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：	ChiCTR2600122241
最近更新日期： Date of Last Refreshed on：	2026-04-10 14:16:12
注册时间： Date of Registration：	2026-04-10 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	呋喹替尼联合EGFR单抗用于RAS野生型转移性结直肠癌三线治疗的II期研究
Public title：	A Phase Il Study of Fruquintinib Plus Anti-EGFR Monoclonal Antibody in RAS Wild-Type Metastatic Colorectal Cancer as Third-Line Therapy
注册题目简写：
English Acronym：
研究课题的正式科学名称：	呋喹替尼联合EGFR单抗用于RAS野生型转移性结直肠癌三线治疗的II期研究
Scientific title：	A Phase Il Study of Fruquintinib Plus Anti-EGFR Monoclonal Antibody in RAS Wild-Type Metastatic Colorectal Cancer as Third-Line Therapy
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：	孙永琨	研究负责人：	孙永琨
Applicant：	Yongkun Sun	Study leader：	Yongkun Sun
申请注册联系人电话： Applicant telephone：	+86 10 87788800	研究负责人电话： Study leader's telephone：	+86 10 87788800
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：	hsunyk@cicams.ac.cn	研究负责人电子邮件： Study leader's E-mail：	hsunyk@126.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：	河北省廊坊经济技术开发区花园道67号	研究负责人通讯地址：	河北省廊坊经济技术开发区花园道67号
Applicant address：	No. 67, Huayuan Road, Langfang Economic and Technological Development Zone, Hebei Province	Study leader's address：	No. 67, Huayuan Road, Langfang Economic and Technological Development Zone, Hebei 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：	中国医学科学院肿瘤医院
Applicant's institution：	Cancer Hospital Chinese Academy of Medical Sciences
研究负责人所在单位：	中国医学科学院肿瘤医院
Affiliation of the Leader：	Cancer Hospital Chinese Academy of Medical Sciences

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：	25/318-0318	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：	中国医学科学院肿瘤医院廊坊院区伦理委员会
Name of the ethic committee：	The Ethics Committee of Lang fang Campus of Cancer Hospital, Chinese Academy of Medical Sciences
伦理委员会批准日期： Date of approved by ethic committee：	2025-12-30 00:00:00
伦理委员会联系人：	贾硕鹏
Contact Name of the ethic committee：	Jia Shuopeng
伦理委员会联系地址：	河北省廊坊经济技术开发区花园道67号
Contact Address of the ethic committee：	No. 67, Huayuan Road, Langfang Economic and Technological Development Zone, Hebei Province
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 316 5918495	伦理委员会联系人邮箱： Contact email of the ethic committee：	3319091412@stu.cpu.edu.cn

研究实施负责（组长）单位：

中国医学科学院肿瘤医院廊坊院区

Primary sponsor：

Langfang Campus of Chinese Academy of Medical Sciences Cancer Hospital

研究实施负责（组长）单位地址：

河北省廊坊经济技术开发区花园道67号

Primary sponsor's address：

No. 67, Huayuan Road, Langfang Economic and Technological Development Zone, Hebei 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)：	河北	市(区县)：
Country：	China	Province：	Hebei	City：
单位(医院)：	中国医学科学院肿瘤医院廊坊院区	具体地址：	河北省廊坊经济技术开发区花园道67号
Institution hospital：	Langfang Campus of Chinese Academy of Medical Sciences Cancer Hospital	Address：	No. 67, Huayuan Road, Langfang Economic and Technological Development Zone, Hebei Province

经费或物资来源：

无

Source(s) of funding：

None

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：

II期临床试验

Study phase：

2

研究设计：

单臂

Study design：

Single arm

研究目的：

评估呋喹替尼联合西妥昔单抗β治疗RAS野生型难治性转移性结直肠癌的疗效与安全性

Objectives of Study：

Evaluate the efficacy and safety of fruquintinib combined with cetuximab β in the treatment of RAS wild-type refractory metastatic 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：

Inclusion criteria

1.Have been fully informed about the study and have voluntarily signed a written informed consent form;
2.Aged 18–75 years (inclusive);
3.Histologically confirmed advanced metastatic colorectal adenocarcinoma;
4.Tumor tissue genotyping demonstrating wild-type NRAS, KRAS, and BRAF;
5.Have previously received first-line oxaliplatin- and irinotecan-based therapy, or have received at least two lines of standard chemotherapy and experienced treatment failure. These standard regimens must have included fluoropyrimidines, oxaliplatin, and irinotecan, with or without bevacizumab or cetuximab. Treatment failure is defined as disease progression during treatment or within 3 months after the last dose, or unacceptable toxicity. Each line of therapy must have included at least one cycle of one or more chemotherapeutic agents. If recurrence or metastasis occurs during or within 6 months after completion of adjuvant/neoadjuvant therapy, such therapy will be considered a failure of first-line chemotherapy for advanced disease;
6.At least one measurable lesion according to RECIST version 1.1;
7.ECOG performance status of 0–1;
8. Expected survival time >= 12 weeks; 
9. Within 7 days before enrollment, the function of major organs must meet the following requirements (the use of any blood components and growth factors is not allowed within 14 days before enrollment): 
(1) Absolute neutrophil count >= 1.5 × 10^9/L; 
(2) Platelets >= 80 × 10^9/L; 
(3) Hemoglobin >= 8 g/dL; 
(4) Total bilirubin <= 1.5 × ULN; 
(5) ALT and AST <= 2.5 × ULN (for patients with liver metastasis <= 5 × ULN); 
(6) Serum creatinine <= 1.5 × ULN, and endogenous creatinine clearance rate >= 50 ml/min; 
(7) International Normalized Ratio (INR) <= 1.5 or Activated Partial Thromboplastin Time (APTT) <= 1.5 × ULN;
10.Good compliance and willingness to cooperate with follow-up;

