注册号：
Registration number：
ChiCTR2600116626 最近更新日期：
Date of Last Refreshed on：
2026-01-13 10:41:06 注册时间：
Date of Registration：
2026-01-13 00:00:00 注册号状态：
预注册Registration Status：
Prospective registration注册题目：
芦康沙妥珠单抗联合特瑞普利单抗用于三阴乳腺癌新辅助治疗的单臂、多中心、Ⅱ期临床试验Public title：
A single-arm, multicenter, phase II clinical trial on sacituzumab tirumotecan with toripalimab in neoadjuvant therapy for triple-negative breast cancer注册题目简写：English Acronym：研究课题的正式科学名称：
芦康沙妥珠单抗联合特瑞普利单抗用于三阴乳腺癌新辅助治疗的单臂、多中心、Ⅱ期临床试验Scientific title：
A single-arm, multicenter, phase II clinical trial on sacituzumab tirumotecan with toripalimab in neoadjuvant therapy for triple-negative breast 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：
孙正魁
研究负责人：
孙正魁 Applicant：
Zhengkui Sun
Study leader：
Zhengkui Sun 申请注册联系人电话：
Applicant telephone：
+86 139 0700 0210
研究负责人电话：
Study leader's telephone：
+86 139 0700 0210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：
403810956@qq.com
研究负责人电子邮件：
Study leader's E-mail：
403810956@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：
江西省南昌市北京东路519号
研究负责人通讯地址：
江西省南昌市北京东路519号Applicant address：
No.519, East Beijing Road, Nanchang City, JIangxi Provence, China
Study leader's address：
No.519, East Beijing Road, Nanchang City, JIangxi Provence, China申请注册联系人邮政编码：
Applicant postcode：
330029
研究负责人邮政编码：
Study leader's postcode：
330029申请人所在单位：
江西省肿瘤医院Applicant's institution：
Jiangxi Cancer Hospital研究负责人所在单位：
江西省肿瘤医院Affiliation of the Leader：
Jiangxi 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：
2025207-YW205
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：
江西省肿瘤医院医学伦理委员会Name of the ethic committee：
Medical Ethics Committee of Jiangxi Cancer Hospital伦理委员会批准日期：
Date of approved by ethic committee：
2025-12-31 00:00:00伦理委员会联系人：
余忠建Contact Name of the ethic committee：
Zhongjian Yu伦理委员会联系地址：
江西省南昌市北京东路519号Contact Address of the ethic committee：
No. 519, East Beijing Road, Nanchang City, Jiangxi Province伦理委员会联系人电话：
Contact phone of the ethic committee：
+86 136 6709 0686
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：
江西省肿瘤医院Primary sponsor：
Jiangxi Cancer Hospital研究实施负责（组长）单位地址：
江西省南昌市北京东路519号Primary sponsor's address：
No. 519, East Beijing Road, Nanchang City, Jiangxi 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)：
江西
市(区县)：
南昌
Country：
China
Province：
JIangxi
City：
Nanchang
单位(医院)：
江西省肿瘤医院
具体地址：
江西省南昌市北京东路519号
Institution
hospital：
Jiangxi Cancer Hospital
Address：
No. 519, East Beijing Road, Nanchang City, Jiangxi Province经费或物资来源：
上海君实医药科技股份有限公司；四川科伦博泰生物医药股份有限公司Source(s) of funding：
Shanghai Junshi Pharmaceutical Technology Co., Ltd;Sichuan Kelun Botai Biopharmaceutical Co., Ltd研究疾病：
乳腺癌 Target disease：
Breast 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：
芦康沙妥珠单抗联合特瑞普利单抗用于三阴乳腺癌新辅助治疗的疗效和安全性。 Objectives of Study：
Efficacy and safety of sacituzumab tirumotecan with toripalimab in neoadjuvant treatment of triple negative breast 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.受试者自愿加入本研究，签署知情同意书，依从性好；
