ChiCTR2500107176 版本V1.0 版本创建时间2025/08/05 17:58:10 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：

 ChiCTR2500107176 

最近更新日期：

Date of Last Refreshed on：

 2025-08-05 17:57:43 

注册时间：

Date of Registration：

 2025-08-05 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

靶向肿瘤抗原治疗结直肠癌基础与临床应用研究

Public title：

Basic and clinical application research on tumor antigen- targeted therapy for colorectal cancer

注册题目简写：

English Acronym：

研究课题的正式科学名称：

靶向肿瘤抗原治疗结直肠癌基础与临床应用研究

Scientific title：

Basic and clinical application research on tumor antigen- targeted therapy for colorectal cancer

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：

方金满 

研究负责人：

方金满 

Applicant：

Jinman Fang 

Study leader：

Jinman fang 

申请注册联系人电话：

Applicant telephone：

 +86 13721084358

研究负责人电话：

Study leader's
telephone：

+86 13721084358

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：

 fjman@cmpt.ac.cn

研究负责人电子邮件：

Study leader's E-mail：

 fjman@cmpt.ac.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：

中国科学院合肥肿瘤医院

研究负责人通讯地址：

安徽省合肥市蜀山区仰桥路68号

Applicant address：

Hefei Cancer Hospital of the Chinese Academy of Sciences

Study leader's address：

Hefei Cancer Hospital, Chinese Academy of Sciences, 68 YangQiao Road, Science Island, Shushan District, Hefei City, Anhui 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：

中国科学院合肥肿瘤医院

Applicant's institution：

Hefei Cancer Hospital of the Chinese Academy of Sciences

研究负责人所在单位：

中国科学院合肥肿瘤医院

Affiliation of the Leader：

Hefei Cancer Hospital,Chinese Academy of Sciences

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：

 PJ-KY2023-117

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：

中国科学院合肥肿瘤医院医学伦理委员会

Name of the ethic committee：

Ethics Committee of Hefei Cancer Hospital, Chinese Academy of Sciences

伦理委员会批准日期：

Date of approved by ethic committee：

 2023-12-22 00:00:00

伦理委员会联系人：

圣孟飞

Contact Name of the ethic committee：

Mengfei Sheng

伦理委员会联系地址：

安徽省合肥市蜀山区仰桥路68号

Contact Address of the ethic committee：

Hefei Cancer Hospital, Chinese Academy of Sciences, 68 YangQiao Road, Science Island, Shushan District, Hefei City, Anhui Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 551 65596092

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 2578741022@qq.com

研究实施负责（组长）单位：

中国科学院合肥肿瘤医院

Primary sponsor：

Hefei Cancer Hospital,Chinese Academy of Sciences

研究实施负责（组长）单位地址：

安徽省合肥市蜀山区仰桥路68号

Primary sponsor's address：

Hefei Cancer Hospital, Chinese Academy of Sciences, 68 YangQiao Road, Science Island, Shushan District, Hefei City, Anhui 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)：

安徽省

市(区县)：

Country：

China

Province：

Anhui

City：

单位(医院)：

中国科学院合肥肿瘤医院

具体地址：

安徽省合肥市蜀山区仰桥路68号

Institution
hospital：

Hefei Cancer Hospital,Chinese Academy of Sciences

Address：

Hefei Cancer Hospital, Chinese Academy of Sciences, 68 YangQiao Road, Science Island, Shushan District, Hefei City, Anhui Province

经费或物资来源：

安徽省重点研发计划（项目编号：2022e07020054）

Source(s) of funding：

Anhui Provincial Key Research and Development Program (Project No. : 2022e07020054)

研究疾病：

结直肠癌  

Target disease：

colorectal 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：

主要研究目的：评价AFN18在消化系统肿瘤中的安全性。 次要研究目的：初步评价AFN18的治疗效果。  

Objectives of Study：

Main research objective: To evaluate the safety of AFN18 in digestive system tumors. Secondary research objective: To preliminarily assess the therapeutic effect of AFN18.

