ChiCTR2600116578 版本V1.0 版本创建时间2026/01/12 17:39:22 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：

 ChiCTR2600116578 

最近更新日期：

Date of Last Refreshed on：

 2026-01-12 17:39:08 

注册时间：

Date of Registration：

 2026-01-12 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

新辅助放化免在潜在可切除的合并食管瘘/评价为食管瘘高风险的局部晚期食管鳞癌的安全性的单臂I期研究

Public title：

Neoadjuvant PD-1 inhibitor plus chemotherapy and radiotherapy for potentially resectable locally advanced esophageal squamous cell carcinoma with esophageal fistula or high-risk for esophageal fistula: a single-arm phase I trial

注册题目简写：

English Acronym：

研究课题的正式科学名称：

新辅助放化免在潜在可切除的合并食管瘘/评价为食管瘘高风险的局部晚期食管鳞癌的安全性的单臂I期研究

Scientific title：

Neoadjuvant PD-1 inhibitor plus chemotherapy and radiotherapy for potentially resectable locally advanced esophageal squamous cell carcinoma with esophageal fistula or high-risk for esophageal fistula: a single-arm phase I trial

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：

王奇峰 

研究负责人：

王奇峰 

Applicant：

Qifeng Wang 

Study leader：

Qifeng Wang 

申请注册联系人电话：

Applicant telephone：

 +86 28 8542 0681

研究负责人电话：

Study leader's
telephone：

+86 28 8542 0681

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：

 wangqifeng@scszlyy.org.cn

研究负责人电子邮件：

Study leader's E-mail：

 wangqifeng@scszlyy.org.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：

四川省成都市天府新区万安街茂业路666号四川省肿瘤医院

研究负责人通讯地址：

四川省成都市天府新区万安街茂业路666号四川省肿瘤医院

Applicant address：

Sichuan Cancer Hospital & Institute No. 666, Maoye Road, Wan'an Street, Tianfu New Areax Chengdu, Sichuan Province, China

Study leader's address：

Sichuan Cancer Hospital & Institute No. 666, Maoye Road, Wan'an Street, Tianfu New Areax Chengdu, Sichuan 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：

四川省肿瘤医院

Applicant's institution：

Sichuan Cancer Hospital

研究负责人所在单位：

四川省肿瘤医院

Affiliation of the Leader：

Sichuan Cancer Hospital

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：

 SCCHEC-02-2025-128

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：

四川省肿瘤医院医学科研与医疗新技术伦理委员会

Name of the ethic committee：

Ethics Conmittee for Medical Research and New Medical Technology of Sichuan Cancer Hospital Ethics

伦理委员会批准日期：

Date of approved by ethic committee：

 2025-06-04 00:00:00

伦理委员会联系人：

王青青

Contact Name of the ethic committee：

Qingqing Wang

伦理委员会联系地址：

四川省成都市人民南路四段55号

Contact Address of the ethic committee：

No. 55, Section 4, Renmin South Road, Chengdu, Sichuan Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 28 8542 0681

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：

四川省肿瘤医院

Primary sponsor：

Sichuan Cancer Hospital

研究实施负责（组长）单位地址：

四川省成都市人民南路四段55号

Primary sponsor's address：

No. 55, Section 4, Renmin South Road, Chengdu, Sichuan 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)：

成都

市(区县)：

Country：

China

Province：

Chengdu

City：

单位(医院)：

四川省肿瘤医院

具体地址：

四川省成都市人民南路四段55号

Institution
hospital：

Sichuan Cancer Hospital

Address：

No. 55, Section 4, Renmin South Road, Chengdu, Sichuan Province

经费或物资来源：

江苏恒瑞医药股份有限公司

Source(s) of funding：

Jiangsu Hengrui Medicine Co., Ltd.

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：

 I期临床试验 

Study phase：

1

研究设计：

单臂 

Study design：

Single arm 

研究目的：

评价新辅助放化免治疗潜在可切除的合并食管瘘或评价为食管瘘高风险的局部晚期食管鳞癌患者的安全性。  

Objectives of Study：

To evaluate the safety of neoadjuvant chemoradiotherapy and PD-1 in the treatment of potentially resectable locally advanced esophageal squamous cell carcinoma with esophageal fistula or high risk of esophageal fistula.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

