注册号：
Registration number：
ChiCTR2600117076 最近更新日期：
Date of Last Refreshed on：
2026-01-19 17:57:10 注册时间：
Date of Registration：
2026-01-19 00:00:00 注册号状态：
预注册Registration Status：
Prospective registration注册题目：
依沃西单抗（AK112）联合化疗用于局部晚期口腔鳞 癌新辅助治疗的前瞻性、单中心、单臂临床研究Public title：
Prospective, Single-Center, Single-Arm Clinical Study of Ivosidenib (AK112) Combined with Chemotherapy for Neoadjuvant Treatment of Locally Advanced Oral Squamous Cell Carcinoma注册题目简写：English Acronym：研究课题的正式科学名称：
依沃西单抗（AK112）联合化疗用于局部晚期口腔鳞癌新辅助治疗的前瞻性、单中心、单臂临床研究Scientific title：
Prospective, Single-Center, Single-Arm Clinical Study of Ivosidenib (AK112) Combined with Chemotherapy for Neoadjuvant Treatment of Locally Advanced Oral Squamous Cell Carcinoma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：
章杰
研究负责人：
章杰 Applicant：
Zhang Jie
Study leader：
Zhang Jie 申请注册联系人电话：
Applicant telephone：
+86 791 88692133
研究负责人电话：
Study leader's telephone：
+86 791 88692201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：
zhjprs@163.com
研究负责人电子邮件：
Study leader's E-mail：
zhjprs@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：
南昌市东湖区永外正街17号
研究负责人通讯地址：
南昌市东湖区永外正街17号Applicant address：
17# Yongwai Zhengjie, Nanchang City, Jiangxi Province, China
Study leader's address：
17# Yongwai Zhengjie, Nanchang City, Jiangxi Province, China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：
南昌大学第一附属医院Applicant's institution：
The First Affiliated Hospital of Nanchang University研究负责人所在单位：
南昌大学第一附属医院Affiliation of the Leader：
The first affiliated hostipal of nanchang university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：
IIT[2025]临伦审第892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：
南昌大学第一附属医院医学伦理委员会（IIT分会）Name of the ethic committee：
The First Affiliated Hospital of Nanchang University Institutional Review Board (IIT)伦理委员会批准日期：
Date of approved by ethic committee：
2025-12-16 00:00:00伦理委员会联系人：
舒展Contact Name of the ethic committee：
Shu Zhan伦理委员会联系地址：
南昌市东湖区永外正街17号Contact Address of the ethic committee：
17# Yongwai Zhengjie, Nanchang City, Jiangxi Province, China伦理委员会联系人电话：
Contact phone of the ethic committee：
+86 791 88692201
伦理委员会联系人邮箱：
Contact email of the ethic committee：
493831410@qq.com研究实施负责（组长）单位：
南昌大学第一附属医院Primary sponsor：
The first affiliated hostipal of nanchang university研究实施负责（组长）单位地址：
南昌市东湖区永外正街17号Primary sponsor's address：
17# Yongwai Zhengjie, Nanchang City, Jiangxi Province, China试验主办单位(项目批准或申办者)：
Secondary sponsor：
国家：
中国
省(直辖市)：
江西省
市(区县)：
Country：
China
Province：
Jiangxi
City：
单位(医院)：
南昌大学第一附属医院
具体地址：
南昌市东湖区永外正街17号
Institution
hospital：
The first affiliated hostipal of nanchang university
Address：
17# Yongwai Zhengjie, Nanchang City, Jiangxi Province, China经费或物资来源：
自选课题（自筹）Source(s) of funding：
Self-selected Topic研究疾病：
口腔鳞癌 Target disease：
oral squamous cell carcinoma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：
