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：	ChiCTR2400088741
最近更新日期： Date of Last Refreshed on：	2024-08-26 15:09:23
注册时间： Date of Registration：	2024-08-26 00:00:00
注册号状态：	补注册
Registration Status：	Retrospective registration
注册题目：	等离子体治疗恶性泛实体肿瘤的安全性、有效性临床研究
Public title：	A clinical study of the safety and efficacy of plasma in the treatment of malignant pan-solid tumors
注册题目简写：
English Acronym：
研究课题的正式科学名称：	等离子体治疗恶性泛实体肿瘤的安全性、有效性临床研究
Scientific title：	A clinical study of the safety and efficacy of plasma in the treatment of malignant pan-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：	徐舒	研究负责人：	徐舒
Applicant：	Xu Shu	Study leader：	Xu Shu
申请注册联系人电话： Applicant telephone：	+86 18126081081	研究负责人电话： Study leader's telephone：	+86 18126081801
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：	selflearner@126.com	研究负责人电子邮件： Study leader's E-mail：	selflearner@126.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：	广东省深圳市光明区马田街道松白路4253号	研究负责人通讯地址：	深圳市光明区马田街道松白路4253号
Applicant address：	4253 Songbai Road, Matian Street, Guangming District, Shenzhen, Guangdong, China	Study leader's address：	4253 Songbai Road, Matian Street, Guangming District, Shenzhen, Guangdong, China
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：	深圳市光明区人民医院
Applicant's institution：	Shenzhen Guangming District People‘s Hospital
研究负责人所在单位：	深圳市光明区人民医院
Affiliation of the Leader：	Shenzhen Guangming District People's Hospital

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：	LL-KT-2024003	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：	深圳市光明区人民医院伦理委员会
Name of the ethic committee：	Ethics Committee of Shenzhen Guangming District People's Hospital
伦理委员会批准日期： Date of approved by ethic committee：	2024-01-23 00:00:00
伦理委员会联系人：	邹琛
Contact Name of the ethic committee：	Zou Chen
伦理委员会联系地址：	深圳市光明区马田街道松白路4253号
Contact Address of the ethic committee：	4253 Songbai Road, Matian Street, Guangming District, Shenzhen, Guangdong, China
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 755 27548303	伦理委员会联系人邮箱： Contact email of the ethic committee：	chris_zou@163.com

研究实施负责（组长）单位：

深圳市光明区人民医院

Primary sponsor：

Shenzhen Guangming District People's Hospital

研究实施负责（组长）单位地址：

深圳市光明区马田街道松白路4253号

Primary sponsor's address：

4253 Songbai Road, Matian Street, Guangming District, Shenzhen, Guangdong, China

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：	中国	省(直辖市)：	广东	市(区县)：
Country：	China	Province：	Guangdong	City：
单位(医院)：	深圳市光明区人民医院	具体地址：	深圳市光明区马田街道松白路4253号
Institution hospital：	Shenzhen Guangming District People's Hospital	Address：	4253 Songbai Road, Matian Street, Guangming District, Shenzhen

经费或物资来源：

深圳市科技创新委重大项目;深圳市医学科学研究院临床专项

Source(s) of funding：

Shenzhen Science and Technology Innovation Commission; Shenzhen Medical Academy of Research and Translation