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.受试者年龄应在18-75周岁之间（包括边界值），性别不限. 2.满足以下条件之一， A.组织病理学或细胞学确诊的，经标准治疗失败或无标准治疗的晚期/复发难治的或III期局部晚期的消化道肿瘤患者。B.II/III期可手术根治伴高复发风险的直肠癌患者，该类病人作为一个亚组参与研究。高复发风险定义为满足至少以下一种，a）T4分期， b）组织学分级为低分化或未分化，c）临床表现为肠梗阻或肠穿孔，d）血管、淋巴、神经周围侵犯的组织学征象， e）癌组织周围清扫的淋巴结少于12个；并且患者术后辅助化疗前ctDNA阳性。如经开放或者腹腔镜手术探查，腹水脱落细胞学等病理证实腹腔种植性病灶的，无论ctDNA是否阳性均可入组。 3.东部肿瘤协作组织（ECOG）评分体能状态为0或1 。 4.根据RECIST 1.1标准，符合2.A的受试者需有至少一个可测量的靶病灶。 5.通过减瘤手术、穿刺活检或根治性手术能够取到足够用于NGS基因测序（WES和RNAseq）的肿瘤样本和血液样本。一年以内的福尔马林固定后经石蜡包埋（FFPE）的肿瘤样本、活检标本也可以用于本研究。筛选出的新生抗原数目不少于5个，才具备入组基础条件。 6.预期生存时间≥6个月。 7.无严重血液学及肝、肾、凝血功能、心脏功能异常，筛选期实验室检查（检查日前14天内未接受过粒细胞集落刺激因子（G-CSF）、粒细胞-巨噬细胞集落刺激因子（GM-CSF）、红细胞输注及血小板输注支持治疗）结果需符合下列标准： 血液学: 中性粒细胞绝对值（ANC) ≥1.5×10^9/L; 血小板（PLT）≥75×10^9/L; 血红蛋白（Hb）≥90 g/L 肝功能 :总胆红素（TBIL）≤1.5×正常值上限(ULN) (Gilbert综合症除外，伴肝转移者≤3×ULN)) ; 天门冬氨酸氨基转移酶（AST）及谷氨酸氨基转移酶（ALT）≤2.5×ULN（伴肝转移者≤5×ULN） 肾功能: 血清肌酐（Scr）≤1.5×ULN; 肌酐清除率（Ccr）（仅血清肌酐＞1.5× ULN时需计算）≥60 mL/min（根据Cockcroft-Gault公式计算） 凝血功能: 凝血酶原时间（PT）≤1.5×ULN; 活化部分凝血活酶时间（APTT）≤1.5×ULN； 8.男性和育龄期女性应同意从签署知情同意书开始直至末次用药后3个月内采取有效的避孕措施；育龄期女性受试者首次用药前7天内的血或尿妊娠试验必须为阴性。 育龄期女性定义：已过月经初潮但还未绝经（除绝经以外无确定原因连续≥12个月闭经）且未接受过绝育手术（切除卵巢和/或子宫）的女性，均被认为具有生育能力，称为育龄期女性。 9.基于受试者的一般身体状况和实验室检查，经研究者充分评估，认为参加该项临床试验获益大于风险； 10.受试者在整个试验期间，依从性好，配合随访，能够定期到研究中心进行相关的检测、评价以及管理；

