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：	ChiCTR2600116444
最近更新日期： Date of Last Refreshed on：	2026-01-09 16:37:18
注册时间： Date of Registration：	2026-01-09 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	阿得贝利单抗联合GP方案一线治疗晚期肝内胆管癌的探索性研究
Public title：	Exploratory Study of Adebrelimab Combined with GP Regimen as First-Line Therapy for Advanced Intrahepatic Cholangiocarcinoma
注册题目简写：
English Acronym：
研究课题的正式科学名称：	阿得贝利单抗联合GP方案一线治疗晚期肝内胆管癌的探索性研究
Scientific title：	Exploratory Study of Adebrelimab Combined with GP Regimen as First-Line Therapy for Advanced Intrahepatic Cholangiocarcinoma
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：	梅魁敏	研究负责人：	梅魁敏
Applicant：	Mei Kuimin	Study leader：	Mei Kuimin
申请注册联系人电话： Applicant telephone：	+86 151 0516 9882	研究负责人电话： Study leader's telephone：	+86 151 0516 9882
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：	meikuiminseu@163.com	研究负责人电子邮件： Study leader's E-mail：	meikuiminseu@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：	中国江苏省南京市秦淮区杨公井34标34号	研究负责人通讯地址：	中国江苏省南京市秦淮区杨公井34标34号
Applicant address：	No. 34, Block 34, Yanggong Well, Qinhuai District, Nanjing City, Jiangsu Province, China	Study leader's address：	No. 34, Block 34, Yanggong Well, Qinhuai District, Nanjing City, Jiangsu Province, China
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：	中国人民解放军东部战区总医院
Applicant's institution：	Eastern Theater Command General Hospital of the People's Liberation Army
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 Command General Hospital of the 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-KYLL-25-41	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：	Clinical Research Ethics Committee of Eastern Theater Command General Hospital of the People's Liberation Army
伦理委员会批准日期： Date of approved by ethic committee：	2025-12-23 00:00:00
伦理委员会联系人：	董平平
Contact Name of the ethic committee：	Dong Pingping
伦理委员会联系地址：	中国江苏省南京市秦淮区杨公井34标34号
Contact Address of the ethic committee：	No. 34, Block 34, Yanggong Well, Qinhuai District, Nanjing City, Jiangsu Province, China
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 25 8086 4362	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 Command General Hospital of the People's Liberation Army

研究实施负责（组长）单位地址：

中国江苏省南京市秦淮区杨公井34标34号

Primary sponsor's address：

No. 34, Block 34, Yanggong Well, Qinhuai District, Nanjing City, Jiangsu Province, 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)：	江苏	市(区县)：	南京
Country：	China	Province：	Jiangsu	City：	Nanjing
单位(医院)：	中国人民解放军东部战区总医院	具体地址：	中国江苏省南京市秦淮区杨公井34标34号
Institution hospital：	Eastern Theater Command General Hospital of the People's Liberation Army	Address：	No. 34, Block 34, Yanggong Well, Qinhuai District, Nanjing City, Jiangsu Province, China

经费或物资来源：

院内课题经费

Source(s) of funding：

Institutional Project Funding

研究疾病：

晚期肝内胆管癌

Target disease：

Advanced Intrahepatic Cholangiocarcinoma

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：

观察和评价阿得贝利单抗联合吉西他滨和顺铂一线治疗晚期肝内胆管癌的有效性和安全性。

Objectives of Study：

Observing and evaluating the efficacy and safety of Adebrelimab in combination with gemcitabine and cisplatin as first-line treatment for advanced intrahepatic cholangiocarcinoma.

