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：	ChiCTR2600124228
最近更新日期： Date of Last Refreshed on：	2026-05-09 09:15:07
注册时间： Date of Registration：	2026-05-09 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	优替德隆联合安罗替尼二线治疗晚期非特指型软组织肉瘤有效性及安全性的多中心、单臂、II期临床研究
Public title：	Efficacy and Safety of Utidelone Combined with Anlotinib as Second-Line Therapy for Advanced Non-Specific Soft Tissue Sarcoma: A Multicenter, Single-Arm, Phase II Clinical Study
注册题目简写：
English Acronym：
研究课题的正式科学名称：	优替德隆联合安罗替尼二线治疗晚期非特指型软组织肉瘤有效性及安全性的多中心、单臂、II期临床研究
Scientific title：	Efficacy and Safety of Utidelone Combined with Anlotinib as Second-Line Therapy for Advanced Non-Specific Soft Tissue Sarcoma: A Multicenter, Single-Arm, Phase II Clinical Study
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：	许昕	研究负责人：	朱栋元;许昕
Applicant：	Xu Xin	Study leader：	Zhu Dongyuan;Xu Xin
申请注册联系人电话： Applicant telephone：	+86 531 6762 6279	研究负责人电话： Study leader's telephone：	+86 531 6762 6279
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：	xuxin666@163.com	研究负责人电子邮件： Study leader's E-mail：	405683898@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：	山东省济南市槐荫区济兖路440号	研究负责人通讯地址：	山东省济南市槐荫区济兖路440号
Applicant address：	No. 440, Jizuan Road, Huaing District, Jinan City, Shandong Province	Study leader's address：	No. 440, Jizuan Road, Huaing District, Jinan City, Shandong 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：	山东第一医科大学附属肿瘤医院(山东省肿瘤防治研究院山东省肿瘤医院)
Applicant's institution：	Shandong First Medical University Affiliated Tumor Hospital (Shandong Provincial Tumor Prevention and Control Research Institute, Shandong Provincial Tumor Hospital)
研究负责人所在单位：	山东第一医科大学附属肿瘤医院（山东省肿瘤防治研究院、山东省肿瘤医院）
Affiliation of the Leader：	Shandong First Medical University Affiliated Tumor Hospital (Shandong Provincial Tumor Prevention and Control Research Institute, Shandong Provincial Tumor 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：	SDZLEC2026-023-001	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：	山东第一医科大学附属肿瘤医院伦理委员会
Name of the ethic committee：	Ethics Committee of Shandong First Medical University Affiliated Tumor Hospital
伦理委员会批准日期： Date of approved by ethic committee：	2026-03-16 00:00:00
伦理委员会联系人：	李朝伟
Contact Name of the ethic committee：	Li Chaowei
伦理委员会联系地址：	山东省济南市槐荫区济兖路440号
Contact Address of the ethic committee：	No. 440, Jiyan Road, Huaiyin District, Jinan City, Shandong Province
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 531 67627162	伦理委员会联系人邮箱： Contact email of the ethic committee：	sdzlllh803@126.com

研究实施负责（组长）单位：

山东第一医科大学附属肿瘤医院

Primary sponsor：

Shandong First Medical University Affiliated Tumor Hospital

研究实施负责（组长）单位地址：

山东省济南市槐荫区济兖路440号

Primary sponsor's address：

No. 440, Jiyan Road, Huaiyin District, Jinan City, Shandong 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)：	山东省	市(区县)：
Country：	China	Province：	Shandong	City：
单位(医院)：	山东第一医科大学附属肿瘤医院	具体地址：	山东省济南市槐荫区济兖路440号
Institution hospital：	Shandong First Medical University Affiliated Tumor Hospital	Address：	No. 440, Jiyan Road, Huaiyin District, Jinan City, Shandong Province

经费或物资来源：

自选课题（自筹）

Source(s) of funding：

Self-selected topic (self-funded)

研究疾病：

非特指型软组织肉瘤

Target disease：

Soft tissue sarcoma, not otherwise specified

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：

评价优替德隆联合安罗替尼二线治疗晚期非特指型软组织肉瘤的有效性与安全性

Objectives of Study：

Evaluation of the efficacy and safety of uterideolin combined with anlotinib as a second-line treatment for advanced non-specific type soft tissue sarcoma

