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：	ChiCTR2600125208
最近更新日期： Date of Last Refreshed on：	2026-05-22 11:18:09
注册时间： Date of Registration：	2026-05-22 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	评价低剂量放疗（LDRT）联合化免治疗（特瑞普利单抗联合紫杉醇和顺铂）在复发或晚期食管鳞癌患者中有效性和安全性的单臂、开放标签 II 期临床研究
Public title：	A single-arm, open-label phase II clinical study to evaluate the efficacy and safety of low-dose radiotherapy (LDRT) combined with chemioimmunotherapy (toripalimab combined with paclitaxel and cisplatin) in patients with recurrent or advanced esophageal squamous cell carcinoma.
注册题目简写：
English Acronym：
研究课题的正式科学名称：	评价低剂量放疗（LDRT）联合化免治疗（特瑞普利单抗联合紫杉醇和顺铂）在复发或晚期食管鳞癌患者中有效性和安全性的单臂、开放标签 II 期临床研究
Scientific title：	A single-arm, open-label phase II clinical study to evaluate the efficacy and safety of low-dose radiotherapy (LDRT) combined with chemioimmunotherapy (toripalimab combined with paclitaxel and cisplatin) in patients with recurrent or advanced 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：	宋斌斌	研究负责人：	徐茂义
Applicant：	Song Binbin	Study leader：	Maoyi Xu
申请注册联系人电话： Applicant telephone：	+86 573 8251 9701	研究负责人电话： Study leader's telephone：	+86 182 5858 8339
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：	ab_wy2005@aliyun.com	研究负责人电子邮件： Study leader's E-mail：	18258588339@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：	浙江省嘉兴市中环南路1882号	研究负责人通讯地址：	浙江省嘉兴市中环南路1882号
Applicant address：	No. 1882, Zhonghuan South Road, Jiaxing City, Zhejiang Province	Study leader's address：	No. 1882, Zhonghuan South Road, Jiaxing City, Zhejiang Province
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：	嘉兴市第一医院
Applicant's institution：	The First Hospital of Jiaxing
研究负责人所在单位：	嘉兴市第一医院
Affiliation of the Leader：	The First Hospital of Jiaxing

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：	2025-LP-931	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：	嘉兴市第一医院医学伦理委员会
Name of the ethic committee：	Medical Ethics Committee of The First Hospital of Jiaxing
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：	许文
Contact Name of the ethic committee：	Wen Xu
伦理委员会联系地址：	浙江省嘉兴市中环南路1882号
Contact Address of the ethic committee：	No. 1882, Zhonghuan South Road, Jiaxing City, Zhejiang Province
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 573 89976378	伦理委员会联系人邮箱： Contact email of the ethic committee：	xwkikimi@163.com

研究实施负责（组长）单位：

嘉兴市第一医院

Primary sponsor：

The First Hospital of Jiaxing

研究实施负责（组长）单位地址：

浙江省嘉兴市中环南路1882号

Primary sponsor's address：

No. 1882, Zhonghuan South Road, Jiaxing City, Zhejiang 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)：	浙江省	市(区县)：
Country：	China	Province：	Zhejiang	City：
单位(医院)：	嘉兴市第一医院	具体地址：	浙江省嘉兴市中环南路1882号
Institution hospital：	The First Hospital of Jiaxing	Address：	No. 1882, Zhonghuan South Road, Jiaxing City, Zhejiang Province

经费或物资来源：

自选课题（自筹）

Source(s) of funding：

Self-selected topic

研究疾病：

复发或晚期食管鳞癌

Target disease：

Recurrent or advanced 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：

主要目的评价 LDRT 联合特瑞普利单抗、紫杉醇和顺铂治疗复发或晚期食管鳞癌患者的6 个月无进展生存期(PFS)率。次要目的 1.LDRT 联合化免治疗对食管癌患者的无进展生存期(PFS)影响。 2.LDRT 联合化免治疗对食管癌患者的总生存(OS)影响。 3.LDRT 联合化免治疗对食管癌患者的客观缓解率(ORR)影响。 4.LDRT 联合化免治疗对食管癌患者的疾病控制率(DCR)影响。 5.LDRT 联合化免治疗对食管癌患者的生活质量(QoL)影响。 6.LDRT 联合化免治疗对食管癌患者的安全性（Security）影响。 7.探索性分析患者血液、粪便、咽拭子样本中的潜在的预测性生物标志物。

Objectives of Study：

Main objective Evaluate the 6-month progression-free survival (PFS) rate of LDRT combined with teprotumumab, paclitaxel and cisplatin in patients with recurrent or advanced esophageal squamous cell carcinoma. Secondary objectives 1. The impact of LDRT combined with immunotherapy on the progression-free survival (PFS) of patients with esophageal cancer. 2. The impact of LDRT combined with immunotherapy on the overall survival (OS) of patients with esophageal cancer. 3. The impact of LDRT combined with immunotherapy on the objective response rate (ORR) of patients with esophageal cancer. 4. The impact of LDRT combined with immunotherapy on the disease control rate (DCR) of patients with esophageal cancer. 5. The impact of LDRT combined with immunotherapy on the quality of life (QoL) of patients with esophageal cancer. 6. The impact of LDRT combined with immunotherapy on the safety (Security) of patients with esophageal cancer. 7. Exploratory analysis of potential predictive biomarkers in patient blood, stool, and throat swab samples.

