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Trial search Nation, Province(City) Code of disease Primary sponsor(s) Secondary sponsor(s) Funding source Recruiting status Register status Measure Ethical committee Study type

Dose-Exposure Study of Icaritin Soft Capsules in Patients with Advanced Hepatocellular Carcinoma

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注册号：

Registration number：

ChiCTR2600117381 

最近更新日期：

Date of Last Refreshed on：

2026-01-23 08:58:32 

注册时间：

Date of Registration：

2026-01-23 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

淫羊藿素软胶囊在晚期肝细胞癌患者中的剂量-暴露研究

Public title：

Dose-Exposure Study of Icaritin Soft Capsules in Patients with Advanced Hepatocellular Carcinoma

注册题目简写：

English Acronym：

研究课题的正式科学名称：

淫羊藿素软胶囊在晚期肝细胞癌患者中的剂量-暴露研究

Scientific title：

Dose-Exposure Study of Icaritin Soft Capsules in Patients with Advanced Hepatocellular Carcinoma

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：

陈俊丽 

研究负责人：

陈映霞 

Applicant：

Junli Chen 

Study leader：

Yingxia Chen 

申请注册联系人电话：

Applicant telephone：

+86 10 8070 9213

研究负责人电话：

Study leader's telephone：

+86 25 6902 3999

申请注册联系人传真 ：

Applicant Fax：

+86 10 62964349

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：

junli.chen@shenoen.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：

北京昌平区生命园路26号1号楼

研究负责人通讯地址：

江苏省南京市江宁区淳化街道吉印大道3789号南京天印山医院

Applicant address：

Building 1, 26 Life Garden Road, Changping District, Beijing

Study leader's address：

Nanjing Tianyinshan Hospital, No. 3789, Jiyin Avenue, Chunhua Sub-district, Jiangning District, Nanjing City, 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：

北京珅诺基医药科技有限公司

Applicant's institution：

Beijing Shenogen Pharmaceutical Technology Co., LTD

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/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

E2025-009-01

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：

Nanjing Tianyinshan Hospital Medical Ethics Committee

伦理委员会批准日期：

Date of approved by ethic committee：

2025-03-31 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 City

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 25 8308 6021

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：

江苏省人民医院 南京天印山医院

Primary sponsor：

Jiangsu Provincial People's Hospital Nanjing Tianyinshan Hospital

研究实施负责（组长）单位地址：

江苏省南京是鼓楼区广州路300号江苏省人民医院 江苏省南京市江宁区淳化街道吉印大道3789号南京天印山医院

Primary sponsor's address：

Jiangsu Provincial People's Hospital, No. 300 Guangzhou Road, Gulou District, Nanjing, Jiangsu Province Nanjing Tianyinshan Hospital, No. 3789, Jiyin Avenue, Chunhua Sub-district, Jiangning District, Nanjing City, 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)：

南京市

Country：

China

Province：

Jiangsu

City：

Nanjing

单位(医院)：

江苏省人民医院

具体地址：

江苏省南京是鼓楼区广州路300号江苏省人民医院

Institution
hospital：

Jiangsu Provincial People's Hospital

Address：

Jiangsu Provincial People's Hospital, No. 300 Guangzhou Road, Gulou District, Nanjing City, Jiangsu Province

国家：

中国

省(直辖市)：

江苏省

市(区县)：

南京市

Country：

China

Province：

Jiangsu

City：

Nanjing

单位(医院)：

南京天印山医院

具体地址：

江苏省南京市江宁区淳化街道吉印大道3789号南京天印山医院

Institution
hospital：

Nanjing Tianyinshan Hospital

Address：

Nanjing Tianyinshan Hospital, No. 3789, Jiyin Avenue, Chunhua Sub-district, Jiangning District, Nanjing City, Jiangsu Province

经费或物资来源：

协办单位：北京珅诺基医药科技有限公司

Source(s) of funding：

Co-organizer: Beijing Shenogen Medical Technology Co., LTD

Target disease：

hepatocellular carcinoma

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：

探索晚期肝细胞癌患者中开展多剂量单次和单剂量多次口服淫羊藿素软胶囊的剂量-暴露研究，探索淫羊藿素软胶囊在患者体内的药代动力学特征。  

Objectives of Study：

To conduct a dose-exposure study of multiple-dose single-administration and single-dose multiple-administration oral epimedium extract soft capsules in patients with advanced hepatocellular carcinoma, and to explore the pharmacokinetic characteristics of epimedium extract soft capsules in the patients' bodies.

