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：	ChiCTR2600126260
最近更新日期： Date of Last Refreshed on：	2026-06-05 15:43:32
注册时间： Date of Registration：	2026-06-05 00:00:00
注册号状态：	补注册
Registration Status：	Retrospective registration
注册题目：	肝动脉灌注化疗联合贝伐珠单抗和PD-1单抗序贯西达本胺联合方案一线治疗BCLC C期肝细胞癌的前瞻性、单臂、多中心、Ⅱ期临床研究
Public title：	A Prospective, Single-Arm, Multicenter, Phase II Clinical Study of Hepatic Arterial Infusion Chemotherapy Combined with Bevacizumab and PD-1 Monoclonal Antibody Followed by Chidamide Combination as First-Line Treatment for BCLC Stage C Hepatocellular Carcinoma
注册题目简写：
English Acronym：
研究课题的正式科学名称：	肝动脉灌注化疗联合贝伐珠单抗和PD-1单抗序贯西达本胺联合方案一线治疗BCLC C期肝细胞癌的前瞻性、单臂、多中心、Ⅱ期临床研究
Scientific title：	A Prospective, Single-Arm, Multicenter, Phase II Clinical Study of Hepatic Arterial Infusion Chemotherapy Combined with Bevacizumab and PD-1 Monoclonal Antibody Followed by Chidamide Combination as First-Line Treatment for BCLC Stage C 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：	左孟轩	研究负责人：	黄子林, 李旺
Applicant：	Mengxuan Zuo	Study leader：	Zilin Huang, Wang Li
申请注册联系人电话： Applicant telephone：	+86 189 2426 6069	研究负责人电话： Study leader's telephone：	+86 20 8734 3272
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：	zuomx@sysucc.org.cn	研究负责人电子邮件： Study leader's E-mail：	liwang@sysucc.org.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：	广州市东风东路651号	研究负责人通讯地址：	广州市东风东路651号
Applicant address：	651 Dongfeng Road East, Guangzhou, China	Study leader's address：	651 Dongfeng Road East, Guangzhou, China
申请注册联系人邮政编码： Applicant postcode：	510060	研究负责人邮政编码： Study leader's postcode：	510060
申请人所在单位：	中山大学肿瘤防治中心
Applicant's institution：	Sun Yat-Sen University Cancer Center
研究负责人所在单位：	中山大学肿瘤防治中心
Affiliation of the Leader：	Sun Yat-Sen University Cancer Center

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：	B2025-217-01	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：	中山大学肿瘤防治中心伦理委员会
Name of the ethic committee：	Ethics Committee of Sun Yat-Sen University Cancer Center
伦理委员会批准日期： Date of approved by ethic committee：	2025-06-03 00:00:00
伦理委员会联系人：	古德彬
Contact Name of the ethic committee：	Debin Gu
伦理委员会联系地址：	广州市东风东路651号
Contact Address of the ethic committee：	651 Dongfeng Road East, Guangzhou, China
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 137 1925 4439	伦理委员会联系人邮箱： Contact email of the ethic committee：	llwyh@sysucc.org.cn

研究实施负责（组长）单位：

中山大学肿瘤防治中心

Primary sponsor：

Sun Yat-Sen University Cancer Center

研究实施负责（组长）单位地址：

广州市东风东路651号

Primary sponsor's address：

651 Dongfeng Road East, Guangzhou, 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)：	中山大学肿瘤防治中心	具体地址：	广州市东风东路651号
Institution hospital：	Sun Yat-Sen University Cancer Center	Address：	651 Dongfeng Road East, Guangzhou, China

经费或物资来源：

深圳微芯生物科技股份有限公司; 南京正大天晴制药有限公司

Source(s) of funding：

Shenzhen Wigen Biotech Co., Ltd.; Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd.