入组前签署书面知情同意书 1. 年龄18－75岁，男女均可； 2. 治疗前经MDT讨论为合并食管瘘或评估为食管瘘高风险； 3. 治疗前经MDT讨论评估潜在可手术切除的局部晚期食管鳞癌； 4. 无远处转移； 5. 愿意接受营养评估，并进行胃肠营养管支持治疗； 6. 存在符合RECIST v1.1定义的可测量和/或不可测量病灶； 7. ECOG评分：0～1； 8. 预期生存期大于6个月； 9. 重要器官的功能符合下列要求（不包括在14天内用任何血液成分及细胞生长因子）： ?正常的骨髓储备功能，中性粒细胞≥1,500/mm3，血小板计数≥100,000/mm3，血红蛋白≥5.6 mmol/L (9g/dL)； ?正常的肾功能或血清肌酸酐≤1.5 mg/d和/或肌酸酐清除率≥60 ml/min ?正常肝功能或胆红素≤1.5倍ULN，ASAT & ALST≤1.5倍ULN 10. 非手术绝育或育龄期女性患者，需要在研究治疗期间和研究治疗期结束后3个月内采用一种经医学认可的避孕措施（如宫内节育器，避孕药或避孕套）；非手术绝育的育龄期女性患者在研究入组前的7 天内血清或尿HCG检查必须为阴性；而且必须为非哺乳期；非手术绝育或育龄期男性患者，需要同意与其配偶在研究治疗期间和研究治疗期结束后3个月内采用一种经医学认可的避孕措施。 受试者自愿加入本研究，依从性好，配合安全性和生存期随访。

Inclusion criteria

Sign a written informed consent form before joining the group 1. Age range: 18-75 years old, both male and female are welcome; 2. Prior to treatment, MDT discussion was conducted to determine the presence of esophageal fistula or to assess a high risk of esophageal fistula; 3. Prior to treatment, MDT discussion was conducted to evaluate the potential for surgical resection of locally advanced esophageal squamous cell carcinoma; 4. No distant metastasis; 5. Willing to undergo nutritional assessment and receive gastrointestinal nutrition support therapy; 6. There are measurable and/or unmeasurable lesions that meet the definition of RECIST v1.1; 7. ECOG score: 0 to 1; 8. Expected survival period greater than 6 months; 9. The function of important organs meets the following requirements (excluding the use of any blood components and cell growth factors within 14 days): Normal bone marrow reserve function, neutrophil count >=1500/mm^3, platelet count >= 100000/mm3, hemoglobin >= 5.6 mmol/L (9g/dL); Normal renal function or serum creatinine <= 1.5 mg/d and/or creatinine clearance rate >= 60 ml/min Normal liver function or bilirubin <= 1.5 times ULN, ASAT&ALST <= 1.5 times ULN 10. Non surgical sterilization or female patients of childbearing age are required to use a medically approved contraceptive measure (such as intrauterine device, contraceptive pill, or condom) during the study treatment period and within 3 months after the end of the study treatment period; Female patients of childbearing age who undergo non-surgical sterilization must have a negative serum or urine HCG test within 7 days prior to enrollment in the study; And it must be during non lactation period; Non surgical sterilization or male patients of childbearing age need to agree to use a medically approved contraceptive measure with their spouse during the study treatment period and within 3 months after the end of the study treatment period. The subjects voluntarily joined this study, showed good compliance, and cooperated with safety and survival follow-up.

