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：	ChiCTR2600118379
最近更新日期： Date of Last Refreshed on：	2026-02-04 16:47:40
注册时间： Date of Registration：	2026-02-04 00:00:00
注册号状态：	补注册
Registration Status：	Retrospective registration
注册题目：	腔内灌注阿得贝利单抗联合最佳治疗方案治疗胰腺癌伴胸腹腔积液的单中心、前瞻性临床研究
Public title：	Intracavitary Infusion of Adebrelimab combined with the best standard treatment for the Treatment of Pancreatic Cancer with Pleural and Peritoneal Effusions: A Single-center, Prospective, Clinical Trial
注册题目简写：
English Acronym：
研究课题的正式科学名称：	腔内灌注阿得贝利单抗联合最佳治疗方案治疗胰腺癌伴胸腹腔积液的单中心、前瞻性临床研究
Scientific title：	Intracavitary Infusion of Adebrelimab combined with the best standard treatment for the Treatment of Pancreatic Cancer with Pleural and Peritoneal Effusions: A Single-center, Prospective, Clinical Trial
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：	陈超	研究负责人：	褚晓源,刘秀峰
Applicant：	Chao Chen	Study leader：	Xiaoyuan Chu, Xiufeng Liu
申请注册联系人电话： Applicant telephone：	+86 156 5658 9583	研究负责人电话： Study leader's telephone：	+86 159 5057 9776
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：	zhuzihao000102@163.com	研究负责人电子邮件： Study leader's E-mail：	njjloncologycc@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：	江苏省南京市鼓楼区中央路19号	研究负责人通讯地址：	江苏省南京中山东路305号
Applicant address：	No. 19, Zhongyang Road, Gulou District, Nanjing, Jiangsu Province, China	Study leader's address：	No. 305 Zhongshan East Road, 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：	江苏恒瑞医药股份有限公司
Applicant's institution：	Jiangsu Hengrui Pharmaceuticals Co., Ltd.
研究负责人所在单位：	中国人民解放军东部战区总医院
Affiliation of the Leader：	Eastern Theater General Hospital of the Chinese People's Liberation Army

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：	DZQH-KYLLFS-25-19	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：	中国人民解放军东部战区总医院临床研究伦理委员会
Name of the ethic committee：	Ethics Committee of Clinical Research, Eastern Theater General Hospital of the Chinese People's Liberation Army
伦理委员会批准日期： Date of approved by ethic committee：	2025-07-29 00:00:00
伦理委员会联系人：	吴琼
Contact Name of the ethic committee：	Qiong Wu
伦理委员会联系地址：	江苏省南京中山东路305号
Contact Address of the ethic committee：	No. 305 Zhongshan East Road, Nanjing, Jiangsu Province
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 25 8086 3234	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：

中国人民解放军东部战区总医院

Primary sponsor：

Eastern Theater General Hospital of the Chinese People's Liberation Army

研究实施负责（组长）单位地址：

江苏省南京中山东路305号

Primary sponsor's address：

No. 305 Zhongshan East Road, 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)：	江苏省	市(区县)：
Country：	China	Province：	Jiangsu Province	City：
单位(医院)：	中国人民解放军东部战区总医院	具体地址：	江苏省南京中山东路305号
Institution hospital：	Eastern Theater General Hospital of the Chinese People's Liberation Army	Address：	No. 305 Zhongshan East Road, Nanjing, Jiangsu Province

经费或物资来源：

本试验所有的阿得贝利单抗均由江苏恒瑞医药股份有限公司免费提供

Source(s) of funding：

All adebrelimab used in this trial is provided free of charge by Jiangsu Hengrui Pharmaceuticals Co., Ltd.

研究疾病：

胰腺癌

Target disease：

Pancreatic 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：

本研究主要目的在于观察和评价腔内灌注阿得贝利单抗联合研究者选择的最佳治疗方案治疗胰腺癌伴胸腹腔积液患者的安全性和有效性。

Objectives of Study：

The primary objective of this study is to observe and evaluate the safety and efficacy of intraluminal perfusion of adebrelimab in combination with the investigator’s choice of best treatment regimen in patients with pancreatic cancer accompanied by pleural or peritoneal effusion.