研究疾病：

泛实体瘤

Target disease：

Pan-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：

其它

Study phase：

N/A

研究设计：

非随机对照试验

Study design：

Non randomized control

研究目的：

主要目的：评价等离子体辅助治疗恶性实体肿瘤患者的安全性次要目的：评价等离子体辅助治疗恶性实体肿瘤患者的有效性

Objectives of Study：

Primary objective: to evaluate the safety of CAP-assisted therapy in patients with malignant solid tumors. Secondary objective: to evaluate the effectiveness of CAP-assisted therapy in patients with malignant solid 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. Patients or their legal guardians voluntarily participate and sign an informed consent form;
2. Patients with malignant solid tumors aged 18 to 70 years old (including 18 and 70 years old), no gender restriction;
3. Patients with histologically and/or cytologically confirmed malignant solid tumors, including but not limited to colorectal cancer, esophageal cancer, gastric cancer, renal cancer, hepatocellular carcinoma, lung cancer, prostate cancer, pancreatic cancer, breast cancer, thyroid cancer, ovarian cancer, endometrial cancer, cervical cancer, bladder cancer, melanoma, mesothelioma, synovial sarcoma, and cholangiocarcinoma, etc., with feasible radical surgical/minimally invasive treatments assessed by imaging;
4. Histologically and/or cytologically confirmed malignant solid tumors, including but not limited to colorectal cancer, esophageal cancer, gastric cancer, renal cancer, hepatocellular carcinoma, lung cancer, prostate cancer, pancreatic cancer, breast cancer, thyroid cancer, ovarian cancer, endometrial cancer, cervical cancer, bladder cancer, melanoma, mesothelioma, synovial sarcoma, and cholangiocarcinoma, etc., which require at least two or more measurable foci, with at least one of which meeting the Indications for minimally invasive therapy, advanced patients on first-line or more than first-line therapy, whose therapy must contain immunotherapeutic agents (meaning immune checkpoint inhibitors);
5. ECOG score <2 or KPS score >=70 with an expected survival time of >= 6 months;
6. Patients with good function of major tissues and organs: 1) Liver function: Child-Pugh score <7, 2) Lung function: indoor oxygen saturation >= 95%,3) Cardiac function: left ventricular ejection fraction (LVEF) >= 40%;
7. Laboratory tests within 1 week before enrollment must meet the following criteria: 1) white blood cell (WBC) >= 3.0×10^9/L, platelet (PLT) >= 80×10^9/L, hemoglobin (HB) >=90g/L, neutrophil absolute value (NEU) >=1.5×10^9/L,2) Glutamine aminotransferase (ALT) and alanine aminotransferase (AST) <=2.5×ULN, or ALT and AST <=5×ULN in patients with liver metastases, serum total bilirubin (TBil) <=2.5 ULN,3)Serum creatinine (Cr) <=1.5 × ULN and endogenous creatinine clearance >= 60 mL/min,④ PT International Normalized Ratio (INR) or Prothrombin Time (PT) or Activated Partial Thromboplastin Time (APTT) <= 1.5 x ULN unless the subject is on anticoagulation therapy;
8.Women of childbearing age must confirm a negative serum pregnancy test and agree to use effective contraception for the duration of the study.

排除标准：

1.处于妊娠期或哺乳期女性，或者有妊娠可能的女性在首次治疗前妊娠检测阳性；具有生育能力但不愿意接受避孕措施的患者或其性伴侣不愿意接受避孕措施的；
2.患者入组前4周内患有无法控制的感染性疾病，包括但不限于活动性肺结核、重症肺炎等；幽门螺旋杆菌感染导致的慢性胃炎、HPV导致的慢性妇科炎症，及其他不需要抗感染治疗但与微生物相关的慢性炎症除外；
3.有颅内肿瘤、脊髓压迫或有中枢系统转移瘤，若临床症状稳定并维持至少4 周以上，并且已经停止全身性激素药（剂量>10mg/天的泼尼松或其它等疗效激素）、脱水药等治疗大于4 周的患者可以纳入；
4.未控制的胸腔积液、心包积液，或需要反复引流的腹水（一月一次或更频繁）；
5.影像结果显示≥50%的肝脏被肿瘤占据；或肿瘤大小超过25cm；或门静脉、肠系膜静脉或下腔静脉中存在癌栓，且有脱落风险；
6.有肝性脑病病史或症状；
7.甲状腺功能异常≧3级，药物治疗后功能正常者除外；
8.有脏器衰竭情况，例如NYHA心脏功能IV级，肝功能Child-pugh达到C级，肾脏衰竭或尿毒症，呼吸衰竭症状；
9.存在需要治疗干预的心脏病，或高血压控制不良（收缩压>160 mmHg，或舒张压>100 mmHg）；
10.有器官移植史或目前正在等待器官移植，包括但不限于肝移植；
11.既往血清HCV或HIV或梅毒确证试验阳性（HCV抗体阳性但HCV RNA阴性者可以纳入）；或存在 HBV/HCV共感染；如一个月内相关实验室检查均为阴性，则可入组；
12.患有严重的自身免疫疾病或者免疫缺陷疾病病史且可能随时活动，包括但不限于：葡萄膜炎、炎症性肠病、肝炎、垂体炎、肾炎、甲状腺功能亢进（患有白癜风或在童年期哮喘已完全缓解，成人后无需任何干预的患者可纳入）、ITP、皮肌炎、SLE等；
13.患者在入组前4周内参加过，或仍旧在其他任何临床试验中；
14.患有精神疾病或其他中枢神经系统疾病；
15.患者存在药物滥用/成瘾；
16.入组前4周内接种过任何抗感染疫苗（如流感疫苗、水痘疫苗等）；
17.患者入组前4周内系统性使用糖皮质激素（使用吸入糖皮质激素患者除外）；
18.研究者认为可影响方案依从性，或影响患者签署知情同意书（ICF），或不适宜参加本临床试验的具有临床意义的任何其它疾病或状况。