上市后药物 Study phase：
4研究设计：
单臂 Study design：
Single arm 研究目的：
主要研究目的是依沃西单抗（AK112）联合化疗用于局晚期口腔鳞癌新辅助治疗的有效性，次要研究目的是依沃西单抗（AK112）联合化疗用于局晚期口腔鳞癌新辅助治疗的安全性，探索性目的是评估生物标记物（如受试者肿瘤组织 PD-L1 表达）与疗效相关性 Objectives of Study：
Primary objective: To evaluate the efficacy of Ivonescimab (AK112) combined with chemotherapy as neoadjuvant treatment for locally advanced oral squamous cell carcinoma. Secondary objective: To assess the safety of Ivonescimab (AK112) combined with chemotherapy as neoadjuvant treatment for locally advanced oral squamous cell carcinoma. Exploratory objective: To investigate the correlation between biomarkers (e.g., PD-L1 expression in the subject's tumor tissue) and treatment efficacy.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. 在实施任何试验相关流程之前，签署书面知情同意；
2. 男性或女性，年龄≥18岁且≤75岁；
3. 局晚期（T1~2 N1-3 /T3~4 任何N，M0）口腔鳞癌，且由研究者评估病灶可切除；
4. 首次用药前未接受过针对口腔癌的系统性或局部抗肿瘤治疗，包括放疗、化疗、 免疫 治疗、生物制剂、小分子靶向治疗等；
5. 同意接受根治性手术治疗并经外科医师判断无手术禁忌的患者；
6. ECOG评分0-1分；
7. 预期生存时间≥3个月；
8. 根据RECIST V1.1标准至少存在一个可评估病灶的患者；
9. 足够器官功能，受试者需满足如下实验室指标：
血液学：白细胞≥4000/μL、中性粒细胞≥2.000/μL、血红蛋白≥9 g/dL、血小板 ≥100000/μL；
肝功能：胆红素≤1.5 倍正常上限（ULN）（已知患Gilbert 病且血清胆红素水平 ≤3 倍 ULN 的患者可入组），AST 和 ALT≤3 倍 ，且碱性磷酸酶≤3 倍 ULN； 白蛋白≥3g / dL；
肾功能：血清肌酐≤1.5 倍 ULN 或根据 Cockcroft-Gault公式肌酐清除率≥60 mL/min。
10. 患者能够遵守研究计划的访视、治疗计划、实验室检查和其他研究程序。Inclusion criteria
1. Prior to conducting any trial-related procedures, the subject shall sign the written informed consent;
2. Male or female, aged >= 18 years and <= 75 years;
3. Diagnosed with locally advanced oral squamous cell carcinoma (OSCC) (T1-T2 N1-3 / T3-T4 any N, M0), with lesions assessed as resectable by the investigator.
4. No prior systemic or local anti-tumor therapy for OSCC before the first dose of study treatment, including radiotherapy, chemotherapy, immunotherapy, biological agents, small-molecule targeted therapy, etc.
5. Patients who consented to receive radical surgical treatment and were judged to have no surgical contraindications by a surgeon.
6. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
7. Expected survival time of >=3 months.
8. Patients with at least one evaluable lesion in accordance with the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.
9. Sufficient organ function, and the subjects must meet the following laboratory parameters:
Hematology: White blood cell (WBC) count >= 4,000/μL, neutrophil count >= 2,000/μL, hemoglobin (Hb) >= 9 g/dL, platelet count >= 100,000/μL.
Hepatic function: Total bilirubin <=1.5 × upper limit of normal (ULN) (patients with known Gilbert’s syndrome and serum bilirubin level <= 3 × ULN are eligible for enrollment); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <= 3 × ULN, and alkaline phosphatase (ALP) <= 3 × ULN; serum albumin >= 3 g/dL.
Renal function: Serum creatinine <= 1.5 × ULN or creatinine clearance rate >= 60 mL/min calculated by the Cockcroft-Gault formula.
