ChiCTR2600122750 版本V1.0 版本创建时间2026/04/17 09:31:36 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

 ChiCTR2600122750 

最近更新日期：

Date of Last Refreshed on：

 2026-04-17 09:31:29 

注册时间：

Date of Registration：

 2026-04-17 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

阿得贝利单抗联合甲磺酸阿帕替尼二线维持治疗晚期结直肠癌的前瞻性、单中心、单臂II期临床研究

Public title：

A prospective, single-center, single-arm Phase II clinical study of adebrelimab combined with apatinib mesylate for second-line maintenance treatment of advanced colorectal cancer

注册题目简写：

English Acronym：

研究课题的正式科学名称：

阿得贝利单抗联合甲磺酸阿帕替尼二线维持治疗晚期结直肠癌的前瞻性、单中心、单臂II期临床研究

Scientific title：

A prospective, single-center, single-arm Phase II clinical study of adebrelimab combined with apatinib mesylate for second-line maintenance treatment of advanced colorectal cancer

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：

袁钟姝 

研究负责人：

胡文蔚 

Applicant：

Zhongshu Yuan 

Study leader：

Wenwei Hu 

申请注册联系人电话：

Applicant telephone：

 +86 158 5065 0876

研究负责人电话：

Study leader's
telephone：

+86 139 1233 0886

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：

 zhongshu.yuan.zy30@hengrui.com

研究负责人电子邮件：

Study leader's E-mail：

 huwenwei1979@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：

南京市鼓楼区中央路19号金峰大厦11楼

研究负责人通讯地址：

江苏省常州市局前街185号

Applicant address：

11th Floor, Jin Feng Building, No. 19, Zhongyang Road, Gulou District, Nanjing City

Study leader's address：

No. 185, Juqian Street, Changzhou 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：

江苏恒瑞医药股份有限公司

Applicant's institution：

Jiangsu Hengrui Medicine Co., Ltd.

研究负责人所在单位：

常州市第一人民医院

Affiliation of the Leader：

Changzhou First People's Hospital

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：

 (2024)科第148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：

常州市第一人民医院伦理委员会

Name of the ethic committee：

the Ethics Committee of Changzhou First People's Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

 2024-08-07 00:00:00

伦理委员会联系人：

余锦川

Contact Name of the ethic committee：

Jinchuan Yu

伦理委员会联系地址：

江苏省常州市局前街185号

Contact Address of the ethic committee：

No. 185, Juqian Street, Changzhou City, Jiangsu Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 68870261

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：

常州市第一人民医院

Primary sponsor：

Changzhou First People's Hospital

研究实施负责（组长）单位地址：

江苏省常州市局前街185号

Primary sponsor's address：

No. 185, Juqian Street, Changzhou 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

市(区县)：

常州

Country：

China

Province：

Jiangsu

City：

Changzhou

单位(医院)：

常州市第一人民医院

具体地址：

江苏省常州市局前街185号

Institution
hospital：

Changzhou First People's Hospital

Address：

No. 185, Juqian Street, Changzhou City, Jiangsu Province

经费或物资来源：

江苏恒瑞医药股份有限公司

Source(s) of funding：

Jiangsu Hengrui Medicine Co., Ltd.

研究疾病：

结直肠癌  

Target disease：

Colorectal 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：

评估阿得贝利单抗联合甲磺酸阿帕替尼二线维持治疗晚期结直肠癌的有效性及安全性。  

Objectives of Study：

To evaluate the efficacy and safety of adebrelimab combined with apatinib mesylate as second-line maintenance therapy for advanced colorectal cancer.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