药物成份或治疗方案详述：

Description for medicine or protocol of treatment in detail：

纳入标准：

Inclusion criteria

1. Age >= 18 years, ECOG score 0-2. 
2. Pathologically diagnosed as recurrent/metastatic esophageal squamous cell carcinoma. 
3. No history of PD-1 inhibitor treatment, or those who discontinued PD-1 inhibitor treatment for more than three months after treatment (not due to PD-1 resistance). 
4. The functions of important organs meet the following requirements: 
a. Absolute neutrophil count (ANC) >= 1.5 × 10^9/L 
b. Platelets >= 100 × 10^9/L;
c. Hemoglobin >= 9 g/dL;
d. Serum albumin >= 2.8 g/dL;
e. Total bilirubin <= 1.5 × ULN, ALT, AST and/or AKP <= 2.5 × ULN; if there is liver metastasis, ALT and/or AST <= 5 × ULN; if there is liver or bone metastasis, AKP <= 5 × ULN;
f. Serum creatinine <= 1.5 × ULN or creatinine clearance rate > 60 mL/min;
g. For those with lung lesions and known or suspected impaired lung function, forced expiratory volume in one second (FEV1) must be above 1 L. 
5. For pregnant women of reproductive age, the urine or serum pregnancy test result within 72 hours before randomization must be negative. The subjects agree to adequate contraception during the trial. 
6. The subjects voluntarily participate in the study and obtain the informed consent signed by the subject or their legal representative.

排除标准：

1.PD-1抑制剂耐药者。 2.存在或高度怀疑存在食管瘘的受试者。 3.本次诊断时既往抗肿瘤治疗毒性未恢复至≤CTCAE 1级（脱发除外）或者入组/排除标准规定的水平。 4.妊娠期或哺乳期妇女。 5.患有需持续使用皮质类固醇治疗的疾病，除外病情稳定仅需要低效价的外用皮质类固醇激素治疗的湿疹、银屑病、白癜风等皮肤病。 6.目前存在或既往存在自身免疫性疾病或免疫缺陷，包括但不限于:重症肌无力、肌炎、自身免疫性肝炎、系统性红斑狼疮、类风湿关节炎、炎症性肠病、抗磷脂抗体综合征、Wegener 肉芽肿、干燥综合征、格林巴利综合征或多发性硬化症，但以下情况除外: a.曾患自身免疫相关甲状腺功能减退且接受甲状腺激素替代治疗的受试者可参与本研究。 b. 接受胰岛素治疗且病情得到控制的1型糖尿病。 7.有特发性肺纤维化、机化性肺炎(例如，闭塞性细支气管炎)、药物诱发的肺炎或特发性肺炎病史，或筛选期间胸部CT显示有活动性肺炎。 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：如：a.NYHA II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.入组前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；患有活动性结核病；入组前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的情况。 10.已知患有急性或慢性活动性乙型肝炎(HBsAg 阳性且 HBV DNA 病毒载量≥10^3 拷贝数/mL 或>200IU/ml)或急性或慢性活动性丙型肝炎(HCV 抗体阳性且 HCV RNA 阳性)。 11.在PD-1治疗开始前4周内或5个药物消除半衰期内（以较长者为准）接受过全身免疫刺激剂治疗(包括但不限于干扰素和白介素-2)，在开始研究治疗前14天内或5个药物消除半衰期(以时间较长者为准)内接受化疗、免疫治疗(例如，白细胞介素、干扰素、胸腺肽)或任何试验性治疗。 12.经研究者判断，受试者不能配合治疗，或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。 13.转移灶病理诊断与原发灶明确不同或诊断为第二原发肿瘤的。