10. Patients who are able to comply with the scheduled study visits, treatment plans, laboratory examinations and other study procedures.排除标准：
1. 患有除口腔鳞癌之外的其他病理组织学类型（如：腺癌等）；
2. 对PD-1单抗或贝伐珠单抗的任何成分有重度超敏反应史。
3. 对联用化疗药物有禁忌症或过敏史。
4. 存在不可切除因素，包括因为肿瘤原因导致不可切除或存在手术禁忌症或受试 者拒绝手术。
5. 患有已知或可疑的自身免疫性疾病者，包括痴呆和癫痫发作。
6. 复发、远处转移及合并其他恶性肿瘤。
7. 入组前7天内实验室检查值不符合相关标准者。
8. 既往接受过免疫治疗，包括免疫检查点抑制剂（如：抗 PD-1/L1 抗体、抗 CTLA-4 抗 体、抗 TIGIT 抗体、抗 LAG3 抗体等）、免疫检查点激动剂（如：ICOS、CD40、 CD137、 GITR、OX40 抗体等）、免疫细胞治疗等任何针对肿瘤免疫作用机制的治 疗的受试者。
9. 首次给药前2周内接受过具有抗肿瘤适应症的中成药或免疫调节作用的药物（包 括胸腺肽、干扰素、白介素，除外为控制胸水局部使用）系统性全身治疗；
10. 入组前患有需要长期使用免疫抑制药物治疗、或需要全身或局部使用具有免疫 抑制作用剂量的皮质类固醇药物的合并症。
11. HIV阳性者；HBsAg阳性同时检测到HBV DNA拷贝数阳性（定量检测 ≥1000cps/ml）；慢性丙型肝炎血液筛查阳性（HCV抗体阳性）。
12. 妊娠期或哺乳期妇女。
13. 存在任何严重或不能控制的全身性疾病，例如：
(1) 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；
(2) 既往存在心肌炎、心肌病、恶性心律失常病史。首次给药前 12 个月内存 在需住院治疗的不稳定性心绞痛、心肌梗塞、充血性心力衰竭或血管疾病 （如存在破裂风险的主 动脉瘤），或可能影响研究药物安全性评价的其他 心脏损害（如控制不佳的心律失常，心肌梗塞或缺血等）。
(3) 首次给药前 6 个月内存在食管胃底静脉曲张，严重溃疡，伤口未愈，胃肠 穿孔，腹 瘘，胃肠梗阻，腹腔内脓肿或急性胃肠道出血病史；
(4) 首次给药前 1 个月内发生慢性阻塞性肺病急性加重；
(5) 首次给药前 6 个月内发生过任何动脉血栓栓塞事件，NCI CTCAE 5.0 版 3 级及以上 的静脉血栓栓塞事件，短暂性脑缺血发作，脑血管意外，高血压 危象或高血压脑病； 当前存在高血压且经口服降压药物治疗后收缩压 ≥160mmHg 或舒张压≥100mmHg；
(6) 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；
(7) 活动性肺结核；
(8) 存在需要全身性治疗的活动性或未能控制的感染；
(9) 肝脏疾病如肝硬化、失代偿性肝病、急性或慢性活动性肝炎；
(10)糖尿病控制不佳（空腹血糖（FBG）＞10mmol/L）；
(11)尿常规提示尿蛋白≥++，且证实24小时尿蛋白定量＞1.0 g者；
(12)存在精神障碍且无法配合治疗的患者；
14. 在首次给药前天内进行过重大外科手术或发生严重外伤，或在首次给药后的 30 天内有重大外科手术计划者（由研究者决定）；在首次给药前 3 天内进行过较小的 局 部手术（不包括经外周静脉穿刺中心静脉置管术和静脉输液港植入术）。
15. 筛选期影像学显示肿瘤存在明显坏死、空洞，且研究者判定进入研究会引起出 血风险；肿瘤侵犯重要血管及脏器（如主动脉、心脏及心包、上腔静脉、气管、食 管等）； 肿瘤纵隔淋巴结转移侵犯气管、主支气管或存在发生食管气管瘘或食管胸 膜瘘风险。
16. 有严重出血倾向或凝血功能障碍病史；首次给药前 1 个月内存在具有显著临床 意义的出血症状，包括但不限于消化道出血、咳血（定义为咳出或咯出≥1 茶匙鲜血 或小 血块或只咳血无痰液，允许痰中带血者入组）、鼻腔出血（不包括鼻衄出血及 回缩性 涕血）；既往或当前需长期接受治疗性抗凝治疗的患者（例如房颤患者满足 CHADS2 评分≥2 分）。
17. 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。Exclusion criteria：
1. Patients with pathological histologic types other than squamous cell carcinoma (e.g., adenocarcinoma, etc.).
2. A history of severe hypersensitivity to any component of anti-PD-1 monoclonal antibody or bevacizumab.
3. Having contraindications to, or a history of hypersensitivity to the combined chemotherapeutic drugs.
4. Presence of unresectable factors, including unresectability due to tumor-related reasons, existing surgical contraindications, or refusal of surgery by the subject.