研究疾病：

肝癌

Target disease：

hepatocellular carcinoma

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：

II期临床试验

Study phase：

2

研究设计：

单臂

Study design：

Single arm

研究目的：

1. 主要研究目的评估肝动脉灌注化疗联合贝伐珠单抗和PD-1单抗序贯西达本胺联合方案治疗BCLC C期肝细胞癌的中位无进展生存期（PFS） 2. 次要研究目的（1）评估肝动脉灌注化疗联合贝伐珠单抗和PD-1单抗序贯西达本胺联合方案治疗BCLC C期肝细胞癌的客观缓解率（ORR）、疾病控制率（DCR）、疾病缓解持续时间（DoR）、6个月和12个月无进展生存率（PFS）、12个月总生存率（OS）、总生存期（OS）。（2）肝动脉灌注化疗联合贝伐珠单抗和PD-1单抗序贯西达本胺联合方案治疗BCLC C期肝细胞癌的安全性和耐受性。

Objectives of Study：

1. Primary Research Objective To evaluate the median progression-free survival (PFS) of a sequential treatment regimen combining hepatic arterial infusion chemotherapy with bevacizumab and a PD-1 inhibitor followed by chidamide in patients with BCLC stage C hepatocellular carcinoma. 2. Secondary Research Objectives (1) To evaluate the objective response rate (ORR), disease control rate (DCR), duration of response (DoR), 6-month and 12-month progression-free survival (PFS) rates, 12-month overall survival (OS) rate, and overall survival (OS) of the aforementioned sequential regimen in patients with BCLC stage C hepatocellular carcinoma. (2) To assess the safety and tolerability of the sequential treatment regimen combining hepatic arterial infusion chemotherapy with bevacizumab and a PD-1 inhibitor followed by chidamide in patients with BCLC stage C hepatocellular carcinoma.

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. The patient voluntarily joins this study and signs the informed consent form.
2. Aged >=18 years and <=70 years, regardless of gender.
3. Clinically or pathologically confirmed hepatocellular carcinoma of BCLC stage C, with no prior first-line treatment received.
4. At least one intrahepatic evaluable lesion, with intrahepatic lesions as the main tumor burden.
5. Child-Pugh score <=7 (Child-Pugh A-B).
6. BCLC stage C.
7. Ability to swallow tablets normally.
8. ECOG score: 0–1 (refer to appendix for ECOG scoring criteria).
9. Expected survival time >=12 weeks.
10. Functions of vital organs meet the following requirements (no blood components, growth factors, or corrective therapies allowed within 14 days prior to initial treatment):
• Absolute neutrophil count >=3.0×10^9/L;
• Platelets >=80×10^9/L;
• Hemoglobin >=90 g/L;
• Serum albumin >=28 g/L;
• Thyroid-stimulating hormone (TSH) <= 1×ULN (if abnormal, FT3 and FT4 levels should be evaluated simultaneously; if FT3 and FT4 are normal, the patient may be enrolled);
• Bilirubin <=1.5×ULN (within 7 days before initial treatment);
• ALT and AST <=3×ULN (within 7 days before initial treatment);
• ALP <=2.5×ULN; serum creatinine <=1.5×ULN.
11.For non-surgically sterile or fertile female patients, a medically approved contraceptive method (e.g., intrauterine device, oral contraceptives, or condoms) must be used during the study treatment and for 3 months after treatment completion. Non-surgically sterile fertile female patients must have a negative serum or urine HCG test within 72 hours before study enrollment and must not be breastfeeding. Male patients with partners of childbearing potential must use effective contraception during the trial and for 3 months after the last dose.