Inclusion criteria

1. The age of the subjects should be between 18 and 75 years old (inclusive of both boundaries), and there is no restriction on gender. 2. Patients with digestive tract tumors that meet one of the following conditions: A. Diagnosed by histopathology or cytology, have failed standard treatment or have no standard treatment, are difficult to treat with recurrence, or are locally advanced in stage III. B. Patients with stage II/III operable rectal cancer and high risk of recurrence were included as a subgroup in the study. High risk of recurrence is defined as meeting at least one of the following criteria: a) T4 staging, b) histological grading as poorly differentiated or undifferentiated, c) clinical presentation as intestinal obstruction or perforation, d) histological signs of vascular, lymphatic, and nerve invasion, e) less than 12 lymph nodes cleared around cancer tissue; And the patient tested positive for ctDNA before adjuvant chemotherapy after surgery. If there is pathological confirmation of abdominal implantation lesions through open or laparoscopic surgical exploration, ascites cytology, etc., regardless of whether ctDNA is positive, they can be included in the group. 3. The ECOG score for physical fitness status is 0 or 1. According to RECIST 1.1 criteria, subjects who meet 2. A must have at least one measurable target lesion. 5. Sufficient tumor and blood samples for NGS gene sequencing (WES and RNAseq) can be obtained through tumor reduction surgery, biopsy, or radical surgery. Tumor samples and biopsy specimens fixed in formalin and embedded in paraffin (FFPE) within one year can also be used for this study. The number of newly screened antigens must not be less than 5 in order to meet the basic conditions for inclusion in the group. 6. Expected survival time ≥ 6 months. 7. There should be no serious hematological, liver, kidney, coagulation, or cardiac dysfunction. Laboratory tests during the screening period (no granulocyte colony-stimulating factor (G-CSF), granulocyte macrophage colony-stimulating factor (GM-CSF), red blood cell transfusion, or platelet transfusion support therapy received within 14 days prior to the examination date) should meet the following criteria: Hematology: Absolute neutrophil count (ANC) >= 1.5 × 10 ^ 9/L; Platelet count (PLT) >= 75 × 10 ^ 9/L; Hemoglobin (Hb) >= 90 g/L Liver function: Total bilirubin (TBIL) <= 1.5 x upper limit of normal (ULN) (excluding Gilbert syndrome, <= 3 x ULN in patients with liver metastasis); Aspartate aminotransferase (AST) and glutamate aminotransferase (ALT) <= 2.5 × ULN (<= 5 × ULN in patients with liver metastasis) Renal function: serum creatinine (Scr) <= 1.5 × ULN; Creatinine clearance rate (Ccr) (calculated only when serum creatinine is greater than 1.5 × ULN) >= 60 mL/min (calculated according to the Cockcroft Gault formula) Coagulation function: Prothrombin time (PT) <= 1.5 × ULN; Activated partial thromboplastin time (APTT) <= 1.5 × ULN; Men and women of childbearing age should agree to take effective contraceptive measures from the time of signing the informed consent form until 3 months after the last use of medication; Female subjects of childbearing age must have a negative blood or urine pregnancy test within 7 days prior to their first medication. Definition of women of childbearing age: Women who have experienced menarche but have not yet reached menopause (with no definite reason for continuous amenorrhea for >= 12 months other than menopause) and have not undergone sterilization surgery (removal of ovaries and/or uterus) are considered to have fertility and are referred to as women of childbearing age. Based on the general physical condition and laboratory tests of the subjects, after thorough evaluation by the researchers, it is believed that the benefits of participating in this clinical trial outweigh the risks; 10. The subjects had good compliance throughout the entire trial period, cooperated with follow-up visits, and were able to regularly visit the research center for relevant testing, evaluation, and management;

排除标准：

1.在首次使用研究药物前2周内或4个半衰期内（以时间短者为准）接受过化疗、生物治疗、内分泌治疗等抗肿瘤治疗，以下几项除外： ?亚硝基脲或丝裂霉素C为首次使用研究药物前6周内； ?口服氟尿嘧啶类和小分子靶向药物为首次使用研究药物前2周内或药物的5个半衰期内（以时间短者为准）； ?有抗肿瘤适应症的中药为首次使用研究药物前2周内。
2.首次给药前4周内接受过其它未上市的临床研究药物或治疗。
3.首次给药前4周内接种过任何活疫苗。
4. 首次给药前4周内接受过主要脏器外科手术（不包括穿刺活检及以腹腔镜探查活检为目的的）或出现过显著外伤，或需要在试验期间接受择期手术。
5.既往接受过细胞治疗者（如TCR-T、CAR-T、TIL、肿瘤疫苗）。
6.既往接受过同种异体造血干细胞或同种异体骨髓移植，或既往接受过实体器官移植，或目前正在使用免疫抑制药物或抗移植排斥药物。
7.伴有任何活动性的自身免疫性疾病、自身免疫性疾病史、或需要全身性类固醇激素或免疫抑制药物治疗的疾病史或综合征（无需全身治疗的皮肤病或已痊愈的童年时代哮喘/过敏成年后无需任何干预的受试者；接受稳定剂量的甲状腺素替代治疗的自身免疫介导的甲状腺机能减退病史的受试者可以入选本研究）。
8.首次给药前 2 周内使用全身免疫抑制药物（包括但不限于泼尼松> 10 毫克/天、环磷酰胺、硫唑嘌呤、甲氨蝶呤、沙利度胺和 TNF-α 拮抗剂）。接受过一次性、低剂量、全身性免疫抑制药物（例如，一次性剂量地塞米松治疗恶心）的患者可以在研究者讨论并获得批准后参加研究。允许使用吸入性皮质类固醇（例如氟替卡松治疗慢性阻塞性肺疾病）。允许使用口服盐皮质激素（例如，氟氢可的松用于直立性低血压患者）。允许生理剂量的皮质类固醇治疗肾上腺皮质功能不全。
9.对研究药物任何活性或非活性成分过敏者。
10.既往抗肿瘤治疗的不良反应尚未恢复到CTCAE 5.0等级评价≤1级（研究者判断无安全风险的毒性除外，如脱发、2级外周神经毒性、经激素替代治疗稳定的甲状腺功能减退等）。
11.活动性乙型肝炎（HBsAg阳性且HBV-DNA＞研究中心检测下限）；丙型肝炎病毒感染（HCV-RNA＞研究中心检测下限）；HIV抗体检测阳性；梅毒螺旋体抗体阳性。
12.存在经研究者判断无法控制的第三间隙积液（如大量胸水和/或腹水）。
13.严重的心脑血管疾病史，包括但不限于： ?有严重的心脏节律或传导异常，如需要临床干预的室性心律失常、Ⅱ-Ⅲ度房室传导阻滞等；心室率大于100的心房颤动。 ?首次给药前6个月内发生急性冠脉综合征、充血性心力衰竭、主动脉夹层、脑卒中或其他3级及以上心血管事件； ?美国纽约心脏病协会（NYHA）心功能分级≥II级，或有其他研究者判断具有高风险的结构性心脏病； ?经标准治疗仍控制不良的高血压（收缩压 ＞ 150 mmHg，舒张压 ＞ 100 mmHg）；
14.首次给药前1周内存在有活动性感染并需要系统性治疗。
15.通过病史或CT检查发现有活动性肺结核感染，或入组前1年内有活动性肺结核感染病史的受试者，或超过1年以前有活动性肺结核感染病史但未经正规治疗。
16.存在其他严重疾病，包括肝脏疾病、肾脏疾病、神经/精神疾病、内分泌系统疾病、血液系统疾病、免疫系统疾病，研究者判断将影响参加本研究。
17.过去5年内，还患过其他恶性肿瘤，已经治愈的基底细胞皮肤癌、非黑色素瘤皮肤癌、原位宫颈癌、根治性手术后的分化型甲状腺癌除外。
18.已知有酒精或药物依赖。
19.精神障碍者或依从性差者。
20.妊娠期或哺乳期女性。
21.研究者认为受试者存在任何其他临床或实验室检查异常，或其他原因不适合参加本研究。

