ChiCTR2600124917 版本V1.0 版本创建时间2026/05/19 11:41:15 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：

 ChiCTR2600124917 

最近更新日期：

Date of Last Refreshed on：

 2026-05-19 11:40:27 

注册时间：

Date of Registration：

 2026-05-19 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

探索新辅助中等分割放疗联合化疗针对II-III期软组织肉瘤患者的有效性和安全性的单臂II期临床试验

Public title：

A single-arm phase II clinical trial to explore the efficacy and safety of neoadjuvant intermediate fractionated radiotherapy combined with chemotherapy in patients with stage II-III soft tissue sarcoma

注册题目简写：

English Acronym：

研究课题的正式科学名称：

探索新辅助中等分割放疗联合化疗针对II-III期软组织肉瘤患者的有效性和安全性的单臂II期临床试验

Scientific title：

A single-arm phase II clinical trial to explore the efficacy and safety of neoadjuvant intermediate fractionated radiotherapy combined with chemotherapy in patients with stage II-III soft tissue sarcoma

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：

谭智超 

研究负责人：

刘佳勇 

Applicant：

Zhichao Tan 

Study leader：

Jiayong Liu 

申请注册联系人电话：

Applicant telephone：

 +86 10 8819 6745

研究负责人电话：

Study leader's
telephone：

+86 10 8819 6745

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：

 zhichaotan@pku.edu.cn

研究负责人电子邮件：

Study leader's E-mail：

 Liujiayong@aliyun.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：

北京市海淀区阜成路52号

研究负责人通讯地址：

北京市海淀区阜成路52号

Applicant address：

No. 52 Fucheng Road, Haidian District, Beijing

Study leader's address：

No. 52 Fucheng Road, Haidian District, Beijing

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：

北京大学肿瘤医院

Applicant's institution：

Peking University Cancer Hospital

研究负责人所在单位：

北京大学肿瘤医院

Affiliation of the Leader：

Peking University Cancer 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：

 2025KT136

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：

北京肿瘤医院医学伦理委员会

Name of the ethic committee：

Medical Ethics Committee of Beijing Cancer Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

 2025-07-28 00:00:00

伦理委员会联系人：

陆婷

Contact Name of the ethic committee：

Lu Ting

伦理委员会联系地址：

北京市海淀区阜成路52号

Contact Address of the ethic committee：

No. 52 Fucheng Road, Haidian District, Beijing

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 10 8819 6391

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：

北京大学肿瘤医院

Primary sponsor：

Peking University Cancer Hospital

研究实施负责（组长）单位地址：

北京市海淀区阜成路52号

Primary sponsor's address：

No. 52 Fucheng Road, Haidian District, Beijing

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

北京市

市(区县)：

Country：

China

Province：

Beijing

City：

单位(医院)：

北京肿瘤医院

具体地址：

北京市海淀区阜成路52号

Institution
hospital：

Peking University Cancer Hospital

Address：

No. 52 Fucheng Road, Haidian District, Beijing

经费或物资来源：

北京大学世纪金源“腾云临床研究专项”

Source(s) of funding：

Peking University Century Jinyuan 'Tengyun Clinical Research Project'

研究疾病：

软组织肉瘤  

Target disease：

Soft tissue sarcoma

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：

探索新辅助中等分割放疗联合化疗治疗II-III期STS患者的有效性和安全性。  

Objectives of Study：

Exploring the effectiveness and safety of new adjuvant moderate-dose radiotherapy combined with chemotherapy for treating patients with stage II-III STS.