5. Patients with known or suspected autoimmune diseases, including dementia and epileptic seizures.
6. Recurrent tumors, distant metastasis, or concomitant other malignant tumors.
7. Patients with laboratory test results that fail to meet the relevant criteria within 7 days prior to enrollment.
8. Subjects with a history of prior immunotherapy, including immune checkpoint inhibitors (e.g., anti-PD-1/L1 antibodies, anti-CTLA-4 antibodies, anti-TIGIT antibodies, anti-LAG3 antibodies, etc.), immune checkpoint agonists (e.g., ICOS, CD40, CD137, GITR, OX40 antibodies, etc.), adoptive cellular immunotherapy and any other anti-tumor therapies with immunological mechanisms of action.
9. Having received systemic treatment with Chinese patent medicines with anti-tumor indications or drugs with immunomodulatory effects (including thymosin, interferon, interleukin, except for local use for pleural effusion control) within 2 weeks prior to the first dose of study treatment.
10. Having comorbidities requiring long-term treatment with immunosuppressive drugs, or systemic/local administration of corticosteroids at immunosuppressive doses prior to enrollment.
11. HIV-positive subjects; HBsAg-positive subjects with positive HBV DNA copy number (quantitative test ≥ 1000 cps/ml); positive screening for chronic hepatitis C (HCV antibody positive).
12. Pregnant or lactating women.
13. Presence of any severe or uncontrolled systemic diseases, including but not limited to:
(1) Significant and poorly controlled symptomatic abnormalities in cardiac rhythm, conduction or morphology on resting electrocardiogram (ECG), such as complete left bundle branch block, atrioventricular block of grade Ⅱ or higher, ventricular arrhythmia or atrial fibrillation.
(2) A history of myocarditis, cardiomyopathy or malignant arrhythmia. A history of unstable angina pectoris requiring hospitalization, myocardial infarction, congestive heart failure or vascular diseases (e.g., aortic aneurysm with rupture risk) within 12 months prior to the first dose, or other cardiac impairments that may affect the safety evaluation of the study drug (e.g., uncontrolled arrhythmia, myocardial infarction or myocardial ischemia, etc.).
(3) A history of esophagogastric varices, severe ulcer, unhealed wound, gastrointestinal perforation, abdominal fistula, gastrointestinal obstruction, intra-abdominal abscess or acute gastrointestinal bleeding within 6 months prior to the first dose.
(4) An acute exacerbation of chronic obstructive pulmonary disease (COPD) within 1 month prior to the first dose.
(5) Any arterial thromboembolic event, venous thromboembolic event of grade 3 or higher according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0, transient ischemic attack (TIA), cerebrovascular accident, hypertensive crisis or hypertensive encephalopathy within 6 months prior to the first dose; current hypertension with systolic blood pressure >= 160 mmHg or diastolic blood pressure >= 100 mmHg after oral antihypertensive treatment.
(6) A history of non-infectious pneumonia requiring glucocorticoid treatment within 1 year prior to the first dose, or currently having clinically active interstitial lung disease.
(7) Active pulmonary tuberculosis.
(8) Presence of active or uncontrolled infection requiring systemic treatment.
(9) Hepatic diseases such as liver cirrhosis, decompensated liver disease, acute or chronic active hepatitis.
(10) Poorly controlled diabetes mellitus (fasting blood glucose (FBG) > 10 mmol/L).
(11) Urinalysis showing urine protein >= ++ with confirmed 24-hour urine protein quantification > 1.0 g.
(12) Patients with mental disorders who are unable to cooperate with treatment.