排除标准：

具有以下任何一项的患者不能入组本研究 1. 合并气管瘘； 2. 先前接受放疗、化疗、激素治疗、手术或分子靶向治疗； 3. 影像学证实有远处转移患者； 4. 受试者既往或同时患有其它恶性肿瘤（已治愈的皮肤基底细胞癌和宫颈原位癌除外）； 5. 既往曾行PD1或其他PD-1/PD-L1治疗不能入组；已知受试者既往对大分子蛋白制剂，或已知对任何PD-1成分过敏； 6. 受试者存在任何活动性自身免疫病或有自身免疫病病史（如以下，但不局限于：自身免疫性肝炎、间质性肺炎，葡萄膜炎，肠炎，肝炎，垂体炎，血管炎，肾炎，甲状腺功能亢进，甲状腺功能降低；受试者患有白癜风或在童年期哮喘已完全缓解，成人后无需任何干预的可纳入；受试者需要支气管扩张剂进行医学干预的哮喘则不能纳入）； 7. 受试者正在使用免疫抑制剂、或全身、或可吸收的局部激素治疗以达到免疫抑制目的（剂量>10mg/天泼尼松或其他等疗效激素），并在入组前2周内仍在继续使用的； 8. 有临床症状的腹水或胸腔积液，需要治疗性的穿刺或引流； 9. 有未能良好控制的心脏临床症状或疾病，如：（1）NYHA2级以上心力衰竭（2）不稳定型心绞痛（3）1年内发生过心肌梗死（4）有临床意义的室上性或室性心律失常需要治疗或干预的患者； 10. 凝血功能异常（PT>16s、APTT>43s、TT>21s、Fbg>2g/L），具有出血倾向或正在接受溶栓或抗凝治疗； 11. 患者目前（3个月内）存在食道静脉曲张、胃及十二指肠活动性溃疡、溃疡性结肠炎、门脉高压等消化道疾病或未切除的肿瘤存在活动出血，或研究者判定的可能引起消化道出血、穿孔的其他状况； 12. 既往或目前有严重的出血（3个月内出血>30 ml）、咯血（4周内>5 ml的新鲜血液）或者12月内发生血栓栓塞事件（包括卒中事件和/或短暂性脑缺血发作）； 13. 受试者有活动性感染或在筛选期间、首次给药前发生原因不明发热>38.5度（经研究者判断，受试者因肿瘤产生的发热可以入组）； 14. 研究用药前不足4周出现过腹部瘘管、胃肠道穿孔或腹腔脓肿； 15. 既往和目前有肺纤维化史、间质性肺炎、尘肺、放射性肺炎、药物相关肺炎、肺功能严重受损等的客观证据的患者； 16. 受试者先天或后天免疫功能缺陷，如HIV感染者，或活动性肝炎（转氨酶不符合入选标准，乙肝参考： HBV DNA≥10?/ml；丙肝参考： HCV RNA≥103/ml）；慢性乙型肝炎病毒携带者，HBV DNA＜2000 IU/ml（<104拷贝/ml），试验期间必须同时接受抗病毒治疗才可以入组； 17. 受试者正在参加其他临床研究或距离前一项临床研究结束不足1个月；受试者在研究期间可能会接受其他全身抗肿瘤治疗； 18. 研究用药前不足4周内或可能于研究期间接种活疫苗； 19. 受试者已知有精神类药物滥用、酗酒或吸毒史； 20. 受试者无法或不同意负担自费部分的检查和治疗费用，除外临床研究药品，联合放化疗和与临床研究药品联合放化疗相关的SAE； 研究者认为应排除在本研究之外，例如经研究者判断，受试者有其他可能导致本研究被迫中途终止的因素，如，其他的严重疾病（含精神疾病）需要合并治疗，有严重的实验室检查异常，伴有家庭或社会等因素，会影响到受试者的安全，或资料及样品的收集。

Exclusion criteria：

Patients with any of the following conditions cannot be included in this study 1. Merge tracheal fistula; 2. Previously received radiation therapy, chemotherapy, hormone therapy, surgery, or molecular targeted therapy; 3. Imaging confirms the presence of distant metastases in patients; 4. The subject has previous or concurrent malignant tumors (excluding cured skin basal cell carcinoma and cervical carcinoma in situ); 5. Previous PD1 or other PD-1/PD-L1 treatments cannot be included in the study; It is known that the subject has a history of allergies to macromolecular protein preparations or any PD-1 components; 6. Subjects with any active autoimmune disease or history of autoimmune disease (such as but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism; subjects with vitiligo or complete remission of childhood asthma without any intervention in adulthood; subjects with asthma requiring medical intervention with bronchodilators cannot be included); 7. The subject is currently using immunosuppressive agents, systemic or absorbable local hormone therapy to achieve immunosuppressive effects (dose>10mg/day prednisone or other therapeutic hormones), and has continued to use them within 2 weeks prior to enrollment; 8. Ascites or pleural effusion with clinical symptoms require therapeutic puncture or drainage; 9. Patients with uncontrolled cardiac clinical symptoms or diseases, such as: (1) NYHA grade 2 or above heart failure, (2) unstable angina, (3) myocardial infarction within 1 year, and (4) clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention; 10. Abnormal coagulation function (PT>16s, APTT>43s, TT>21s, Fbg>2g/L), with bleeding tendency or undergoing thrombolytic or anticoagulant therapy; 11. The patient currently (within 3 months) has digestive tract diseases such as esophageal varices, active ulcers in the stomach and duodenum, ulcerative colitis, portal hypertension, or active bleeding from unresected tumors, or other conditions determined by the researchers that may cause gastrointestinal bleeding or perforation; 12. Previous or current severe bleeding (bleeding>30 ml within 3 months), hemoptysis (fresh blood>5 ml within 4 weeks), or thromboembolic events (including stroke events and/or transient ischemic attacks) occurring within 12 months; 13. The subject has an active infection or an unexplained fever>38.5 degrees Celsius during the screening period or before the first dose (according to the researcher's judgment, the subject can be included if the fever is caused by the tumor); 14. Having experienced abdominal fistula, gastrointestinal perforation, or abdominal abscess less than 4 weeks prior to medication; 15. Patients with objective evidence of past and current history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, severe impairment of lung function, etc; 16. Subjects have congenital or acquired immune deficiency, such as HIV infected persons, or active hepatitis (transaminase does not meet the inclusion criteria, hepatitis B reference: HBV DNA >= 10 ≮/ml; hepatitis C reference: HCV RNA >= 103/ml); Chronic hepatitis B virus carriers with HBV DNA<2000 IU/ml (<104 copies/ml) must receive antiviral treatment during the trial period in order to be enrolled; 17. The subjects are currently participating in other clinical studies or have been less than one month since the end of the previous clinical study; Participants may receive other systemic anti-tumor treatments during the study period; 18. Less than 4 weeks before the study medication or may receive live vaccine during the study period; 19. The subject is known to have a history of substance abuse, alcoholism, or drug use; 20. The subjects are unable or unwilling to bear the self funded portion of the examination and treatment costs, except for clinical research drugs, combined radiotherapy and chemotherapy, and SAEs related to combined radiotherapy and chemotherapy with clinical research drugs; The researchers believe that the subjects should be excluded from this study, for example, if the researchers determine that there are other factors that may cause the study to be terminated midway, such as other serious illnesses (including mental illnesses) that require concomitant treatment, serious laboratory abnormalities, accompanied by family or social factors, which may affect the safety of the subjects, or the collection of data and samples.

