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：	ChiCTR2500097805
最近更新日期： Date of Last Refreshed on：	2025-02-26 08:46:49
注册时间： Date of Registration：	2025-02-26 00:00:00
注册号状态：	补注册
Registration Status：	Retrospective registration
注册题目：	重组人5型腺病毒注射液（安柯瑞）胸腔内灌注治疗恶性胸腔积液的探索性临床研究
Public title：	Exploratory clinical study on intrathoracic infusion of recombinant human adenovirus type 5 injection (Ankerui) for the treatment of malignant pleural effusion
注册题目简写：
English Acronym：
研究课题的正式科学名称：	重组人5型腺病毒注射液（安柯瑞）胸腔内灌注治疗恶性胸腔积液的探索性临床研究
Scientific title：	Exploratory clinical study on intrathoracic infusion of recombinant human adenovirus type 5 injection (Ankerui) for the treatment of malignant pleural effusion
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：	陈映霞	研究负责人：	陈映霞
Applicant：	Yingxia Chen	Study leader：	Yingxia Chen
申请注册联系人电话： Applicant telephone：	+86 13584061929	研究负责人电话： Study leader's telephone：	+86 25 69023999
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：	chenyingxiacsco@qq.com	研究负责人电子邮件： Study leader's E-mail：	chenyingxiacsco@qq.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：	南京市江宁区吉印大道3789号	研究负责人通讯地址：	南京市江宁区吉印大道3789号
Applicant address：	No. 3789 Jiyin Avenue, Jiangning District, Nanjing City	Study leader's address：	No.3789, Jiyin Avenue, Jiangning District, Nanjing, Jiangsu 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：	南京天印山医院
Applicant's institution：	Nanjing Tianyinshan Hospital
研究负责人所在单位：	南京天印山医院
Affiliation of the Leader：	Nanjing Tianyinshan 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：	E2024-007-01	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：	南京天印山医院医学伦理委员会
Name of the ethic committee：	Medical Ethics Committee of Nanjing Tianyinshan Hospital
伦理委员会批准日期： Date of approved by ethic committee：	2024-11-08 00:00:00
伦理委员会联系人：	赵宁莉
Contact Name of the ethic committee：	Ningli Zhao
伦理委员会联系地址：	南京市江宁区吉印大道3789号
Contact Address of the ethic committee：	No.3789, Jiyin Avenue, Jiangning District, Nanjing, Jiangsu Province
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 25 83086021	伦理委员会联系人邮箱： Contact email of the ethic committee：	506294655@qq.com

研究实施负责（组长）单位：

南京天印山医院

Primary sponsor：

Nanjing Tianyinshan Hospital

研究实施负责（组长）单位地址：

南京市江宁区吉印大道3789号

Primary sponsor's address：

No.3789, Jiyin Avenue, Jiangning District, Nanjing, Jiangsu 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)：	江苏	市(区县)：
Country：	China	Province：	Jiangsu	City：
单位(医院)：	南京天印山医院	具体地址：	南京市江宁区吉印大道3789号
Institution hospital：	Nanjing Tianyinshan Hospital	Address：	No.3789, Jiyin Avenue, Jiangning District, Nanjing, Jiangsu Province

经费或物资来源：

上海三维生物技术有限公司

Source(s) of funding：

Shanghai Sunway Biotech Co., Ltd

研究疾病：

恶性胸腔积液

Target disease：

Malignant pleural effusion

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：

评估重组人5型腺病毒注射液（安柯瑞）胸腔内灌注治疗恶性胸腔积液的安全性、有效性。

Objectives of Study：

Evaluate the safety and efficacy of intrathoracic infusion of recombinant human adenovirus type 5 injection (Ankerui) for the treatment of malignant pleural effusion

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. Voluntarily participate, sign the informed consent form, and have good compliance, and be able to cooperate with diagnosis and treatment and follow-up;
2. Age>=18 years old, male or female;
3. Subjects with malignant tumors confirmed by histopathological and/or cytological examination, pleural effusion must be confirmed by pathology (malignant cells are found in cell precipitation, or pathological changes of malignant tumors are observed in pleural biopsy tissues) or clinically diagnosed as malignant pleural effusion;
4. Have a moderate amount or above of pleural effusion, and clinical judgment requires local treatment for pleural effusion; Definition of moderate effusion and above: maximum depth of pleural effusion >=4 cm on sitting B-ultrasound, or >=500 mL as assessed by CT pleural effusion;
5. Physical condition: ECOG PS<=2 points;
6. Estimated survival >=3 months;
7. The function of the main organs is basically normal, and the laboratory examination meets the following criteria: a) Absolute hematological neutrophil count >=1.5×10^9/L, platelet >=75×109/L, hemoglobin >=80 g/L. b) Renal serum creatinine <=2.0 times ULN and creatinine clearance (CrCl) > 50 mL/min (calculated using the Cockroft Gault formula [see Appendix 2]). c) Liver serum total bilirubin <2×ULN; Subjects without liver metastases: AST and ALT<2.5×ULN; Liver metastases Subjects: AST and ALT<5×ULN; d) International normalized ratio (INR) or prothrombin time (PT) of coagulation function <1.5×ULN, if the subject is receiving anticoagulation therapy, the coagulation index needs to be within the intended range of anticoagulant drugs, and the investigator needs to evaluate that it will not increase the risk of participating in this study to undergo thoracentesis catheterization;
8. Female subjects of childbearing potential with a negative serum pregnancy test within 7 days prior to the start of the study; Female/male subjects of childbearing potential must be willing to practice a reliable method of contraception throughout the study period (screening period to 90 days after the last dose of study drug), including but not limited to: abstinence, male partner has undergone vasectomy, female sterilization surgery, effective intrauterine device, and effective contraceptives.