14. Having undergone major surgery or suffered severe trauma within 14 days prior to the first dose, or having a planned major surgery within 30 days after the first dose (determined by the investigator); having undergone minor local surgery (excluding peripherally inserted central catheter (PICC) placement and port implantation) within 3 days prior to the first dose.
15. Screening imaging showing obvious tumor necrosis or cavitation, and the investigator judges that study enrollment may cause bleeding risk; tumor invasion of major blood vessels and visceral organs (e.g., aorta, heart and pericardium, superior vena cava, trachea, esophagus, etc.); mediastinal lymph node metastasis of the tumor with invasion of trachea or main bronchus, or presence of risk for esophagotracheal fistula or esophagopleural fistula.
16. A history of severe bleeding tendency or coagulation dysfunction; presence of clinically significant bleeding symptoms within 1 month prior to the first dose, including but not limited to gastrointestinal bleeding, hemoptysis (defined as coughing up >= 1 teaspoon of fresh blood or small blood clots, or hemoptysis without sputum; subjects with blood-tinged sputum are eligible for enrollment), epistaxis (excluding nasal bleeding and post-nasal drip hemoptysis); patients with a history of, or current long-term therapeutic anticoagulant treatment (e.g., patients with atrial fibrillation with CHADS2 score >= 2 points).
17. Presence of medical history, disease evidence, treatment or abnormal laboratory test results that may interfere with trial results or prevent the subject from completing the entire study, or other conditions deemed inappropriate for enrollment by the investigator due to potential risks;研究实施时间：
Study execute time：
从
From
2026-01-01 00:00:00至
To
2027-01-01 00:00:00
征募观察对象时间：
Recruiting time：
从
From
2026-01-20 00:00:00
至
To
2026-05-01 00:00:00干预措施：
Interventions：
组别：
实验组
样本量：
15
Group：
experimental group
Sample size：
干预措施：
AK112 联合化疗（AK112+卡铂+培美曲塞/紫杉醇或 AK112+多西他赛）
干预措施代码：
Intervention：
AK112 in combination with chemotherapy (AK112 plus carboplatin plus pemetrexed/paclitaxel, or AK112 plus docetaxel)
Intervention code：研究实施地点：
Countries of recruitment and research settings：
国家：
中国
省(直辖市)：
江西省
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：
三级甲等
Institution
hospital：
The first affiliated hostipal of nanchang university
Level of the institution：
Tertiary A测量指标：
Outcomes：
指标中文名：
总生存期（OS）
指标类型：
次要指标
Outcome：
Overall Survival (OS)
Type：
Secondary indicator
测量时间点：
从受试者入组（或随机化）日期起，至受试者因任何原因死亡的日期为止的时间间隔
测量方法：
通过定期随访（如门诊随访、电话随访、电子随访系统等）跟踪受试者生存状态，记录受试者入组日期及死亡日期（若发生死亡）；若受试者失访，以最后一次确认存活的随访日期为截尾时间，计算入组日期至死亡 / 截尾日期的时间间隔
Measure time point of outcome：
From enrollment to death
Measure method：
The survival status of subjects is monitored through regular follow-up (e.g., outpatient follow-up, telephone follow-up, electronic follow-up system, etc.), and the date of enrollment and date of death (if death occurs) of each subject are recorded; if a subject is lost to follow-up, the date of the last follow-up with confirmed survival is regarded as the censoring time, and the time interval from the date of enrollment to the date of death or censoring is calculated.
指标中文名：
无事件生存期（EFS）
指标类型：
次要指标
Outcome：
Event-Free Survival (EFS)
Type：
Secondary indicator
测量时间点：
治疗开始到首次发生以下任何事件的时间: 疾病 进展而无法进行手术治疗、局部或远处复发、任何原因导致的死亡
测量方法：
借助影像学检查（如 CT、MRI 等）确认疾病进展或肿瘤复发；
通过随访记录受试者 “无法手术的疾病进展” 或死亡事件；
若受试者失访，以最后一次确认未发生事件的随访日期为截尾时间，计算 “治疗开始日期” 至 “事件发生 / 截尾日期” 的时间间隔
Measure time point of outcome：
The time from the start of treatment to the first occurrence of any of the following events: disease
Measure method：
Disease progression or tumor recurrence is confirmed by means of imaging examinations (e.g., CT, MRI, etc.);
Events of "unresectable disease progression" or death in subjects are recorded through follow-up;
If a subject is lost to follow-up, the date of the last follow-up with confirmed absence of events is regarded as the censoring time, and the time interval from the "date of treatment initiation" to the "date of event occurrence or censoring" is calculated.
