中国临床试验注册中心 - 世界卫生组织国际临床试验注册平台一级注册机构

注册号： Registration number：	ChiCTR2500098924
最近更新日期： Date of Last Refreshed on：	2025-03-17 08:57:30
注册时间： Date of Registration：	2025-03-17 00:00:00
注册号状态：	补注册
Registration Status：	Retrospective registration
注册题目：	食管鳞癌新辅助化疗联合PD-1的疗效、安全性及病理退缩模式
Public title：	The efficacy, safety, and pathological regression pattern of neoadjuvant chemotherapy combined with PD-1 in esophageal squamous cell carcinoma
注册题目简写：
English Acronym：
研究课题的正式科学名称：	食管鳞癌新辅助化疗联合PD-1的疗效、安全性及病理退缩模式
Scientific title：	The efficacy, safety, and pathological regression pattern of neoadjuvant chemotherapy combined with PD-1 in 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：	沈国义	研究负责人：	沈国义
Applicant：	Guoyi Shen	Study leader：	Guoyi Shen
申请注册联系人电话： Applicant telephone：	+86 139 6019 1636	研究负责人电话： Study leader's telephone：	+86 139 6019 1636
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：	175722185@qq.com	研究负责人电子邮件： Study leader's E-mail：	175722185@qq.com
申请单位网址(自愿提供)： Applicant website(voluntary supply)：	175722185@qq.com	研究负责人网址(自愿提供)： Study leader's website(voluntary supply)：	175722185@qq.com
申请注册联系人通讯地址：	福建省漳州市芗城区胜利西路59号	研究负责人通讯地址：	福建省漳州市芗城区胜利西路59号
Applicant address：	No.59 Shengli West Road, Xiangcheng District, Zhangzhou City, Fujian Province	Study leader's address：	No.59 Shengli West Road, Xiangcheng District, Zhangzhou City, Fujian Province
申请注册联系人邮政编码： Applicant postcode：	363000	研究负责人邮政编码： Study leader's postcode：	363000
申请人所在单位：	福建医科大学附属漳州市医院
Applicant's institution：	Zhangzhou Hospital Affiliated to Fujian Medical University
研究负责人所在单位：	福建医科大学附属漳州市医院
Affiliation of the Leader：	Zhangzhou Hospital Affiliated to Fujian 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：	漳医伦2025KYZ125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：	福建省漳州市医院医学伦理委员会
Name of the ethic committee：	Ethics Committee of Zhangzhou Hospital Affiliated to Fujian Medical University
伦理委员会批准日期： Date of approved by ethic committee：	2025-02-25 00:00:00
伦理委员会联系人：	蒋辉
Contact Name of the ethic committee：	Jiang Hui
伦理委员会联系地址：	福建省漳州市芗城区胜利西路59号
Contact Address of the ethic committee：	No.59 Shengli West Road, Xiangcheng District, Zhangzhou City, Fujian Province
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 596 208 2587	伦理委员会联系人邮箱： Contact email of the ethic committee：	baiyundao@163.com

研究实施负责（组长）单位：

福建医科大学附属漳州市医院

Primary sponsor：

Zhangzhou Hospital Affiliated to Fujian Medical University

研究实施负责（组长）单位地址：

福建省漳州市芗城区胜利西路59号

Primary sponsor's address：

No.59 Shengli West Road, Xiangcheng District, Zhangzhou City, Fujian 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)：	福建	市(区县)：	漳州
Country：	China	Province：	Fujian	City：	Zhangzhou
单位(医院)：	福建医科大学附属漳州市医院	具体地址：	福建省漳州市芗城区胜利西路59号
Institution hospital：	Zhangzhou Hospital Affiliated to Fujian Medical University	Address：	No.59 Shengli West Road, Xiangcheng District, Zhangzhou City, Fujian Province

经费或物资来源：

吴阶平基金会科研专项基金

Source(s) of funding：

Wu Jiaping Foundation Research Special Fund

研究疾病：

食管癌

Target disease：

Esophageal 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：

其它

Study phase：

N/A

研究设计：

单臂

Study design：

Single arm

研究目的：

评估斯鲁利单抗联合白蛋白紫杉醇及顺铂用于可切除的食管鳞癌患者术前新辅助治疗的疗效（pCR率）及安全性。

Objectives of Study：

To evaluate the efficacy (pathological complete response rate) and safety of srulimab combined with albumin paclitaxel and cisplatin for preoperative neoadjuvant therapy in resectable esophageal squamous cell carcinoma patients.

