ChiCTR2600124196 版本V1.0 版本创建时间2026/05/08 16:04:00 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：

 ChiCTR2600124196 

最近更新日期：

Date of Last Refreshed on：

 2026-05-08 16:03:55 

注册时间：

Date of Registration：

 2026-05-08 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

低剂量放疗联合维贝柯妥塔单抗及普特利单抗新辅助治疗EGFR阳性局晚期可切除食管鳞癌疗效和安全性的前瞻性、单臂临床研究（ESCC-LDR-03）

Public title：

A Prospective, Single-Arm Clinical Study of Neoadjuvant Low-Dose Radiotherapy Combined With Vibepolimab and Pucilizumab in Locally Advanced Resectable EGFR-Positive Esophageal Squamous Cell Carcinoma (ESCC-LDR-03)

注册题目简写：

English Acronym：

研究课题的正式科学名称：

低剂量放疗联合维贝柯妥塔单抗及普特利单抗新辅助治疗EGFR阳性局晚期可切除食管鳞癌疗效和安全性的前瞻性、单臂临床研究（ESCC-LDR-03）

Scientific title：

A Prospective, Single-Arm Clinical Study of Neoadjuvant Low-Dose Radiotherapy Combined With Vibepolimab and Pucilizumab in Locally Advanced Resectable EGFR-Positive Esophageal Squamous Cell Carcinoma (ESCC-LDR-03)

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：

许明芳 

研究负责人：

李梦侠 

Applicant：

Mingfang Xu 

Study leader：

Mengxia Li 

申请注册联系人电话：

Applicant telephone：

 +86 23 6874 6515

研究负责人电话：

Study leader's
telephone：

+86 23 6874 6515

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：

 xusiyi023@tmmu.edu.cn

研究负责人电子邮件：

Study leader's E-mail：

 limengxia@tmmu.edu.cn

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：

重庆市渝中区长江支路10号

研究负责人通讯地址：

重庆市渝中区长江支路10号

Applicant address：

10# Changjiang Branch Road, Yuzhong District, Chongqing

Study leader's address：

10# Changjiang Branch Road, Yuzhong District, Chongqing

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：

陆军军医大学大坪医院

Applicant's institution：

Daping Hospital, Army Medical University

研究负责人所在单位：

陆军军医大学大坪医院

Affiliation of the Leader：

Daping Hospital, Army Medical 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：

 医研伦审2026(092)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：

中国人民解放军陆军特色医学中心伦理委员会

Name of the ethic committee：

Ethics Committee of the Specialised Medical Centre of the Chinese People’s Liberation Army Ground Force

伦理委员会批准日期：

Date of approved by ethic committee：

 2026-04-21 00:00:00

伦理委员会联系人：

王晶晶

Contact Name of the ethic committee：

Jingjing Wang

伦理委员会联系地址：

重庆市渝中区长江支路10号

Contact Address of the ethic committee：

10# Changjiang Branch Road, Yuzhong District, Chongqing

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 23 6875 7140

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：

陆军军医大学大坪医院

Primary sponsor：

Daping Hospital, Army Medical University

研究实施负责（组长）单位地址：

重庆市渝中区长江支路10号

Primary sponsor's address：

10# Changjiang Branch Road, Yuzhong District, Chongqing

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

重庆

市(区县)：

渝中区

Country：

China

Province：

Chongqing

City：

Yuzhong District

单位(医院)：

陆军军医大学大坪医院

具体地址：

重庆市渝中区长江支路10号

Institution
hospital：

Daping Hospital, Army Medical University

Address：

10# Changjiang Branch Road, Yuzhong District, Chongqing

经费或物资来源：

无

Source(s) of funding：

None

研究疾病：

食管鳞癌  

Target disease：

Esophageal 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：

 II期临床试验 

Study phase：

2

研究设计：

单臂 

Study design：

Single arm 

研究目的：

评价维贝柯妥塔单抗联合普特利单抗及低剂量放疗新辅助治疗EGFR阳性局晚期可切除食管鳞癌的病理完全缓解率（pCR）。  

Objectives of Study：

Evaluate the pathological complete response rate (pCR) of neoadjuvant therapy with vebicostatin combined with puterilimumab and low-dose radiotherapy for locally advanced, resectable EGFR-positive esophageal squamous cell carcinoma.