1. ≥18岁，性别不限； 2. 经病理学确诊的晚期结直肠癌受试者； 3. 既往曾接受过一线标准治疗且治疗失败。 “治疗失败”的定义：（1）治疗过程中疾病进展或末次治疗后的3个月内疾病进展，均有明确影像学或临床进展证据；（2）因无法耐受化疗不良事件而退出标准治疗的受试者，按 CTCAE 5.0标准，其不耐受的血液学不良事件严重等级需达到 IV 度以上（血小板下降为III度以上）或非血液学不良事件严重等级达到 III 度以上，且研究者判断该受试者重复原方案治疗仍然无法耐受。注：1) 如辅助治疗期间或完成后 ≤6 个月内出现疾病进展，则认为该辅助治疗即是针对进展期疾病的一线治疗。2) 允许前期治疗是化疗联合单抗药物（贝伐珠单抗，西妥昔单抗，帕尼单抗，阿柏西普等）。 4. 根据 RECIST 1.1 标准，受试者至少具有一个可测量的靶病灶； 5. ECOG评分：0~1 分； 6. 预计生存期 ≥3 个月； 7. 主要器官功能良好，即入组前14天内相关检查指标满足以下要求：（1）血常规检查（筛选前14天内未输血，未用过升白、升血小板药物）：血红蛋白 > 90 g/L；中性粒细胞计数> 1.5×109/L；血小板计数> 100×109/L；（2）生化检查：总胆红素 ≤ 1.5×ULN（正常值上限）；血谷丙转氨酶（ALT）和血谷草转氨酶（AST）≤ 2×ULN；如有肝转移，则ALT和AST ≤ 5×ULN；内生肌酐清除率 ≥ 60 ml/min（Cockcroft-Gault公式）；（3）心脏多普勒超声评估：左室射血分数 (LVEF，Left ventricular ejection fraction) ≥ 50%； 8. 若患有乙型肝炎病毒（HBV）感染，如 HBsAg 阳性，需检测 HBV-DNA，且HBV-DNA 需<2000 IU/mL（若研究中心只有 copy/mL 检测单位，则必须<104 copy/mL）；对于 HBV-DNA≥2000 IU/mL 的受试者，首次用药前接受至少 1 周的抗病毒治疗（仅允许使用核苷类药物如恩替卡韦、富马酸替诺福韦酯和富马酸丙酚替诺福韦片），且病毒拷贝数相比首次用药前下降 10 倍（1 lg）以上。对于 HBV 感染者，需在研究期间全程接受抗病毒治疗。丙型肝炎病毒（HCV）-RNA 阳性受试者必须按治疗指南接受抗病毒治疗； 9. 育龄妇女在首次用药前 3 天内必须妊娠检测为（βHCG）阴性。

Inclusion criteria

1. ≥18 years old, gender not limited; 2. Subjects with advanced colorectal cancer confirmed by pathology; 3. Previously received first-line standard treatment but failed. The definition of "treatment failure" : (1) There is clear imaging or clinical evidence of disease progression during the treatment process or within 3 months after the last treatment; (2) For subjects who withdraw from standard treatment due to intolerable adverse events of chemotherapy, according to the CTCAE 5.0 standard, the severity level of the intolerant hematological adverse event should reach grade IV or above (platelet count decrease to grade III or above), or the severity level of the non-hematological adverse event should reach grade III or above. Moreover, the researchers determined that the subject still could not tolerate repeated treatment with the original plan. Note: 1) If disease progression occurs during or within ≤6 months after the completion of adjuvant therapy, it is considered that the adjuvant therapy is the first-line treatment for advanced diseases. 2) The allowed early treatment is chemotherapy combined with monoclonal antibody drugs (bevacizumab, cetuximab, panitumab, aflibercept, etc.). 4. According to the RECIST 1.1 standard, the subject has at least one measurable target lesion; 5. ECOG score: 0 to 1 point; 6. Expected survival period ≥3 months; 7. The main organ functions are good, that is, the relevant examination indicators meet the following requirements within 14 days before enrollment: (1) Blood routine test (no blood transfusion and no drugs for increasing white blood count or platelet count within 14 days before screening) : Hemoglobin > 90 g/L; Neutrophil count > 1.5×109/L; Platelet count > 100×109/L; (2) Biochemical test: Total bilirubin ≤ 1.5×ULN (upper limit of normal value); Blood alanine aminotransferase (ALT) and blood aspartate aminotransferase (AST) ≤ 2×ULN; If there is liver metastasis, ALT and AST should be ≤ 5×ULN. Endogenous creatinine clearance rate ≥ 60 ml/min (Cockcroft-Gault formula); (3) Cardiac Doppler ultrasound assessment: Left ventricular ejection fraction (LVEF) ≥ 50%; 8. If there is hepatitis B virus (HBV) infection, such as positive HBsAg, HBV-DNA testing is required, and HBV-DNA should be less than 2000 IU/mL (if the research center only has a copy/mL testing unit, it must be less than 104 copy/mL). For subjects with HBV-DNA≥2000 IU/mL, they received antiviral treatment for at least one week before the first administration (only nucleoside drugs such as entecavir, tenofovir fumarate disoproxil, and tenofovir profol fumarate tablets were allowed), and the viral copy number decreased by more than 10 times (1 lg) compared to before the first administration. For HBV-infected individuals, antiviral treatment must be received throughout the study period. Subjects positive for hepatitis C virus (HCV) -RNA must receive antiviral treatment in accordance with the treatment guidelines; 9.Women of childbearing age must have a negative (βHCG) pregnancy test within 3 days before their first medication.