药物成份或治疗方案详述：

本研究拟入组20例年龄≥18岁、经组织学或细胞学确诊为胰腺癌，且合并恶性胸腔积液或腹腔积液的患者。入组标准包括胸腔积液或腹腔积液细胞学明确为恶性，且胸腔积液为中等及以上（≥4 cm），根据RECIST1.1标准至少有1个可测量病灶，ECOG评分为0–3。所有患者将接受阿得贝利单抗600 mg于D2、D8胸/腹腔内注入，Q4W，联合研究者选择的最佳治疗方案，直至疾病进展且研究者认为继续治疗不再有临床获益或毒性不可耐受为止。本研究的主要终点为总生存期（OS），次要终点包括无进展生存期（PFS）、胸腹水控制率及安全性。

Description for medicine or protocol of treatment in detail：

This study plans to enroll 20 patients aged ≥18 years who are histologically or cytologically confirmed with pancreatic cancer complicated by malignant pleural or peritoneal effusion. Eligibility criteria include cytological confirmation of malignancy in pleural or peritoneal effusion, pleural effusion of at least moderate degree (≥4 cm), at least one measurable lesion according to RECIST 1.1 criteria, and an ECOG performance status of 0–3. All patients will receive intrapleural or intraperitoneal administration of adebrelimab 600 mg on days 2 and 8, every 4 weeks, in combination with the investigator’s choice of best treatment regimen, until disease progression and the investigator considers further treatment to provide no additional clinical benefit or toxicity becomes intolerable. The primary endpoint of this study is overall survival (OS), and secondary endpoints include progression-free survival (PFS), control rate of pleural/peritoneal effusion, and safety.

纳入标准：

Inclusion criteria

1.Age: above 18 years;
2.Subjects with pancreatic cancer confirmed by histology/cytology;
3.For tumor-related pleural or peritoneal effusion, hemorrhagic pleural or peritoneal effusion, the pathology or cytology of pleural/peritoneal effusion must confirm malignancy, and the pleural/peritoneal effusion must be moderate or above (>=4 cm), with clinical judgment indicating the need for intervention.
4.At least one measurable lesion according to RECIST 1.1 criteria;
5.ECOG performance status: 0–3;
6.Expected survival >= 2 months;
7.Major organ function must be normal, meeting the following criteria:
1)Hematology test criteria (no blood transfusion or blood products within 14 days, and no use of G-CSF or other hematopoietic stimulating factors for correction):
HB >= 80 g/L;
ANC >= 1.0 × 10⁹/L;
PLT >= 50 × 10⁹/L;
2)Biochemical test criteria:
TBIL < 3 × ULN;
ALT and AST < 5 × ULN;
Serum creatinine <= 1.25 × ULN or creatinine clearance > 45 ml/min (Cockcroft-Gault formula);
8.Subjects with chronic HBV infection must receive antiviral therapy, and HBV DNA must be < 10,000 IU/mL;
9.Women of childbearing potential must have taken reliable contraceptive measures or have a negative pregnancy test (serum or urine) within 7 days prior to enrollment, and must agree to use appropriate contraception during the study and for 8 weeks after the last dose of the investigational drug. Male subjects must agree to use appropriate contraception or have undergone surgical sterilization during the study and for 8 weeks after the last dose of the investigational drug;
10.Subjects must voluntarily participate in this study, sign the informed consent form, have good compliance, and be willing to cooperate with follow-up.

排除标准：

1. 无症状胸腹腔积液且不需要临床干预； 2. 有穿刺治疗禁忌症； 3. 存在免疫治疗禁忌症（包括长期服用激素、放射性肺炎、放射性肝炎、放射性肠炎病史等）； 4. 活动性自身免疫性疾病（如白癜风，银屑病，需要激素替代治疗的甲状腺功能减退等）； 5. 乙肝合并有丙肝、活动性丙型肝炎、HIV、梅毒感染、活动性肺结核等患者； 6. 处于活动期或临床控制不佳的严重感染。在首次给药前4周内有重度感染，包括但不限于因感染、菌血症或重度肺炎并发症而住院治疗； 7. 已知异体器官移植史和自体造血干细胞移植史； 8. 既往和目前有肺纤维化史、间质性肺炎、尘肺、药物相关肺炎、肺功能严重受损等肺部疾病； 9. 具有精神类药物滥用史且无法戒除者或有精神障碍的； 10. 前4周内参加过其他抗肿瘤药物临床试验的； 11. 胸腹腔使用过PD-1/PD-L1单抗及其他免疫治疗药物的； 12. 合并未能控制的中枢神经系统转移，具有颅高压表现； 13. 具有出血倾向，特别是4周内出现过明显的消化道出血；或正在接受溶栓或抗凝治疗； 14. 既往或同时患有其它未治愈的恶性肿瘤，已治愈的皮肤基底细胞癌、宫颈原位癌和浅表性膀胱癌除外； 15. 怀孕或哺乳期妇女；有生育能力的患者不愿或无法采取有效的避孕措施者； 16. 研究者判断其他可能影响临床研究进行及研究结果判定的情况。