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.自愿签署知情同意书，并遵循方案要求； 2.年龄18-80岁，性别不限； 3.体力状况评分ECOG<=1； 4.有至少一个可测量病灶（RECIST 1.1标准）； 5.根据美国癌症联合委员会（AJCC）/TNM分期系统第八版的定义，治疗前临床分期为局部晚期（T1-4aN+M0或T3-4aN0M0）胸段食管鳞癌患者； 6.经中心实验室IHC检测EGFR表达阳性（>=1+）； 7.既往未接受过针对食管鳞癌的系统治疗，包括药物治疗、放疗、手术治疗等； 8.有充分的器官和骨髓功能，筛查所做的实验室检查必须符合下列标准： 骨髓：中性粒细胞计数绝对值（ANC）>=1.5×10^9/L，血小板计数>=100×10^9/L，血红蛋白>=90 g/L，且首次给药前14天内未接受过输血或生物反应调节剂（如促粒细胞、红细胞生长因子等）治疗； 肝脏：总胆红素（TBIL）<=1.5×ULN；丙氨酸氨基转移酶（ALT）和天门冬氨酸氨基转移酶（AST）和碱性磷酸酶（ALP）<=2.5×ULN；血清白蛋白>=30 g/L； 肾脏：肌酐清除率（Ccr）>=50 mL/min（根据Cockcroft and Gault公式）； 凝血功能：国际标准化比值（INR）<=1.5×ULN，且活化部分凝血活酶时间（APTT）<=1.5×ULN（除正在接受治疗性抗凝药物外）； 无严重心脏功能异常，左心室射血分数（LVEF）>=50%； 9.具有生育能力的男性和育龄期女性愿意从签署知情同意书开始至试验药物末次给药后6个月内采取有效避孕措施；育龄期女性包括绝经前女性和绝经后2年内的女性。育龄期女性在首次试验药物给药前7天内的血妊娠检测结果必须为阴性。

Inclusion criteria

1. Voluntarily sign the informed consent form and follow the program requirements; 2. Age 18-80 years old, gender is not limited; 3. Physical fitness score ECOG<=1; 4. Have at least one measurable lesion (RECIST 1.1 criteria); 5. Patients with thoracic esophageal squamous cell carcinoma with locally advanced (T1-4aN M0 or T3-4aN0M0) thoracic esophageal squamous cell carcinoma before treatment according to the definition of the eighth edition of the American Joint Committee on Cancer (AJCC)/TNM staging system; 6. Positive EGFR expression detected by IHC in the central laboratory (>=1); 7. No previous systemic treatment for esophageal squamous cell carcinoma, including drug therapy, radiotherapy, surgical treatment, etc.; 8. Have adequate organ and bone marrow function, and the laboratory tests performed for screening must meet the following criteria: Bone marrow: absolute neutrophil count (ANC) >=1.5×10^9/L, platelet count >=100×10^9/L, hemoglobin >=90 g/L, and no blood transfusion or biological response modifiers (such as granulocytes, erythrocyte growth factor, etc.) therapy within 14 days before the first dose; Liver: Total bilirubin (TBIL)<=1.5×ULN; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) and alkaline phosphatase (ALP) <=2.5× ULN; Serum albumin>=30 g/L; Kidney: creatinine clearance (Ccr) >=50 mL/min (according to the Cockcroft and Gault formula); Coagulation function: International normalized ratio (INR) <=1.5×ULN, and activated partial thromboplastin time (APTT) <=1.5×ULN (except those receiving therapeutic anticoagulant drugs); No serious cardiac dysfunction, left ventricular ejection fraction (LVEF) >=50%; 9. Males of childbearing potential and females of childbearing age are willing to take effective contraceptive measures from signing the informed consent form to 6 months after the last dose of the trial drug; Women of childbearing age include premenopausal women and women within 2 years of postmenopause. Women of childbearing age must have a negative blood pregnancy test result within 7 days before the first dose of trial drug.