排除标准：

1. 以往或同时患有其它恶性肿瘤，但是已治愈的皮肤基底细胞癌和宫颈原位癌除外； 2. 既往接受过 ICS（如PD-1/PD-L1抑制剂、CTLA-4抑制剂）治疗的受试者； 3. 4周内参加过其他药物临床试验； 4. 接受其它治疗造成的损害未恢复者，其中接受亚硝基或丝裂霉素的间隔距服用研究药物 ≥6周；接受其它细胞毒性药物、靶向药物、放疗或手术 ≥4周，且伤口已完全愈合；接受中成药或中药 ≥2周； 5. 具有影响口服药物的多种因素（比如无法吞咽、慢性腹泻和肠梗阻等）； 6. 有出血病史，筛选前4周内发生任何严重分级达到 CTCAE 5.0中 3 度或以上的出血事件； 7. 筛选前已知有中枢神经系统转移或有中枢神经系统转移病史的受试者。对于临床疑似中枢神经系统转移的受试者，入组前28天内必须进行增强CT或增强核磁共振（MRI，Magnetic Resonance Imaging）检查，排除中枢神经系统转移； 8. 患有高血压且经单一降压药物治疗无法获得良好控制者（收缩压 > 140 mmHg，舒张压 > 90 mmHg）；具有不稳定型心绞痛病史者；筛选前3个月内新诊断为心绞痛者或筛选前6个月内发生心肌梗塞事件；心律失常（包括QTcF： 男性 ≥ 450 ms，女性 ≥ 470 ms）需长期使用抗心律失常药物及纽约心脏病协会分级 ≥ II级心功能不全； 9. 尿常规提示尿蛋白 ≥ ++ 且证实24小时尿蛋白定量 >1.0 g； 10. 患有活动性感染、首次用药前7天内有不明原因发热≥ 38.5℃、或基线期白细胞计数 > 15×109/L； 11. 既往或目前有间质性肺炎/间质性肺病、需接受糖皮质激素系统治疗的肺炎；目前有活动性肺炎或肺功能检查证实肺功能重度受损者； 12. 长期未愈合的伤口或愈合不全的骨折； 13. 影像学显示肿瘤已侵犯重要血管周或经研究者判断受试者肿瘤在治疗期间有极高可能侵袭重要血管而引起致命大出血的情况； 14. 凝血功能异常，具有出血倾向者（入组前14天必须满足：在不使用抗凝剂的情况下INR在正常值范围内）；应用抗凝剂或维生素K 拮抗剂如华法林、肝素或其类似物治疗的受试者；在凝血酶原时间国际标准化比值（INR，International Normalized Ratio）≤ 1.5的前提下，允许以预防目的使用小剂量华法林（1 mg口服，每日一次）或小剂量阿司匹林（每日用量不超过100 mg）； 15. 筛选前一年内发生过动/静脉血栓事件，如脑血管意外（包括暂时性缺血性发作）、深静脉血栓（因前期化疗行静脉置管引发静脉血栓经研究者判断已痊愈者除外）及肺栓塞等； 16. 既往存在甲状腺功能异常，即使在药物治疗的情况下，甲状腺功能仍不能维持在正常范围内； 17. 具有精神类药物滥用史且无法戒除者或有精神障碍的； 18. 有临床症状，需要临床干预或稳定时间小于4周的浆膜腔积液（如胸腔积液、心包积液和腹水）； 19. 有免疫缺陷病史，或患有其它获得性、先天性免疫缺陷疾病，或有器官移植史； 20. 根据研究者的判断，有严重的危害受试者安全或影响受试者完成研究的伴随疾病。