排除标准：

1. 既往经组织学/细胞学确诊的含纤维板层肝细胞癌、肉瘤样肝细胞癌、胆管癌等成分； 2. 患者存在任何活动性自身免疫病或有自身免疫病病史（如以下，但不局限于：自身免疫性肝炎、间质性肺炎，葡萄膜炎，肠炎，肝炎，垂体炎，血管炎，肾炎，甲状腺功能亢进；患者患有白癜风；在童年期哮喘已完全缓解，成人后无需任何干预的可纳入；患者需要支气管扩张剂进行医学干预的哮喘则不能纳入）； 3. 患者入组前2周内正在使用免疫抑制剂、或全身激素治疗以达到免疫抑制目的（剂量>10mg/天泼尼松或其他等疗效激素）； 4. 已知对于任何研究药物成分过敏；或既往对其他单克隆抗体发生过重度过敏反应； 5. 已知有肝性脑病病史者或有器官移植史者； 6. 患有高血压，且经降压药物治疗无法获得良好控制（收缩压≥140mmHg 或者舒张压≥90 mmHg）； 7. 有未能良好控制的心脏临床症状或疾病，如：（1）NYHA2 级以上心力衰竭；（2）不稳定型心绞痛；（3）1年内发生过心肌梗死；（4）有临床意义的室上性或室性心律失常需要治疗或干预；（5）Tc>450ms（男性）；QTc>470ms (女性)； 8. 凝血功能异常（INR>2.0、PT>16s），具有出血倾向或正在接受溶栓或抗凝治疗，允许预防性使用小剂量阿司匹林、低分子肝素； 9. 入组前3个月内出现过显著临床意义的出血症状或具有明确的出血倾向，如日咳/咯血2.5ml及以上、消化道出血、有出血危险的食管胃底静脉曲张、出血性胃溃疡或患有脉管炎等； 10. 经内镜评估存在严重胃食管静脉曲张，或有门静脉高压且存在高出血风险证据者； 11. 入组前6个月内发生的动/静脉血栓事件，如脑血管意外（包括暂时性缺血性发作、脑出血、脑梗塞）、深静脉血栓及肺栓塞等； 12. 已知存在的遗传性或获得性出血及血栓倾向（如血友病人，凝血机能障碍，血小板减少等）； 13. 尿常规提示尿蛋白≥++并经证实24小时尿蛋白量>1.0g； 14. 患者有活动性感染、用药前7天内有不明原因发热≥38.5℃、或基线期白细胞计数>15×109/L； 15. 患者先天或后天免疫功能缺陷（如HIV感染者）； 16. HBV-DNA>2000 IU/ml（或104拷贝/ml）；或HCV-RNA>103拷贝/ml；或HBsAg+且抗HCV抗体阳性患者； 17. 患者既往3年内或同时患有其它恶性肿瘤（已治愈的皮肤基底细胞癌和宫颈原位癌除外）； 18. 有临床症状的腹水，需要穿刺、引流者或既往 3 个月内接受过腹水引流者，仅影像学显示少量腹水但不伴有临床症状者除外； 19. 患者既往曾接受过其他抗PD-1抗体治疗或其他针对PD-1/PD-L1的免疫治疗或其他免疫治疗。既往接受过抗VEGF和/或VEGFR、RAF、MEK、PDGFR、 FGFR 等信号通路的靶向治疗。 20. 研究用药前不足4周内或可能于研究期间接种活疫苗； 21. 怀孕或哺乳期妇女，或不愿采取避孕措施的育龄妇女； 22. 经研究者判断，患者有其他可能影响研究结果或导致本研究被迫中途终止的因素，如酗酒、药物滥用、其他的严重疾病（含精神疾病）需要合并治疗，有严重的实验室检查异常，伴有家庭或社会等因素，会影响到患者的安全。

Exclusion criteria：

1. Histologically/cytologically confirmed components such as fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, or cholangiocarcinoma. 2. Presence of any active autoimmune disease or history of autoimmune disease (including, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism; patients with vitiligo; childhood asthma that has completely resolved and requires no intervention in adulthood may be included; asthma requiring medical intervention with bronchodilators is excluded). 3. Use of immunosuppressive agents or systemic corticosteroids for immunosuppressive purposes (dose >10mg/day prednisone or equivalent) within 2 weeks prior to enrollment. 4. Known allergy to any component of the study drug(s); or history of severe allergic reaction to other monoclonal antibodies. 5. Known history of hepatic encephalopathy or organ transplantation. 6. Hypertension that is not well controlled with antihypertensive medication (systolic blood pressure >=140 mmHg or diastolic blood pressure >=90 mmHg). 7. Poorly controlled cardiac clinical symptoms or diseases, such as: (1) heart failure of NYHA class 2 or higher; (2) unstable angina; (3) myocardial infarction within 1 year; (4) clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention; (5) QTc > 450 ms (male) or QTc > 470 ms (female). 8. Abnormal coagulation (INR >2.0, PT >16 s), hemorrhagic tendency, or undergoing thrombolytic or anticoagulant therapy (prophylactic use of low-dose aspirin or low molecular weight heparin is allowed). 9. Clinically significant bleeding symptoms or definite hemorrhagic tendency within 3 months prior to enrollment, such as hemoptysis/expectoration of blood >=2.5 mL, gastrointestinal bleeding, esophageal/gastric varices with bleeding risk, hemorrhagic gastric ulcer, or vasculitis, etc. 10. Severe gastroesophageal varices confirmed by endoscopy, or portal hypertension with evidence of high bleeding risk. 11. Arterial/venous thrombotic events within 6 months prior to enrollment, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism, etc. 12. Known hereditary or acquired bleeding and thrombotic tendency (e.g., hemophilia, coagulation dysfunction, thrombocytopenia, etc.). 13. Urinalysis showing urine protein >=++ and confirmed 24-hour urinary protein >1.0 g. 14. Active infection, unexplained fever >=38.5°C within 7 days prior to medication, or baseline white blood cell count >15×10^9/L. 15. Congenital or acquired immunodeficiency (e.g., HIV infection). 16. HBV-DNA >2000 IU/mL (or 10^4 copies/mL); or HCV-RNA >10^3 copies/mL; or HBsAg positive and anti-HCV antibody positive. 17. History or concurrent diagnosis of other malignancies within the past 3 years (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix). 18. Symptomatic ascites requiring paracentesis or drainage, or history of ascites drainage within the past 3 months (patients with only imaging showing a small amount of ascites without clinical symptoms are excluded from this criterion). 19. Prior treatment with other anti-PD-1 antibodies, other immunotherapy targeting PD-1/PD-L1, or other immunotherapy. Prior treatment with targeted therapies against VEGF and/or VEGFR, RAF, MEK, PDGFR, FGFR, and other signaling pathways. 20. Administration of a live vaccine within 4 weeks before the study treatment or potential administration during the study period. 21. Pregnant or lactating women, or women of childbearing potential unwilling to use contraception. 22. Other factors deemed by the investigator as likely to affect the study results or lead to premature termination of the study, such as alcoholism, drug abuse, other serious diseases (including mental illness) requiring concomitant treatment, severe laboratory abnormalities, or accompanying familial or social factors that may compromise patient safety.