排除标准：

1.正在参与或首次给药前4周内参加过其他临床研究并接受了研究治疗; 2.首次给药前14天内接受过全身性化疗或接受过胸腔灌注药物治疗者，若受试者在近期抗肿瘤治疗过程中未发生过严重的AE（3/4级），或筛选期已经恢复到≤2级，经研究者评估，受试者一般情况稳定时，洗脱期最短可为7天。已有的其他全身性治疗（如定期使用的靶向药物、内分泌治疗药物等）不需洗脱； 3.伴有前期治疗未恢复的>1级的AE，除非部分2级未恢复的AE经研究者判断症状稳定，且不影响受试者参与本研究的安全性，如脱发等; 4.存在胸腔穿刺禁忌症者或计划治疗侧为包裹性积液; 5.首次用药前6个月内发生过动/静脉血栓事件，如脑血管意外（包括缺血性脑卒中及脑出血等）、深静脉血栓及肺栓塞等; 6.有严重的心脑血管疾病史，包括但不限于：6个月内出现过心肌梗塞，或目前存在不稳定性心绞痛、心律失常等；美国纽约心脏协会（NYHA）心功能分级>=II级的充血性心力衰竭； 7.未控制的原发性脑瘤或中枢神经转移瘤受试者，具有明显的颅内高压症或神经精神症状，或有其它证据证明受试者中枢神经系统转移尚未控制，研究者判断不适合入组。以下情况可参加本研究：受试者在研究入组前>4周完成了中枢神经系统转移的放疗或手术，且受试者的神经系统稳定>=4周; 8.患有不易控制的神经精神疾病、精神障碍或存在药物滥用情况，可能影响研究依从性; 9.存在需要全身性治疗的活动性感染（病毒、真菌或细菌），乙型肝炎和/或丙型肝炎阳性者除外; 10.已知有人类免疫缺陷病毒（HIV）感染史; 11.有同类生物制剂过敏史者，例如使用腺病毒载体疫苗过敏; 12.妊娠期或哺乳期女性受试者; 13.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; 14.存在有可能干扰研究结果、妨碍受试者全程参与研究的病史或疾病、治疗或实验室异常，或研究者认为参与研究不符合受试者的最大利益。

Exclusion criteria：

1.Have participated in other clinical studies and received study treatment within 4 weeks prior to or during the first administration of medication; 2.If the subject has received systemic chemotherapy or thoracic perfusion drug treatment within 14 days before the first administration, and has not experienced severe adverse events (grade 3/4) during recent anti-tumor treatment, or has recovered to ≤ grade 2 during the screening period, and the subject's general condition is stable according to the researcher's evaluation, the shortest washout period can be 7 days. Existing systemic treatments (such as regularly used targeted drugs, endocrine therapy drugs, etc.) do not require elution; 3.AE with a grade greater than 1 that has not recovered from previous treatment, unless some AE with a grade 2 that has not recovered has been judged by the researcher to have stable symptoms and does not affect the safety of participants in this study, such as hair loss; 4.Patients with contraindications for thoracentesis or those with encapsulated fluid on the planned treatment side; 5.Within 6 months prior to the first use of medication, there have been incidents of arterial/venous thrombosis, such as cerebrovascular accidents (including ischemic stroke and cerebral hemorrhage), deep vein thrombosis, and pulmonary embolism; 6.Has a serious history of cardiovascular and cerebrovascular diseases, including but not limited to: having experienced myocardial infarction within 6 months, or currently having unstable angina, arrhythmia, etc; Congestive heart failure with NYHA functional class >= II; 7.Subjects with uncontrolled primary brain tumors or central nervous system metastases who exhibit significant intracranial hypertension or neurological symptoms, or have other evidence of uncontrolled central nervous system metastases, are deemed unsuitable for inclusion by the researchers. The following situations are eligible to participate in this study: subjects who have completed radiotherapy or surgery for central nervous system metastasis more than 4 weeks before enrollment, and whose nervous system has been stable for >= 4 weeks; 8.Suffering from uncontrollable neurological and psychiatric disorders, mental disorders, or substance abuse that may affect research compliance; 9.There are active infections (viruses, fungi, or bacteria) that require systemic treatment, except for those who are positive for hepatitis B and/or C; 10.Known history of human immunodeficiency virus (HIV) infection; 11.Individuals with a history of allergies to similar biological agents, such as those allergic to adenovirus vector vaccines; 12.Pregnant or lactating female subjects; 13.The subject has known activity or suspected autoimmune disease. Allow subjects who are in a stable state and do not require systemic immunosuppressive therapy to be enrolled; 14.There are medical histories or diseases, treatments or laboratory abnormalities that may interfere with the research results, hinder the full participation of the subjects in the study, or the researchers believe that participating in the study is not in the best interests of the subjects.

