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：	ChiCTR2600123643
最近更新日期： Date of Last Refreshed on：	2026-04-28 15:43:31
注册时间： Date of Registration：	2026-04-28 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	QL1706联合化疗二线治疗晚期食管鳞癌的前瞻性、开放性、单中心临床研究
Public title：	Prospective, Open-Label, Single-Center Clinical Study of QL1706 Combined Chemotherapy as Second-Line Treatment for Advanced Esophageal Squamous Cell Carcinoma
注册题目简写：
English Acronym：
研究课题的正式科学名称：	QL1706联合化疗二线治疗晚期食管鳞癌的前瞻性、开放性、单中心临床研究
Scientific title：	Prospective, Open-Label, Single-Center Clinical Study of QL1706 Combined Chemotherapy as Second-Line Treatment for 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：	戴夕超	研究负责人：	戴夕超
Applicant：	Xichao Dai	Study leader：	Xichao Dai
申请注册联系人电话： Applicant telephone：	+86 515 66696963	研究负责人电话： Study leader's telephone：	+86 515 66696963
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：	rosefor1110@163.com	研究负责人电子邮件： Study leader's E-mail：	rosefor1110@163.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：	江苏省盐城市盐都区人民南路66号	研究负责人通讯地址：	江苏省盐城市人民南路66号
Applicant address：	No. 66 Renmin South Road, Yandu District, Yancheng City, Jiangsu Province	Study leader's address：	No. 66 Renmin South Road, Yancheng City, Jiangsu 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：	盐城市第一人民医院
Applicant's institution：	The First People's Hospital of Yancheng City
研究负责人所在单位：	盐城市第一人民医院
Affiliation of the Leader：	Yancheng First People's 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：	2026-IIT-005	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：	盐城市第一人民医院伦理审查委员会
Name of the ethic committee：	Institutional Review Board of the First People's Hospital of Yancheng
伦理委员会批准日期： Date of approved by ethic committee：	2026-02-06 00:00:00
伦理委员会联系人：	刘敏
Contact Name of the ethic committee：	Liu Min
伦理委员会联系地址：	江苏省盐城市人民南路66号
Contact Address of the ethic committee：	No. 66 Renmin South Road, Yancheng City, Jiangsu Province
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 515 66696823	伦理委员会联系人邮箱： Contact email of the ethic committee：	lmin89@163.com

研究实施负责（组长）单位：

盐城市第一人民医院

Primary sponsor：

Yancheng First People's Hospital

研究实施负责（组长）单位地址：

江苏省盐城市人民南路66号

Primary sponsor's address：

No. 66 Renmin South Road, Yancheng City, Jiangsu 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)：	江苏省	市(区县)：
Country：	China	Province：	Jiangsu	City：
单位(医院)：	盐城市第一人民医院	具体地址：	江苏省盐城市人民南路66号
Institution hospital：	Yancheng First People's Hospital	Address：	No. 66 Renmin South Road, Yancheng City, Jiangsu Province

经费或物资来源：

徐州医科大学-齐鲁临床研究基金

Source(s) of funding：

Xuzhou Medical University Qilu Clinical Research Fund

研究疾病：

食管鳞癌

Target disease：

Esophageal squamous 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：

上市后药物

Study phase：

4

研究设计：

单臂

Study design：

Single arm

研究目的：

评价QL1706联合化疗二线治疗晚期食管鳞癌的有效性和安全性。

Objectives of Study：

Evaluation of the Efficacy and Safety of QL1706 Combined with Chemotherapy as Second-Line Treatment for Advanced 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：