药物成份或治疗方案详述：

术前新辅助治疗药物为斯鲁利单抗+白蛋白紫杉醇+顺铂，术前治疗2个周期，3周为一个周期。每个治疗周期的第1天静脉给药斯鲁利单抗注射液固定剂量300mg。随后静脉给药白蛋白紫杉醇（260 mg/m2，D1），以及静脉给药铂类（顺铂（80-100mg/m2，D1），受试者将在最后一个新辅助治疗周期结束后4-6周内接受根治性手术切除。非PCR患者术后继续进行斯鲁利单抗+白蛋白紫杉醇+顺铂方案，给药方案同术前，使新辅助+辅助总周期达到4个周期，后续是否免疫维持由研究者根据受试者实际临床情况综合考虑。PCR患者采取随访观察。

Description for medicine or protocol of treatment in detail：

The preoperative neoadjuvant therapy regimen consisted of srulimab+ albumin paclitaxel + cisplatin, with 2 cycles of preoperative treatment, each cng 3 weeks. On the first day of each treatment cycle, srulimab was aycle lastidministered intravenously at a fixed dose of 300 mg. Subsequently, albumin paclitaxel (260 mg/m2, D1) was administered intravenously, followed by platinum (cisplatin, 80-100 mg/m2, D1). Participants would undergo curative surgery within 4-6 weeks after completing the last neoadjuvant therapy cycle. Non-PCR patients continued to receive SRL300 + albumin paclitaxel + cisplatin postoperatively, following the same dosing schedule as preoperatively, for a total of 4 neoadjuvant + adjuvant cycles. The decision on whether to continue immunotherapy maintenance would be made by the investigator based on the patient's actual clinical situation. PCR patients were placed under follow-up observation.

纳入标准：

Inclusion criteria

Patients enrolled in the study must meet all of the following conditions:
1) Capable of providing written informed consent and understanding and agreeing to comply with the study requirements and schedule of assessments.
2) At least 18 years of age (or the legal age of consent within the jurisdiction where the study is conducted) at the time of signing the informed consent form.
3) Histologically confirmed esophageal squamous cell carcinoma.
4) Pathologically confirmed locally advanced resectable (cT3N1M0/T1-3N2M0) esophageal squamous cell carcinoma (AJCC 8th).
a. Assessed to be potentially R0 resection-eligible prior to treatment.
b. Treatment-naïve patients at initial diagnosis.
5) Measurable disease present as per RECIST 1.1 criteria.
6) ECOG PS score of 0 or 1.
7) Expected survival time >= 12 weeks.
8) Patients must have good organ function, with screening laboratory values obtained within <=7 days prior to randomization meeting the following requirements:
a. Patients who are not allowed blood transfusions or growth factor support within <=14 days before sample collection during the screening period, and: absolute neutrophil count >= 1.5 x 10^9/L, platelets >=75 x 10^9/L, hemoglobin  >= 9 g/dL or  >= 5.6 mmol/L;
b. Serum creatinine <=1.5 x upper limit of normal (ULN) or estimated glomerular filtration rate  >= 60 mL/min/1.73 m2 using the Chronic Kidney Disease Epidemiology Collaboration formula;
c. Serum total bilirubin <= 1.5 x ULN (total bilirubin must be < 3 x ULN in patients with Gilbert syndrome);
d. AST and ALT <=2.5 x ULN.
9) Fertile females must agree to use highly effective contraception during the study period and for  >=120 days after the last administration of study drug, with a negative urine or serum pregnancy test result within <= 7 days prior to randomization.
10) Unsterilized males must agree to use highly effective contraception during the study period and for >=120 days after the last administration of study drug.
a. A male is defined as sterilized if, prior to enrollment, his semen sample has been examined and found to be free of sperm, which is definitive evidence of male sterility.
b. For the purposes of this study, males with known low sperm counts (meeting the definition of subfertility") are not considered infertile.

