ChiCTR2600122369 版本V1.0 版本创建时间2026/04/13 14:23:31 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：

ChiCTR2600122369 

最近更新日期：

Date of Last Refreshed on：

2026-04-13 14:22:24 

注册时间：

Date of Registration：

2026-04-13 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

艾帕洛利托沃瑞利组合抗体联合或不联合化疗治疗二线及以上复发或转移性头颈部鳞状细胞癌患者的疗效与安全性研究

Public title：

A study investigating the efficacy and safety of the combination of iparomlimab and tuvonralimab with or without chemotherapy in second-line and subsequent treatments for recurrent or metastatic head and neck squamous cell carcinoma

注册题目简写：

English Acronym：

研究课题的正式科学名称：

艾帕洛利托沃瑞利组合抗体联合或不联合化疗治疗二线及以上复发或转移性头颈部鳞状细胞癌患者的疗效与安全性研究

Scientific title：

A study investigating the efficacy and safety of the combination of iparomlimab and tuvonralimab with or without chemotherapy in second-line and subsequent treatments for recurrent or metastatic head and neck 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：

曾越灿 

研究负责人：

曾越灿 

Applicant：

Yuecan Zeng 

Study leader：

Yuecan Zeng 

申请注册联系人电话：

Applicant telephone：

+86 19946610752

研究负责人电话：

Study leader's telephone：

+86 19946610752

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：

wellyy2005@hotmail.com

研究负责人电子邮件：

Study leader's E-mail：

wellyy2005@hainmc.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：

海南省海口市椰海大道368号

研究负责人通讯地址：

海南省海口市椰海大道368号

Applicant address：

No. 368, Ye Hai Avenue, Haikou City, Hainan Province

Study leader's address：

No. 368, Ye Hai Avenue, Haikou City, Hainan 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：

海南医科大学第二附属医院

Applicant's institution：

The Second Affiliated Hospital of Hainan Medical University

研究负责人所在单位：

海南医科大学第二附属医院

Affiliation of the Leader：

The Second Affiliated Hospital of Hainan Medical University

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

2025-K121-01

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：

海南医学院第二附属医院医学伦理审查委员会

Name of the ethic committee：

Medical Ethics Review Committee of the Second Affiliated Hospital of Hainan Medical College

伦理委员会批准日期：

Date of approved by ethic committee：

2025-11-10 00:00:00

伦理委员会联系人：

刘春华

Contact Name of the ethic committee：

Liu Chunhua

伦理委员会联系地址：

海南省海口市椰海大道368号

Contact Address of the ethic committee：

No. 368, Ye Hai Avenue, Haikou City, Hainan Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 898 66809348

伦理委员会联系人邮箱：

Contact email of the ethic committee：

qiu826shi@163.com

研究实施负责（组长）单位：

海南医科大学第二附属医院

Primary sponsor：

The Second Affiliated Hospital of Hainan Medical University

研究实施负责（组长）单位地址：

海南省海口市椰海大道368号

Primary sponsor's address：

No. 368, Ye Hai Avenue, Haikou City, Hainan 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)：

海南省

市(区县)：

Country：

China

Province：

Hainan

City：

单位(医院)：

海南医科大学第二附属医院

具体地址：

海南省海口市椰海大道368号

Institution
hospital：

The Second Affiliated Hospital of Hainan Medical University

Address：

No. 368, Ye Hai Avenue, Haikou City, Hainan Province

经费或物资来源：

中国青年创业就业基金会

Source(s) of funding：

The China Foundation For Youth Entrepreneurship And Employment

Target disease：

patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC)

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：

评估艾帕洛利托沃瑞利组合抗体联合或不联合化疗治疗二线及以上复发或转移性头颈部鳞状细胞癌（R/M HNSCC）患者的客观缓解率（ORR）  

Objectives of Study：

To evaluate the objective response rate (ORR) of the combination of iparomlimab and tuvonralimab in second-line and subsequent treatments for recurrent or metastatic head and neck squamous cell carcinoma, with or without chemotherapy