Exclusion criteria：

1. Previously or concurrently suffering from other malignant tumors, except for cured basal cell carcinoma of the skin and cervical carcinoma in situ; 2. Subjects who have previously received ICS treatment (such as PD-1/PD-L1 inhibitors, CTLA-4 inhibitors); Have participated in other drug clinical trials within 3 to 4 weeks; 4. For those who have not recovered from damage caused by other treatments, where the interval between receiving nitrosamines or mitomycin is ≥6 weeks from taking the study drug; Have received other cytotoxic drugs, targeted drugs, radiotherapy or surgery for ≥4 weeks, and the wound has completely healed; Have received Chinese patent medicine or traditional Chinese medicine for at least 2 weeks; 5. There are multiple factors that affect oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction, etc.); 6. A history of bleeding, with any severe bleeding event reaching grade 3 or above in CTCAE 5.0 within 4 weeks prior to screening; 7. Subjects who were known to have central nervous system metastases or a history of central nervous system metastases before screening. For subjects with clinically suspected central nervous system metastases, enhanced CT or enhanced Magnetic Resonance Imaging (MRI) examinations must be conducted within 28 days before enrollment to rule out central nervous system metastases. 8. Individuals with hypertension who have not achieved good control with a single antihypertensive drug (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg); Those with a history of unstable angina pectoris; Those who were newly diagnosed with angina pectoris within 3 months before screening or had a myocardial infarction event within 6 months before screening; Arrhythmia (including QTcF: ≥ 450 ms in men and ≥ 470 ms in women) requires long-term use of antiarrhythmic drugs and a New York Heart Association grade of ≥ II heart failure. 9. Urine routine test indicates urine protein ≥ ++ and confirms 24-hour urine protein quantification > 1.0g; 10. Suffering from active infection, having an unexplained fever of ≥ 38.5℃ within 7 days before the first medication, or a white blood cell count of > 15×109/L at the baseline period; 11. Previous or current interstitial pneumonia/interstitial lung disease, pneumonia requiring systemic treatment with glucocorticoids; Those who currently have active pneumonia or have been confirmed by pulmonary function tests to have severe impaired lung function; 12. Long-term unhealed wounds or incompletely healed fractures; 13. The imaging shows that the tumor has invaded the area around important blood vessels or the researcher determines that the tumor of the subject has a very high possibility of invading important blood vessels during treatment and causing fatal massive hemorrhage; 14. Patients with abnormal coagulation function and bleeding tendency (the INR must be within the normal range without the use of anticoagulants 14 days before enrollment); Subjects treated with anticoagulants or vitamin K antagonists such as warfarin, heparin or their analogues; On the premise that the International Normalized Ratio (INR) of prothrombin time is ≤ 1.5, low-dose warfarin (1 mg orally once daily) or low-dose aspirin (daily dosage not exceeding 100 mg) is allowed for preventive purposes. 15. Events of active or venous thrombosis that occurred within one year prior to screening, such as cerebrovascular accidents (including transient ischemic attacks), deep vein thrombosis (except for venous thrombosis caused by intravenous catheterization due to previous chemotherapy and judged by the researcher to have been cured), and pulmonary embolism, etc. 16. There has been a history of thyroid dysfunction, and even with drug treatment, the thyroid function still cannot be maintained within the normal range. 17. Those with a history of abuse of psychotropic drugs and unable to quit, or those with mental disorders; 18. Serous cavity effusions with clinical symptoms that require clinical intervention or have been stable for less than 4 weeks (such as pleural effusion, pericardial effusion and ascites); 19. Have a history of immune deficiency, or suffer from other acquired or congenital immune deficiency diseases, or have a history of organ transplantation; 20. According to the researcher's judgment, there are serious concomitant diseases that endanger the safety of the subjects or affect their completion of the study.

研究实施时间：

Study execute time：

从 From 2026-04-30 00:00:00至 To 2028-10-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2026-04-30 00:00:00 至 To 2028-10-31 00:00:00

干预措施：

Interventions：

组别：

试验组

样本量：

 34

Group：

group

Sample size：

干预措施：

阿得贝利单抗+阿帕替尼

干预措施代码：

Intervention：

Adebrelimab + apatinib

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)：

 常州 

Country：

China

Province：

Jiangsu

City：

Changzhou

单位(医院)：

 常州市第一人民医院 

单位级别：

 三甲 

Institution
hospital：

Changzhou First People's Hospital

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：

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：

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：

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：

Measure time point of outcome：

Measure method：

指标中文名：

不良事件

指标类型：

次要指标

Outcome：

Adverse event

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：

标本中文名：

尿液

组织：

Sample Name：

Urine

Tissue：

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

Note：

标本中文名：

粪便

组织：

Sample Name：

Stool

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 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：

Blinding：

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, 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：

  2026-04-17 09:31:29