排除标准：

1) 既往接受过抗 PD-1、抗 PD-L1、抗 PD-L2、TIGIT 或任何其他特异性靶向 T 细胞共刺激或检查点通路的抗体或药物治疗。 2) 有活动性自身免疫性疾病或者有自身免疫性疾病史但可能复发的患者。注：患以下疾病的患者可以进一步筛选而不被排除： a. 控制良好的 1 型糖尿病； b. 甲状腺功能减退症(仅使用激素替代治疗即可控制)； c. 控制良好的乳糜泻； d. 无需全身治疗的皮肤病(例如白癜风、银屑病、脱发)； e. 已缓解并且在没有外部触发因素的情况下不会复发任何其他疾病。 3) 在随机化前<= 2 年有任何活动性恶性肿瘤，除外本研究中正在研究的特定癌症以及已经治愈的任何局部复发性癌症(例如已切除的基底细胞或鳞状细胞性皮肤癌、浅表膀胱癌、宫颈原位癌或乳腺原位癌)。 4) 在随机化前<=14 天有任何需要用皮质类固醇全身治疗(剂量> 10 mg/d 的泼尼松或同类药物等效剂量)或其他免疫抑制剂治疗的病症。注:目前正在使用或之前使用过以下任何类固醇方案的患者可以入选： a. 肾上腺素替代性类固醇(泼尼松<=10 mg/d 或同类药物等效剂量)； b. 全身吸收量极小的局部、眼用、关节内、鼻内和吸入性皮质类固醇； c. 短期(<=7 天)皮质类固醇预防(例如，对造影剂过敏)或治疗非自身免疫病症(例如，由接触性过敏原引起的迟发型超敏反应)。 5) 在随机前<= 14 天，存在控制不良的糖尿病、>=3 级低白蛋白血症或尽管进行标准治疗仍存在> 1 级的钾、钠或校正后钙实验室检查异常。 6) 有间质性肺病、非感染性肺炎或控制不良的肺病史，包括肺纤维化、急性肺病等。注：肺功能显著受损或基线时需要辅助吸氧的患者必须在筛选时接受肺功能评估。 7) 在随机化前 14 天内患有需要全身性抗细菌、抗真菌或抗病毒治疗的感染(包括肺结核感染等)。注:允许慢性乙型肝炎病毒(HBV)或丙型肝炎病毒(HCV)感染患者接受抗病毒治疗。 8) 筛选时存在未经治疗的慢性乙型肝炎或 HBV DNA > 500 IU/mL(或> 2500 拷贝/mL) 的慢性 HBV 携带者。注：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 < 500 IU/mL 或< 2500 拷贝/mL)可以入组。可检测到 HBsAg 或可检测到 HBV DNA 的患者应根据治疗指南进行管理。筛选时正在接受抗病毒治疗的患者应在入组前接受治疗> 2 周。 9) 活动性丙型肝炎患者。注：筛选时 HCV 抗体检测阴性或筛选时 HCV 抗体检测阳性但随后 HCV RNA 检测阴性的患者可以入组。将仅对 HCV 抗体检测阳性的患者进行 HCV RNA 检测。筛选时正在接受抗病毒治疗的患者应在入组前接受治疗> 2 周。 10) 已知人免疫缺陷病毒(HIV)感染史。 11) 随机化前<= 28 天进行任何大手术。注：如果在随机化前> 28 天进行了任何大手术，则在随机化前患者必须从治疗的毒性和/或并发症中充分恢复。 12) 既往进行异基因干细胞移植或者器官移植。 13) 有以下任何心血管风险因素： a. 随机化前<=28 天出现心源性胸痛，定义为限制工具性日常生活活动的中度疼痛； b. 随机化前<=28 天曾发生肺栓塞； c. 随机化前<=6 个月有任何急性心肌梗死史； d. 随机化前<=6 个月有达到纽约心脏病协会(NYHA)III 或 IV 级的任何心力衰竭史； e. 随机化前<=6 个月曾发生 >=2 级的室性心律失常； f. 随机化前<=6 个月曾发生脑血管意外； g. 随机化前 <=28 天存在无法通过标准降压药控制的控制不良的高血压；注：控制不良的高血压定义为重复测量时收缩压 >= 140 mmHg 或舒张压 >= 90 mmHg； h. 随机化前<=28 天有任何晕厥或癫痫发作。 14) 有对其他单克隆抗体发生重度超敏反应的病史。 15) 在研究药物首次给药之前 14 天或 5 个半衰期内(以较长者为准)接受过任何化疗、免疫治疗(如白细胞介素、干扰素、胸腺肽等)或任何试验治疗。或在研究药物首次给药之前 14 天内接受过姑息性放疗或其他局部治疗。 16) 随机化前<=28 天接种过活疫苗。注：季节性流感疫苗通常是灭活疫苗，允许使用。鼻内疫苗是活疫苗，不允许使用。 17) 存在不利于研究药物给药，或影响药物毒性或 AE 的解释；或导致研究执行的依从性不足的基础疾病(包括实验室检查结果异常)、酒精或药物滥用或依赖。 18) 妊娠期或哺乳期女性。 19) 同时参与另一项治疗性临床试验。注：允许同时参与观察性或非干预性研究。此外，在临床研究中已完成药物治疗并处于随访期的患者可入选本研究。