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.年龄≥18周岁的男性或女性； 2.ECOG评分≤2； 3.预期生存时间≥6月； 4.经病理学确诊的II-III期STS患者（按照第8版美国癌症联合会［American Joint Committee on Cancer，AJCC］分期）； 5.T分期≥2期，G分级为2-3级（FNCLCC）的STS； 6.肿瘤区域既往未接受过放疗； 7.根据RECIST v1.1标准，存在至少1个可测量病灶，基线时经计算机断层扫描（CT）或磁共振成像（MRI）（首选静脉注射造影剂）准确测量显示共长直径≥10mm（淋巴结除外，淋巴结的短轴必须≥15mm），且病灶适合反复准确测量； 8.血常规检查：血红蛋白（Hb）≥80g/L（14天内未输血）；中性粒细胞计数（NEUT）≥1.5×10^9/L；血小板（PLT）≥75×10^9/L； 9.生化检查：谷丙转氨酶（ALT）及谷草转氨酶（AST）≤ 2.5×ULN（肿瘤肝脏转移者，≤ 5×ULN）；血清总胆红素（TBIL）≤1.5×ULN（Gilbert综合症患者，≤ 3×ULN）；血清肌酐（Cr）≤1.5×ULN，且 肌酐清除率＞50μmol/L； 10.凝血功能：活化部分凝血活酶时间（APTT）、国际标准化比值（INR）、 凝血酶原时间（PT）≤1.5×ULN； 11.女性应同意在研究期间 和研究结束后6个月内必须采用避孕措施（如宫内 节育器[IUD]，避孕药或避孕套）；在研究入组前的7天内血清或尿妊娠 试验阴性，且必须为非哺乳期患者；男性应同意在研究期间和研究期结束后6个月内必须采用避孕措施； 12.患者自愿加入本研究，签署书面知情同意书（informed consent form, ICF），并且能够遵守访视的相关规定和程序

Inclusion criteria

1. Males or females aged >=18 years; 2. ECOG performance status <=2; 3. Expected survival time >=6 months; 4. Patients with pathologically confirmed stage II-III STS (according to the 8th edition of the American Joint Committee on Cancer [AJCC] staging); 5. STS with T stage >=2 and grade 2-3 (FNCLCC); 6. Tumor area has not previously received radiotherapy; 7. According to RECIST v1.1 criteria, at least one measurable lesion exists, with baseline measurement by CT or MRI (preferably with intravenous contrast) showing a sum of the longest diameters >=10 mm (excluding lymph nodes; lymph nodes must have a short axis >=15 mm), and lesions suitable for repeated accurate measurement; 8. Blood routine tests: Hemoglobin (Hb) >=80 g/L (no transfusion within 14 days); absolute neutrophil count (NEUT) >=1.5×10^9/L; platelets (PLT) >=75×10^9/L; 9. Biochemistry tests: ALT and AST <=2.5×ULN (<=5×ULN for patients with liver metastases); total bilirubin (TBIL) <=1.5×ULN (<=3×ULN for patients with Gilbert's syndrome); serum creatinine (Cr) <=1.5×ULN, and creatinine clearance >50 μmol/L; 10. Coagulation function: APTT, INR, and PT <=1.5×ULN; 11. Female patients must agree to use contraception during the study and for 6 months after the study (e.g., IUD, oral contraceptives, or condoms); have a negative serum or urine pregnancy test within 7 days before enrollment, and must not be breastfeeding; male patients must agree to use contraception during the study and for 6 months after the study; 12. Patients voluntarily participate in this study, sign the informed consent form (ICF), and are able to comply with the visit schedule and procedures.

