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：	ChiCTR2600127189
最近更新日期： Date of Last Refreshed on：	2026-06-26 11:27:15
注册时间： Date of Registration：	2026-06-26 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	一项评估WSK-IM02在伴恶性胸/腹腔积液的晚期实体瘤患者中安全性及初步疗效的单臂、开放、前瞻性I期临床研究
Public title：	A Single-Arm, Open-Label, Prospective Phase I Clinical Study to Evaluate the Safety and Preliminary Efficacy of WSK-IM02 in Patients with Advanced Solid Tumors Complicated by Malignant Pleural or Peritoneal Effusions
注册题目简写：
English Acronym：
研究课题的正式科学名称：	一项评估WSK-IM02在伴恶性胸/腹腔积液的晚期实体瘤患者中安全性及初步疗效的单臂、开放、前瞻性I期临床研究
Scientific title：	A Single-Arm, Open-Label, Prospective Phase I Clinical Study to Evaluate the Safety and Preliminary Efficacy of WSK-IM02 in Patients with Advanced Solid Tumors Complicated by Malignant Pleural or Peritoneal Effusions
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：	刘廷	研究负责人：	石华山
Applicant：	Liu Ting	Study leader：	Huashan Shi
申请注册联系人电话： Applicant telephone：	+86 19182843926	研究负责人电话： Study leader's telephone：	+86 18980606519
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：	1924658083@qq.com	研究负责人电子邮件： Study leader's E-mail：	shihuashan@scu.edu.cn
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：	成都市外南国学巷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：	37 Guoxue Alley, Wuhou District, Chengdu, Sichuan Province	Study leader's address：	#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 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：	2026年审(883)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：	Ethics Committee on Biomedical Research West China Hospital of Sichuan University
伦理委员会批准日期： Date of approved by ethic committee：	2026-04-23 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：	四川省成都市武侯区国学巷37号
Contact Address of the ethic committee：	#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 85422654	伦理委员会联系人邮箱： Contact email of the ethic committee：	188974152@qq.com

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：

四川省成都市武侯区国学巷37号

Primary sponsor's address：

#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 of Sichuan University	Address：	#37 Guoxue Lane, Wuhou District, Chengdu City, Sichuan Province

经费或物资来源：

2025YCZD172

Source(s) of funding：

2025YCZD172

研究疾病：

经病理组织学或细胞学确诊的晚期实体瘤患者（包括但不限于肺癌、胃癌、卵巢癌、乳腺癌、胰腺癌等）。

Target disease：

Patients with advanced solid tumors confirmed by histopathology or cytology (including but not limited to lung cancer, gastric cancer, ovarian cancer, breast cancer, pancreatic cancer, etc.).

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期临床试验

Study phase：

1

研究设计：

单臂

Study design：

Single arm

研究目的：

评价WSK-IM02在伴标准治疗失败的恶性胸/腹腔积液的晚期实体瘤患者中的安全性及耐受性

Objectives of Study：

To evaluate the safety and tolerability of WSK-IM02 in patients with advanced solid tumors and malignant pleural or peritoneal effusions refractory to standard therapy