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 in the study and sign the informed consent form;  
2. Age 18 to 75 years, either sex;  
3. Histologically and/or cytologically confirmed diagnosis of unresectable advanced or metastatic intrahepatic cholangiocarcinoma;  
4. No prior exposure to immunotherapy;  
5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1;  
6. Adequate organ function as defined by the following criteria: absolute neutrophil count >=1.5×10^9/L; platelet count >=75×10^9/L; hemoglobin >=90 g/L; serum albumin >=30 g/L; creatinine clearance >=60 mL/min; thyroid-stimulating hormone (TSH) <=1 times the upper limit of normal, with normal serum T3 and T4 levels; women of childbearing potential must have a negative pregnancy test (β-hCG) prior to initiation of treatment; women of childbearing potential and men (who have sexual relations with women of childbearing potential) must agree to use contraception during treatment and for 6 months after the last dose of therapy.

排除标准：

1. 其他原发性恶性肿瘤病史，但以下情况除外：a. 以根治为目的接受过治疗的恶性肿瘤，并且在首次给药前>=5年无已知活动性疾病，且复发的潜在风险较低；b. 充分治疗过的非黑色素瘤皮肤癌或无疾病证据的恶性雀斑样痣；c. 充分治疗的原位癌，无疾病证据。 2. 目前伴有间质性肺炎或间质性肺病，或既往有需激素治疗的间质性肺炎或间质性肺病病史者，或其他可能干扰免疫相关肺毒性判断和处理的肺纤维化、机化性肺炎（例如，闭塞性细支气管炎）、尘肺、药物相关肺炎、特发性肺炎或在筛选期胸部 CT 显示患有活动性肺炎或肺功能严重受损的受试者；活动性结核。 3. 存在活动性自身免疫病或有自身免疫病病史且可能复发[包括但不局限于自身免疫性肝炎、间质性肺炎、葡萄膜炎、肠炎、垂体炎、血管炎、肾炎、甲状腺功能亢进、甲状腺功能降低（仅通过激素替代治疗可以控制的受试者可入组）]；患有无需系统治疗的皮肤病如白癜风、银屑病、脱发，接受胰岛素治疗的经控制的 I 型糖尿病或在童年期哮喘已完全缓解，成人后无需任何干预的可入组；需要支气管扩张剂进行医学干预的哮喘患者则不能入组。 4. 首次研究治疗前 2 周内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>10 mg/天泼尼松或其他等疗效激素）。 5. 有活动性感染、首次研究治疗前 1 周内有不明原因发热>=38.5℃、或基线期白细胞计数>15×10^9/L；首次研究治疗前 2 周内口服或静脉给予治疗性抗生素（用药时间不超过 48 小时静脉给予的预防性抗生素除外）者。 6. 先天或后天免疫功能缺陷（如 HIV 感染者）者。 7. 首次研究治疗前4 周内接受过减毒活疫苗治疗，或预期于研究末次给药后 60 天内需要接种此类疫苗。 8. 首次研究治疗前6 个月内出现显著临床意义的出血症状或具有明确的出血倾向，如消化道出血、重度食管胃底静脉曲张、出血性胃溃疡或患有脉管炎等，基线期若大便潜血阳性，可复查，复查后若仍为阳性，需要进行胃镜检查。 9. 已知存在的遗传性或获得性出血（如凝血功能障碍）或血栓倾向，如血友病病人，凝血机制障碍，血小板减少等；目前正在接受出于治疗目的使用全剂量口服或注射抗凝药物或溶栓药物（允许预防性使用小剂量阿司匹林等）。 10. 首次研究治疗前6 个月内发生过动脉血栓栓塞事件，如脑血管意外（包括暂时性缺血性发作、脑出血、脑梗塞）、CTCAE 3 级以上的深静脉血栓、肺栓塞等。 11. 有未能良好控制的心脏临床症状或疾病，如：（1）按照纽约心脏病协会（NYHA）标准 II 级以上心脏功能不全或彩色多普勒超声心电图：LVEF（左室射血分数）<50%；（2）不稳定型心绞痛；（3）随机前 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）静息状态下 QTc> 450ms（男性）； QTc>470ms（女性）。 12. 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>=90mmHg)（基于>=2 次测量获得的 BP 读数的平均值），允许通过使用降压治疗实现上述参数：既往曾出现高血压危象或高血压性脑病。 13. 首次研究治疗前 6 个月内出现重大血管疾病（例如，需要手术修补或近期有外周动脉血栓形成的主动脉瘤）。 14. 有严重、未愈合或裂开的伤口以及活动期溃病或未经治疗的骨折者。 15. 首次研究治疗前 4 周内接受过大手术治疗（诊断除外）或预期需在研究期间进行大手术治疗。 16. 不能吞咽药片、吸收不良综合症或任何影响胃肠吸收的状况者。 17. 首次研究治疗前6 个月内曾患肠梗阻和/或曾有胃肠道梗阻临床体征或症状，包括与原有疾病有关或需要常规肠外水化、肠外营养或管饲的不完全梗阻。在初始诊断时如果有不完全梗阻/梗阻综合征/肠梗阻体征/症状的患者接受了明确（外科）治疗以消退症状时，经综合评估后患者可入组。 18. 首次研究治疗前 2 周内仍在使用强CYP3A4诱导剂或首次研究治疗前 1周内仍在使用强CYP3A4抑制剂者。 19. 已知对任何研究药物或辅料过敏者。 20. 首次研究治疗前 4 周内有参加其他药物临床研究。 21. 妊娠或哺乳期女性。 22. 研究者认为不适合参加该研究的其他因素。