排除标准：

1.因本次入组的肿瘤既往接受含蒽环类药物的治疗并确认无效； 2.在本方案给药前28天内接受过任何研究型药物治疗； 3.首次给药前2周内接受过具有抗肿瘤适应症的中草药或免疫调节作用药物（包括胸腺肽、干扰素、白介素）的系统性全身治疗； 4.正在参与另一项干预性临床研究，或处于干预性研究的随访阶段 5.已知有中枢神经系统（Central Nervous System，CNS）转移和/或脊髓压迫和／或癌性脑膜炎，有软脑脊膜癌病史。对于脑转移病灶经过放疗或手术治疗后症状稳定的患者，只要符合下列所有标准，可参与本项研究：中枢神经系统之外有可测量的病灶：无中脑、脑桥、脑膜、延髓或脊髓转移；脑转移治疗后没有新的或扩大的脑转移瘤的证据，并在研究治疗之前停止了皮质类固醇和抗惊厥药物治疗至少14天则可以参加；无症状脑转移患者，需对脑转移病灶进行放疗，治疗后满足上述条件可以入选研究： 6.在研究药物首次给药之前4周之内接受过重大的外科手术（开颅、开胸或开腹手术或其它由研究者定义）或者存在未愈合的伤口、溃疡或骨折。注：以姑息治疗为目的，对于孤立病灶的局部手术治疗是可以接受的； 7.未能控制的并发疾病，如： · 开始研究治疗前4周内发生严重感染，包括但不限于因感染、菌血症或重症肺炎并发症而住院治疗； · HIV感染者（HIV 1/2抗体阳性）； · 症状性充血性心力衰竭（纽约心脏病协会分级II-IV级）或心脏彩超检查提示LVEF（左室射血分数）<50%，或控制不佳的心律失常； · 心肌炎病史； · 需要立即干预的食管或胃底静脉曲张（例如，套扎或硬化治疗）或有门静脉高压证据。根据研究者的意见或咨询胃肠病学专家或肝脏病学专家认为其出血风险较高； · 在入组治疗前6个月内发生过任何动脉血栓栓塞时间，包括心肌梗死、不稳定型心绞痛、脑血管意外或一过性脑缺血发作等； · 在入组研究前3个月内发生任何危及生命的出血事件且需要医学干预治疗如：输血治疗、手术或局部治疗、持续药物等治疗； · 不受控制的代谢紊乱或其他非恶性肿瘤器官或全身性疾病或癌症继发反应，并可导致较高医学风险和/或生存期评价不确定性，经研究者判断不适合入组或存在经研究者判断不适合入组的其他情况； · 在入选研究前6个月内有胃肠道穿孔和/或瘘管的病史； · 有肠梗阻（除外已手术根治的肠梗阻）或肠穿孔风险的患者（包括但不限于急性憩室炎、腹腔脓肿、腹腔癌病史）或以下疾病的病史：广泛肠切除（部分结肠切除或广泛小肠切除，并发慢性腹泻）、克罗恩氏病、溃疡性结肠炎或慢性腹泻； · 显著的营养不良，如需要静脉补充营养液；首次治疗前营养不良已纠正4周以上的除外； · 食管或气管腔内支架植入术后； · 符合以下特征的神经、精神疾病或社会状况：影响研究要求的依从性，显著增加不良事件风险，或影响患者提供书面知情同意书的能力，例如有精神分裂症、药物滥用史等。 8.5年内患者既往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、根治术后的局部前列腺癌、甲状腺乳头状癌除外)； 9.预计在试验治疗期间接受其他抗肿瘤治疗； 10.患有活动性肺结核（TB）或活动性梅毒的患者，正在接受抗结核治疗或者筛选前1年内接受过抗结核治疗； 11.无法控制的重大癫痫发作或上腔静脉综合征； 12.存在化疗/放疗的禁忌症或其他不适合采用该研究方案的疾病； 13.首次给药前 4 周内发生严重感染，包括但不局限于伴有需要住院治疗的并发症、败血症或严重肺炎； 14.未治疗的慢性乙型肝炎患者或慢性乙型肝炎病毒（HBV）携带者且HBV DNA＞1000IU/mL，及活动性丙型肝炎患者应排除。非活动性乙型肝炎表面抗原（HbsAg）携带者，经治疗且稳定的乙型肝炎患者（HBV DNA<1000IU/mL），以及已治愈的丙型肝炎患者可以入组。对于 HCV Ab 阳性的受试者，仅在 HCV RNA 检测结果呈阴性的情况下，才有资格参与研究； 15.根据研究者的判断，采用反复引流或其他方法仍然无法稳定控制的胸腔积液、心包积液或腹水的受试者； 16.未得到控制的并发疾病，包括症状性充血性心力衰竭（按照纽约心脏病协会功能分级确定的 3 或 4 级）、未得到控制的高血压、不稳定型心绞痛、控制不佳的心律失常、急性或正患有心肌缺血的证据、重度活动性消化性溃疡病或胃炎，或会限制受试者依从研究要求或影响受试者提供书面知情同意能力的精神疾病/社会状况。入组前 6 个月内发生过任何动脉血栓栓塞事件，包括心肌梗死、脑血管意外或短暂性脑缺血发作，有深静脉血栓、肺栓塞或其它任何严重血栓栓塞的病史； 17.已知对蒽环类或异环磷酰胺的任何成分过敏； 18.妊娠期或哺乳期女性； 19.研究者认为可能会导致接受研究药物治疗有风险，或将干扰研究药物的评价或受试者安全性或研究结果解析的任何状况； 20.存在化疗或免疫治疗的禁忌症或其他不适合采用该研究方案的疾病