Inclusion criteria

1.Age >= 18 years, gender unrestricted;
2.Histologically or cytologically confirmed esophageal squamous cell carcinoma;
3.Previous systemic therapy (only second-line subjects can be enrolled);
4.ECOG PS 0-1;
5.At least one measurable lesion (according to RECIST 1.1);
6.Adequate organ and bone marrow function, defined as follows: hemoglobin >= 9.0 g/dL, absolute neutrophil count >= 1.5×10^9/L, platelet count >= 100×10^9/L, INR <= 1.5, total bilirubin (TBL) <= 1.5×ULN, AST and ALT <= 2.5×ULN, serum albumin >= 3.0 g/dL, serum creatinine <= 1.5×ULN or measured creatinine clearance > 60 mL/min or calculated creatinine clearance > 60 mL/min using the Cockcroft-Gault formula (using actual body weight): for men: creatinine clearance = (weight x (140 - age)) / (72 x serum creatinine); for women: creatinine clearance = (weight x (140 - age)) / (72 x serum creatinine) x 0.85, where CL = mL/min; serum creatinine = mg/dL;
7.Patients with active HBV infection should have received antiviral treatment for more than 2 weeks according to local antiviral treatment guidelines before enrollment and should continue treatment for 6 months after study drug administration;
8.Negative HCV antibody test at screening, or positive HCV antibody test at screening but negative HCV RNA test subsequently;
9.Expected survival >= 12 weeks;
10.Patients have signed the informed consent form and voluntarily join this study.

排除标准：

1.具有较高食管瘘风险，例如食管瘘的既往史或相关症状，或原发肿瘤浸润至大血管或气管；
2.完全性食道梗阻的证据，不适合治疗；
3.活动性或既往记录的自身免疫类疾病或炎症性疾病（包括炎症性肠病[如，结肠炎或克罗恩病]、憩室炎（憩室病除外）、系统性红斑狼疮、结节病综合征或Wegener综合征[肉芽肿伴多血管炎、Graves病、类风湿性关节炎、垂体炎和葡萄膜炎等]）。以下是本标准的例外情况：(a)白癜风或脱发患者；(b)甲状腺功能减退（如，Hashimoto综合征后）且接受稳定激素替代治疗的患者；(c)无需全身性治疗的任何慢性皮肤疾病；(d)可纳入近5年内无活动性疾病的患者，但是仅在咨询研究医师后方可纳入；(e)仅依靠饮食即可控制的乳糜泻患者；
4.活动性感染，包括结核病（临床评价包括临床病史、体格检查、影像学结果和符合当地治疗原则的结核病检查）；
5.未受控制的并发症，包括但不限于持续感染或活动性感染、症状性充血性心脏衰竭、未受控制的高血压、不稳定型心绞痛、不受控制的心脏心律不齐、活动性间质性肺疾病、与伴有腹泻的严重慢性胃肠道疾病，或限制研究要求依从性、显著增加发生AE的风险或损害患者提供书面知情同意能力的精神疾病/社会状况；
6.既往存在甲状腺功能异常，并且在药物治疗的情况下，甲状腺功能仍不能维持在正常范围内；
7.在QL1706首次给药前14天内，正在或既往使用过免疫抑制药物。以下是本标准的例外情况：(a)鼻内、吸入、外用类固醇或局部注射类固醇（如，关节内注射；(b)不超过生理剂量的全身用糖皮质激素，相当于10 mg/天泼尼松或其等效物；(c)类固醇激素，作为超敏反应的预治疗用药（如，CT扫描预治疗用药）；
8.具有精神类药物滥用史且无法戒除者或有精神障碍的；
9.已知有间质性肺病或活动性非感染性肺炎病史或证据；
10.研究药物首次给药前30天内接种减毒活疫苗。注：如果入选，患者在接受研究药物治疗期间及研究药物末次给药后30天内不得接种活疫苗；
11.已知会对任何研究药物或其任何辅料产生过敏反应或超敏反应；
12.同时入组另一项临床研究，除非该研究是一项观察性（非干预性）临床研究，或是干预性研究的随访期；
13.研究者判定其他不适合纳入研究的情况；
14.既往使用过QL1706或其他PD-1/CTLA4双抗。