研究实施时间：

Study execute time：

从 From 2024-11-11 00:00:00至 To 2025-11-28 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2024-11-11 00:00:00 至 To 2025-11-28 00:00:00

干预措施：

Interventions：

组别：	重组人5型腺病毒注射液	样本量：	12
Group：	Recombinant human adenovirus type 5 injection	Sample size：	12
干预措施：	受试者于第1 天、第 3 天和第 5 天接受安柯瑞给药，给药剂量为 3 支/次（约 1.5×10^12 vp/次）。研究者可根据受试者的一般情况及病情程度评估是否增加给药剂量至 4 支/次（约 2.0 ×10^12 vp/次），每次给药前可根据受试者情况尽量引流胸腔积液。	干预措施代码：
Intervention：	Subjects were administered by Ankerex on Day 1, Day 3 and Day 5 at a dose of 3 sticks/time (approximately 1.5×10^12 VP/time). The investigator can assess whether to increase the dose to 4 sticks per dose (approximately 2.0) according to the subject's general condition and the extent of the disease×10^12 VP/time), the pleural effusion can be drained as much as possible according to the subject's condition before each dose.	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	中国	省(直辖市)：	江苏	市(区县)：
Country：	China	Province：	Jiangsu	City：
单位(医院)：	南京天印山医院	单位级别：	三甲
Institution hospital：	NANJING TIANYINSHAN HOSPITAL	Level of the institution：	Tertiary A

国家：	中国	省(直辖市)：	江西	市(区县)：
Country：	China	Province：	Jiangxi	City：
单位(医院)：	南昌大学第一附属医院	单位级别：	三级甲等
Institution hospital：	The First Affiliated Hospital of Nanchang University	Level of the institution：	Tertiary A

测量指标：

Outcomes：

指标中文名：	安全性	指标类型：	主要指标
Outcome：	Safety	Type：	Primary indicator
测量时间点：	筛选期、治疗期（D1、D3、D5、D15）、末次给药后28天	测量方法：	生命体征、体格检查、ECOG PS、ECG 和实验室检查等
Measure time point of outcome：	Screening period, treatment period (D1, D3, D5, D15), 28 days after the last administration	Measure method：	Vital signs, physical examination, ECOG PS, ECG, and laboratory tests, etc

指标中文名：	前60天内穿刺引流发生频率	指标类型：	次要指标
Outcome：	Frequency of puncture drainage within the first 60 days	Type：	Secondary indicator
测量时间点：	60天内需要治疗时	测量方法：	计算穿刺引流发生次数
Measure time point of outcome：	When treatment is needed within 60 days	Measure method：	Calculate the number of occurrences of puncture drainage

指标中文名：	至重复穿刺时间（TTRP）	指标类型：	次要指标
Outcome：	Time to Repeat Puncture (TTRP)	Type：	Secondary indicator
测量时间点：	末次给药后28天	测量方法：	CT或B超检查
Measure time point of outcome：	28 days after the last administration	Measure method：	CT or B-ultrasound examination

指标中文名：	3个月总生存率	指标类型：	次要指标
Outcome：	3-month overall survival rate	Type：	Secondary indicator
测量时间点：	安全性随访（末次给药后28天）后每30（±7天）	测量方法：	生存随访
Measure time point of outcome：	Safety follow-up (28 days after last administration) every 30 (± 7 days)	Measure method：	Survival follow-up

指标中文名：	胸腔积液客观缓解率	指标类型：	次要指标
Outcome：	Objective relief rate of pleural effusion	Type：	Secondary indicator
测量时间点：	末次给药后28天（+5天）	测量方法：	CT或B超检查
Measure time point of outcome：	28 days (+5 days) after the last administration	Measure method：	CT or B-ultrasound examination

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：	无	组织：
Sample Name：	NA	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：

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)：

NA

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）：	论文发表后6个月内，ResMan, http://www.medresman.org.cn/login.aspx。
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	Within 6 months of publication, ResMan, http://www.medresman.org.cn/login.aspx.
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：	病例记录表
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：	无/No
注册人： Name of Registration：	2025-02-26 08:46:34