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. Age >=18 years and <=75 years.
2. Voluntarily sign the informed consent form.
3. Patients with advanced solid tumors confirmed by histopathology or cytology (including but not limited to lung cancer, gastric cancer, ovarian cancer, breast cancer, pancreatic cancer, etc.).
4. Histologically or cytologically confirmed malignant pleural/ascitic effusion requiring drainage; or, in the absence of histological/cytological evidence, pleural effusion with clear imaging evidence of malignant pleural/peritoneal lesions on chest/abdominal CT and clinically diagnosed as malignant pleural/peritoneal effusion.
5. Have received standard systemic therapy and present with clinical symptoms due to serosal cavity metastasis.
6. ECOG performance status: 0–2; patients with ECOG 3 may be enrolled if the investigator believes that resolution of pleural effusion could improve the score to 2 or above.
7. Expected survival >=3 months.
8. Adequate major organ function, meeting the following criteria from laboratory tests within 14 days prior to treatment:;
9. Hematology (no blood transfusion or hematopoietic growth factor support within 14 days): Absolute neutrophil count (NEUT) >=1.5×10⁹/L; Platelet count (PLT) >=80×10⁹/L; Hemoglobin (Hb) >=80 g/L.
10. Liver function: Alanine aminotransferase (ALT) <=2.5 × ULN; Aspartate aminotransferase (AST) <=2.5 × ULN; if liver metastases present, ALT and AST <=5 × ULN.
11. Renal function: Serum creatinine (Cr) <=1.5 × ULN or creatinine clearance (Ccr) >50 mL/min.
12. Coagulation function: Activated partial thromboplastin time (APTT) <=1.5 × ULN; International normalized ratio (INR) <=1.5 × ULN.
13. Subjects of childbearing potential (both male and female) must agree to use highly effective contraceptive measures from the time of signing informed consent until at least 6 months after the last dose of the study drug.
14. Able to tolerate thoracentesis/paracentesis catheter placement or already have a functional thoracic/abdominal drainage catheter, and agree to receive study drug administration via this route.

排除标准：

1.首次研究药物给药前4周内参加过任何其他药物临床试验； 2.研究药物首次给药2周内接受过针对胸/腹水的局部腔内治疗（如滑石粉、博来霉素、抗血管生成药物等，单纯诊断性或缓解症状的穿刺引流除外）； 3.首次研究药物给药前2周内胸/腹腔外放疗，或入组前8周内胸/腹膜或肺部/腹腔病灶根治性放疗（注：允许胸/腹部姑息性放疗）。 4.首次研究药物给药前4周内接受过大型胸部或腹部手术且未完全恢复，或在研究期间计划接受择期大手术者； 5.研究治疗开始时，既往抗肿瘤治疗（包括化疗、放疗、靶向或免疫治疗）引起的任何毒性反应尚未恢复至≤1级（根据NCI-CTCAE v6.0，脱发、色素沉着等研究者判断无安全风险的毒性除外）； 6.有症状的、未控制的中枢神经系统（CNS）转移或脑膜转移，经研究者判断不适合入组； 7已知人类免疫缺陷病毒（HIV）感染，或活动性乙型肝炎（HBsAg阳性且HBV DNA > 500 IU/mL或研究中心正常值上限，经有效抗病毒治疗后降至正常范围者可入组），或活动性丙型肝炎（HCV抗体阳性且HCV RNA阳性），或活动性梅毒感染； 8.需要全身性抗生素、抗病毒或抗真菌治疗的活动性、未控制的感染（由研究者判断）； 9.妊娠期或哺乳期妇女； 10.已知有药物滥用史、酗酒史或吸毒史；既往有明确的重度精神障碍或认知障碍史，且研究者认为可能影响研究依从性或安全性评估； 11.存在任何活动性自身免疫性疾病，或有需要全身免疫抑制剂治疗（如糖皮质激素>10 mg/天泼尼松等效剂量、甲氨蝶呤、霉酚酸酯等）的自身免疫病病史，允许局部使用糖皮质激素或吸入/关节内注射激素； 12.首次研究药物给药前2周内，需要全身性使用皮质类固醇（剂量相当于泼尼松>10 mg/日）或其他免疫抑制剂，预计研究期间仍需长期使用者； 13.患有控制不佳或严重的心血管疾病，例如：NYHA分级Ⅱ-Ⅳ级的心力衰竭；不稳定性心绞痛或首次用药前6个月内发生过心肌梗死；有临床意义且需要治疗或干预的室性或室上性心律失常。经抗高血压治疗后血压仍控制不佳（收缩压≥160 mmHg和/或舒张压≥100 mmHg）。 14.患有控制不佳的代谢性疾病（如糖化血红蛋白≥8%的糖尿病，伴有临床症状）、既往有重度胃肠道出血史、当前存在未控制的严重腹泻（CTCAE ≥2级）或完全性/需要干预的严重胃肠道梗阻； 15.已知对试验药物（WSK-IM02）或其任何辅料成分、脂质体制剂、或卡那霉素过敏者； 16.首次给药前6个月内发生过严重血栓栓塞事件（如深静脉血栓、肺栓塞、脑血管意外）、脑梗或具有临床意义的出血性疾病史，或有明确的出血倾向； 17.给药部位存在活动性局部感染（如穿刺点感染、脓肿、腹膜炎、脓胸等）； 18.存在无法纠正的凝血功能障碍，导致胸/腹腔穿刺或置管具有高风险。 19.患有任何其他并发的、严重的和/或未控制的医学状况（如活动性结核、未控制的癫痫、肝性脑病、门静脉高压伴活动性出血风险等），经研究者判定可能影响患者安全或干扰研究结果评估； 20.研究者认为存在任何可能增加患者风险、影响研究药物给药、干扰研究评估或损害患者依从性的其他因素，包括但不限于无法合作、严重的心理社会问题等。