指标中文名：
病理完全缓解（pCR）率
指标类型：
次要指标
Outcome：
Pathological Complete Response (pCR) rate
Type：
Secondary indicator
测量时间点：
每位受试者完成手术切除治疗后，获取其手术标本并完成病理组织学检查的时间
测量方法：
收集受试者手术切除的肿瘤标本，进行病理组织学检查；
依据病理评估标准（判断标本中是否存在残留的浸润性肿瘤细胞），确定是否达到 “病理完全缓解”；
统计达到 pCR 的受试者数量，计算其占总入组受试者的比例（即 pCR 率）
Measure time point of outcome：
Obtain their surgical specimens and complete histopathological examination
Measure method：
Tumor specimens resected from subjects during surgery are collected for histopathological examination;
According to pathological assessment criteria (which judge whether there are residual invasive tumor cells in the specimen), it is determined whether "pathological complete response" is achieved;
The number of subjects who achieve pCR is counted, and the proportion of these subjects among all enrolled subjects (i.e., the pCR rate) is calculated.
指标中文名：
R0 切除率
指标类型：
次要指标
Outcome：
R0 Resection Rate
Type：
Secondary indicator
测量时间点：
每位受试者完成手术切除治疗后，对其手术标本切缘完成病理组织学检查的时间
测量方法：
手术中获取肿瘤切除标本的边缘组织（含原发灶、区域淋巴结切缘）；
对切缘组织进行病理组织学检查，判断是否存在肿瘤细胞残留；
统计 “切缘无肿瘤残留（即 R0 切除）” 的受试者数量，计算其占总接受手术切除受试者的比例（即 R0 切除率）
Measure time point of outcome：
Margin specimen for histopathological examination
Measure method：
Marginal tissues of the resected tumor specimens (including margins of the primary tumor and regional lymph nodes) are obtained intraoperatively;
Histopathological examination is performed on the marginal tissues to determine the presence of residual tumor cells;
The number of subjects with no residual tumor cells in the margins (i.e., R0 resection) is counted, and the proportion of these subjects among all subjects who underwent surgical resection (i.e., the R0 resection rate) is calculated.
指标中文名：
基于 RECIST 1.1 版评估的客观缓解率（ORR）
指标类型：
次要指标
Outcome：
Objective Response Rate (ORR) Assessed According to RECIST Version 1.1
Type：
Secondary indicator
测量时间点：
治疗期间按预设的随访周期（如每 2-3 个治疗周期）进行影像学评估，直至疾病进展、治疗结束或研究终止
测量方法：
治疗前对受试者靶病灶进行基线影像学（CT/MRI 等）检查，记录靶病灶的最长径总和；
治疗期间按预设周期重复相同影像学检查，依据 RECIST 1.1 标准判定靶病灶状态：
完全缓解（CR）：所有靶病灶消失；
部分缓解（PR）：靶病灶最长径总和较基线缩小≥30%；
统计达到 “CR+PR” 的受试者数量，计算其占可评估疗效受试者的比例（即 ORR）
Measure time point of outcome：
Disease progression, discontinuation of treatment, or study termination
Measure method：
Imaging assessments are performed at prespecified follow-up cycles (e.g., every 2–3 treatment cycles) during treatment until disease progression, discontinuation of treatment, or study termination.