Exclusion criteria：

1. Women who are pregnant or breastfeeding, or women with the possibility of pregnancy who have a positive pregnancy test prior to the first treatment, patients of childbearing potential who are unwilling to accept contraception or whose sexual partners are unwilling to accept contraception; 2. patients with uncontrollable infectious diseases within 4 weeks prior to enrollment, including but not limited to active tuberculosis, severe pneumonia, etc.,chronic gastritis due to Helicobacter pylori infection, chronic gynecological inflammation due to HPV, and other chronic inflammatory diseases that do not require anti-infective treatment but are associated with microorganisms are excluded; 3. Patients with intracranial tumors, spinal cord compression, or with metastases to the central system may be included if their clinical symptoms are stable and maintained for at least 4 weeks, and treatment with systemic hormonal agents (prednisone at a dose of >10mg/day or other equipotent hormones), or dehydrating agents has been discontinued for >4 weeks; 4. uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage (once a month or more frequently); 5. imaging findings that show >=50% of the liver occupied by a tumor,or tumor size greater than 25 cm, or presence of a cancerous embolus in the portal, mesenteric, or inferior vena cava that is at risk of dislodgement; 6. history or symptoms of hepatic encephalopathy; 7. Abnormal thyroid function >= grade 3, except for normal function after medication; 8. Presence of organ failure, e.g. NYHA Cardiac Function Class IV, Liver Function Child-pugh up to Class C, Renal Failure or Uremia, Respiratory Failure symptoms; 9. presence of cardiac disease requiring therapeutic intervention, or poorly controlled hypertension (systolic blood pressure >160 mmHg, or diastolic blood pressure >100 mmHg); 10. History of organ transplantation or currently awaiting an organ transplant, including but not limited to liver transplantation; 11. previous positive serum HCV or HIV or syphilis confirmatory test (HCV antibody positive but HCV RNA negative can be included), or presence of HBV/HCV co-infection, if all relevant laboratory tests are negative within one month, they can be enrolled; 12. Have a history of severe autoimmune disease or immunodeficiency disease that may be active at any time, including but not limited to: uveitis, inflammatory bowel disease, hepatitis, pituitary gland inflammation, nephritis, hyperthyroidism (patients with vitiligo or asthma that has been completely remitted in childhood and does not require any intervention in adulthood may be enrolled), ITP, dermatomyositis, and SLE; 13. patients who have participated in, or are still in, any other clinical trial within 4 weeks prior to enrollment; 14. the patient has a psychiatric or other central nervous system disorder; 15. the patient has substance abuse/addiction; 16. The patient has received any anti-infective vaccine (e.g., influenza vaccine, varicella vaccine, etc.) within 4 weeks prior to enrollment; 17. Systemic use of glucocorticoids by the patient within 4 weeks prior to enrollment (except for patients using inhaled glucocorticoids); 18. Any other disease or condition of clinical significance that, in the opinion of the investigator, could affect adherence to the regimen, or affect the patient's ability to sign the Informed Consent Form (ICF), or make participation in this clinical trial inappropriate.