研究实施时间：

Study execute time：

从 From 2025-05-01 00:00:00至 To 2027-05-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2025-06-17 00:00:00 至 To 2027-05-31 00:00:00

干预措施：

Interventions：

组别：

试验组

样本量：

 9

Group：

Experimental group

Sample size：

干预措施：

卡瑞利珠单抗联合放化疗

干预措施代码：

Intervention：

Chemotherapy and radiotherapy plus Camrelizumab

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 成都 

市(区县)：

  

Country：

China

Province：

Chengdu

City：

单位(医院)：

 四川省肿瘤医院 

单位级别：

 三甲 

Institution
hospital：

Sichuan Cancer Hospital

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

安全性

指标类型：

主要指标

Outcome：

Safety

Type：

Primary 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：

肿瘤组织

组织：

Sample Name：

Tumor tissue

Tissue：

人体标本去向

 使用后保存  

说明

Fate of sample：

Preservation after use  

Note：

标本中文名：

血液

组织：

Sample Name：

Blood

Tissue：

人体标本去向

 使用后保存  

说明

Fate of sample：

Preservation 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 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:

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

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）：

研究结束后，通过ResMan(www.medresman.org.cn)方式共享。预计共享的时间为2028-12-31。

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

After the research is completed, it will be shared through ResMan (www.edresman. org. cn). The expected sharing time is December 31, 2028.

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：

样本由专人负责收集，并交由专业测序公司进行检测和质控，测序下机后的原始数据由专人负责拷贝和存储，以上数据均由项目负责人审查后，移交数据管理员，进行数据再次审核。数据的录入与修改数据录入与管理由数据管理员负责。数据锁定在确认建立的数据库正确后，由项目负责人、数据管理员、统计分析人员对数据进行锁定。锁定后的数据文件不再作改动。数据处理在试验数据全部录入并锁定后，将数据库交统计分析人员按任务书要求进行统计分析。完成统计分析后，由统计分析人员写出统计分析报告，交由本试验的主要研究者写出试验总结报告。

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

The samples are collected by a dedicated person and handed over to a professional sequencing company for testing and quality control. The original data is copied and stored by a dedicated person. The above data is reviewed by the project leader and then transferred to the data administrator for further review. The data entry and modification are the responsibility of the data administrator. After confirming the correctness of the established database, the data is locked by the project leader, data administrator, and statistical analyst. The locked data file will no longer be modified. After all experimental data is entered and locked, the database is handed over to statistical analysts for statistical analysis according to the requirements of the task book. After completing the statistical analysis, the statistical analyst shall write a statistical analysis report, which shall be submitted to the main researcher of this experiment to write a summary report.

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：

  2026-01-12 17:39:08