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.在任何试验相关流程实施之前，签署书面知情同意； 2.年龄≥18周岁，≤75岁，性别不限； 3.ECOG PS评分为0-2分； 4.病理学确诊的复发性或转移性头颈部鳞状细胞癌，部位包括口咽、口腔、下咽或喉部； 5.接受过针对复发性或转移性HNSCC的全身系统性治疗； 6.预期生存时间>3个月； 7.根据RECIST1.1标准至少有1个可测量病灶； 8.既往抗肿瘤治疗所致的所有急性毒性反应缓解至 0-1 级（根据 NCI CTCAE 5.0 版）或者至入选/排除标准可接受的水平； 9.总三碘甲腺原氨酸（T3）或游离T3和游离甲状腺素（T4）在正常范围内。（可以接受通过甲状腺替代疗法控制）。无症状的T3，游离T3或游离T4异常的受试者可以入选； 10.具有充分的器官和骨髓功能，分组前7天内实验室检查值符合下列要求(获得实验室检查的前14天内不允许通过给予任何血液成分、细胞生长因子、白蛋白及其他纠正治疗的药物来满足条件)，具体如下： (1)血常规：绝对中性粒细胞计数（absolute neutrophil count, ANC）≥1.5×10^9/L； 血小板计数（platelet, PLT）≥75×10^9/L（肝硬化、脾亢患者为≥50×10^9/L）； 血红蛋白含量（hemoglobin, HGB）≥90 g/L； (2)肝功能：血清总胆红素（total bilirubin, TBIL）≤1.5×正常上限（upper limit of normal value, ULN）；丙氨酸氨基转移酶（alanine aminotransferase, ALT）、天门冬氨酸氨基转移酶（aspartate transferase, AST）≤5×ULN； (3)肾功能：血清肌酐（creatinine, Cr）≤ 1.5×ULN 或肌酐清除率（clearance of creatinine, CCr）≥ 50mL/min（Cockcroft-Gault 公式）；尿蛋白定性≤1+；如尿蛋白定性 ≥2+，则需进行 24 h 尿蛋白定量检查，如 24 h 尿蛋白定量 <1 g，则可以接受；(4) 凝血功能：国际标准化比率（international normalized ratio，INR）和活化部分凝血活酶时间（activated partial thromboplastin time ，APTT）≤ 2倍ULN；

Inclusion criteria

1.Sign a written informed consent form before any trial-related procedures are performed; 2.Ages 18 to 75, regardless of gender; 3.ECOG performance status of 0–2; 4.Pathologically confirmed recurrent or metastatic squamous cell carcinoma of the head and neck, including the oropharynx, oral cavity, hypopharynx, or larynx; 5.Has received systemic therapy for recurrent or metastatic HNSCC; 6.Expected survival time > 3 months; 7.At least one measurable lesion according to the RECIST 1.1 criteria; 8.All acute toxicities resulting from prior anticancer therapy must have resolved to Grade 0–1 (according to NCI CTCAE Version 5.0) or to a level acceptable under the inclusion/exclusion criteria; 9.Total triiodothyronine (T3) or free T3 and free thyroxine (T4) are within the normal range. (These levels may be controlled by thyroid replacement therapy.) Asymptomatic subjects with abnormal T3, free T3, or free T4 levels may be enrolled; 10.Patients must have adequate organ and bone marrow function, and laboratory test results within 7 days prior to grouping must meet the following requirements (conditions must not be met by administering any blood components, cell growth factors, albumin, or other corrective medications within 14 days prior to obtaining the laboratory tests), as follows: (1) Complete blood count (CBC): Absolute neutrophil count (ANC) >= 1.5 × 10^9/L; Platelet count (PLT) >= 75 × 10^9/L (>= 50 × 10^9/L for patients with cirrhosis or splenomegaly); Hemoglobin (HGB) >= 90 g/L; (2) Liver function: Serum total bilirubin (TBIL) <= 1.5×upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <= 5×ULN; (3) Renal function: Serum creatinine (Cr) <= 1.5×ULN or creatinine clearance (CCr) >= 50 mL/min (Cockcroft-Gault formula); Qualitative urine protein <= 1+; if qualitative urine protein is >= 2+, a 24-hour urine protein quantification test must be performed; if the 24-hour urine protein quantification is < 1 g, it is acceptable; (4)Coagulation function: International Normalized Ratio (INR) and Activated Partial Thromboplastin Time (APTT) <= 2 times the upper limit of normal (ULN);