研究实施时间：

Study execute time：

从 From 2026-04-01 00:00:00至 To 2028-04-01 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2026-04-09 00:00:00 至 To 2028-04-01 00:00:00

干预措施：

Interventions：

组别：	试验组	样本量：	40
Group：	Test group	Sample size：	40
干预措施：	肝动脉灌注化疗联合贝伐珠单抗和PD-1单抗序贯西达本胺	干预措施代码：
Intervention：	Hepatic Arterial Infusion Chemotherapy (HAIC) Combined with Bevacizumab and PD-1 Monoclonal Antibody, Followed by Chidamide.	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)：	中山大学肿瘤防治中心	单位级别：	三甲
Institution hospital：	Sun Yat-Sen University Cancer Center	Level of the institution：	Tertiary A

国家：	中国	省(直辖市)：	广东省	市(区县)：
Country：	China	Province：	Guangdong	City：
单位(医院)：	连州市人民医院	单位级别：	三甲
Institution hospital：	The People's Hospital of Lianzhou City	Level of the institution：	Tertiary A

国家：	中国	省(直辖市)：	广东省	市(区县)：
Country：	China	Province：	Guangdong	City：
单位(医院)：	惠州市中心人民医院	单位级别：	三甲
Institution hospital：	Huizhou Central People's Hospital	Level of the institution：	Tertiary A

国家：	中国	省(直辖市)：	广东省	市(区县)：
Country：	China	Province：	Guangdong	City：
单位(医院)：	广东药科大学附属第一医院	单位级别：	三甲
Institution hospital：	The First Affiliated Hospital of Guangdong Pharmaceutical University	Level of the institution：	Tertiary A

测量指标：

Outcomes：

指标中文名：	无进展生存期	指标类型：	主要指标
Outcome：	Progression-Free Survival (PFS)	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	总生存期	指标类型：	次要指标
Outcome：	Overall Survival (OS)	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

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：	疾病控制率	指标类型：	次要指标
Outcome：	Disease Control Rate (DCR)	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	疾病缓解持续时间	指标类型：	次要指标
Outcome：	Duration of Response (DOR)	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	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)：

Not used

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：
Blinding：
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）：	研究公开发表后6月内，可通过中山大学肿瘤防治中心 https://www.researchdata.org.cn/共享，数据访问权限需向该中心申请并通过审核后获取。
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	Within 6 months after the research is publicly published, it can be accessed through the Cancer Prevention and Treatment Center of Sun Yat sen University https://www.researchdata.org.cn/ Sharing and data access permissions need to be applied for and approved by the center before obtaining them. Reference Knowledge 84/5000 AI Translation and Mapping AI Large Model Translation Within six months after the research is publicly published, it can be shared through the Sun Yat-sen University Cancer Center's https://www.researchdata.org.cn/ portal. Access to the data requires an application to the center and approval.
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
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：	2026-06-05 15:43:32