Exclusion criteria：

1.Within 23 weeks prior to the first use of the study drug or within 4 half-lives (whichever is shorter), patients have received anti-tumor treatments such as chemotherapy, radiotherapy, biological therapy, endocrine therapy, or immunotherapy. Exclusions include the following: ? For nitrogen mustard or mitomycin C, it is within 6 weeks prior to the first use of the study drug; ? For oral fluorouracil and small molecule targeted drugs, it is within 2 weeks prior to the first use of the study drug or within 5 half-lives of the drug (whichever is shorter); For traditional Chinese medicine with anti-tumor indications, it is within 2 weeks prior to the first use of the study drug. 2.Within 4 weeks prior to the first administration, had received any other unapproved clinical research drugs or treatments. 3.Within 4 weeks prior to the first administration, any live vaccine has been administered. 4.Within 4 weeks prior to the first administration, the subject has undergone major surgical procedures on major organs (excluding biopsy procedures) or has suffered significant trauma, or requires elective surgery during the trial period. 5.Those who have previously received cell therapy (such as TCR-T, CAR-T, TIL, tumor vaccines). 6.Has previously received allogeneic hematopoietic stem cell or allogeneic bone marrow transplantation, or has previously undergone solid organ transplantation, or is currently using immunosuppressive drugs or anti-transplant rejection drugs. 7.Any active autoimmune disease, history of autoimmune disease, or history of a disease or syndrome requiring systemic steroid hormones or immunosuppressive drugs for treatment (excluding dermatological conditions requiring systemic treatment or childhood asthma/allergy that has been cured and does not require any intervention in adulthood; subjects with a history of autoimmune-mediated hypothyroidism and stable dose of thyroid hormone replacement therapy can be included in this study). 8.For the first administration, use systemic immunosuppressive drugs within 2 weeks prior to the administration (including but not limited to prednisone > 10 mg/day, cyclophosphamide, azathioprine, methotrexate, thalidomide, thalidomide, and TNF-α antagonists). Patients who have received a single, low-dose, systemic immunosuppressive drug (for example, a single dose of dexamethasone for treating nausea) can participate in the study after discussing with the PI and obtaining approval. Inhalation corticosteroids (such as fluticasone for treating chronic obstructive pulmonary disease) are allowed. Oral mineralocorticoids (such as fludrocortisone for patients with orthostatic hypotension) are allowed. Physiological doses of corticosteroids for treating adrenal insufficiency are permitted. Subjects with a history of autoimmune-mediated hypothyroidism can be enrolled in this study. 9.Those who are allergic to any active or inactive ingredients of the research drug. 10.The adverse reactions from previous anti-tumor treatments have not yet recovered to a CTCAE 5.0 grade evaluation of <= 1 (except for toxicities that the investigator deems to be safe, such as hair loss, grade 2 peripheral neuropathy, stable hypothyroidism after hormone replacement therapy, etc.). 11.Active hepatitis B (with HBsAg positive and HBV-DNA above the detection limit set by the research center); hepatitis C virus infection (HCV-RNA above the detection limit set by the research center); positive HIV antibody test result; positive Treponema pallidum antibody test result. 12.There is third-space effusion that cannot be controlled by the researchers (such as a large amount of pleural effusion and/or ascites). 13.History of severe cardiovascular and cerebrovascular diseases, including but not limited to: ? Severe cardiac rhythm or conduction abnormalities, such as ventricular arrhythmias requiring clinical intervention, second- to third-degree atrioventricular block, etc.; atrial fibrillation with a ventricular rate greater than 100 beats per minute ? Acute coronary syndrome, congestive heart failure, aortic dissection, stroke or other grade 3 or above cardiovascular events within 6 months prior to the first administration ? NYHA cardiac function classification >= II, or other researchers have judged to have high-risk structural heart disease ? Hypertension that remains poorly controlled despite standard treatment (systolic blood pressure > 150 mmHg, diastolic blood pressure > 100 mmHg); 14.There was an active infection within one week before the first administration, and systemic treatment was required. 15.Subjects who were found to have active tuberculosis infection through medical history or CT examination, or who had a history of active tuberculosis infection within 1 year prior to enrollment, or who had a history of active tuberculosis infection more than 1 year ago but did not receive proper treatment. 16.There are other serious diseases, including liver diseases, kidney diseases, neurological/psychiatric diseases, endocrine system diseases, blood system diseases, and immune system diseases. The researchers have determined that these conditions will affect participation in this study. 17.Over the past five years, there have been no other malignant tumors. Basal cell skin cancer, non-melanoma skin cancer, stage 0 cervical cancer, and differentiated thyroid cancer that have been cured are excluded. 18.It is known that there is a history of alcohol or drug dependence. 19.Individuals with mental disorders or those with poor compliance. 20.Pregnant or lactating women. 21.The researchers believed that the participants had any other clinical or laboratory abnormalities, or other reasons that made them unsuitable to participate in this study.

研究实施时间：

Study execute time：

从 From 2023-12-22 00:00:00至 To 2028-12-21 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2025-09-01 00:00:00 至 To 2027-12-31 00:00:00

干预措施：

Interventions：

组别：

900 μg剂量组

样本量：

 9

Group：

900 μg dose group

Sample size：

干预措施：

肌肉注射个体化肿瘤新生抗原mRNA疫苗，针对患者肿瘤中特有的新生抗原的靶向免疫治疗

干预措施代码：

Intervention：

Muscle injection of individualized tumor neoantigen mRNA vaccine for targeted immunotherapy targeting the specific neoantigens present in the patient'

Intervention code：

组别：

1200 μg剂量组

样本量：

 9

Group：

1200 μg dose group

Sample size：

干预措施：

肌肉注射个体化肿瘤新生抗原mRNA疫苗，针对患者肿瘤中特有的新生抗原的靶向免疫治疗

干预措施代码：

Intervention：

Muscle injection of individualized tumor neoantigen mRNA vaccine for targeted immunotherapy targeting the specific neoantigens present in the patient'

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 安徽省 

市(区县)：

  

Country：

China

Province：

Anhui

City：

单位(医院)：

 中国科学院合肥肿瘤医院 

单位级别：

 三级医院 

Institution
hospital：

Hefei Cancer Hospital,Chinese Academy of Sciences

Level of the institution：

Tertiary

测量指标：

Outcomes：

指标中文名：

生命体征

指标类型：

主要指标

Outcome：

vital signs

Type：

Primary indicator

测量时间点：

筛选期（-70至-57天）和首次用药前7天内、D1、D8、D15、维持治疗期（每3周1次）和治疗结束访视

测量方法：

医生常规检查

Measure time point of outcome：

Screening period and the 7 days prior to the first medication administration, D1, D8, D15, EOT