排除标准：

1.自愿签署知情同意书，并遵循方案要求； 2.年龄18-80岁，性别不限； 3.体力状况评分ECOG<=1； 4.有至少一个可测量病灶（RECIST 1.1标准）； 5.根据美国癌症联合委员会（AJCC）/TNM分期系统第八版的定义，治疗前临床分期为局部晚期（T1-4aN+M0或T3-4aN0M0）胸段食管鳞癌患者； 6.经中心实验室IHC检测EGFR表达阳性（>=1+）； 7.既往未接受过针对食管鳞癌的系统治疗，包括药物治疗、放疗、手术治疗等； 8.有充分的器官和骨髓功能，筛查所做的实验室检查必须符合下列标准： 骨髓：中性粒细胞计数绝对值（ANC）>=1.5×10^9/L，血小板计数>=100×10^9/L，血红蛋白>=90 g/L，且首次给药前14天内未接受过输血或生物反应调节剂（如促粒细胞、红细胞生长因子等）治疗； 肝脏：总胆红素（TBIL）<=1.5×ULN；丙氨酸氨基转移酶（ALT）和天门冬氨酸氨基转移酶（AST）和碱性磷酸酶（ALP）<=2.5×ULN；血清白蛋白>=30 g/L； 肾脏：肌酐清除率（Ccr）>=50 mL/min（根据Cockcroft and Gault公式）； 凝血功能：国际标准化比值（INR）<=1.5×ULN，且活化部分凝血活酶时间（APTT）<=1.5×ULN（除正在接受治疗性抗凝药物外）； 无严重心脏功能异常，左心室射血分数（LVEF）>=50%； 9.具有生育能力的男性和育龄期女性愿意从签署知情同意书开始至试验药物末次给药后6个月内采取有效避孕措施；育龄期女性包括绝经前女性和绝经后2年内的女性。育龄期女性在首次试验药物给药前7天内的血妊娠检测结果必须为阴性。 本回答由 AI 生成，内容仅供参考，请仔细甄别。 1) 既往3年内有其他原发性恶性肿瘤病史，除外已完全根治性切除的皮肤基底细胞癌、浅表膀胱癌、皮肤鳞状细胞癌或原位宫颈癌； 2) 存在周围神经病变≥2级（依据CTCAE v5.0）； 3) 接受过以下任一治疗： ? 首次给药前7天内接受过经静脉给药的抗生素治疗； ? 首次给药前4周内接受过其他临床试验的研究药； ? 首次给药前4周内接受过减毒活疫苗，允许接种灭活季节性流感疫苗或批准的不含活病毒的COVID-19疫苗； ? 首次给药前4周内接受过全身免疫刺激药物治疗（包括但不限于干扰素、白介素-2等）； ? 首次给药前4周内接受过重大手术治疗（如经腹、胸等手术，不包括诊断性穿刺、输液装置植入或消化道支架植入等手术），或预期在研究新辅助治疗期间需要进行非针对肿瘤的重大手术治疗； ? 既往接受过抗PD-1、抗PD-L1、抗PD-L2、抗CD137或抗CTLA-4抗体（包括伊匹木单抗）或靶向作用于T细胞共同刺激或免疫检查点通路的任何其他抗体或药物的免疫治疗； 4) 患有临床上显著的（即活跃的）心血管疾病：入组前6个月内发生的脑血管意外/中风//心肌梗死，不稳定型心绞痛，充血性心力衰竭（NYHA Ⅱ级及以上），或需要药物治疗的严重心律失常； 5) 有活动性感染证据包括乙型肝炎（需同时满足HBsAg阳性，且HBV DNA≥2000 IU/ml，并排除药物或其他原因所致肝炎），丙型肝炎（需同时满足抗-HCV抗体阳性，且HCV RNA结果大于检测下限）或人类免疫缺陷病毒（HIV）感染；未控制的活动性细菌、其他病毒、真菌、立克次体或寄生虫感染，除非在研究药物给药前获得治疗并消退； 6) 首次给药前4周内体重减轻超过10%（除非采取了适当的营养支持措施）； 7) 原发性免疫缺陷病史者或具有活动性自身免疫性疾病者，正在使用免疫抑制剂或全身激素治疗（剂量≥10 mg/天的泼尼松或其他等效激素），并在入组前2周内仍在继续使用； 注意：1型糖尿病、激素替代治疗稳定的甲状腺功能减退症（包括自身免疫性甲状腺病导致的甲状腺功能减退症）、不需要全身治疗的银屑病、白癜风或牛皮癣患者可以入组，使用局部外用或吸入性糖皮质激素，或短期（≤7天）使用糖皮质激素进行预防或治疗非自身免疫性的，且非频繁发生的过敏性疾病除外。 8) 既往有或合并间质性肺炎、放射性肺炎、重度慢性阻塞性肺疾病、重度肺功能不全、有症状的支气管痉挛等病史； 9) 器官移植史，包括异体外周干细胞或骨髓移植。经审慎评估后，可以考虑接受自体造血干细胞移植（HSTC）≥ 5年前并且具有正常骨髓功能（不依赖输血）的患者参加研究； 10) 研究者认为不适合参加本临床试验的其他情况，包括但不限于严重的精神疾病、中枢神经障碍、药物滥用等。 1.既往3年内有其他原发性恶性肿瘤病史，除外已完全根治性切除的皮肤基底细胞癌、浅表膀胱癌、皮肤鳞状细胞癌或原位宫颈癌； 2.存在周围神经病变>=2级（依据CTCAE v5.0）； 3.接受过以下任一治疗： 首次给药前7天内接受过经静脉给药的抗生素治疗； 首次给药前4周内接受过其他临床试验的研究药； 首次给药前4周内接受过减毒活疫苗，允许接种灭活季节性流感疫苗或批准的不含活病毒的COVID-19疫苗； 首次给药前4周内接受过全身免疫刺激药物治疗（包括但不限于干扰素、白介素-2等）； 首次给药前4周内接受过重大手术治疗（如经腹、胸等手术，不包括诊断性穿刺、输液装置植入或消化道支架植入等手术），或预期在研究新辅助治疗期间需要进行非针对肿瘤的重大手术治疗； 既往接受过抗PD-1、抗PD-L1、抗PD-L2、抗CD137或抗CTLA-4抗体（包括伊匹木单抗）或靶向作用于T细胞共同刺激或免疫检查点通路的任何其他抗体或药物的免疫治疗； 4.患有临床上显著的（即活跃的）心血管疾病：入组前6个月内发生的脑血管意外/中风/心肌梗死，不稳定型心绞痛，充血性心力衰竭（NYHA II级及以上），或需要药物治疗的严重心律失常； 5.有活动性感染证据包括乙型肝炎（需同时满足HBsAg阳性，且HBV DNA>=2000 IU/ml，并排除药物或其他原因所致肝炎），丙型肝炎（需同时满足抗-HCV抗体阳性，且HCV RNA结果大于检测下限）或人类免疫缺陷病毒（HIV）感染；未控制的活动性细菌、其他病毒、真菌、立克次体或寄生虫感染，除非在研究药物给药前获得治疗并消退； 6.首次给药前4周内体重减轻超过10%（除非采取了适当的营养支持措施）； 7.原发性免疫缺陷病史者或具有活动性自身免疫性疾病者，正在使用免疫抑制剂或全身激素治疗（剂量>=10 mg/天的泼尼松或其他等效激素），并在入组前2周内仍在继续使用； 注意：1型糖尿病、激素替代治疗稳定的甲状腺功能减退症（包括自身免疫性甲状腺病导致的甲状腺功能减退症）、不需要全身治疗的银屑病、白癜风或牛皮癣患者可以入组，使用局部外用或吸入性糖皮质激素，或短期（<=7天）使用糖皮质激素进行预防或治疗非自身免疫性的，且非频繁发生的过敏性疾病除外。 8.既往有或合并间质性肺炎、放射性肺炎、重度慢性阻塞性肺疾病、重度肺功能不全、有症状的支气管痉挛等病史； 9.器官移植史，包括异体外周干细胞或骨髓移植。经审慎评估后，可以考虑接受自体造血干细胞移植（HSTC）>=5年前并且具有正常骨髓功能（不依赖输血）的患者参加研究； 10.研究者认为不适合参加本临床试验的其他情况，包括但不限于严重的精神疾病、中枢神经障碍、药物滥用等。