Exclusion criteria：

1.Have a high risk of esophageal fistula, such as a history of esophageal fistula or related symptoms, or the primary tumor has infiltrated major blood vessels or the trachea; 2.Evidence of complete esophageal obstruction, unsuitable for treatment; 3.Active or previously recorded autoimmune diseases or inflammatory disorders (including inflammatory bowel disease [such as colitis or Crohn's disease], diverticulitis (except diverticulosis), systemic lupus erythematosus, sarcoidosis syndrome or Wegener's syndrome [granulomatous polyangiitis, Graves' disease, rheumatoid arthritis, pituitary inflammation and uveitis, etc.]); The following are the exceptions to this standard: (1) patients with vitiligo or alopecia; (2) patients with hypothyroidism (such as Hashimoto's syndrome) who are receiving stable hormone replacement therapy; (3) any chronic skin disease that does not require systemic treatment; (4) patients who can be included within the past 5 years without active disease, but only after consultation with the research physician; (5) patients with celiac disease that can be controlled by diet alone; 4.Active infection, including tuberculosis (clinical evaluation includes clinical history, physical examination, imaging results and tuberculosis examination in accordance with local treatment principles); 5.Uncontrolled complications, including but not limited to persistent infection or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, uncontrolled cardiac arrhythmia, active interstitial lung disease, severe chronic gastrointestinal disease accompanied by diarrhea, or conditions that limit the study's compliance requirements, significantly increase the risk of AE occurrence or impair the patient's ability to provide written informed consent; 6.Previous thyroid dysfunction, and in the case of drug treatment, the thyroid function still cannot be maintained within the normal range; 7.Within 14 days before the first administration of QL1706, using immunosuppressive drugs currently or previously. The following are the exceptions to this standard: (1) intranasal, inhalation, topical steroids or local injections of steroids (such as intra-articular injection); (2) no more than the physiological dose of systemic glucocorticoids, equivalent to 10 mg/day prednisone or its equivalent; (3) steroid hormones as pre-treatment medication for hypersensitivity reactions (such as CT scan pre-treatment medication); 8.Those with a history of substance abuse of psychotropic drugs and unable to quit or with mental disorders; 9.Known history of interstitial lung disease or active non-infectious pneumonia or evidence thereof; 10.Within 30 days before the first administration of the study drug, received live attenuated vaccines. Note: If selected, patients shall not receive live vaccines during the study drug treatment and within 30 days after the last administration of the study drug; 11.Known to have allergic reactions or hypersensitivity reactions to any study drug or its excipients; 12.Enrolled in another clinical study at the same time, unless the study is an observational (non-interventional) clinical study or the follow-up period of an intervention study; 13.The investigator determines other circumstances that are not suitable for inclusion in the study. 14.Previous use of QL1706 or other PD-1/CTLA-4 bispecific antibodies.

研究实施时间：

Study execute time：

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

征募观察对象时间：

Recruiting time：

从 From 2026-05-01 00:00:00 至 To 2027-05-01 00:00:00

干预措施：

Interventions：

组别：	试验组	样本量：	30
Group：	Experimental group	Sample size：	30
干预措施：	药物干预	干预措施代码：
Intervention：	Pharmacological intervention	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	中国	省(直辖市)：	江苏省	市(区县)：
Country：	China	Province：	Jiangsu	City：
单位(医院)：	盐城市第一人民医院	单位级别：	三级甲等
Institution hospital：	Yancheng First People's Hospital	Level of the institution：	Tertiary A

测量指标：

Outcomes：

指标中文名：	缓解持续时间	指标类型：	次要指标
Outcome：	Duration of Response	Type：	Secondary indicator
测量时间点：		测量方法：	CT
Measure time point of outcome：		Measure method：	CT

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：	治疗期，每个周期1次	测量方法：	安全性评估，包括生命体征、体格检查、实验室检查等
Measure time point of outcome：	Treatment period, once per cycle	Measure method：	Safety assessment, including vital signs, physical examination, laboratory tests, etc.

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：		测量方法：	CT
Measure time point of outcome：		Measure method：	CT

指标中文名：	总生存期	指标类型：	次要指标
Outcome：	Overall Survival	Type：	Secondary indicator
测量时间点：	治疗期，每个周期1次，生存随访期，每3个月随访1次	测量方法：	随访
Measure time point of outcome：	During treatment, once per cycle; during survival follow-up, once every 3 months.	Measure method：	Follow-up

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：		测量方法：	CT
Measure time point of outcome：		Measure method：	CT

指标中文名：	客观缓解率	指标类型：	主要指标
Outcome：	Objective Response Rate	Type：	Primary indicator
测量时间点：		测量方法：	CT
Measure time point of outcome：		Measure method：	CT

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：	外周血	组织：
Sample Name：	Peripheral Blood	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)：

None

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	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）：	N/A
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	N/A
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：	CRF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：	无/No
注册人： Name of Registration：	2026-04-28 15:42:40