Exclusion criteria：

1. Because the tumor enrolled this time has received previous anthracycline-containing treatment and is confirmed to be ineffective; 2. Received any investigational drug within 28 days prior to the administration of this regimen; 3. Received systemic therapy with anti-tumor indications of Chinese herbal medicine or immunomodulatory drugs (including thymus peptide, interferon, interleukin) within 2 weeks before the first dose; 4. Is participating in another interventional clinical study, or is in the follow-up phase of the interventional study 5. Known central nervous system (CNS) metastases and/or spinal cord compression and/or carcinomatous meningitis, with a history of leptomeningeal cancer. Patients with stable symptoms after radiotherapy or surgery with brain metastases may participate in this study as long as they meet all of the following criteria: measurable lesions outside the central nervous system: no midbrain, pons, meninges, bulbar or spinal cord metastases; No evidence of new or enlarging brain metastases after treatment of brain metastases and discontinuation of corticosteroid and anticonvulsant drug therapy for at least 14 days prior to study treatment may be enrolled; Patients with asymptomatic brain metastases who need radiotherapy for brain metastases can be enrolled in the study if they meet the above conditions after treatment: 6. Have undergone major surgical surgery (craniotomy, thoracotomy or laparotomy or other as defined by the investigator) within 4 weeks prior to the first dose of study drug, or have unhealed wounds, ulcers or fractures. Note: For the purpose of palliative care, local surgical treatment of isolated lesions is acceptable; 7. Uncontrolled intercurrent diseases, such as: · Serious infection within 4 weeks prior to initiation of study treatment, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia; HIV-infected (HIV 1/2 antibody positive); Symptomatic congestive heart failure (New York Heart Association class II-IV) or LVEF (left ventricular ejection fraction) <50% on cardiac ultrasound, or poorly controlled arrhythmias; History of myocarditis; Esophageal or gastric varices requiring immediate intervention (e.g., banding or sclerotherapy) or evidence of portal hypertension. In the opinion of the investigator or in consultation with a gastroenterologist or hepatatologist, the risk of bleeding is high; Have had any arterial thromboembolism within 6 months prior to enrollment treatment, including myocardial infarction, unstable angina, cerebrovascular accident or transient ischemic attack, etc.; Any life-threatening bleeding event within 3 months prior to enrollment in the study that requires medical intervention such as: blood transfusion therapy, surgical or local therapy, continuous medication and other treatments; Uncontrolled metabolic disorders or other non-malignant neoplastic organs or systemic diseases or secondary reactions to cancer, and can lead to higher medical risk and/or uncertainty in survival evaluation, and are judged by the investigator to be unsuitable for enrollment or have other conditions judged by the investigator to be unsuitable for enrollment; History of gastrointestinal perforation and/or fistula within 6 months prior to study enrollment; Patients at risk of intestinal obstruction (excluding surgically cured intestinal obstruction) or intestinal perforation (including but not limited to acute diverticulitisHistory of intra-abdominal abscess, intra-abdominal cancer) or history of: extensive bowel resection (partial colectomy or extensive small bowel resection complicated by chronic diarrhea), Crohn's disease, ulcerative colitis, or chronic diarrhea; significant malnutrition, such as the need for intravenous nutrient fluids; Unless malnutrition has been corrected for more than 4 weeks before the first treatment; After esophageal or endotracheal stent implantation; Neurological, psychiatric or social conditions that affect compliance with study requirements, significantly increase the risk of adverse events, or affect the patient's ability to provide written informed consent, such as having schizophrenia, a history of substance abuse, etc. 8. Patients with other malignant tumors in the past or at the same time within 5 years (except for cured basal cell carcinoma of the skin and carcinoma in situ of the cervix, local prostate cancer after radical resection, and papillary thyroid carcinoma); 9. Anticipated receipt of other anti-tumor therapy during the trial treatment period; 10. Patients with active tuberculosis (TB) or active syphilis, who are receiving anti-tuberculosis treatment or have received anti-tuberculosis treatment within 1 year before screening; 11 Uncontrollable major seizures or superior vena cava syndrome; 12. Presence of contraindications to chemotherapy/radiotherapy or other diseases that are not suitable for the use of this study protocol; 13. Severe infection, including but not limited to complications requiring hospitalization, sepsis, or severe pneumonia, within 4 weeks prior to the first dose; 14. Patients with untreated chronic hepatitis B or chronic hepatitis B virus (HBV) carriers with HBV DNA > 1000IU/mL, and patients with active hepatitis C should be excluded. Carriers of inactive hepatitis B surface antigen (HbsAg), treated and stable hepatitis B patients (HBV DNA<1000IU/mL), and cured hepatitis C patients may be enrolled. For subjects who are HCV Ab positive, only if the HCV RNA test result is negative, will be eligible to participate in the study; 15. Subjects with pleural effusion, pericardial effusion, or ascites that cannot be stably controlled by repeated drainage or other methods according to the judgment of the investigator; 16. Uncontrolled intercurrent illness, including symptomatic congestive heart failure (grade 3 or 4 as determined by the New York Heart Association functional scale), uncontrolled hypertension, unstable angina, poorly controlled arrhythmia, evidence of acute or ongoing myocardial ischemia, severely active peptic ulcer disease, or gastritis, or psychiatric illness/social situation that would limit the subject's compliance with study requirements or affect the subject's ability to provide written informed consent. Any arterial thromboembolic event, including myocardial infarction, cerebrovascular accident, or transient ischemic attack, with a history of deep vein thrombosis, pulmonary embolism, or any other major thromboembolic attack within 6 months prior to enrollment; 17. Known hypersensitivity to any component of anthracyclines or ifosfamide; 18. Pregnant or lactating females; 19. In the opinion of the investigator, it may lead to risk treatment with the study drug, or will interfere with the study drugany condition of the evaluation or interpretation of the subject's safety or study results; 20. Presence of contraindications to chemotherapy or immunotherapy or other not