指标中文名：
临床降期率（T 和/或 N 降期）
指标类型：
次要指标
Outcome：
Clinical Downstaging Rate (T and/or N Downstaging)
Type：
Secondary indicator
测量时间点：
每位受试者完成新辅助治疗后、手术前（或手术切除后获取病理标本时），对比治疗前的基线 TNM 分期
测量方法：
治疗前：通过影像学检查（CT/MRI 等）、病理活检等明确基线临床 TNM 分期（记录 T 分期、N 分期）；
新辅助治疗完成后：再次通过影像学检查（或手术标本病理检查）评估治疗后的 TNM 分期；
统计 “治疗后 T 分期降低和 / 或 N 分期降低” 的受试者数量，计算其占接受新辅助治疗受试者的比例（即临床降期率）
Measure time point of outcome：
after completion of neoadjuvant therapy and before surgery
Measure method：
Before treatment: Baseline clinical TNM stage (with T stage and N stage documented) is determined by means of imaging examinations (CT/MRI, etc.), pathological biopsy, and other methods;
After completion of neoadjuvant therapy: Post-treatment TNM stage is re-assessed via imaging examinations (or histopathological examination of surgical specimens);
The number of subjects with reduced post-treatment T stage and/or N stage is counted, and the proportion of these subjects among those who received n
指标中文名：
主要病理缓解（MPR）率
指标类型：
主要指标
Outcome：
Major Pathological Response (MPR) Rate
Type：
Primary indicator
测量时间点：
每位受试者完成手术切除治疗后，对其手术标本完成病理组织学检查的时间
测量方法：
收集受试者手术切除的肿瘤标本，进行病理组织学检查；
评估标本中残留的存活肿瘤细胞比例：以 “存活肿瘤细胞占总肿瘤区域的比例≤10%” 作为 MPR 的判定标准；
统计达到 MPR 标准的受试者数量，计算其占接受手术切除治疗受试者的比例（即 MPR 率）
Measure time point of outcome：
after completion of surgical resection
Measure method：
Tumor specimens resected from subjects during surgery are collected, and histopathological examination is performed on the specimens;
The proportion of residual viable tumor cells in the specimens is assessed: the proportion of viable tumor cells accounting for ≤ 10% of the total tumor area is used as the criteria for determining MPR;
The number of subjects who meet the MPR criteria is counted, and the proportion of these subjects among those who underwent surgical resection (i.e., the MPR rate)
指标中文名：
无疾病生存期（DFS）
指标类型：
次要指标
Outcome：
Disease-Free Survival (DFS)
Type：
Secondary indicator
测量时间点：
从受试者手术治疗完成日期起，至首次经影像学检查确认疾病复发、或因任何原因死亡的时间（以先发生的事件为准）
测量方法：
术后通过定期随访（含门诊随访、影像学检查随访等）跟踪受试者状态；
借助 CT/MRI 等影像学检查确认疾病复发事件，同时记录受试者死亡事件（若发生）；
若受试者失访，以最后一次确认无疾病复发的随访日期为截尾时间，计算 “手术完成日期” 至 “复发 / 死亡 / 截尾日期” 的时间间隔
Measure time point of outcome：
After completion of surgery until recurrence or death
Measure method：
Postoperatively, the status of subjects is monitored through regular follow-up (including outpatient follow-up, imaging follow-up, etc.);
Disease recurrence events are confirmed by means of imaging examinations (CT/MRI, etc.), and meanwhile, death events of subjects are recorded if they occur;
If a subject is lost to follow-up, the date of the last follow-up with confirmed absence of disease recurrence is regarded as the censoring time, and the time interval from the "date of surgery completion"采集人体标本：
Collecting sample(s)
from participants：
标本中文名：
肿瘤原发灶组织标本
组织：
Sample Name：
Primary Tumor Focus Tissue Specimen
Tissue：
人体标本去向
使用后保存
说明
Fate of sample：
Preservation
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：
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）：
-The way of sharing IPD”(include metadata and
protocol,
If use web-based public database, please provide
the
url)：
-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：
数据采集：病例记录表(CRF); 数据管理：电子采集和管理系统（EDC)Data collection and Management (A
standard data collection and management system
include a CRF and an electronic data capture：
Data collection: Case Record Form (CRF); Data Management: Electronic Collection and Management System (EDC)数据与安全监察委员会：
Data and Safety Monitoring Committee：
有/Yes注册人：
Name of Registration：
2026-01-19 17:56:46