研究实施时间：

Study execute time：

从 From 2024-02-01 00:00:00至 To 2026-12-31 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2024-03-07 00:00:00 至 To 2026-12-31 00:00:00

干预措施：

Interventions：

组别：	试验组	样本量：	50
Group：	treatment group	Sample size：	50
干预措施：	等离子体辅助治疗	干预措施代码：
Intervention：	CAP-assisted therapy	Intervention code：

组别：	对照组	样本量：	50
Group：	control group	Sample size：	50
干预措施：	按照指南进行的常规治疗，包括手术、化疗、放疗、靶向治疗、免疫治疗	干预措施代码：
Intervention：	conventional treatments according to guidelines, including surgery, chemotherapy, radiotherapy, targeted therapy, and immunotherapy	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	中国	省(直辖市)：	广东	市(区县)：
Country：	China	Province：	Guangdong	City：
单位(医院)：	深圳市光明区人民医院	单位级别：	三级甲等
Institution hospital：	Shenzhen Guangming District People's Hospital	Level of the institution：	Tertiary A

测量指标：

Outcomes：

指标中文名：	不良事件或严重不良事件	指标类型：	主要指标
Outcome：	Adverse events, serious adverse event	Type：	Primary indicator
测量时间点：	等离子体治疗开始到治疗结束后24月内	测量方法：	不良事件（AE）的总体发生率；3级或以上AE的发生率；严重不良事件（SAE）的发生率；导致无法耐受等离子体治疗的AE发生率；导致终止试验的AE发生率。
Measure time point of outcome：	From the start of CAP treatment to 24 months after the end of CAP treatment	Measure method：	The overall incidence of adverse events (AEs); incidence of grade 3 or higher AEs; incidence of serious adverse events (SAEs); incidence of AEs leading to intolerance of plasma therapy; incidence of AEs leading to termination of the trial.

指标中文名：	客观缓解率	指标类型：	次要指标
Outcome：	Objective remission rate	Type：	Secondary indicator
测量时间点：	治疗后第1、3、6、9、12、18、24月	测量方法：	影像学评估，依据RECIST 1.1标准或iRECIST标准评估肿瘤疾病状态。
Measure time point of outcome：	The 1st, 3rd, 6th, 9th, 12th, 18th, and 24th months after treatment	Measure method：	Imaging evaluation to assess tumor disease status based on RECIST 1.1 criteria or iRECIST criteria.

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：	治疗后第1、3、6、9、12、18、24月	测量方法：	从等离子体治疗开始到患者死亡的时间
Measure time point of outcome：	The 1st, 3rd, 6th, 9th, 12th, 18th, and 24th months after treatment	Measure method：	Time from the date of CAP treatment to the patient's death

指标中文名：	无进展生存期	指标类型：	次要指标
Outcome：	progression-free survival	Type：	Secondary indicator
测量时间点：	治疗后第1、3、6、9、12、18、24	测量方法：	影像学评估，依据RECIST 1.1标准或iRECIST标准评估肿瘤进展时间
Measure time point of outcome：	The 1st, 3rd, 6th, 9th, 12th, 18th, and 24th months after treatment	Measure method：	Imaging evaluation, assessing tumor progression time based on RECIST 1.1 or iRECIST criteria

指标中文名：	无疾病生存期	指标类型：	次要指标
Outcome：	disease-free survival	Type：	Secondary indicator
测量时间点：	治疗后第1、3、6、9、12、18、24月	测量方法：	影像学评估肿瘤复发时间
Measure time point of outcome：	The 1st, 3rd, 6th, 9th, 12th, 18th, and 24th months after treatment	Measure method：	Imaging assessment of tumor recurrence time

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：	治疗后第1、3、6、9、12、18、24月	测量方法：	影像学评估，依据RECIST 1.1标准或iRECIST标准评估肿瘤疾病状态，计算比例
Measure time point of outcome：	The 1st, 3rd, 6th, 9th, 12th, 18th, and 24th months after treatment	Measure method：	Imaging assessment, evaluating tumor disease status based on RECIST 1.1 or iRECIST criteria, and calculating the proportion

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：	外周血	组织：
Sample Name：	peripheral 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：	肿瘤组织	组织：
Sample Name：	Tumor 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	70	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	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）：	2025年9月通过学术交流或合作，共享原始数据，仅限于原始记录的纸质数据和报告内容
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	September of 2025. Share raw data through academic exchange or collaboration, limited to paper data and report content of raw records only
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，电子病历
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	Medical record form AND electronic medical record
数据与安全监察委员会： Data and Safety Monitoring Committee：	无/No
注册人： Name of Registration：	2024-08-26 15:09:23