研究实施时间：

Study execute time：

从 From 2025-05-31 00:00:00至 To 2027-05-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2025-09-10 00:00:00 至 To 2025-12-30 00:00:00

干预措施：

Interventions：

组别：

治疗组

样本量：

 89

Group：

treatment group

Sample size：

干预措施：

表柔比星+异环磷酰胺，手术，放疗

干预措施代码：

Intervention：

Chemotherapy (epirubicin+ifosfamide) surgery Radiotherapy

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 北京市 

市(区县)：

 市辖区 

Country：

China

Province：

Beijing

City：

单位(医院)：

 北京肿瘤医院 

单位级别：

 三甲 

Institution
hospital：

Peking University Cancer Hospital

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

术后显著病理缓解率

指标类型：

主要指标

Outcome：

major pathological response

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

局部控制率

指标类型：

次要指标

Outcome：

Local 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：

无病生存率

指标类型：

次要指标

Outcome：

Disease-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：

总生存率

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：

血清

组织：

Sample Name：

serum

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：

正在进行

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:

公开/Public

盲法：

无

Blinding：

None

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

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/login.aspx，在试验结束6个月内上传试验数据。

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

http://www.medresman.org.cn/login.aspx, data were uploaded within 6 months after the end of the trial.

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：

ResMan, http://www.medresman.org.cn/login.aspx

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

ResMan, http://www.medresman.org.cn/login.aspx

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：

  2026-05-19 11:40:27