Exclusion criteria：

1.Asymptomatic pleural or peritoneal effusion that does not require clinical intervention; 2.Contraindications to puncture therapy; 3.Contraindications to immunotherapy (including long-term use of corticosteroids, history of radiation pneumonitis, radiation hepatitis, radiation enteritis, etc.); 4.Active autoimmune diseases (such as vitiligo, psoriasis, hypothyroidism requiring hormone replacement therapy, etc.); 5.Patients with hepatitis B combined with hepatitis C, active hepatitis C, HIV, syphilis infection, or active tuberculosis; 6.Severe active infections that are uncontrolled. Severe infections within 4 weeks prior to the first dose, including but not limited to hospitalization due to infection, bacteremia, or severe pneumonia complications; 7.Known history of allogeneic organ transplantation or autologous hematopoietic stem cell transplantation; 8.Past or current history of pulmonary diseases such as pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, drug-related pneumonitis, or severely impaired lung function; 9.History of psychiatric drug abuse that cannot be discontinued or psychiatric disorders; 10.Participation in another clinical trial involving anti-tumor drugs within 4 weeks prior; 11.Prior use of PD-1/PD-L1 monoclonal antibodies or other immunotherapy drugs via intrapleural/intraperitoneal administration; 12.Uncontrolled central nervous system metastases with manifestations of intracranial hypertension; 13.Bleeding tendency, especially significant gastrointestinal bleeding within 4 weeks; or currently receiving thrombolytic or anticoagulant therapy; 14.History of or concurrent untreated malignancies, except for cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, and superficial bladder cancer; 15.Pregnant or lactating women; patients of childbearing potential who are unwilling or unable to adopt effective contraceptive measures; 16.Any other conditions deemed by the investigator as potentially affecting the conduct of the clinical study or the interpretation of study results.

研究实施时间：

Study execute time：

从 From 2025-11-04 00:00:00至 To 2028-06-30 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2025-11-04 00:00:00 至 To 2027-06-30 00:00:00

干预措施：

Interventions：

组别：	单臂	样本量：	20
Group：	single-arm	Sample size：	20
干预措施：	腔内灌注阿得贝利单抗+研究者选择的最佳治疗方案	干预措施代码：
Intervention：	Intraluminal perfusion of adebrelimab+investigator’s choice of best treatment regimen	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	中国	省(直辖市)：	江苏省	市(区县)：
Country：	China	Province：	Jiangsu Province	City：
单位(医院)：	中国人民解放军东部战区总医院	单位级别：	三甲
Institution hospital：	Eastern Theater General Hospital of the Chinese People's Liberation Army	Level of the institution：	Tertiary A

测量指标：

Outcomes：

指标中文名：	总生存期	指标类型：	主要指标
Outcome：	Overall Survival	Type：	Primary indicator
测量时间点：		测量方法：	从随机化/入组日期起至受试者死亡的时间，以日期计算；仍存活者或失访者取最后一次随访日期进行截尾。
Measure time point of outcome：		Measure method：	Time from randomization/enrollment to death from any cause. Patients still alive or lost to follow-up will be censored at the date of last follow-up.

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：	根据RECIST 1.1标准，由研究者评估达到完全缓解（CR）或部分缓解（PR）的受试者所占比例
Measure time point of outcome：		Measure method：	The proportion of patients achieving complete response (CR) or partial response (PR) as assessed by the investigator according to RECIST 1.1 criteria.