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. Provided written informed consent before performing any trial-related procedures;
5 x the upper limit of normal (ULN); e) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <= 2.5 x ULN (ALT or AST <= 5 x ULN is allowed for patients with liver metastasis); f) Serum creatinine <= 1.5 x ULN and creatinine clearance rate (calculated using the Cockcroft-Gault formula) >= 60 ml/min; g) Good coagulation function, defined as international normalized ratio (INR) or prothrombin time (PT) <= 1.5 x ULN; h) Normal thyroid function, defined as thyroid stimulating hormone (TSH) within the normal range. If the baseline TSH exceeds the normal range, patients with total T3 (or FT3) and FT4 within the normal range can also be enrolled; i) Myocardial enzyme spectrum within normal range (such as laboratory abnormalities that are considered purely laboratory and have no clinical significance can also be enrolled); 
10. For pregnant women of reproductive age, they should undergo urine or serum pregnancy test within 3 days before receiving the first dose of the study drug (on the first day of the first cycle) and the result should be negative. If the urine pregnancy test result cannot be confirmed as negative, a blood pregnancy test is required. Non-reproductive-aged women are defined as those who have been post-menopausal for at least 1 year, or have undergone surgical sterilization or hysterectomy;
11. If there is a risk of conception, all subjects (regardless of gender) must use a contraceptive method with an annual failure rate of less than 1% throughout the treatment period until 6 months after the last administration of the study drug.2. Age >=18 years old, and <=75 years old, regardless of gender;
3. Soft tissue sarcoma, not otherwise specified confirmed by histopathological examination;
4. Advanced patients who failed standard first-line drug therapy;
5. Interval between previous treatments: must be >=3 weeks for systemic therapy and >=2 weeks for radiotherapy or surgery.
6. At least one radiographic measurable lesion according to RECIST1.1 criteria;
7.ECOG score 0-1;
8. Expected survival time >3 months;
9. Good organ function if the following laboratory parameters were met: a) absolute neutrophil count (ANC) > 1.5x10^9 /L without granulocyte colony-stimulating factor administration for the past 14 days; 6 b) platelet count >=100×10^9 /L without blood transfusion in the past 14 days; c) hemoglobin >9g/dL in the past 14 days without blood transfusion or erythropoietin use; d) Total bilirubin <=1.5× upper limit of normal value (ULN); e) aspartate aminotransferase (AST), alanine aminotransferase (ALT) <=2.5×ULN (patients with liver metastasis were allowed ALT or AST<=5×ULN); f) serum creatinine <=1.5×ULN and creatinine clearance rate (calculated by Cockcroft-Gault common formula) >=60ml/min; g) good coagulation function, defined as INR or PT <=1.5 times ULN; h) euthyroidism, defined as thyroid stimulating hormone (TSH) within the normal range. If the baseline TSH was beyond the normal range, the subjects could be included if the total T3 (or FT3) and FT4 were within the normal range. i) myocardial enzymes within the normal range (simple laboratory abnormalities that were judged by the investigators to be clinically insignificant were also allowed);
10. For female subjects of childbearing age, a urine or serum pregnancy test with a negative result should be performed within 3 days prior to receiving the first dose of study drug (day 1 of cycle 1). If a urine pregnancy test could not be confirmed as negative, a blood pregnancy test was requested. Women who were not of reproductive age were defined as those who had been postmenopausal for at least 1 year or had undergone surgical sterilization or hysterectomy.
11. If there was a risk of pregnancy, all subjects (male or female) were required to use contraception with an annual failure rate of less than 1% for the entire treatment period until 6 months after the last dose of study drug on treatment.