排除标准：

1.有明确的其他类型癌症病史，与本研究目标癌种（头颈部鳞状细胞癌）无关； 2.有中枢神经系统转移或脑转移的受试者； 3.急性或者慢性活动性乙型肝炎或丙型肝炎感染者，乙型肝炎病毒（HBV） DNA＞1000IU/ml且抗病毒治疗无效；丙型肝炎病毒（HCV）RNA＞10^3拷贝/ml且经评估不适合免疫治疗；乙肝表面抗原（HbsAg）与抗HCV抗体同时阳性； 4.既往3个月内发生任何危及生命的出血事件，包括需要输血治疗、手术或局部治疗、持续药物治疗； 5.既往6个月内动、静脉血栓栓塞事件，包括心肌梗死、不稳定型心绞痛、脑血管意外或一过性脑缺血发作、肺动脉栓塞、深静脉血栓或其它任何严重血栓栓塞的病史。植入式静脉输液港或导管源性血栓形成，或浅表静脉血栓形成，经过常规抗凝治疗后血栓稳定者除外。允许预防性使用小剂量低分子肝素（如依诺肝素40 mg/天）； 6.首次给药前2周内，连续10天使用阿司匹林（＞ 325 mg/天）或其他已知可以抑制血小板功能的药物如双嘧达莫或氯吡格雷等； 7.症状性充血性心力衰竭（纽约心脏病协会分级II-IV级）。症状性或控制不佳的心律失常。先天性长QT综合征病史或筛查时校正的QTc＞500ms（使用Fridericia法计算）； 8.严重出血倾向或凝血功能障碍，或正在接受溶栓治疗； 9.既往6个月内有胃肠道穿孔和/或瘘管病史，肠梗阻病史（包括需要肠外营养的不完全肠梗阻），广泛肠切除（部分结肠切除或广泛小肠切除，并发慢性腹泻）、克罗恩氏病、溃疡性结肠炎或长期慢性腹泻； 10.既往和目前有肺纤维化史、间质性肺炎、尘肺、药物相关肺炎、肺功能严重受损等肺部疾病； 11.已知有酒精滥用、精神类药物滥用或吸毒史； 12.既往有明确的神经或精神障碍史，如癫痫、痴呆、精神分裂症等； 13.活动性肺结核(TB)，正在接受抗结核治疗或者首次给药前1年内接受过抗结核治疗者； 14.人免疫缺陷病毒（HIV）感染者（HIV 1/2抗体阳性），已知的梅毒感染者； 15.处于活动期或临床控制不佳的严重感染。在首次给药前4周内有重度感染，包括但不限于因感染、菌血症或重度肺炎并发症而住院治疗； 16.首次给药前2年内发生过需要全身性治疗（例如使用缓解疾病药物、皮质类固醇或免疫抑制剂）的活动性自身性免疫疾病。允许使用替代疗法（例如甲状腺素、胰岛素或者用于肾上腺或垂体机能不全的生理性皮质类固醇等）。已知的原发性免疫缺陷病史。仅存在自身免疫抗体阳性的患者需根据研究者判断确认是否存在自身免疫性疾病； 17.首次给药前4周之内使用过免疫抑制药物，不包括喷鼻、吸入性或其他途径的局部糖皮质激素或生理剂量的系统性糖皮质激素（即不超过10mg/天泼尼松或等效剂量的其他糖皮质激素）、允许因治疗哮喘、慢性阻塞性肺疾病等疾病的呼吸困难症状临时使用糖皮质激素； 18.首次给药前4周之内或计划在研究期间接受减毒活疫苗； 19.首次给药前4周之内接受过重大的外科手术（开颅、开胸或开腹手术）或者未愈合的伤口、溃疡或骨折。首次给药之前7天内接受过组织穿刺活检或其他小外科手术，以静脉输液为目的的静脉穿刺置管除外； 20.不受控制/无法纠正的代谢紊乱或其它非恶性肿瘤器官疾病或全身性疾病或癌症继发反应，并可导致较高医学风险和/或生存期评价不确定性； 21.在首次给药前5年内诊断为其他恶性肿瘤，不包括经过根治的皮肤基底细胞癌、皮肤鳞状细胞癌和/或经过根治切除的原位癌。如果给药前5年以上诊断为其他恶性肿瘤或肝癌，需对复发转移病灶进行病理学或细胞学诊断； 22.已知对研究药物成分（如艾帕洛利托沃瑞利组合抗体、铂类、多西他赛或紫杉醇有严重过敏反应史； 23.首次给药前4周内接受过其他临床试验的治疗或正在进行另一项临床研究； 24.妊娠或哺乳的女性患者； 25.可能会导致以下结果的其它急性或慢性疾病、精神疾病或实验室检测值异常：增加研究参与或研究药物给药的相关风险，或者干扰研究结果的解读，而且根据研究者的判断将患者列为不符合参加本研究的资格；