Exclusion criteria：

1) History of prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, TIGIT, or any other antibody or drug that targets T cell co-stimulation or checkpoint pathways. 2) Patients with active autoimmune diseases or a history of autoimmune diseases who may experience recurrence. Note: Patients with the following conditions may be further screened without being excluded: a. Well-controlled type 1 diabetes; b. Hypothyroidism (only requiring hormone replacement therapy for control); c. Well-controlled celiac disease; d. Skin conditions not requiring systemic treatment (e.g., vitiligo, psoriasis, alopecia); e. Any other disease in remission and not likely to recur without external triggers. 3) Active malignancy within <= 2 years before randomization, except for the specific cancer under investigation in this study and any locally recurrent cancers that have been cured (e.g., basal cell or squamous cell skin cancer that has been surgically removed, superficial bladder cancer, cervical intraepithelial neoplasia, or ductal carcinoma in situ of the breast). 4) Any condition within <=14 days before randomization that requires treatment with systemic corticosteroids (dose > 10 mg/d of prednisone or equivalent dose of other glucocorticoids) or other immunosuppressants. Note: Patients currently using or previously used any of the following steroid regimens may be enrolled: a. Adrenal replacement steroids (prednisone <=10 mg/d or equivalent dose of other glucocorticoids); b. Topical, ophthalmic, intramuscular, intra-articular, nasal, and inhaled corticosteroids with minimal systemic absorption; c. Short-term (<=7 days) use of corticosteroids for prevention (e.g., for contrast dye allergy) or treatment of non-autoimmune conditions (e.g., contact dermatitis). 5) Uncontrolled diabetes mellitus, >= Grade 3 hypoalbuminemia, or laboratory test abnormalities of potassium, sodium, or corrected calcium > Grade 1 despite standard therapy within <= 14 days before randomization. 6) History of interstitial lung disease, noninfectious pneumonitis, or poorly controlled lung disease including pulmonary fibrosis, acute lung injury, etc. Note: Patients with significantly impaired pulmonary function or requiring supplemental oxygen at baseline must undergo pulmonary function assessment during screening. 7) Infections within 14 days before randomization that require systemic antimicrobial therapy (including tuberculosis infections) such as antibacterial, antifungal, or antiviral therapy. Note: Patients with chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) infection may be allowed to receive antiviral therapy. 8) Untreated chronic hepatitis B or HBV DNA > 500 IU/mL (or > 2500 copies/mL) in chronic HBV carriers at screening. Note: Non-active hepatitis B surface antigen (HBsAg) carriers and treated and stable hepatitis B patients (HBV DNA < 500 IU/mL or < 2500 copies/mL) may be included. Patients with detectable HBsAg or detectable HBV DNA should be managed according to treatment guidelines. Patients receiving antiviral therapy at screening should be treated for > 2 weeks before enrollment. 9) Patients with active hepatitis C virus infection. Note: Patients who are HCV antibody negative at screening or HCV antibody positive at screening but subsequently HCV RNA negative may be included. HCV RNA testing will only be performed on patients who are HCV antibody positive. Patients receiving antiviral therapy at screening should be treated for > 2 weeks before enrollment. 10) Known history of human immunodeficiency virus (HIV) infection. 11) Any major surgery within <= 28 days before randomization. Note: If any major surgery was performed more than 28 days before randomization, the patient must have fully recovered from the toxic effects and/or complications of the treatment by the time of randomization. 12) History of allogeneic stem cell transplantation or organ transplantation. 13) Any of the following cardiovascular risk factors: a. Cardiac chest pain within <= 28 days before randomization, defined as moderate pain that limits instrumental activities of daily living; b. Pulmonary embolism within<= 28 days before randomization; c.Within<=6 months before randomization, have a history of any acute myocardial infarction; d. A history of any heart failure classified as New York Heart Association (NYHA) class III or IV within<=6 months before randomization; e. History of>=2-degree ventricular arrhythmias within <=6 months before randomization; f. Cerebrovascular accident within <=6 months before randomization; g. Uncontrolled hypertension within<=28 days before randomization, not controlled by standard antihypertensive medications; Note: Uncontrolled hypertension is defined as systolic blood pressure >=140 mmHg or diastolic blood pressure >=90 mmHg on repeated measurements; h. Presence of any syncope or epileptic seizure within <=28 days before randomization. 14) History of severe hypersensitivity reaction to other monoclonal antibodies. 15) Any chemotherapy, immunotherapy (such as interleukins, interferons, thymosin, etc.), or any investigational therapy within 14 days before the first administration of the study drug or within 5 half-lives, whichever is longer. Or palliative radiotherapy or other local therapy within 14 days before the first administration of the study drug. 16) Live vaccine administration within <=28 days before randomization. Note: Seasonal influenza vaccines are usually inactivated vaccines and are allowed for use. Intranasal vaccines are live vaccines and are not allowed for use. 17) Underlying diseases that preclude the administration of the study drug, or affect the interpretation of drug toxicity or AE; or lead to inadequate compliance with the conduct of the study (including abnormal laboratory findings), alcohol or drug abuse or dependence. 18) Women who are pregnant or breastfeeding. 19) Participation in another therapeutic clinical trial at the same time. Note: Concurrent participation in observational or non-interventional studies is allowed. In addition, patients who have completed drug treatment in a clinical study and are in the follow-up period can be enrolled in this study.