药物成份或治疗方案详述：

单次给药： 设3个剂量组，分别单次口服600 mg、900 mg和1200 mg 淫羊藿素； 多次给药： 每次600 mg淫羊藿素，一天2次给药，共给药7天。 

Description for medicine or protocol of treatment in detail：

Single Administration: Three dose groups were set up, with a single oral administration of 600 mg, 900 mg, and 1200 mg icaritin respectively. Multiple Administrations: icaritin was administered at 600 mg each time, twice a day, for a total of 7 days. 

纳入标准：

1) 年龄>=18周岁，男女不限； 2) 严格符合中国临床肿瘤学会（CSCO）《原发性肝癌诊疗指南》（2022版）中的HCC临床诊断标准，和/或经过病理组织/细胞学检查确诊的HCC患者； 3) 不可手术切除或转移性HCC患者； 4) 首次用药距肝切除术>3个月，距局部消融、肝动脉介入或放射治疗结束时间>4周（放射性粒子植入需＞3个月），且有关不良反应恢复<=1级； 5) 首次用药前2周内，没有使用具有肝癌适应症的药物，包括靶向治疗药、免疫治疗药、化疗药和现代中药制剂； 6) 首次用药前14天内，未输血或血制品、未使用造血刺激因子、未输白蛋白或血制品； 7) Child-Pugh肝功能评分A级（5/6分）； 8) 体力状况ECOG评分为0-1； 9) 预期生存时间>=12周； 10) 主要器官功能基本正常，符合下列要求： 1. 骨髓：血小板>=60 × 109/L，血红蛋白>= 85g /L，白细胞>=3.0×109/L； 2. 肝脏：总胆红素<=1.5倍正常值上限（ULN），天冬氨酸转氨酶（AST）和丙氨酸转氨酶（ALT）<=5×ULN；白蛋白>= 28 g / L； 3. 肾脏：血清肌酐<=1.5×ULN，或肌酐清除率>=50 mL/min； 11) HBV-DNA<104 copies/mL（2000IU/mL）； 12) 育龄女性必须在首次用药前7天内行妊娠试验且结果为阴性；育龄男性：试验期间及结束后的3个月内采取有效的避孕措施； 13) 受试者自愿加入本研究，签署知情同意书，依从性好，配合随访； 14) 签署知情前4周内未参加其他临床试验；如果其他试验筛选失败病例，但是符合本试验要求者可以入组。

Inclusion criteria

1: Aged >= 18 years, regardless of gender; 2: Patients with hepatocellular carcinoma (HCC) who strictly meet the clinical diagnostic criteria for HCC specified in the CSCO Guidelines for the Diagnosis and Treatment of Primary Liver Cancer (2022 Edition) issued by the Chinese Society of Clinical Oncology (CSCO), and/or have been diagnosed with HCC via pathological tissue/cytological examination; 3: Patients with unresectable or metastatic hepatocellular carcinoma (HCC); 4: The interval between the first dose of medication and hepatectomy is > 3 months; the interval between the first dose and the end of local ablation, hepatic arterial intervention, or radiotherapy is > 4 weeks (for radioactive seed implantation, the interval needs to be > 3 months); and the recovery of relevant adverse reactions is <= Grade 1; 5: Within 2 weeks before the first dose of medication, no drugs with indications for liver cancer have been used, including targeted therapeutic drugs, immunotherapeutic drugs, chemotherapeutic drugs, and modern Chinese medicine preparations; 6: Within 14 days before the first dose of medication, no blood or blood products have been transfused, no hematopoietic stimulants have been used, and no albumin or blood products have been transfused; 7: Child-Pugh liver function score of Grade A (5/6 points); 8: Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1; 9: Expected survival time of >= 12 weeks; 10: Basic normal function of major organs, meeting the following requirements: 1. Bone marrow: Platelet count >= 60 × 10⁹/L, hemoglobin >= 85 g/L, white blood cell count >= 3.0 × 10⁹/L; 2. Liver: Total bilirubin <= 1.5 times the upper limit of normal (ULN), aspartate transaminase (AST) and alanine transaminase (ALT) <= 5 × ULN; albumin >= 28 g/L; 3. Kidney: Serum creatinine <= 1.5 × ULN, or creatinine clearance rate >= 50 mL/min; 11: HBV-DNA < 10⁴ copies/mL (2000 IU/mL); 12: Women of childbearing age must undergo a pregnancy test within 7 days before the first dose of medication, and the result must be negative; men of childbearing age: effective contraceptive measures must be taken during the trial and within 3 months after the end of the trial; 13: Subjects voluntarily participate in this study, sign the informed consent form, have good compliance, and cooperate with follow-up; 14: No participation in other clinical trials within 4 weeks before signing the informed consent form; if a case fails the screening of other trials but meets the requirements of this trial, it can be enrolled.