Exclusion criteria：

1. Voluntarily sign the informed consent form and follow the program requirements; 2. Age 18-80 years old, gender is not limited; 3. Physical fitness score ECOG<=1; 4. Have at least one measurable lesion (RECIST 1.1 criteria); 5. Patients with thoracic esophageal squamous cell carcinoma with locally advanced (T1-4aN+M0 or T3-4aN0M0) thoracic esophageal squamous cell carcinoma as defined by the eighth edition of the American Joint Committee on Cancer (AJCC)/TNM staging system; 6. Positive EGFR expression by IHC test in the central laboratory (>=1+); 7. No previous systemic treatment for esophageal squamous cell carcinoma, including drug therapy, radiotherapy, surgical treatment, etc.; 8. Have adequate organ and bone marrow function, and the laboratory tests performed for screening must meet the following criteria: Bone marrow: absolute neutrophil count (ANC) >=1.5×10^9/L, platelet count >=100×10^9/L, hemoglobin >=90 g/L, and no blood transfusion or biological response modifiers (such as granulocytes, erythrocyte growth factor, etc.) therapy within 14 days before the first dose; Liver: Total bilirubin (TBIL)<=1.5×ULN; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) and alkaline phosphatase (ALP) <=2.5× ULN; Serum albumin>=30 g/L; Kidney: creatinine clearance (Ccr) >=50 mL/min (according to the Cockcroft and Gault formula); Coagulation function: International normalized ratio (INR) <=1.5×ULN, and activated partial thromboplastin time (APTT) <=1.5×ULN (except those receiving therapeutic anticoagulant drugs); No serious cardiac dysfunction, left ventricular ejection fraction (LVEF) >=50%; 9. Males of childbearing potential and females of childbearing age are willing to take effective contraceptive measures from signing the informed consent form to 6 months after the last dose of the trial drug; Women of childbearing age include premenopausal women and women within 2 years of postmenopause. Women of childbearing age must have a negative blood pregnancy test result within 7 days before the first dose of trial drug. This answer is AI-generated and is for informational purposes only, please screen carefully. 1) History of other primary malignancies within the past 3 years, except for completely radical resected basal cell carcinoma of the skin, superficial bladder cancer, cutaneous squamous cell carcinoma or cervical cancer in situ; 2) Presence of peripheral neuropathy ≥ grade 2 (according to CTCAE v5.0); 3) Received any of the following treatments: ? Received intravenous antibiotic therapy within 7 days before the first dose; ? Investigational drugs that have received other clinical trials within 4 weeks before the first dose; ? Receipt of live attenuated vaccines within 4 weeks prior to the first dose, inactivated seasonal influenza vaccines or approved COVID-19 vaccines without live virus are allowed; ? Received systemic immunostimulatory drugs (including but not limited to interferon, interleukin-2, etc.) within 4 weeks before the first dose; ? Received major surgical treatment (such as transabdominal, thoracic, etc., excluding diagnostic puncture, infusion device implantation, gastrointestinal stent implantation, etc.), or expected to require major surgical treatment other than tumor during the study neoadjuvant therapy; ? Previous immunotherapy with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibodies (including ipilimumab) or any other antibody or drug targeting T cell co-stimulation or immune checkpoint pathways; 4) Clinically significant (i.e., active) cardiovascular disease: cerebrovascular accident/stroke// myocardial infarction, unstable angina, congestive heart failure (NYHA class II and above), or severe arrhythmia requiring medication within 6 months prior to enrollment; 5) Evidence of active infection including hepatitis B (HBsAg positivity and HBV DNA ≥2000 IU/ml, and exclusion of hepatitis caused by drugs or other causes), hepatitis C (anti-HCV antibody positivity and HCV RNA result greater than the lower limit of detection) or human immunodeficiency virus (HIV) infection; Uncontrolled active bacterial, other viral, fungal, rickettsia, or parasitic infection unless treated has been obtained prior to study drug administration and has resolved; 6) Weight loss of more than 10% within 4 weeks before the first dose (unless appropriate nutritional support measures are taken); 7) Those with a history of primary immunodeficiency or active autoimmune diseases, who are using immunosuppressants or systemic hormone therapy (dose ≥ 10 mg/day of prednisone or other equivalent hormones), and continue to use them within 2 weeks before enrollment; Note: Patients with type 1 diabetes mellitus, hypothyroidism stable on hormone replacement therapy (including hypothyroidism due to autoimmune thyroid disease), psoriasis, vitiligo, or psoriasis not requiring systemic therapy may be enrolled with topical or inhaled glucocorticoids, or short-term (≤7 days) glucocorticoids for prophylaxis or treatment of non-autoimmune and infrequent allergic diseases. 