2.年龄：18-75 周岁（签署知情同意书时）；
3.ECOG PS 评分：0~1 分；
4.经组织或细胞病理学证实的三阴浸润性乳腺癌受试者，HER2 免疫组化0-1+或2+并原位杂交（ISH）阴性；ER 阴性和PR阴性：阳性染色的肿瘤细胞占所有肿瘤细胞的比例<10%；
5.就诊时的临床分期为T2-4 加任何N、M0 或任何T 加N1-3、M0；
6.临床分期为T0-1 时，区域淋巴结阳性需经病理学确认（细针穿刺或粗针活检）；
7.受试者同意在新辅助治疗后达到手术标准时接受乳腺癌切除术；
8.主要器官功能良好，符合下列标准：
（1）血红蛋白（HGB）≥90g/L（检查前7 天内未输血、未使用造血刺激因子类药物纠正）；
（2）中性粒细胞绝对值（NEUT）≥1.5×109/L（检查前7天内未输血、未使用造血刺激因子类药物纠正）；
（3）血小板计数（PLT）≥100×109/L（检查前7 天内未输血、未使用造血刺激因子类药物纠正）。
（4）总胆红素（TBIL）≤1.5倍正常值上限(ULN)；
（5）丙氨酸基转移酶（ALT）和天门冬氨酸基转移酶（AST）≤1.5×ULN；
（6）血清肌酐（CR）≤1.5×ULN或肌酐清除率(CCr)≥60ml/min；
（7）血清白蛋白≥30g/L；
（8）凝血酶原时间（PT）≤1.5×ULN（未接受过抗凝治疗）；
（9）活化部分凝血活酶时间（APTT）≤1.5×ULN（未接受过抗凝治疗）；
（10）国际标准化比值（INR）≤1.5×ULN（未接受过抗凝治疗）；
（11）心脏彩超评估：左室射血分数(LVEF)≥50%。
9.育龄女性受试者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、避孕药或避孕套）；在研究入组前的7天内血清妊娠试验阴性，且必须为非哺乳期受试者；男性受试者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。Inclusion criteria
1.The subjects voluntarily participated in this study, signed the informed consent form, and demonstrated good compliance;
2. Age: 18-75 years (at the time of signing the informed consent form);
3. ECOG PS score: 0~1;
4. Subjects with triple-negative invasive breast cancer confirmed by histopathology or cytology, HER2 immunohistochemistry 0-1+ or 2+ and negative for in situ hybridization (ISH); ER-negative and PR-negative: the proportion of tumor cells with positive staining among all tumor cells is <10%;
5. The clinical stage at the time of diagnosis was T2-4 with any N, M0 or any T with N1-3, M0;
6. When the clinical stage is T0-1, positive regional lymph nodes require pathological confirmation (via fine-needle aspiration or core needle biopsy);
7. The subject agrees to undergo breast cancer resection upon meeting surgical criteria after neoadjuvant therapy;
8. The main organs function well and meet the following criteria:
Hemoglobin (HGB) >=90 g/L (no blood transfusion or use of hematopoietic stimulating factor drugs for correction within 7 days before the test);
(2) Absolute neutrophil count (NEUT) >=1.5×10^9/L (no blood transfusion or hematopoietic stimulant medication used within 7 days prior to the test for correction);
(3) Platelet count (PLT) >= 100 × 10^9/L (no blood transfusion or correction with hematopoietic stimulating factor drugs within 7 days prior to the test).
(4) Total bilirubin (TBIL) <= 1.5 times the upper limit of normal (ULN);
(5) Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <=1.5×ULN;
(6) Serum creatinine (CR) <=1.5×ULN or creatinine clearance (CCr) >=60ml/min;
(7) Serum albumin >= 30 g/L;
Prothrombin time (PT) <=1.5×ULN (no prior anticoagulant therapy);
(9) Activated partial thromboplastin time (APTT) <=1.5×ULN (without prior anticoagulant therapy);
(10) International Normalized Ratio (INR) <= 1.5 × ULN (no history of anticoagulant therapy);
(11) Echocardiographic evaluation: Left ventricular ejection fraction (LVEF) >=50%.