Exclusion criteria：

1. Participation in any other drug clinical trial within 4 weeks prior to the first administration of the study drug; 2. Receipt of local intracavitary therapy (e.g., talc, bleomycin, anti-angiogenic agents, etc.) for pleural/ascitic fluid within 2 weeks prior to the first administration of the study drug, excluding simple diagnostic or symptom-relieving paracentesis/drainage; 3. Extra-thoracic/extra-abdominal radiotherapy within 2 weeks prior to the first administration of the study drug, or radical radiotherapy to the pleura/peritoneum or pulmonary/abdominal lesions within 8 weeks prior to enrollment (Note: Palliative radiotherapy to the chest/abdomen is permitted); 4. Major thoracic or abdominal surgery within 4 weeks prior to the first administration of the study drug without full recovery, or planned elective major surgery during the study period; 5. Any toxicity from prior anti-tumor therapy (including chemotherapy, radiotherapy, targeted therapy, or immunotherapy) that has not resolved to ≤ Grade 1 (according to NCI-CTCAE v6.0) at the start of study treatment, except for toxicities such as alopecia, pigmentation, or other toxicities deemed by the investigator to pose no safety risk; 6. Symptomatic, uncontrolled central nervous system (CNS) metastases or leptomeningeal metastases that are deemed unsuitable for enrollment by the investigator; 7. Known human immunodeficiency virus (HIV) infection, active hepatitis B (HBsAg positive with HBV DNA > 500 IU/mL or above the upper limit of normal of the study center; patients whose HBV DNA returns to normal range after effective antiviral therapy may be enrolled), active hepatitis C (HCV antibody positive with HCV RNA positive), or active syphilis infection; 8. Active, uncontrolled infection requiring systemic antibiotics, antivirals, or antifungals (as judged by the investigator); 9. Pregnant or lactating women; 10. Known history of drug abuse, alcohol abuse, or substance abuse; prior definite history of severe mental or cognitive impairment that may affect study compliance or safety assessment as judged by the investigator; 11. Presence of any active autoimmune disease, or history of autoimmune disease requiring systemic immunosuppressive therapy (e.g., corticosteroids >10 mg/day prednisone equivalent, methotrexate, mycophenolate mofetil, etc.); topical corticosteroids or inhaled/intra-articular steroids are permitted; 12. Need for systemic corticosteroids (at a dose equivalent to prednisone >10 mg/day) or other immunosuppressants within 2 weeks prior to the first administration of the study drug, with anticipated long-term use during the study period; 13. Poorly controlled or severe cardiovascular disease, such as: New York Heart Association (NYHA) class II-IV heart failure; unstable angina or myocardial infarction within 6 months prior to first dose; clinically significant ventricular or supraventricular arrhythmias requiring treatment or intervention; poorly controlled blood pressure despite antihypertensive therapy (systolic blood pressure >=160 mmHg and/or diastolic blood pressure >=100 mmHg); 14. Poorly controlled metabolic disease (e.g., diabetes with HbA1c >=8% with clinical symptoms), prior history of severe gastrointestinal bleeding, current uncontrolled severe diarrhea (CTCAE Grade >=2), or complete/severe gastrointestinal obstruction requiring intervention; 15. Known hypersensitivity to the study drug (WSK-IM02) or any of its excipients, liposomal formulations, or kanamycin; 16. History of severe thromboembolic events (e.g., deep vein thrombosis, pulmonary embolism, cerebrovascular accident), cerebral infarction, or clinically significant bleeding disorders within 6 months prior to first dose, or clear bleeding tendency; 17. Active local infection at the administration site (e.g., puncture site infection, abscess, peritonitis, empyema, etc.); 18. Uncorrectable coagulation dysfunction posing high risk for thoracentesis/paracentesis or catheter placement; 19. Any other concurrent, serious, and/or uncontrolled medical condition (e.g., active tuberculosis, uncontrolled epilepsy, hepatic encephalopathy, portal hypertension with active bleeding risk, etc.) that may compromise patient safety or interfere with study outcome assessment as judged by the investigator; 20. Any other factors that may increase patient risk, affect study drug administration, interfere with study assessments, or impair patient compliance, including but not limited to inability to cooperate, severe psychosocial issues, etc., as judged by the investigator.