Exclusion criteria：

1.A confirmed history of other types of cancer unrelated to the target cancer in this study (head and neck squamous cell carcinoma); 2.Subjects with central nervous system metastases or brain metastases; 3.Patients with acute or chronic active hepatitis B or C; those with hepatitis B virus (HBV) DNA > 1,000 IU/mL who have failed antiviral therapy; those with hepatitis C virus (HCV) RNA > 10^3 copies/mL who have been assessed as unsuitable for immunotherapy; and those who are simultaneously positive for hepatitis B surface antigen (HBsAg) and anti-HCV antibodies; 4.Any life-threatening bleeding episode within the past 3 months, including those requiring blood transfusion, surgery, or local treatment, or ongoing medication; 5.A history of arterial or venous thromboembolic events within the past 6 months, including myocardial infarction, unstable angina, cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis, or any other serious thromboembolic event. Implantable venous access ports or catheter-related thrombosis, or superficial vein thrombosis, unless the thrombus is stable following conventional anticoagulation therapy. Prophylactic use of low-dose low-molecular-weight heparin (e.g., enoxaparin 40 mg/day) is permitted; 6.Use of aspirin (> 325 mg/day) or other drugs known to inhibit platelet function, such as dipyridamole or clopidogrel, for 10 consecutive days within 2 weeks prior to the first dose; 7.Symptomatic congestive heart failure (New York Heart Association Class II–IV). Symptomatic or poorly controlled arrhythmias. History of congenital long QT syndrome or a corrected QTc > 500 ms on screening (calculated using the Fridericia formula); 8.A severe bleeding tendency or coagulation disorder, or currently undergoing thrombolytic therapy; 9.A history of gastrointestinal perforation and/or fistula within the past 6 months; a history of intestinal obstruction (including partial intestinal obstruction requiring parenteral nutrition); extensive intestinal resection (partial colectomy or extensive small bowel resection complicated by chronic diarrhea); Crohn’s disease; ulcerative colitis; or long-term chronic diarrhea; 10.A history of or current pulmonary conditions such as pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, drug-induced pneumonia, or severe impairment of lung function; 11.Known history of alcohol abuse, psychotropic substance abuse, or drug use; 12.A history of specific neurological or psychiatric disorders, such as epilepsy, dementia, schizophrenia, etc; 13.Active pulmonary tuberculosis (TB), individuals currently undergoing antituberculosis treatment, or those who received antituberculosis treatment within one year prior to the first dose; 14.Individuals infected with human immunodeficiency virus (HIV) (HIV-1/2 antibody-positive) and individuals with known syphilis; 15.Active severe infections or infections that are not well clinically controlled. Severe infections within 4 weeks prior to the first dose, including but not limited to hospitalization due to complications from infection, bacteremia, or severe pneumonia; 16.Active autoimmune disease requiring systemic treatment (e.g., disease-modifying antirheumatic drugs, corticosteroids, or immunosuppressants) within 2 years prior to the first dose. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroids for adrenal or pituitary insufficiency) is permitted. Known history of primary immunodeficiency. Patients who are only positive for autoimmune antibodies must be evaluated by the investigator to determine whether an autoimmune disease is present; 17.Use of immunosuppressive drugs within 4 weeks prior to the first dose, excluding topical corticosteroids administered via nasal spray, inhalation, or other routes, or systemic corticosteroids at physiological doses (i.e., no more than 10 mg/day of prednisone or an equivalent dose of other corticosteroids); temporary use of corticosteroids to treat dyspnea associated with conditions such as asthma or chronic obstructive pulmonary disease is permitted; 18.Within 4 weeks prior to the first dose, or if the patient is scheduled to receive an attenuated live vaccine during the study; 19.Major surgery (craniotomy, thoracotomy, or laparotomy) within 4 weeks prior to the first dose, or unhealed wounds, ulcers, or fractures. Tissue biopsy or other minor surgical procedures within 7 days prior to the first dose, excluding venipuncture or catheter placement for the purpose of intravenous infusion; 20.Uncontrolled or uncorrectable metabolic disorders, other non-malignant organ diseases, systemic diseases, or secondary reactions to cancer, which may result in a higher medical risk and/or uncertainty regarding survival prognosis; 21.A diagnosis of another malignancy within 5 years prior to the first dose, excluding curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or carcinoma in situ that has been curatively resected. If another malignancy or hepatocellular carcinoma was diagnosed more than 5 years prior to dosing, a pathological or cytological diagnosis of the recurrent or metastatic lesions is required; 22.A history of severe allergic reactions to study drug components (such as the epa-loritovireli combination antibody, platinum agents, docetaxel, or paclitaxel); 23.Has received treatment in another clinical trial or is currently participating in another clinical study within 4 weeks prior to the first dose; 24.Pregnant or breastfeeding patients; 25.Other acute or chronic medical conditions, psychiatric disorders, or abnormal laboratory test results that may lead to the following: increased risks associated with study participation or administration of the study drug, or interference with the interpretation of study results; and, in the investigator’s judgment, render the patient ineligible for participation in this study;