Measure method：

Routine medical examination

指标中文名：

肿瘤影像学评估

指标类型：

次要指标

Outcome：

Tumor imaging assessment

Type：

Secondary indicator

测量时间点：

筛选期（-70至-57天）和首次用药前7天内至整个研究期间

测量方法：

颈部、胸部、腹部、及盆腔增强CT/MRI

Measure time point of outcome：

The screening period and throughout the entire treatment period

Measure method：

Enhanced CT/MRI of the neck, chest, abdomen and pelvis

指标中文名：

凝血功能

指标类型：

主要指标

Outcome：

coagulation function

Type：

Primary indicator

测量时间点：

筛选期（-70至-57天）和首次用药前7天内、D8、D15、维持治疗期（每3周1次）和治疗结束访视。

测量方法：

实验室检查

Measure time point of outcome：

Screening period and the 7 days prior to the first medication administration, D8, D15, EOT

Measure method：

laboratory inspection

指标中文名：

12导联心电图

指标类型：

主要指标

Outcome：

12-lead electrocardiogram

Type：

Primary indicator

测量时间点：

筛选期（-70至-57天）和首次用药前7天内、D8、D15、维持治疗期（每3周1次）和治疗结束访视

测量方法：

实验室检查

Measure time point of outcome：

Screening period and the 7 days prior to the first medication administration, D8, D15, EOT

Measure method：

laboratory inspection

指标中文名：

血生化

指标类型：

主要指标

Outcome：

blood biochemistry

Type：

Primary indicator

测量时间点：

筛选期（-70至-57天）和首次用药前7天内、D8、D15、维持治疗期（每3周1次）和治疗结束访视。

测量方法：

实验室检查

Measure time point of outcome：

Screening period and the 7 days prior to the first medication administration, D8, D15, EOT

Measure method：

laboratory inspection

指标中文名：

ECOG评分

指标类型：

主要指标

Outcome：

ECOG score

Type：

Primary indicator

测量时间点：

筛选期（-70至-57天）和首次用药前7天内、D1、D8、D15、维持治疗期（每3周1次）和治疗结束访视；

测量方法：

医生常规检查

Measure time point of outcome：

Screening period and the 7 days prior to the first medication administration, D1, D8, D15, EOT

Measure method：

Routine medical examination

指标中文名：

血常规

指标类型：

主要指标

Outcome：

blood routine examination

Type：

Primary indicator

测量时间点：

筛选期（-70至-57天）和首次用药前7天内、D8、D15、维持治疗期（每3周1次）和治疗结束访视。

测量方法：

实验室检查

Measure time point of outcome：

Screening period and the 7 days prior to the first medication administration, D8, D15, EOT

Measure method：

laboratory inspection

指标中文名：

尿常规

指标类型：

主要指标

Outcome：

urine routines

Type：

Primary indicator

测量时间点：

筛选期（-70至-57天）和首次用药前7天内、D8、D15、维持治疗期（每3周1次）和治疗结束访视。

测量方法：

实验室检查

Measure time point of outcome：

Screening period and the 7 days prior to the first medication administration, D8, D15, EOT

Measure method：

laboratory inspection

指标中文名：

甲状腺功能

指标类型：

主要指标

Outcome：

thyroid function

Type：

Primary indicator

测量时间点：

筛选期（-70至-57天）和首次用药前7天内、D8、D15、维持治疗期（每3周1次）和治疗结束访视。

测量方法：

实验室检查

Measure time point of outcome：

Screening period and the 7 days prior to the first medication administration, D8, D15, EOT

Measure method：

laboratory inspection

指标中文名：

体格检查

指标类型：

主要指标

Outcome：

physical examination

Type：

Primary indicator

测量时间点：

筛选期（-70至-57天）和首次用药前7天内、D1、D8、D15、维持治疗期（每3周1次）和治疗结束访视；

测量方法：

医生常规检查

Measure time point of outcome：

Screening period and the 7 days prior to the first medication administration, D1, D8, D15, EOT

Measure method：

Routine medical examination

采集人体标本：

Collecting sample(s)
from participants：

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：

肿瘤样本

组织：

Sample Name：

Tumor 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 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)：

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）：

研究结束后仅共享研究必需的最小数据集，?临床检测数据、基因组测序数据、影像数据等匿名化处理?，平台内受控访问?；

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

After the research is completed, only the minimum data set necessary for the research will be shared. Clinical test data, genomic sequencing data, imaging data, etc. will be anonymized and accessed under controlled conditions within the platform.

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：

病例记录表

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

Case record form

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2025-08-05 17:57:43