9. Female subjects of childbearing age must agree to use contraception (such as intrauterine devices, oral contraceptives, or condoms) during the study and for 6 months after its completion; they must have a negative serum pregnancy test within 7 days prior to study enrollment and be non-lactating; male subjects must agree to use contraception during the study and for 6 months after its completion.排除标准：
1.IV期转移性乳腺癌，或其他研究者判断不能通过新辅助治疗达到根治性手术切除的受试者。
2.双侧乳腺癌。
3.既往有浸润性乳腺癌或导管原位癌病史（当前诊断前>5年仅接受乳房切除术治疗的导管原位癌除外）。
4.既往接受过任何针对乳腺癌的抗肿瘤治疗，包括化疗、内分泌治疗、靶向治疗、放疗、手术治疗（乳腺癌诊断活检、当前诊断前>5年仅接受乳房切除术治疗的导管原位癌除外）等。
5.合并疾病及病史
（1）5 年内出现过或当前同时患有其它恶性肿瘤。以下两种情况可以入组：经单一手术治疗的其他恶性肿瘤，达到连续5 年的无疾病生存（DFS）；治愈的子宫颈原位癌、非黑色素瘤的皮肤癌和表浅的膀胱肿瘤 [Ta (非浸润性肿瘤)，Tis (原位癌) 和T1 (肿瘤浸润基膜)]；
（2）既往治疗的不良反应未能恢复至CTCAEv5.0级评分≤1级，除外2级脱发、2级外周神经毒性、2级贫血、非临床显著性和无症状性实验室异常、经激素替代治疗稳定的甲状腺功能减退等经研究者判断无安全风险的毒性；
（3）首次给药前4周内接受过重大外科治疗、明显创伤性损伤或预期研究治疗期间可能接受重大手术者（方案规定的手术除外），或存在长期未治愈的伤口或骨折。（重大手术定义为国家手术分级目录2022 版中3 级及以上的手术）；
（4）存在影响静脉注射、静脉采血疾病；
（5）存在先天性出血、凝血功能障碍疾病，或在研究治疗开始前28天内患有出血、凝血性疾病，或研究治疗开始前7天内使用阿司匹林>325mg/天(最大抗血小板剂量)或双嘧达莫、噻氯匹定、氯吡格雷和西洛他唑治疗；
（6）首次给药前6个月内发生过动脉/深静脉血栓事件，如脑血管意外(包括暂时性缺血性发作、脑出血、脑梗塞，无症状且无需治疗的腔隙性脑梗塞除外)、深静脉血栓及肺栓塞等；植入式静脉输液港或导管源性血栓形成者接受血栓消失且无需抗凝治疗后入组；
（7）血压控制不理想（收缩压≥150mmHg或舒张压≥100mmHg）；
（8）患有重大心血管疾病，包括下列任何情况：①按照纽约心脏病协会（NYHA）标准II级及以上心脏功能不全；②有临床显著意义的室性心律失常病史（如持续性室性心动过速、室颤、尖端扭转型室性心动过速）或需要持续抗心律失常药物治疗的心律失常；③不稳定型心绞痛；④6个月内出现过心肌梗死；⑤经Fridericia-修正的QT间期（QTcF）男性>450毫秒（msec），女性>470msec（若QTc异常，可间隔2分钟以上连续检测三次，取其平均值）；⑥先天性长QT综合征病史或家族史；
（9）研究治疗开始前14天内存在未能控制的≥CTCAE2级的感染；
（10）既往发生过需要类固醇药物干预治疗的间质性肺病/肺炎（非感染型）病史，或目前伴有间质性肺病/肺炎，或筛选期影像提示疑似间质性肺病/肺炎且无法排除的受试者；
（11）首次给药前3个月内存在中重度肺功能障碍/疾病者，包括但不限于特发性肺组织纤维化、机化性肺炎/闭塞性细支气管炎、重度哮喘、重度慢性阻塞性肺疾病（COPD）、限制性肺病等；筛选期存在活动性肺结核、药物诱导的肺炎、需要治疗的放射性肺炎或有临床症状的活动性肺炎；以及任何伴随肺部受累的自身免疫性、结缔组织或炎性疾病（类风湿性关节炎、干燥综合征、结节病等），或既往接受过全肺切除术等；