排除标准：

1) 中、重度腹水，即该项指标Child-Pugh评分>2；不受控制的或中、重度胸腔积液、心包积液 ； 2) 首次用药前28天内接受过大手术（开颅手术、开胸手术、开腹手术、髋关节置换术等）； 3) 肝胆管细胞癌和纤维板层细胞癌；既往5年内或同时存在其他恶性肿瘤，但是原位宫颈癌、曾经治疗的基底细胞癌和浅表膀胱肿瘤（Ta，Tis，T1）除外； 4) 妊娠或哺乳期妇女； 5) 患有CTCAE分级Ⅱ级以上心肌缺血或心肌梗塞、控制不良的心律失常，和/或NYHA标准Ⅲ～Ⅳ级的心功能不全； 6) 之前接受过异体脏器移植，包括肝移植，或者计划在试验期间接受肝移植； 7) 签署知情前6个月内曾经发生肝性脑病和/或肝性肾病； 8) 活动性丙肝，即抗-HCV阳性或HCV-RNA阳性且ALT和/或AST＞2×ULN； 9) 人免疫缺陷病毒(HIV)检查结果为阳性，或随机时存在严重感染（NCI-CTCAE分级>=3级）； 10) 无法吞咽、慢性腹泻或肠梗阻，明显影响药物服用和吸收； 11) 签署知情前6个月之内有消化道出血病史，或者具有明确的消化道出血倾向，例如：局部活动性溃疡病灶、大便潜血>=2+（持续的便潜血阳性需接受胃镜和（或）肠镜检查以排查）； 12) 患者具有已知或疑诊的活动性自身免疫性疾病； 13) 已知发生中枢神经系统转移，疑有中枢神经系统转移者需进行头颅MRI检查排除； 14) 凝血功能明显异常：国际标准化比值（INR）> 1.5或者凝血酶原时间（PT）> 16 s； 15) 有精神分裂症，或者精神类药物滥用史； 16) 已知对淫羊藿素及辅料过敏或不能耐受； 17) 研究者认为妨碍患者参加本试验的其他状况。

Exclusion criteria：

1: Moderate to severe ascites, i.e., a Child-Pugh score of > 2 for this indicator; uncontrolled or moderate to severe pleural effusion, pericardial effusion; 2: Having undergone major surgery (such as craniotomy, thoracotomy, laparotomy, hip replacement surgery, etc.) within 28 days before the first dose of medication; 3: Cholangiocellular carcinoma and fibrolamellar carcinoma; a history of other malignant tumors within the past 5 years or concurrent presence of other malignant tumors, except for carcinoma in situ of the cervix, previously treated basal cell carcinoma, and superficial bladder tumors (Ta, Tis, T1); 4: Pregnant or lactating women; 5: Patients with myocardial ischemia or myocardial infarction of Grade Ⅱ or higher according to CTCAE classification, uncontrolled arrhythmia, and/or heart failure of Grade Ⅲ-Ⅳ according to NYHA criteria; 6: Patients who have previously received allogeneic organ transplantation (including liver transplantation) or plan to receive liver transplantation during the trial; 7: Patients who have experienced hepatic encephalopathy and/or hepatic nephropathy within 6 months before signing the informed consent form; 8: Active hepatitis C, i.e., positive anti-HCV or positive HCV-RNA, with ALT and/or AST > 2× ULN; 9: Positive result in human immunodeficiency virus (HIV) test, or presence of severe infection (Grade >= 3 according to NCI-CTCAE classification) at the time of randomization; 10: Inability to swallow, chronic diarrhea, or intestinal obstruction, which significantly affects drug administration and absorption; 11: A history of gastrointestinal bleeding within 6 months before signing the informed consent form, or a clear tendency for gastrointestinal bleeding (e.g., local active ulcer lesions, fecal occult blood >= 2+; persistent positive fecal occult blood requires gastroscopy and/or colonoscopy for investigation); 12: Patients with known or suspected active autoimmune diseases; 13: Known central nervous system (CNS) metastasis; patients with suspected CNS metastasis must undergo cranial MRI examination to rule out the possibility; 14: Significant abnormalities in coagulation function: international normalized ratio (INR) > 1.5 or prothrombin time (PT) > 16 s; 15: A history of schizophrenia or abuse of psychotropic drugs; 16: Known allergy or intolerance to icariin and its excipients; 17: Other conditions that, in the investigator’s judgment, would prevent the patient from participating in this trial.