排除标准：

1.需除外以下种类以外的所有软组织肉瘤：化疗高度敏感的肉瘤:胚胎性/腺泡状横纹肌肉瘤、尤文肉瘤;化疗不敏感的肉瘤:腺泡状软组织肉瘤和骨外黏液样软骨肉瘤、高分化脂肪肉瘤、透明细胞肉瘤、炎性肌纤维母细胞瘤、恶性血管周上皮样细胞瘤、胃肠道间质瘤和韧带样纤维瘤病； 2.凝血功能障碍； 3.研究用药前不足4周内或可能于研究期间接种活疫苗； 4.当前正在参与干预性临床研究治疗，或在首次给药前4周内接受过其他研究药物或使用过研究器械治疗； 5.在研究之前4周内接受过重大外科手术（开颅、开胸或开腹手术）或预期在研究治疗期间需要接受大手术。 6.已知异体器官移植（角膜移植除外）或异体造血干细胞移植； 7.在开始治疗前，尚未从任何干预措施引起的毒性和/或并发症中充分恢复（即CTCAE<=1级或达到基线，不包括乏力或脱发）； 8.长期未治愈的伤口或骨折； 9.存在任何严重或不能控制的全身性疾病，例如： a.静息心电图在节律、传导或形态上出现有重大且症状严重难以控制的异常，如完全性左束支传导阻滞，Ⅱ度以上心脏传导阻滞，室性心律失常或心房颤动； b.不稳定型心绞痛，充血性心力衰竭，纽约心脏病协会（NYHA）分级>=2级的慢性心衰； c.在入选治疗前6个月内发生过任何动脉血栓、栓塞或缺血，如心肌梗死、不稳定型心绞痛、脑血管意外或一过性脑缺血发作等； d.首次给药前1年内存在需要糖皮质激素治疗的非感染性肺炎病史，或当前存在临床活动性间质性肺病； e.活动性肺结核； f.存在需要全身性治疗的活动性或未能控制的感染； g.存在临床活动性憩室炎、腹腔脓肿、胃肠道梗阻； h.肝脏疾病如肝硬化、失代偿性肝病、急慢性活动性肝炎； i.糖尿病控制不佳（空腹血糖（FBG）＞10mmol/L）； j.存在精神障碍且无法配合治疗的患者； k.已知存在有症状的中枢神经系统转移和/或癌性脑膜炎； 10.有可能干扰试验结果、妨碍受试者全程参与研究的病史或疾病证据、治疗或实验室检查值异常，或研究者认为其他不适合入组的情况研究者认为存在其他潜在风险不适合参加本研究。 11. 患者有(A)高血压控制不佳；(B)中枢神经系统转移；(C)由以前的癌症治疗引起的持续的临床显著毒性；(D)活动性乙肝、丙型肝炎或艾滋病毒。

Exclusion criteria：

1. All soft tissue sarcomas except the following: highly chemotherapy-sensitive sarcomas: embryonal/alveolar rhabdomyosarcoma, Ewing's sarcoma; Chemotherapy-insensitive sarcomas: alveolar soft tissue sarcoma and extraskeletal myxoid chondrosarcoma, well-differentiated liposarcoma, clear cell sarcoma, inflammatory myofibroblastic tumor, malignant perivascular epithelioid cell tumor, gastrointestinal stromal tumor and desmoid fibromatosis; 2. Coagulation dysfunction; 3. Live vaccine administered less than 4 weeks before or possibly during the study administration; 4. Currently participating in an interventional clinical study treatment, or receiving another study drug or using a study device within 4 weeks before the first dose; 5. Had undergone major surgical procedures (craniotomy, thoracotomy, or laparotomy) within 4 weeks prior to the study or anticipated need for major surgery during the study treatment. 6. Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation; 7. Has not fully recovered from any intervention-related toxicity and/or complications before starting treatment (i.e., CTCAE<= grade 1 or baseline, excluding fatigue or alopecia); 8. Long-term unhealed wounds or fractures; 9. The presence of any serious or uncontrolled systemic disease, such as: a. Significant rhythm, conduction or morphological abnormalities on resting electrocardiogram that are symptomatic and difficult to control, such as complete left bundle branch block, second or greater degree heart block, ventricular arrhythmia or atrial fibrillation; b. Unstable angina pectoris, congestive heart failure, New York Heart Association (NYHA) class >=2 chronic heart failure; c. Any arterial thrombosis, embolism, or ischemia, such as myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack, occurred within 6 months before enrollment; d. A history of noninfectious pneumonia requiring glucocorticoid therapy within 1 year before the first dose or current clinically active interstitial lung disease; e. Active pulmonary tuberculosis; f. the presence of active or uncontrolled infection requiring systemic therapy; g. Presence of clinically active diverticulitis, abdominal abscess, and gastrointestinal obstruction; h. liver diseases such as cirrhosis, decompensated liver disease, acute and chronic active hepatitis; i. poorly controlled diabetes (fasting blood glucose (FBG) > 10mmol/L); j. patients with a mental disorder who are unable to cooperate with treatment; k. known presence of symptomatic central nervous system metastases and/or carcinomatous meningitis; 10. Medical history or evidence of disease, treatment or laboratory abnormalities, or other conditions deemed by the investigator to be inappropriate for enrollment that may interfere with the results of the trial or preclude full participation in the study. 11. The patient had (A) poorly controlled hypertension; (B) central nervous system metastases; (C) persistent clinically significant toxicity due to previous cancer treatment; (D) active hepatitis B, hepatitis C or HIV.