Exclusion criteria：

1. History of other primary malignant tumors, except the following: a. Malignant tumors previously treated with curative intent and no known active disease for >=5 years prior to first dose, with low risk of recurrence; b. Adequately treated non-melanoma skin cancer or malignant lentigo maligna without evidence of disease; c. Adequately treated carcinoma in situ without evidence of disease. 2. Current interstitial pneumonia or interstitial lung disease, or history of interstitial pneumonia or interstitial lung disease requiring steroid treatment; or other pulmonary conditions that may interfere with assessment and management of immune-related pulmonary toxicity, such as pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), pneumoconiosis, drug-related pneumonia, idiopathic pneumonia, or subjects with active pneumonia or severely impaired lung function demonstrated by chest CT during screening; active tuberculosis. 3. Active autoimmune disease or history of autoimmune disease with potential for recurrence [including but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism (subjects with hypothyroidism controlled solely by hormone replacement therapy may be enrolled)]; subjects with dermatologic conditions not requiring systemic therapy such as vitiligo, psoriasis, or alopecia; subjects with well-controlled type I diabetes mellitus requiring insulin therapy or childhood asthma fully resolved without intervention in adulthood may be enrolled; subjects requiring bronchodilator medical intervention for asthma are excluded. 4. Use of immunosuppressive agents or systemic steroids for immunosuppressive purposes within 2 weeks prior to first study treatment (dose >10 mg/day prednisone or equivalent). 5. Active infection; unexplained fever >=38.5°C within 1 week prior to first study treatment; or baseline white blood cell count >15×10^9/L; use of therapeutic oral or intravenous antibiotics within 2 weeks prior to first study treatment (prophylactic intravenous antibiotics administered for <=48 hours are exempt). 6. Congenital or acquired immunodeficiency (e.g., HIV infection). 7. Receipt of live attenuated vaccine within 4 weeks prior to first study treatment, or planned receipt of such vaccine within 60 days after the last study dose. 8. Clinically significant bleeding events or clear bleeding tendency within 6 months prior to first study treatment, such as gastrointestinal bleeding, severe esophageal/gastric varices, hemorrhagic gastric ulcer, or vasculitis; if fecal occult blood test is positive at baseline, retesting is permitted; if still positive, gastroscopy is required. 9. Known hereditary or acquired bleeding disorders (e.g., coagulopathy) or thrombotic tendency, such as hemophilia, coagulation disorders, or thrombocytopenia; currently receiving full-dose oral or injectable anticoagulants or thrombolytics for therapeutic purposes (prophylactic low-dose aspirin is permitted). 10. Arterial thromboembolic events within 6 months prior to first study treatment, such as cerebrovascular accidents (including transient ischemic attack, intracerebral hemorrhage, cerebral infarction), CTCAE grade >=3 deep vein thrombosis, or pulmonary embolism. 11. Poorly controlled cardiac symptoms or disease, including: (1) NYHA class II or higher heart failure or echocardiography showing LVEF (left ventricular ejection fraction) <50%; (2) unstable angina; (3) myocardial infarction within 1 year prior to randomization; (4) clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention; (5) resting QTc >450 ms (males); QTc >470 ms (females). 12. Hypertension poorly controlled despite antihypertensive therapy (systolic BP >=140 mmHg or diastolic BP >=90 mmHg, based on average of >=2 measurements); use of antihypertensive therapy to achieve these parameters is permitted; history of hypertensive crisis or hypertensive encephalopathy excludes enrollment. 13. Major vascular disease within 6 months prior to first study treatment (e.g., abdominal aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis). 14. Severe, non-healing, or dehisced wounds; active ulcers; or untreated fractures. 15. Major surgery (excluding diagnostic procedures) within 4 weeks prior to first study treatment, or anticipated need for major surgery during the study period. 16. Inability to swallow tablets, malabsorption syndrome, or any condition affecting gastrointestinal absorption. 17. History of intestinal obstruction and/or clinical signs or symptoms of gastrointestinal obstruction within 6 months prior to first study treatment, including partial obstruction related to underlying disease requiring routine parenteral hydration, parenteral nutrition, or tube feeding; patients with partial obstruction/obstruction syndrome/intestinal obstruction signs/symptoms at initial diagnosis who received definitive (surgical) treatment to resolve symptoms may be enrolled after comprehensive evaluation. 18. Use of strong CYP3A4 inducers within 2 weeks prior to first study treatment, or strong CYP3A4 inhibitors within 1 week prior to first study treatment. 19. Known hypersensitivity to any study drug or excipient. 20. Participation in another drug clinical trial within 4 weeks prior to first study treatment. 21. Pregnant or lactating females. 22. Other factors deemed unsuitable for study participation by the investigator.