（12）活动性病毒性肝炎且控制不佳者；满足以下要求者可以筛选：HBsAg阳性。受试者须满足HBVDNA定量<2000IU/ml（或1×104copy/ml）或在研究开始前至少接受1周抗HBV治疗且病毒指数降低10倍（1个log值）及以上，同时受试者愿意在整个研究期间全程接受抗HBV治疗；HCV感染者（HCV Ab或HCV RNA阳性）：研究者判断处于稳定状态或入组时正在接受抗病毒治疗且研究中继续接受已批准的抗病毒治疗。
（13）需要治疗的活动性梅毒感染者；
（14）准备进行或既往接受过异体骨髓移植或实体器官移植者；
（15）需使用免疫抑制剂、或全身或可吸收的局部激素治疗以达到免疫抑制目的，并在首次给药前7天内仍需继续使用的受试者（糖皮质激素每日剂量≤10mg泼尼松或其他等疗效激素除外）；
（16）有免疫缺陷病史，包括HIV阳性或患有其它获得性、先天性免疫缺陷疾病，或有器官移植史者；
（17）糖尿病控制不佳（空腹血糖（FBG）＞10mmol/L）；
（18）尿常规提示尿蛋白≥++，且证实24小时尿蛋白定量＞1.0g者；
（19）肾功能衰竭需要血液透析或腹膜透析者；
（20）患有癫痫并需要治疗者；
（21）具有精神类药物滥用史且无法戒除或有精神障碍者；
6. 肿瘤相关症状及治疗
（1）在研究治疗开始前接受过原发肿瘤和/或腋窝淋巴结切除活检，或接受过前哨淋巴结活检；
（2）研究治疗开始前3周内曾接受过手术、化疗、放疗或其它抗肿瘤疗法（从末次治疗结束时间开始计算洗脱期）；
（3）因任意恶性肿瘤既往接受过紫杉类或卡铂治疗；
（4）研究治疗开始前2周内接受过NMPA批准药物说明书中明确具有抗肿瘤适应症的中成药（包括但不限于复方斑蝥胶囊、康艾注射液、康莱特胶囊/注射剂、艾迪注射液、鸦胆子油注射剂/胶囊、消癌平片/注射剂、华蟾素胶囊等）治疗。
7. 研究治疗相关
（1）使用特瑞普利单克隆抗体后出现过重度超敏反应者；
（2）研究治疗开始前2周内发生过未能控制的活动性自身免疫性疾病；
（3）对任何研究药物或药物中的任何成分或辅料过敏；
（4）研究治疗开始前28 天内接种过活疫苗，包括：麻疹、流行性腮腺炎、风疹、水痘、黄热病、季节性流感、H1N1流感、狂犬病、BCG和伤寒疫苗。
8. 根据研究者的判断，存在严重危害受试者安全或影响受试者完成研究的情况。Exclusion criteria：
1. Stage IV metastatic breast cancer, or other subjects deemed by researchers to be ineligible for curative resection through neoadjuvant therapy.
2. Bilateral breast cancer.
3. History of invasive breast cancer or ductal carcinoma in situ (excluding ductal carcinoma in situ treated only with mastectomy >5 years prior to the current diagnosis).
4. Any prior anti-tumor treatment for breast cancer, including chemotherapy, endocrine therapy, targeted therapy, radiotherapy, and surgical treatment (excluding ductal carcinoma in situ diagnosed by biopsy, where only mastectomy was performed more than 5 years before the current diagnosis).
