注册号:
Registration number:
ChiCTR2500113560 最近更新日期:
Date of Last Refreshed on:
2025-12-01 09:54:59 注册时间:
Date of Registration:
2025-12-01 00:00:00 注册号状态:
预注册Registration Status:
Prospective registration注册题目:
低剂量放疗联合化免新辅助治疗局晚期可切除 食管鳞癌疗效和安全性的单臂、II期临床研究Public title:
A Single-Arm, Phase II Clinical Study on the Efficacy and Safety of Low-Dose Radiotherapy Combined with Chemoimmunotherapy as Neoadjuvant Treatment for Locally Advanced Resectable Esophageal Squamous Cell Carcinoma注册题目简写:English Acronym:研究课题的正式科学名称:
低剂量放疗联合化免新辅助治疗局晚期可切除 食管鳞癌疗效和安全性的单臂、II期临床研究Scientific title:
A Single-Arm, Phase II Clinical Study on the Efficacy and Safety of Low-Dose Radiotherapy Combined with Chemoimmunotherapy as Neoadjuvant Treatment for Locally Advanced Resectable Esophageal 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:
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(2025)第362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Name of the ethic committee:
Army Medical Center of PLA伦理委员会批准日期:
Date of approved by ethic committee:
2025-11-25 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:
评估低剂量放疗联合化免新辅助治疗局晚期可切除食管鳞癌的安全性和有效性 Objectives of Study:
Evaluating the Safety and Efficacy of Low-Dose Radiotherapy Combined with Chemoimmunotherapy as Neoadjuvant Treatment for Locally Advanced Resectable 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.年龄18岁-80岁,男女均可;
2.经组织学或细胞学初次确诊的可手术切除的cT1-4aN+M0或cT3-4aN0M0胸段食管鳞癌;
3.既往未经过任何针对食管癌的局部及系统抗肿瘤治疗;
4.ECOG 0-1分;
5.重要器官的功能符合下列要求:
a)中性粒细胞绝对计数≥1.5×10^9/L;
b)血小板≥80×10^9/L;
c)血红蛋白≥80×10^9/L;
d)总胆红素≤1.5正常值上限;
e)血清肌酐正常值以内
f)谷丙转氨酶、谷草转氨酶≤2.5正常值上限;
g)既往无尚未治愈的严重合并症或其它重大疾病;
6.胸外科医师判断可切除且可以耐受手术者;
7.具有生育能力的女性受试者,以及伴侣为育龄期的男性受试者,需要在研究治疗期间,及最后一次化疗后至少6个月内采用一种经医学认可的避孕措施;
8.受试者自愿加入本研究,签署知情同意书,依从性好,配合随访。Inclusion criteria
1. Aged 18 to 80 years, both male and female;
2. Initially diagnosed with surgically resectable cT1-4aN+M0 or cT3-4aN0M0 thoracic esophageal squamous cell carcinoma confirmed by histology or cytology;
3. No prior local or systemic antitumor treatment for esophageal cancer;
4. ECOG score of 0-1;
5. Function of vital organs meets the following criteria: a) Absolute neutrophil count >= 1.5 × 10⁹/L; b) Platelets >= 80 × 10⁹/L; c) Hemoglobin >= 80 × 10⁹/L; d) Total bilirubin <= 1.5 × upper limit of normal (ULN); e) Serum creatinine within normal range; f) Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <= 2.5 × ULN; g) No history of severe comorbidities or other major diseases that have not been cured;
6. Deemed resectable and able to tolerate surgery by a thoracic surgeon;
7. Female subjects of childbearing potential and male subjects with partners of childbearing potential must use a medically approved contraceptive method during the study treatment period and for at least 6 months after the last chemotherapy;
8. Subjects voluntarily join this study, sign the informed consent form, demonstrate good compliance, and cooperate with follow-up.排除标准:
1.肿瘤伴气管/支气管/大血管侵犯或深溃疡型食管癌;
2.入组前6个月内有消化道穿孔和/或瘘管、大出血以及肺功能差或慢性间质性肺病的患者。
3.已知对由中国仓鼠卵巢细胞(CHO)生产的生物药品或PD-1单抗制剂任何成分过敏或有超敏反应。
4.对白蛋白结合型紫杉醇、卡铂和其他铂类药物有过敏史。
5.既往或正在接受以下治疗:
a)同时入组另外一项临床研究,除非是观察性(非干预性)临床研究或者干预性临床研究随访。
b)首次使用研究药物前2周内需要给予皮质类固醇(相当于每天10mg的强的松)或免疫缺陷抑制剂进行系统治疗的受试者,除外针对食管局部炎症和预防过敏以及恶心、呕吐使用皮脂内固醇的情况。在没有活动性自身免疫疾病的情况下,外用或吸入类固醇是允许的,如果患者在试验过程中需要意外服用免疫抑制药物,将予以允许,但强烈建议尽快减少剂量。
c)接种过抗肿瘤疫苗者或者研究药物首次给药前4周内接种过活疫苗。
6.有活动性的自身免疫性疾病、自身免疫性疾病史(例如间质性肺炎、结肠炎、肝炎、垂体炎、血管炎、肾炎、甲状腺功能亢进症、甲状腺功能减退症,包括但不限于这些疾病或综合征);除外白癜风或已痊愈的童年时代哮喘/过敏,成人后无需任何干预的患者;使用稳定剂量的甲状腺替代激素治疗的自身免疫介导的甲状腺功能减退症;使用稳定剂量的胰岛素的Ⅰ型糖尿病(通过稳定剂量的胰岛素给药方案治疗后,血糖得以控制的1型糖尿病患者,可入选本研究)。
7.有免疫缺陷病史,包括HIV检测阳性,或患有其他获得性、先天性免疫缺陷疾病,或有器官移植史和异基因骨髓移植史。
8.受试者具有未能良好控制的心血管临床症状或疾病,包括但不限于:a.NYHAⅡ级以上心力衰竭。b.不稳定型心绞痛。c.1年内发生过心肌梗死。d.有临床意义的室上性或室性心律失常未经临床干预或临床干预后仍控制不佳。
9.活动性乙肝[慢性或急性;定义为筛选期乙肝表面抗原(HBsAg)检测结果呈阳性且HBVDNA拷贝数>1000cps/ml]或丙肝患者;
10.患有活动性肺结核的患者(临床诊断包括临床病史、体格检查和影像学发现,以及根据当地医疗常规进行的TB检查)。
11.首次使用研究药物前4周内发生过严重感染(CTCAE>2级),如需要住院治疗的严重肺炎、菌血症、感染合并症等;基线胸部影像学检查提示存在活动性肺部炎症、首次使用研究药物前2周内存在感染的症状和体征或需要口服或静脉使用抗生素治疗,除外预防性使用抗生素。
12.治疗前28天内接受过大型手术(诊断性手术除外),或预期将在研究期间接受大型手术。
13.首次使用研究药物前5年内曾诊断为任何其他恶性肿瘤,除外具有低风险和死亡风险的恶心肿瘤(5年生存率>90%),如经充分治疗的基底细胞或鳞状细胞皮肤癌或宫颈原位癌除外。
14.经研究者判断,受试者有其他可能导致其被迫中途终止研究的因素,如患有其他严重疾病(含精神疾病)需要合并治疗,实验室检查值严重异常,家庭或社会因素,可能影响到受试者安全或试验资料收集的情况。Exclusion criteria:
1. Tumors with tracheal/bronchial/great vessel invasion or deeply ulcerated esophageal cancer;