研究实施时间：

Study execute time：

从 From 2026-07-01 00:00:00至 To 2029-07-01 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2026-07-01 00:00:00 至 To 2029-07-01 00:00:00

干预措施：

Interventions：

组别：	实验组	样本量：	8
Group：	Experimental	Sample size：	8
干预措施：	采用传统“3+3”设计进行剂量递增。研究起始剂量为 3.33 μg/kg，后续递增剂量依次为 8.33、16.67μg/kg，使用 50-100mL 生理盐水作为溶剂，胸/腹腔注射，每周两次，每 2 周为一个治疗周期。	干预措施代码：
Intervention：	A traditional "3+3" design was adopted for dose escalation. The starting dose was 3.33 μg/kg, with subsequent escalating doses of 8.33 and 16.67 μg/kg. The study drug was administered via intrapleural or intraperitoneal injection, using 50–100 mL of normal saline as the solvent, twice weekly, with each 2-week period defined as one treatment cycle.	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：	三级甲等
Institution hospital：	West China Hospital of Sichuan University	Level of the institution：	Tertiary A

测量指标：

Outcomes：

指标中文名：	安全性评估	指标类型：	主要指标
Outcome：	safety evaluation	Type：	Primary indicator
测量时间点：	3个月	测量方法：	安全性评估包括生命体征、体格检查、ECOG体能状态、血常规、血生化、尿常规、凝血功能、妊娠试验、12-ECG、超声心动图等。
Measure time point of outcome：	3 months	Measure method：	The safety evaluation includes vital signs, physical examination, ECOG performance status, routine blood tests, routine blood biochemistry, routine urinalysis, coagulation function, pregnancy test, 12-lead ECG, echocardiography, and others.

指标中文名：	客观缓解率	指标类型：	次要指标
Outcome：	Objective Response Rate (ORR)	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	无进展生存期	指标类型：	次要指标
Outcome：	Progression-Free Survival (PFS)	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：

征募研究对象情况：

Recruiting status：

尚未开始

Not yet 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:

不公开/Private

盲法：	无
Blinding：	None

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）：	None
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：	None
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	None
数据与安全监察委员会： Data and Safety Monitoring Committee：	无/No
注册人： Name of Registration：	2026-06-26 11:26:48