研究实施时间：

Study execute time：

从 From 2025-12-23 00:00:00至 To 2026-12-31 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2026-02-01 00:00:00 至 To 2026-12-31 00:00:00

干预措施：

Interventions：

组别：	试验组	样本量：	30
Group：	Trial group	Sample size：	30
干预措施：	阿得贝利单抗1200 mg，iv，每3周为1个给药周期；吉西他滨1000 mg/m^2和顺铂25 mg/m^2，第1天和第8天给药，Q3W，最多8个周期。	干预措施代码：
Intervention：	Adebrelimab 1200 mg, intravenous, once every 3 weeks as one treatment cycle; Gemcitabine 1000 mg/m^2 and Cisplatin 25 mg/m^2, administered on Day 1 and Day 8, Q3W, for a maximum of 8 cycles.	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)：	中国人民解放军东部战区总医院	单位级别：	三甲
Institution hospital：	Eastern Theater Command General Hospital of the People's Liberation Army	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	Type：	Primary 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	Type：	Secondary 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	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	安全性（不良事件（AE）：依据NCI-CTCAE v5.0分级，从签署知情同意书起至末次给药后90天止；严重不良事件（SAE）：符合定义的事件（如死亡、危及生命、住院延长、残疾、先天畸形等），需在24小时内上报）	指标类型：	副作用指标
Outcome：	Safety (Adverse Events [AEs]): Graded according to NCI-CTCAE v5.0, from signing of informed consent until 90 days after the last dose; Serious Adverse Events (SAEs): Events meeting defined criteria (e.g., death, life-threatening, prolonged hospitalization, disability, congenital anomaly, etc.) must be reported within 24 hours.	Type：	Adverse events
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	探索影响临床疗效的生物标志物	指标类型：	次要指标
Outcome：	Exploration of Biomarkers Affecting Clinical Efficacy	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:

公开/Public

盲法：	无
Blinding：	None
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	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）：	无
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：	病例报告表
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	CRF
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：	2026-01-09 16:37:12