排除标准：

1.无法遵守研究方案或研究程序； 2.既往接受过血管内皮生长因子受体（VEGFR）酪氨酸激酶抑制剂（TKI）的治疗； 3.入组前4周内参加过其他药物临床试验； 4.入组前4周内接受过或正在接受其他全身抗肿瘤治疗； 5.患者目前存在药物未能控制的高血压，规定为：收缩压＞140 mmHg 和/或舒张压＞90 mmHg； 6.患者目前有任何影响药物吸收的疾病或状态，或患者不能口服药物； 7.患者目前存在胃及十二指肠活动性溃疡、溃疡性结肠炎等消化道疾病或未切除的肿瘤存在活动出血，或研究者判定的可能引起消化道出血、穿孔的其他状况； 8.入组前6个月内有动脉血栓或深静脉血栓史； 9.入组前2个月内有明显出血倾向证据或病史的患者，如出现黑便、呕血、咯血、大便隐血++或以上（大便隐血+者且存在原发病灶的，必须胃镜排除出血或溃疡方可入组）等； 10.入组前12月内发生卒中事件和/或短暂性脑缺血；有显著临床意义的心血管疾病，包括但不限于入组前6个月内急性心肌梗死、严重/不稳定心绞痛或者冠脉搭桥术；充血性心力衰竭纽约心脏协会（NYHA）分级>2 级；需要药物治疗的室性心律失常；LVEF（左心室射血分数）<50%（超声心动图检查）； 11.在过去5年内患有其它恶性肿瘤，充分治疗后的皮肤基底细胞或鳞状细胞癌，或宫颈等脏器的原位癌除外，肺早期非浸润癌、膀胱非肌层浸润性癌除外； 12.临床上未能控制的活动性感染，如急性肺炎、活动性乙型肝炎或丙型肝炎（既往病史乙肝病毒感染不分药物控制，乙肝病毒DNA>=1×10^4拷贝/mL或者>2000 IU/ml）； 13.妊娠（用药前妊娠检测阳性）或正在哺乳的女性； 14.尿常规提示尿蛋白>=2+，或24小时尿蛋白量>1.0g者； 15.研究者认为不适宜入选本研究的患者；

Exclusion criteria：

1. Unable to comply with the research protocol or research procedures; 2. Previous treatment with vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitors (TKI); 3. Participated in another drug clinical trial within the past 4 weeks; 4. Received or currently receiving other systemic antitumor therapy within 4 weeks prior to enrollment; 5. The patient currently has uncontrolled hypertension that is defined as: systolic pressure > 140 mmHg and/or diastolic pressure > 90 mmHg; 6. The patient currently has any disease or condition that affects drug absorption, or the patient is unable to take oral medications; 7. The patient currently has active gastric and duodenal ulcers, ulcerative colitis, or other gastrointestinal diseases, or the presence of active bleeding from an unremoved tumor, or other conditions that the investigator deems may cause gastrointestinal bleeding or perforation; 8. History of arterial thrombosis or deep vein thrombosis within the past 6 months; 9. Patients with evidence or history of significant bleeding tendency within the past 2 months, such as black stools, hematemesis, hemoptysis, fecal occult blood ++ or above (patients with fecal occult blood + and with primary disease focus must undergo gastroscopy to exclude bleeding or ulcers before being included in the group); 10. Stroke event and/or transient ischemic attack within 12 months prior to enrollment; significant cardiovascular disease with clinical significance, including but not limited to acute myocardial infarction, severe/unstable angina, or coronary artery bypass grafting within 6 months prior to enrollment; congestive heart failure with New York Heart Association (NYHA) class >2; ventricular arrhythmias requiring medication treatment; LVEF (left ventricular ejection fraction) <50% (echocardiography examination); 11. Excluding well-treated basal cell or squamous cell carcinoma of the skin, or in situ carcinoma of the cervix and other organs within the past 5 years, excluding early non-invasive lung cancer and non-muscle invasive bladder cancer; 12. Clinically uncontrolled active infections, such as acute pneumonia, active hepatitis B, or hepatitis C (a history of hepatitis B virus infection regardless of drug control, hepatitis B virus DNA >= 1×10^4 copies/mL or > 2000 IU/mL); 13. Pregnancy (positive pregnancy test before medication) or lactating women; 14. Urinalysis indicating proteinuria >= 2+, or 24-hour urine protein > 1.0 g;

研究实施时间：

Study execute time：

从 From 2026-01-01 00:00:00至 To 2028-10-31 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2026-04-10 00:00:00 至 To 2027-10-31 00:00:00

干预措施：

Interventions：

组别：	试验组	样本量：	46
Group：	Experimental group	Sample size：	46
干预措施：	呋喹替尼+西妥昔单抗β	干预措施代码：
Intervention：	Furquitin + Cetuximab β	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	中国	省(直辖市)：	河北省	市(区县)：
Country：	China	Province：	Hebei	City：
单位(医院)：	中国医学科学院肿瘤医院廊坊院区	单位级别：	三级甲等
Institution hospital：	Langfang Campus of Chinese Academy of Medical Sciences Cancer Hospital	Level of the institution：	Tertiary A

测量指标：

Outcomes：

指标中文名：	客观缓解率	指标类型：	主要指标
Outcome：	Overall response rate	Type：	Primary 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	指标类型：	次要指标
Outcome：	Safety	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：	无进展生存期	指标类型：	次要指标
Outcome：	Progress-free 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：	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：

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	其它	说明
Fate of sample：	0thers	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	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）：	http://www.medresman.org.cn
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	http://www.medresman.org.cn
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：	CRF
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：	有/Yes
注册人： Name of Registration：	2026-04-10 14:16:03