研究实施时间：

Study execute time：

从 From 2026-01-01 00:00:00至 To 2028-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2026-04-13 00:00:00 至 To 2027-12-31 00:00:00  

干预措施：

Interventions：

组别：

单臂

样本量：

32

Group：

One-armed

Sample size：

干预措施：

艾帕洛利托沃瑞利组合抗体

干预措施代码：

Intervention：

Iparomlimab and tuvonralimab combination antibody

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 海南省 

市(区县)：

  

Country：

China 

Province：

Hainan 

City：

 

单位(医院)：

海南医科大学第二附属医院 

单位级别：

三级甲等 

Institution
hospital：

The Second Affiliated Hospital of Hainan Medical University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

客观缓解率

指标类型：

主要指标

Outcome：

Objective Response Rate (ORR)

Type：

Primary indicator

测量时间点：

从接受治疗开始

测量方法：

完全缓解（CR）及部分缓解（PR）的受试者占总受试者的比例。

Measure time point of outcome：

Starting from the beginning of treatment

Measure method：

The proportion of subjects achieving complete remission (CR) and partial remission (PR) out of the total number of subjects

指标中文名：

6个月无疾病进展率

指标类型：

次要指标

Outcome：

6-month progression-free survival rate

Type：

Secondary indicator

测量时间点：

从接受治疗开始，6个月内

测量方法：

自入组至6个月无影像学确认疾病进展或死亡（以先发生者为准）的受试者比例

Measure time point of outcome：

Starting from the beginning of treatment

Measure method：

The proportion of subjects who remained free of radiologically confirmed disease progression or death (whichever occurs first) from enrollment through 6 months

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：

从接受治疗开始

测量方法：

完全缓解（CR）、部分缓解（PR）及疾病稳定（SD）的受试者占总受试者的比例

Measure time point of outcome：

Starting from the beginning of treatment

Measure method：

The proportion of subjects achieving complete remission (CR), partial remission (PR), and stable disease (SD) out of the total number of subjects

指标中文名：

6个月总生存率

指标类型：

次要指标

Outcome：

6-month overall survival rate

Type：

Secondary indicator

测量时间点：

从接受治疗开始，6个月内

测量方法：

自入组至6个月研究结束时仍存活的受试者比例

Measure time point of outcome：

Starting from the beginning of treatment

Measure method：

The proportion of participants who were still alive at the end of the 6-month study period

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：

从接受治疗开始

测量方法：

所有不良事件（AE）、治疗期不良事件（TEAE）、严重不良事件（SAE）和免疫相关不良事件（irAE）的发生率、严重程度及与研究药物的相关性

Measure time point of outcome：

Starting from the beginning of treatment

Measure method：

Incidence, severity, and relationship to the study drug for all adverse events (AE), treatment-emergent adverse events (TEAE), serious adverse events (SAE), and immune-related adverse events (irAE)

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

无

组织：

Sample Name：

NA

Tissue：

人体标本去向

 其它  

说明

Fate of sample：

0thers  

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 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:

不公开/Private

盲法：

无

Blinding：

None

是否共享原始数据：

IPD sharing

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）：

无

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

None

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：

临床试验中的文件（方案和方案修订，完成的 CRF，签署的 ICF 等）需按照要求进行保存和管理

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

Documents related to clinical trials (such as protocols and protocol amendments, completed CRFs, and signed ICFs) must be retained and managed in accordance with requirements

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2026-04-13 14:22:24