2. Patients with gastrointestinal perforation and/or fistula, major bleeding within 6 months prior to enrollment, or those with poor pulmonary function or chronic interstitial lung disease.
3. Known allergy or hypersensitivity to biologics produced by Chinese Hamster Ovary (CHO) cells or any component of PD-1 monoclonal antibody preparations.
4. History of allergy to albumin-bound paclitaxel, carboplatin, or other platinum-based drugs.
5. Prior or ongoing treatments including: a) Concurrent enrollment in another clinical trial, except for observational (non-interventional) studies or follow-up phases of interventional trials. b) Subjects requiring systemic treatment with corticosteroids (equivalent to prednisone ≥10 mg/day) or immunosuppressive agents within 2 weeks before the first dose of the study drug, excluding the use of corticosteroids for local esophageal inflammation, allergy prevention, or management of nausea and vomiting. Topical or inhaled steroids are permitted in the absence of active autoimmune diseases. If immunosuppressive drugs are unexpectedly required during the trial, their use will be allowed but dose reduction is strongly recommended as soon as possible. c) Administration of antitumor vaccines or live vaccines within 4 weeks prior to the first dose of the study drug.
6. Active autoimmune diseases or a history of autoimmune diseases (e.g., interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to these conditions); exceptions include vitiligo or resolved childhood asthma/allergies that require no intervention in adulthood. Autoimmune-mediated hypothyroidism managed with stable thyroid hormone replacement therapy, and type I diabetes controlled with stable insulin regimens are allowed.
7. History of immunodeficiency, including HIV positivity, other acquired or congenital immunodeficiency diseases, or history of organ transplantation or allogeneic bone marrow transplantation.
8. Poorly controlled cardiovascular diseases or clinical symptoms, including but not limited to: a) Heart failure of NYHA class II or higher. b) Unstable angina. c) Myocardial infarction within the past year. d) Clinically significant supraventricular or ventricular arrhythmias that are uncontrolled despite intervention.
9. Active hepatitis B (chronic or acute; defined as HBsAg-positive with HBV DNA >1000 copies/mL) or hepatitis C.
10. Patients with active tuberculosis (diagnosed based on clinical history, physical examination, imaging findings, and local standard TB tests).
11. Severe infections (CTCAE grade >2) within 4 weeks prior to the first dose of the study drug, such as severe pneumonia requiring hospitalization, bacteremia, or complicated infections; active pulmonary inflammation indicated by baseline chest imaging, or signs/symptoms of infection within 2 weeks before the first dose requiring oral or intravenous antibiotics (excluding prophylactic antibiotic use).
12. Major surgery within 28 days before treatment (excluding diagnostic surgery) or anticipated major surgery during the study period.
13. Diagnosis of any other malignancy within 5 years prior to the first dose of the study drug, except for malignancies with low risk and mortality (5-year survival rate >90%), such as adequately treated basal cell or squamous cell skin cancer or cervical carcinoma in situ.
14. Other factors deemed by the investigator to likely necessitate premature study termination, including severe comorbidities (including psychiatric disorders) requiring concurrent treatment, significantly abnormal laboratory values, or familial/social factors that may compromise subject safety or data collection.研究实施时间:
Study execute time:
从
From
2025-12-01 00:00:00至
To
2028-11-30 00:00:00
征募观察对象时间:
Recruiting time:
从
From
2025-12-01 00:00:00
至
To
2027-12-31 00:00:00干预措施:
Interventions:
组别:
单臂
样本量:
30
Group:
Single-Arm
Sample size:
干预措施:
低剂量放疗联合化免新辅助治疗
干预措施代码:
Intervention:
Low-dose radiotherapy combined with chemoimmunotherapy as neoadjuvant treatment
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:
次要指标
Outcome:
Objective Response Rate, ORR
Type:
Secondary 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:
尚未开始
Not yet
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):
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):
NoThe way of sharing IPD”(include metadata and
protocol,
If use web-based public database, please provide
the
url):
No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:
2025-12-01 09:54:42