5. Combined Diseases and Medical History
(1) History of or concurrent presence of other malignant tumors within the past 5 years. The following two conditions qualify for enrollment: other malignant tumors treated with a single surgical procedure and achieving a disease-free survival (DFS) of 5 consecutive years; cured cervical in situ carcinoma, non-melanoma skin cancer, and superficial bladder tumors [Ta (non-invasive tumors), Tis (carcinoma in situ), and T1 (tumor invasion of the basement membrane)];
(2) Adverse reactions from prior treatments failed to recover to a CTCAEv5.0 grade <=1, excluding grade 2 alopecia, grade 2 peripheral neuropathy, grade 2 anemia, non-clinically significant and asymptomatic laboratory abnormalities, hypothyroidism stabilized with hormone replacement therapy, and other toxicities deemed safe by the investigator;
(3) Individuals who had undergone major surgical procedures, significant traumatic injuries, or were expected to require major surgeries during the study treatment period (excluding surgeries specified in the protocol), or those with long-term untreated wounds or fractures (major surgery is defined as Level 3 or above in the 2022 National Surgical Classification Directory);
(4) There are diseases that affect intravenous injection and venous blood sampling;
(5) Presence of congenital bleeding or coagulation disorders, or a history of bleeding or coagulation diseases within 28 days prior to the initiation of the study treatment, or use of aspirin >325 mg/day (maximum antiplatelet dose), or dipyridamole, ticlopidine, clopidogrel, and cilostazol within 7 days before the study treatment begins;
(6) Patients who had experienced arterial/deep venous thrombotic events within 6 months prior to the first dose administration, such as cerebrovascular accidents (excluding transient ischemic attacks, cerebral hemorrhage, cerebral infarction, and asymptomatic, non-treatment-required lacunar infarction), deep vein thrombosis, and pulmonary embolism; those with implantable venous access ports or catheter-induced thrombosis were enrolled after thrombus resolution without requiring anticoagulation therapy;
(7) Inadequate blood pressure control (systolic blood pressure >=150 mmHg or diastolic blood pressure >=100 mmHg);
(8) Suffering from significant cardiovascular diseases, including any of the following conditions: ① Heart failure classified as NYHA Class II or higher; ② A history of clinically significant ventricular arrhythmias (e.g., sustained ventricular tachycardia, ventricular fibrillation, torsades de pointes) or arrhythmias requiring continuous antiarrhythmic medication; ③ Unstable angina; ④ Myocardial infarction occurring within the past 6 months; ⑤ Corrected QT interval (QTcF) >450 milliseconds (msec) in males or >470 msec in females (if QTc is abnormal, three consecutive measurements can be taken with intervals of more than 2 minutes, and the average value will be used); ⑥ History or family history of congenital long QT syndrome;
(9) Study treatment initiation within 14 days of uncontrolled infections of grade >=CTCAE2;
(10) Subjects with a history of interstitial lung disease/ pneumonia (non-infectious type) requiring steroid intervention, or currently accompanied by interstitial lung disease/ pneumonia, or those with imaging suggestive of interstitial lung disease/ pneumonia during screening that cannot be ruled out;
(11) Individuals with moderate to severe pulmonary dysfunction/disease within 3 months prior to the first dose, including but not limited to idiopathic pulmonary fibrosis, organizing pneumonia/bronchiolitis obliterans, severe asthma, severe chronic obstructive pulmonary disease (COPD), restrictive lung disease, etc.; those with active pulmonary tuberculosis, drug-induced pneumonia, treatable radiation pneumonia, or clinically symptomatic active pneumonia during the screening period; as well as any autoimmune, connective tissue, or inflammatory diseases involving pulmonary involvement (rheumatoid arthritis, Sjögren's syndrome, sarcoidosis, etc.), or a history of total pneumonectomy;
(12) Individuals with active viral hepatitis that is poorly controlled; those meeting the following criteria can be screened: HBsAg positive. Subjects must have HBV DNA quantitative <2000 IU/ml (or 1×10⁴ copies/ml) or have received at least 1 week of anti-HBV treatment prior to the study with a viral load reduction of 10-fold (1 log value) or more, while being willing to receive anti-HBV treatment throughout the entire study period; HCV (HCV Ab or HCV RNA positive): The investigator must determine that the condition is stable or that the subject is receiving antiviral treatment at enrollment and will continue approved antiviral therapy during the study.