研究实施时间：

Study execute time：

从 From 2024-10-01 00:00:00至 To 2026-10-01 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2025-03-09 00:00:00 至 To 2026-01-01 00:00:00

干预措施：

Interventions：

组别：	试验组	样本量：	33
Group：	Experimental group	Sample size：	33
干预措施：	斯鲁利单抗联合白蛋白紫杉醇和顺铂用于可切除食管鳞状细胞癌患者的新辅助治疗。	干预措施代码：
Intervention：	Srulimab combined with albumin paclitaxel and cisplatin for preoperative neoadjuvant therapy in resectable esophageal squamous cell carcinoma patients.	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	中国	省(直辖市)：	福建	市(区县)：
Country：	China	Province：	Fujian	City：
单位(医院)：	福建医科大学附属漳州市医院	单位级别：	三甲
Institution hospital：	Zhangzhou Hospital Affiliated to Fujian Medical University	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 Response Rate	Type：	Primary indicator
测量时间点：	手术后1周	测量方法：	病理科评判
Measure time point of outcome：	1 week after surgery	Measure method：	Judged by pathologist

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：	手术后1周	测量方法：	手术医师及病理科医师评判
Measure time point of outcome：	1 week after surgery	Measure method：	Judged by pathologist and pathologists

指标中文名：	主要病理缓解率	指标类型：	次要指标
Outcome：	Major pathological remission rate	Type：	Secondary indicator
测量时间点：	手术后1周	测量方法：	病理科评判
Measure time point of outcome：	1 week after surgery	Measure method：	Judged by pathologist

指标中文名：	1 年无病生存率	指标类型：	次要指标
Outcome：	1 year disease-free survival rate	Type：	Secondary indicator
测量时间点：	手术后1年	测量方法：	随访1年有无复发转移
Measure time point of outcome：	1 year after surgery	Measure method：	Follow-up for 1 year to evaluate whether there is recurrence and metastasis

指标中文名：	不良事件	指标类型：	副作用指标
Outcome：	Adverse Events	Type：	Adverse events
测量时间点：	研究周期内	测量方法：	随访药物不良反应及手术并发症
Measure time point of outcome：	During the entire research	Measure method：	Follow-up adverse drug reactions and surgical complications

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：	无	组织：
Sample Name：	None	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）：	点击下载
Calculated Results after the Study Completed(upload file)：	download

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）：	试验结束6个月后上传到ResMan临床试验公共管理平台 www.medresman.org
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	Upload to the ResMan Clinical Trial Public Management Platform at www.medresman.org within 6 months after the trial ends.
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：	通过病例记录表(Case Record Form, CRF)收集，数据采集包括病历记录表及电子采集和管理系统，病例记录表将被装在特点文件夹内，并锁在研究者办公室，电子信息则保存在特定加密硬盘内，并锁在研究者办公室。
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	Collected through Case Record Form (CRF),the data collection and management system includes a CRF and an electronic data capture. The CRF will be organized into a specific folder and locked in the researcher's office. Electronic data will stored in an encrypted disk and locked in the researcher's office.
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：	2025-03-17 08:57:24