8) Previous history of interstitial pneumonia, radiation pneumonia, severe chronic obstructive pulmonary disease, severe pulmonary insufficiency, symptomatic bronchospasm, etc.; 9) History of organ transplantation, including allogeneic peripheral stem cell or bone marrow transplantation. After careful evaluation, patients who have undergone autologous hematopoietic stem cell transplantation (HSTC) ≥ 5 years ago and have normal bone marrow function (not dependent on blood transfusion) can be considered to participate in the study; 10) Other conditions that the investigator believes are not suitable for participating in this clinical trial, including but not limited to severe mental illness, central nervous system disorders, drug abuse, etc. 1. History of other primary malignant tumors within the past 3 years, except for completely radical resected basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin or cervical cancer in situ; 2. Presence of peripheral neuropathy >=grade 2 (according to CTCAE v5.0); 3. Received any of the following treatments: Received intravenous antibiotic therapy within 7 days before the first dose; Investigational drugs that have received other clinical trials within 4 weeks before the first dose; Received live attenuated vaccines within 4 weeks prior to the first dose, allowing vaccination with inactivated seasonal influenza vaccines or approved COVID-19 vaccines without live virus; Received systemic immunostimulatory drug therapy (including but not limited to interferon, interleukin-2, etc.) within 4 weeks before the first dose; Received major surgical treatment (such as transabdominal, thoracic, etc., excluding diagnostic puncture, infusion device implantation, gastrointestinal stent implantation, etc.) within 4 weeks before the first dose, or is expected to require major surgical treatment for non-tumor during the study neoadjuvant therapy; Previous immunotherapy with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibodies (including ipilimumab) or any other antibodies or drugs targeting T cell co-stimulation or immune checkpoint pathways; 4. Clinically significant (i.e., active) cardiovascular disease: cerebrovascular accident/stroke/myocardial infarction, unstable angina, congestive heart failure (NYHA class II and above), or severe arrhythmia requiring medication within 6 months prior to enrollment; 5. Evidence of active infection including hepatitis B (HBsAg positivity and HBV DNA>=2000 IU/ml, and excluding hepatitis caused by drugs or other causes), hepatitis C (anti-HCV antibody positivity and HCV RNA result greater than the lower limit of detection) or human immunodeficiency virus (HIV) infection; Uncontrolled active bacterial, other viral, fungal, rickettsia, or parasitic infection unless treated has been obtained prior to study drug administration and has resolved; 6. Weight loss of more than 10% within 4 weeks before the first dose (unless appropriate nutritional support measures are taken); 7. Patients with a history of primary immunodeficiency or active autoimmune diseases, who are using immunosuppressants or systemic hormone therapy (dose >=10 mg/day of prednisone or other equivalent hormones) and continue to use them within 2 weeks before enrollment; Note: Patients with type 1 diabetes mellitus, hypothyroidism stable on hormone replacement therapy (including hypothyroidism due to autoimmune thyroid disease), psoriasis, vitiligo, or psoriasis that do not require systemic therapy may be enrolled with the use of topical or inhaled glucocorticoids, or short-term (<=7 days) glucocorticoids for prophylaxis or treatment of non-autoimmune and non-frequent allergic diseases. 8. Previous history of interstitial pneumonia, radiation pneumonia, severe chronic obstructive pulmonary disease, severe pulmonary insufficiency, symptomatic bronchospasm, etc.; 9. History of organ transplantation, including allogeneic peripheral stem cell or bone marrow transplantation. After careful evaluation, patients who underwent autologous hematopoietic stem cell transplantation (HSTC) >=5 years ago and have normal bone marrow function (not dependent on blood transfusion) can be considered to participate in the study; 10. Other conditions that the investigator deems unsuitable for participating in this clinical trial, including but not limited to severe mental illness, central nervous system disorders, drug abuse, etc.