(13) Active syphilis patients requiring treatment;
(14) Those who are about to undergo or have previously received allogeneic bone marrow transplantation or solid organ transplantation;
(15) Subjects who require immunosuppressants, systemic or absorbable local hormonal therapy for immunosuppression and must continue such treatment within 7 days before the first administration (excluding glucocorticoids with a daily dose <=10mg prednisone or equivalent efficacy hormones);
(16) History of immunodeficiency, including HIV-positive status or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation;
(17) Poor diabetes control (fasting blood glucose (FBG) > 10 mmol/L);
(18) Urine routine shows urinary protein >=++and confirms 24-hour urinary protein quantification>1.0g;
(19) Patients with renal failure requiring hemodialysis or peritoneal dialysis;
(20) Individuals with epilepsy who require treatment;
(21) Individuals with a history of abuse of psychotropic drugs who are unable to quit or have mental disorders;
6. Tumor related symptoms and treatment
(1) Having undergone primary tumor and/or axillary lymph node dissection biopsy, or sentinel lymph node biopsy prior to the start of research treatment;
(2) Have undergone surgery, chemotherapy, radiation therapy, or other anti-tumor therapies within the last 3 weeks prior to the start of treatment (the washout period is calculated from the end of the last treatment);
(3) Due to previous treatment with paclitaxel or carboplatin for any malignant tumor;
(4) Within 2 weeks before the start of the study treatment, he has received the treatment of traditional Chinese patent medicines and simple preparations (including but not limited to compound cantharides capsule, Kangai injection, Kanglaite capsule/injection, Aidi injection, Brucea javanica oil injection/capsule, Xiaoaiping tablet/injection, cinobufotalin capsule, etc.) with anti-tumor indications specified in the drug manual approved by NMPA.
7. Research treatment related
(1) Individuals who have experienced severe hypersensitivity reactions after using monoclonal antibodies against Tripril;
(2) Uncontrolled active autoimmune diseases occurred within 2 weeks prior to the start of treatment;
(3) Allergic to any research drug or any ingredient or excipient in the drug;
(4) Vaccination with live vaccines, including measles, mumps, rubella, chickenpox, yellow fever, seasonal influenza, H1N1 influenza, rabies, BCG, and typhoid fever vaccines, within 28 days prior to the start of treatment.
8. According to the researcher's judgment, there are situations that seriously endanger the safety of the subjects or affect their ability to complete the study.研究实施时间：
Study execute time：
从
From
2026-01-01 00:00:00至
To
2028-06-30 00:00:00
征募观察对象时间：
Recruiting time：
从
From
2026-01-25 00:00:00
至
To
2027-12-31 00:00:00干预措施：
Interventions：
组别：
试验组
样本量：
34
Group：
Experimental group
Sample size：
干预措施：
芦康沙妥珠单抗；特瑞普利单抗
干预措施代码：
Intervention：
Sacituzumab tirumotecan; toripalimab
Intervention code：研究实施地点：
Countries of recruitment and research settings：
国家：
中国
省(直辖市)：
江西
市(区县)：
Country：
China
Province：
JIangxi
City：
单位(医院)：
江西省肿瘤医院
单位级别：
三甲
Institution
hospital：
Jiangxi Cancer Hospital
Level of the institution：
Tertiary A
国家：
中国
省(直辖市)：
江西
市(区县)：
Country：
China
Province：
JIangxi
City：
单位(医院)：
赣南医科大学第一附属医院
单位级别：
三甲
Institution
hospital：
The First Affiliated Hospital of Gannan Medical University
Level of the institution：
Tertiary A
国家：
中国
省(直辖市)：
江西
市(区县)：
Country：
China
Province：
Jiangxi
City：
单位(医院)：
南昌大学第一附属医院
单位级别：
三甲
Institution
hospital：
The First Affiliated Hospital of Nanchang University
Level of the institution：
Tertiary A
国家：
中国
省(直辖市)：
江西
市(区县)：
Country：
China
Province：
JIangxi
City：
单位(医院)：
赣州市人民医院
单位级别：
三甲
Institution
hospital：
Ganzhou People's Hospital
Level of the institution：
Tertiary A
国家：
中国
省(直辖市)：
江西
市(区县)：
Country：
China
Province：
JIangxi
City：
单位(医院)：
萍乡市人民医院
单位级别：
三甲
Institution
hospital：
Pingxiang People's Hospital
Level of the institution：
Tertiary A测量指标：
Outcomes：
指标中文名：
病理完全缓解率
指标类型：
主要指标
Outcome：
Pathological complete remission 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：
无事件生存
指标类型：
次要指标
Outcome：
Event 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
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
指标类型：
副作用指标
Outcome：
Safety
Type：
Adverse
events
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：
肿瘤组织
组织：
Sample Name：
Tumor tissue
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：
女性
Gender：
Female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：Blinding：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：
2026-01-13 10:40:42