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：		测量方法：	从入组日期至影像学确认的疾病进展（根据RECIST 1.1标准）或死亡（任一原因）之间的时间；若未发生进展或死亡，则在最后一次无进展评估日期截尾。
Measure time point of outcome：		Measure method：	Time from enrollment to the date of radiologically confirmed disease progression (per RECIST 1.1) or death from any cause, whichever occurs first. Patients without progression or death will be censored at the date of last disease assessment.

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：	根据RECIST 1.1标准，由研究者评估达到完全缓解（CR）、部分缓解（PR）或疾病稳定（SD）的受试者所占比例。
Measure time point of outcome：		Measure method：	The proportion of patients achieving complete response (CR), partial response (PR), or stable disease (SD) as assessed by the investigator according to RECIST 1.1 criteria.

指标中文名：	无穿刺中位生存期	指标类型：	次要指标
Outcome：	Puncture free survival	Type：	Secondary indicator
测量时间点：		测量方法：	从最后一次给药日期起至因胸/腹腔积液需要再次行穿刺抽取或死亡（任一原因）的时间；若未发生事件，则在最后一次随访日期截尾
Measure time point of outcome：		Measure method：	Time from the last dose of study treatment to the date of re-intervention with thoracentesis/paracentesis for pleural/peritoneal effusion or death from any cause, whichever occurs first. Patients without an event will be censored at the date of last follow-up.

指标中文名：	胸腹水控制率	指标类型：	次要指标
Outcome：	Control rate of pleural/peritoneal effusion	Type：	Secondary indicator
测量时间点：		测量方法：	基线评估在入组前3日内完成；治疗期间首次疗效评估在第1疗程结束后、第2疗程开始前3日内进行，第2疗程结束后再次评估，此后每3周评估一次，直至疾病进展（PD）。对于胸腹水客观缓解（CR或PR）的患者，须在首次记录缓解后不少于4周（推荐4–6周）进行复核确认。影像学检查时间可在计划日的±3天内完成（7天窗口期）。胸腹腔积液容量采用彩色超声测量
Measure time point of outcome：		Measure method：	Baseline assessment will be conducted within 3 days prior to enrollment. During treatment, the first efficacy evaluation will be performed within 3 days after completion of cycle 1 and before initiation of cycle 2, with a second evaluation after cycle 2, and subsequently every 3 weeks until disease progression (PD). For patients achieving objective response (CR or PR) of pleural/peritoneal effusion, confirmation must be performed at least 4 weeks (preferably 4–6 weeks) after the initial document

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：	通过记录受试者在治疗期间及随访期内发生的不良事件（AE）和严重不良事件（SAE），并依据NCI-CTCAE（最新版）进行分级，评价治疗的安全性和耐受性。实验室检查、生命体征、体格检查及影像学检查用于辅助安全性评价。
Measure time point of outcome：		Measure method：	Safety will be evaluated by recording adverse events (AEs) and serious adverse events (SAEs) occurring during treatment and follow-up, graded according to the latest version of NCI-CTCAE. Laboratory tests, vital signs, physical examinations, and imaging assessments will be used as supportive measures for safety evaluation.

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：	无	组织：
Sample Name：	N/A	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)：

N/A

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：	N/A
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）：	论文发表后半年内，国家生物信息中心https://www.cncb.ac.cn/。
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	Within six months after the paper is published, the National Center for Bioinformation https://www.cncb.ac.cn/.
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：	本研究的数据采集和管理将通过Excel表格完成。表格将包括病人的基本信息、治疗数据以及随访记录等。数据将在研究结束后进行整理，并通过共享链接进行公开。数据的管理和共享符合相关的规范和要求。如果需要使用电子数据采集（EDC）系统，所有数据将迁移至适当的EDC平台（例如ResMan）进行管理。具体使用的平台和访问方式将在研究结束时提供。
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	Data collection and management for this study will be carried out using Excel spreadsheets. The spreadsheets will include patient information, treatment data, follow-up records, etc. The data will be organized and shared publicly via a link after the study concludes. Data management and sharing will comply with relevant regulations and requirements. If an Electronic Data Capture (EDC) system is required, all data will be migrated to the appropriate EDC platform (e.g., ResMan) for management. The specific platform and access details will be provided upon study completion.
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：	2026-02-04 16:47:32