研究实施时间：

Study execute time：

从 From 2026-04-30 00:00:00至 To 2029-03-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2026-05-08 00:00:00 至 To 2027-09-30 00:00:00

干预措施：

Interventions：

组别：

干预组

样本量：

 30

Group：

intervention group

Sample size：

干预措施：

低剂量放疗联合靶免新辅助治疗

干预措施代码：

Intervention：

Neoadjuvant therapy of low-dose radiotherapy plus targeted immunotherapy

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 重庆市 

市(区县)：

  

Country：

China

Province：

Chongqing

City：

单位(医院)：

 陆军军医大学大坪医院 

单位级别：

 三甲 

Institution
hospital：

Daping Hospital, Army Medical University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

手术后的病理完全缓解率

指标类型：

主要指标

Outcome：

Pathological Complete Response, pCR

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

主要病理缓解率

指标类型：

次要指标

Outcome：

Major Pathological Response, MPR

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

无病生存期

指标类型：

次要指标

Outcome：

Disease-Free Survival, DFS

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

无事件生存期

指标类型：

次要指标

Outcome：

Event-Free Survival, EFS

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, OS

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：

主要指标

Outcome：

Objective Response Rate, ORR

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

手术完成率

指标类型：

次要指标

Outcome：

Surgical Completion 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：

R0切除率

指标类型：

次要指标

Outcome：

R0 Resection 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：

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：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

活检组织

组织：

术后肿瘤活检组织

Sample Name：

Biopsy

Tissue：

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

Note：

标本中文名：

血液

组织：

Sample Name：

Blood

Tissue：

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

Note：

标本中文名：

手术切除组织

组织：

Sample Name：

Surgical Resection Specimen

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 80 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：

Blinding：

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

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)：

NA

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：

CRF

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：

  2026-05-08 16:03:55