研究实施时间：

Study execute time：

从 From 2026-05-07 00:00:00至 To 2029-05-07 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2026-05-09 00:00:00 至 To 2027-05-09 00:00:00

干预措施：

Interventions：

组别：	试验组	样本量：	63
Group：	Experimental group	Sample size：	63
干预措施：	优替德隆+安罗替尼	干预措施代码：
Intervention：	Utidelone + Anlotinib	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	中国	省(直辖市)：	山东省	市(区县)：
Country：	China	Province：	Shandong	City：
单位(医院)：	山东第一医科大学附属肿瘤医院（山东省肿瘤防治研究院、山东省肿瘤医院）	单位级别：	三级甲等
Institution hospital：	Shandong First Medical University and Shandong Academy of Medical Sciences (Shandong Cancer Hospital ＆Institute)	Level of the institution：	Tertiary A

国家：	中国	省(直辖市)：	山东省	市(区县)：
Country：	China	Province：	Shandong	City：
单位(医院)：	临沂市人民医院	单位级别：	三级甲等
Institution hospital：	Linyi People's Hospital	Level of the institution：	Tertiary A

国家：	中国	省(直辖市)：	山东省	市(区县)：
Country：	China	Province：	Shandong	City：
单位(医院)：	济宁医学院附属医院	单位级别：	三级甲等
Institution hospital：	Jining Medical College Affiliated Hospital	Level of the institution：	Tertiary A

国家：	中国	省(直辖市)：	山东省	市(区县)：
Country：	China	Province：	Shandong	City：
单位(医院)：	烟台毓璜顶医院	单位级别：	三级甲等
Institution hospital：	Yantai Yuhuangding Hospital	Level of the institution：	Tertiary A

国家：	中国	省(直辖市)：	山东省	市(区县)：
Country：	China	Province：	Shandong	City：
单位(医院)：	山东第一医科大学第二附属医院	单位级别：	三级甲等
Institution hospital：	The Second Affiliated Hospital of Shandong First Medical University	Level of the institution：	Tertiary A

国家：	中国	省(直辖市)：	山东省	市(区县)：
Country：	China	Province：	Shandong	City：
单位(医院)：	青岛大学附属医院	单位级别：	三级甲等
Institution hospital：	The Affiliated Hospital of Qingdao University	Level of the institution：	Tertiary A

国家：	中国	省(直辖市)：	山东省	市(区县)：
Country：	China	Province：	Shandong	City：
单位(医院)：	潍坊市人民医院	单位级别：	三级甲等
Institution hospital：	Weifang People's Hospital	Level of the institution：	Tertiary A

国家：	中国	省(直辖市)：	山东省	市(区县)：
Country：	China	Province：	Shandong	City：
单位(医院)：	菏泽市牡丹人民医院	单位级别：	三级甲等
Institution hospital：	Heze Mudan 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：	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：	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：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：	无	组织：
Sample Name：	None	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	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：	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：	无/No
注册人： Name of Registration：	2026-05-09 09:15:01