Exclusion criteria：

1. Patients resistant to PD-1 inhibitors. 2. Subjects with or highly suspected presence of esophageal fistula. 3. At the time of this diagnosis, the toxicity of previous anti-tumor treatment has not returned to <= CTCAE grade 1 (except for hair loss) or has not reached the level specified in the inclusion/exclusion criteria. 4. Pregnant or lactating women. 5. Those with diseases requiring continuous use of corticosteroids, except for eczema, psoriasis, vitiligo and other skin diseases that only require low-dose topical corticosteroids for treatment when the condition is stable. 6. Currently have or previously had autoimmune diseases or immune deficiencies, including but not limited to: myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener's granulomatosis, Sjogren's syndrome, Guillain-Barré syndrome or multiple sclerosis, but the following situations are excluded: a. Subjects who previously had autoimmune-related hypothyroidism and received thyroid hormone replacement therapy can participate in this study. b. Type 1 diabetes patients who are under insulin treatment and whose condition is controlled. 7. Have a history of idiopathic pulmonary fibrosis, organizing pneumonia (such as obliterative bronchiolitis), drug-induced pneumonia or idiopathic pneumonia, or have active pneumonia shown on chest CT during the screening period. 8. Have uncontrolled cardiovascular clinical symptoms or diseases, including but not limited to: a. NYHA class II or above heart failure; b. Unstable angina pectoris; c. Having had a myocardial infarction within 1 year; d. Having clinical significance of supraventricular or ventricular arrhythmias that are not controlled by clinical intervention or after clinical intervention. 9. Within 4 weeks before enrollment, have had a severe infection (CTCAE > 2 grade), such as severe pneumonia, sepsis, infection complications, etc. .have active tuberculosis; have symptoms and signs of infection within 2 weeks before enrollment or need oral or intravenous antibiotic treatment, except for preventive use of antibiotics. 10. Known to have acute or chronic active hepatitis B (HBsAg positive and HBV DNA viral load >= 10^3 copies/mL or > 200 IU/ml) or acute or chronic active hepatitis C (HCV antibody positive and HCV RNA positive). 11. Within 4 weeks before PD-1 treatment or within 5 drug elimination half-lives (whichever is longer) received systemic immunostimulant treatment (including but not limited to interferons and interleukin-2), received chemotherapy, immunotherapy (such as interleukin, interferon, thymosin) or any experimental treatment within 14 days before starting the study or within 5 drug elimination half-lives (whichever is longer) after the start of the study treatment. 12. According to the investigator's judgment, the subject cannot cooperate with the treatment, or the subject has other factors that may force them to prematurely terminate the study, such as having other serious diseases (including mental diseases) that require combined treatment, abnormal laboratory test values, family or social factors, which may affect the safety of the subject or the collection of trial data. 13. The pathological diagnosis of metastatic lesions is clearly different from the primary lesion or diagnosed as a second primary tumor.

研究实施时间：

Study execute time：

从 From 2026-05-01 00:00:00至 To 2029-05-31 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2026-05-25 00:00:00 至 To 2028-05-31 00:00:00

干预措施：

Interventions：

组别：	试验组	样本量：	40
Group：	Test group	Sample size：	40
干预措施：	低剂量放疗联合化免治疗	干预措施代码：
Intervention：	Low-dose radiotherapy combined with chemotherapy and immunotherapy	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	中国	省(直辖市)：	浙江省	市(区县)：
Country：	China	Province：	Zhejiang	City：
单位(医院)：	嘉兴市第一医院	单位级别：	三级甲等
Institution hospital：	The First Hospital of Jiaxing	Level of the institution：	Tertiary A

测量指标：

Outcomes：

指标中文名：	6 个月无进展生存期率	指标类型：	主要指标
Outcome：	6-month progression-free survival rate	Type：	Primary indicator
测量时间点：	6个月	测量方法：
Measure time point of outcome：	6 months	Measure method：

指标中文名：	疾病控制率	指标类型：	次要指标
Outcome：	Disease control rate	Type：	Secondary indicator
测量时间点：	每2个月评估1次	测量方法：
Measure time point of outcome：	Evaluate once every two months	Measure method：

指标中文名：	客观缓解率	指标类型：	次要指标
Outcome：	objective remission rate	Type：	Secondary indicator
测量时间点：	每2个月评估1次	测量方法：
Measure time point of outcome：	Evaluate once every two months	Measure method：

指标中文名：	无进展生存期	指标类型：	次要指标
Outcome：	progression free survival	Type：	Secondary indicator
测量时间点：	每2个月评估1次	测量方法：
Measure time point of outcome：	Evaluate once every two months	Measure method：

指标中文名：	生活质量	指标类型：	次要指标
Outcome：	quality of life	Type：	Secondary indicator
测量时间点：	每3个月评估1次	测量方法：	使用欧洲癌症研究和治疗组织(EORTC)生活质量问卷
Measure time point of outcome：	Evaluate once every thre months	Measure method：	Using the quality of life questionnaire of the European Organization for Research and Treatment of Cancer (EORTC)

指标中文名：	安全性	指标类型：	次要指标
Outcome：	security	Type：	Secondary indicator
测量时间点：	2年内每3个月进行随访，2年后每6个月进行随访	测量方法：	NCI CTCEA V6.0
Measure time point of outcome：	Follow-up will be conducted every 3 months within 2 years, and every 6 months after 2 years.	Measure method：	NCI CTCEA V6.0

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：	每2个月评估1次	测量方法：
Measure time point of outcome：	Evaluate once every two months	Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：	大便	组织：
Sample Name：	excrement	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：	咽拭子样本	组织：
Sample Name：	Throat swab sample	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		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)：

NO

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	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）：	在研究成果发表后，原始数据可通过向主要研究者申请获取
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	After publishing the research results, original Data will be made available upon request to the primary investigator.
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：	使用EDC进行数据采集和管理
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	Using EDC for data collection and management
数据与安全监察委员会： Data and Safety Monitoring Committee：	无/No
注册人： Name of Registration：	2026-05-22 11:17:50