those who are HIV positive or have other acquired or congenital immune deficiency diseases, or have a history of organ transplantation; h) Poor control of diabetes (fasting blood glucose (FBG) > 10 mmol/L); i) Urine routine test indicates urine protein >=++, and it is confirmed that the 24-hour urine protein quantification is > 1.0g; j) Patients with epileptic seizures who require treatment; k) Long-term unhealed wounds or fractures, etc. 1) Clinically significant hemoptysis (more than 50ml of hemoptysis per day) occurred within 2 weeks before enrollment; Or significant clinical bleeding symptoms or a clear bleeding tendency, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, baseline fecal occult blood ++ or above, or suffering from phlebitis, etc.

研究实施时间：

Study execute time：

从 From 2025-12-01 00:00:00至 To 2028-12-31 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2025-12-18 00:00:00 至 To 2027-12-31 00:00:00

干预措施：

Interventions：

组别：	试验组	样本量：	32
Group：	Experimental Group	Sample size：	32
干预措施：	VC：静脉注射，7天为一个治疗周期，第1到第3天给药（1.5 g/kg/天），每次给药持续3小时（输注速度最大为1g/min），3天给药结束后暂停4天，这4天期间每日继续口服VC（2g/天），持续4 个周期。治疗结束后立即启动过渡期口服 VC (2g/天），持续 2 周至 VC 血药浓度稳定。口服 2 周VC 后进行疗效评估。口服补充 VC目的是降低停药后出现 VC 反弹性不足而引起的坏血病风险。双硫仑，规格：250mg/胶囊给药方法：口服，每日两次，每次 250 mg ，第一次为VC给药前4小时，第二次为晚饭后	干预措施代码：
Intervention：	VC: Intravenous injection. One treatment cycle lasts for 7 days. Administration on days 1 to 3 (1.5g /kg/ day), with each administration lasting for 3 hours (the maximum infusion rate is 1g/min). After 3 days of administration, pause for 4 days. During these 4 days, continue oral administration of VC daily (2g/ day) for 4 cycles. Immediately after the treatment, start the transitional period of oral administration of VC (2g/ day) and continue for 2 weeks until the blood concentration of VC stabilizes. The therapeutic effect was evaluated after oral administration of VC for 2 weeks. The purpose of oral supplementation of vitamin C is to reduce the risk of scurvy caused by insufficient vitamin C rebound after drug withdrawal. Disulfiram, specification: 250mg/ capsule Administration method: Oral administration, twice a day, 250 mg each time. The first dose is 4 hours before the administration of vitamin C, and the second dose is after dinner	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	中国	省(直辖市)：	四川	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 of Sichuan University	Level of the institution：	Tertiary A

测量指标：

Outcomes：

指标中文名：	无进展生存期	指标类型：	主要指标
Outcome：	Progression-free survival	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	安全性	指标类型：	次要指标
Outcome：	Safety	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 relief	Type：	Secondary 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	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	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：	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：	肺组织	组织：
Sample Name：	Lung tissue	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		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：	无
Blinding：	None
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	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：	CRF
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	CRF
数据与安全监察委员会： Data and Safety Monitoring Committee：	无/No
注册人： Name of Registration：	2025-11-03 17:43:38