研究实施时间：

Study execute time：

从 From 2025-04-01 00:00:00至 To 2025-11-30 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2025-06-09 00:00:00 至 To 2025-11-30 00:00:00  

干预措施：

Interventions：

组别：

单次给药组

样本量：

6

Group：

Single-dose Administration Group

Sample size：

干预措施：

受试者于试验第1天早上进餐，并在30 min内用餐完毕，在餐后30 min时服用药物；用约240 mL温水送服600 mg（6粒）淫羊藿素软胶囊。

干预措施代码：

Intervention：

On Day 1 of the trial, subjects shall have breakfast in the morning and finish the meal within 30 minutes. The drug shall be taken 30 minutes after the meal: 600 mg (6 capsules) of Epimedium Extract Soft Capsules, administered with approximately 240 mL of warm water.

Intervention code：

组别：

单次给药组

样本量：

6

Group：

Single-dose Administration Group

Sample size：

干预措施：

受试者于试验第1天早上进餐，并在30 min内用餐完毕，在餐后30 min时服用药物；用约240 mL温水送服900 mg（9粒）淫羊藿素软胶囊。

干预措施代码：

Intervention：

On Day 1 of the trial, subjects shall have breakfast in the morning and finish the meal within 30 minutes. The drug shall be taken 30 minutes after the meal: 900 mg (9 capsules) of Epimedium Extract Soft Capsules, administered with approximately 240 mL of warm water.

Intervention code：

组别：

单次给药组

样本量：

6

Group：

Single-dose Administration Group

Sample size：

干预措施：

受试者于试验第1天早上进餐，并在30 min内用餐完毕，在餐后30 min时服用药物；用约240 mL温水送服1200 mg（12粒）淫羊藿素软胶囊。

干预措施代码：

Intervention：

On Day 1 of the trial, subjects shall have breakfast in the morning and finish the meal within 30 minutes. The drug shall be taken 30 minutes after the meal: 1200 mg (12 capsules) of Epimedium Extract Soft Capsules, administered with approximately 240 mL of warm water.

Intervention code：

组别：

多次给药组

样本量：

6

Group：

Multiple-dose Administration Group

Sample size：

干预措施：

受试者于早晚餐后30 min时服用药物，早晚餐需在30min内用餐完毕；用约240 mL温水送服600 mg（6粒）淫羊藿素软胶囊。

干预措施代码：

Intervention：

Subjects shall take the drug 30 minutes after breakfast and dinner, and each of these two meals shall be finished within 30 minutes. The drug to be taken is 600 mg (6 capsules) of Epimedium Extract Soft Capsules, administered with approximately 240 mL of warm water.

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)：

 南京 

Country：

China 

Province：

Jiangsu 

City：

Nanjing 

单位(医院)：

江苏省人民医院 

单位级别：

三甲 

Institution
hospital：

Jiangsu Provincial People's Hospital

Level of the institution：

Tertiary A

国家：

 中国

省(直辖市)：

 江苏 

市(区县)：

 南京 

Country：

China 

Province：

Jiangsu 

City：

Nanjing 

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

测量指标：

Outcomes：

指标中文名：

药代动力学

指标类型：

主要指标

Outcome：

Pharmacokinetics

Type：

Primary 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：

结束

/Completed

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:

不公开/Private

盲法：

无

Blinding：

None

是否共享原始数据：

IPD sharing

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）：

国家生物信息中心 China National center for Bioinformation (https://ngdc.cncb.ac.cn/gsub/)。

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

China National center for Bioinformation (https://ngdc.cncb.ac.cn/gsub/).

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：

采用EDC进行数据采集和管理

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

EDC is used for data acquisition and management

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2026-01-23 08:58:17
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