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：	ChiCTR2600118770
最近更新日期： Date of Last Refreshed on：	2026-02-10 17:30:02
注册时间： Date of Registration：	2026-02-10 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	一项评价SIG001在晚期实体瘤患者中的安全性、耐受性、药代动力学、药效动力学和初步疗效的单臂、开放、剂量递增和扩展的I期临床研究
Public title：	A single-arm, open-label, dose-escalating and expansion Phase I clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of SIG001 in patients with advanced solid tumors
注册题目简写：
English Acronym：
研究课题的正式科学名称：	一项评价SIG001在晚期实体瘤患者中的安全性、耐受性、药代动力学、药效动力学和初步疗效的单臂、开放、剂量递增和扩展的I期临床研究
Scientific title：	A single-arm, open-label, dose-escalating and expansion Phase I clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of SIG001 in patients with advanced solid tumors
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：	邱晓彦	研究负责人：	沈琳
Applicant：	Xiaoyan Qiu	Study leader：	Lin Shen
申请注册联系人电话： Applicant telephone：	+86 186 0196 3819	研究负责人电话： Study leader's telephone：	+86 10 8819 6561
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：	qiuxy@bjmu.edu.cn	研究负责人电子邮件： Study leader's E-mail：	doctorshenlin@sina.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：	北京市海淀区学院路38号北京大学免疫系	研究负责人通讯地址：	北京市海淀区阜成路52号
Applicant address：	Department of Immunology, Peking University, No. 38 Xueyuan Road, Haidian District, Beijing	Study leader's address：	No. 52 Fucheng Road, Haidian District, Beijing
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：	广州艾赛吉生物医药科技有限公司
Applicant's institution：	Guangzhou Aisaiji Biomedical Technology Co., Ltd.
研究负责人所在单位：	北京大学肿瘤医院
Affiliation of the Leader：	Peking University 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：	2025YW315	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：	北京大学肿瘤医院临床研究管理委员会
Name of the ethic committee：	Peking University Cancer Hospital Clinical Research Management Committee
伦理委员会批准日期： Date of approved by ethic committee：	2025-12-29 00:00:00
伦理委员会联系人：	盛锡楠
Contact Name of the ethic committee：	Xinan Sheng
伦理委员会联系地址：	北京市海淀区阜成路81号
Contact Address of the ethic committee：	No. 81, Fucheng Road, Haidian District, Beijing
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 10 8819 6391	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：

北京大学肿瘤医院

Primary sponsor：

Peking University Cancer Hospital

研究实施负责（组长）单位地址：

北京市海淀区阜成路52号

Primary sponsor's address：

No. 52 Fucheng Road, Haidian District, Beijing

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：	中国	省(直辖市)：	广东省	市(区县)：	广州市
Country：	China	Province：	Guangdong	City：	Guangzhou
单位(医院)：	广州艾赛吉生物医药科技有限公司	具体地址：	广州市黄埔区科信产业园创研街16号（自编2号楼）706房
Institution hospital：	Guangzhou Aisaiji Biomedical Technology Co., Ltd.	Address：	Room 706, Building 2, No. 16 Chuangyan Street, Kexin Industrial Park, Huangpu District, Guangzhou City

经费或物资来源：

申办方提供

Source(s) of funding：

Provided by the applicant

研究疾病：

晚期上皮来源肿瘤

Target disease：

Advanced epithelial-derived tumors

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：

1.主要研究目的：评估 SIG001 在晚期实体瘤患者中的安全性和耐受性。 2.次要研究目的：确定 SIG001 的 II 期临床研究推荐剂量（Recommended Phase II dose ，RP2D）。评估 SIG001 在晚期实体瘤患者中的药代动力学（Pharmacokinetics ，PK）特征。评估 SIG001 在晚期实体瘤患者中的药效动力学（Pharmacodynamics ，PD）特征。评估 SIG001 在晚期实体瘤患者中的初步抗肿瘤活性。评估 SIG001 在晚期实体瘤患者中的免疫原性。 3.探索性目的：探索 SIG001 的暴露量/剂量与安全性以及临床疗效之间的关系。探索潜在的生物标记物（如 SIG）的表达水平（如适用），并与药物的暴露量、疗效、安全性进行相关性分析。探索事件发生时间终点如缓解持续时间(Duration ofresponse，DoR)和无进展生存期(Progression-free survival ，PFS)。

Objectives of Study：

1.Primary Study Objectives: To evaluate the safety and tolerability of SIG001 in patients with advanced solid tumors. 2.Secondary Study Objectives: To determine the Recommended Phase II dose of SIG001. To assess the pharmacokinetic characteristics of SIG001 in patients with advanced solid tumors. To evaluate the pharmacodynamic characteristics of SIG001 in these patients. To assess the preliminary antitumor activity of SIG001 in patients with advanced solid tumors. To evaluate the immunogenicity of SIG001 in these patients. 3.Exploratory Objectives: To investigate the relationship between the exposure/dose of SIG001 and its safety as well as clinical efficacy. To examine the expression levels of potential biomarkers (such as SIG), if applicable, and analyze their correlation with drug exposure, efficacy, and safety. To study event-related endpoints such as the Duration of Response and Progression-Free Survival in patients treated with SIG001.

药物成份或治疗方案详述：

Description for medicine or protocol of treatment in detail：

纳入标准：

受试者符合以下所有条件者，方可入组本临床研究：
1.    受试者充分理解本研究的要求并自愿签署书面知情同意书；能够遵守本研究的用药要求以及所有与研究相关的程序和评估。
2.    年龄≥18周岁且≤75周岁，性别不限。
3.    经组织学或细胞学确认的标准治疗失败或不耐受或无有效标准治疗方案的局部晚期、复发或转移性恶性肿瘤患者。
4.    根据 RECISTv1.1，受试者至少有 1 个可测量靶病灶。基线时经计算机断层扫描（Computed tomography，CT）或磁共振成像（Magnetic resonance imaging ，MRI）（首选静脉注射造影剂）准确测量显示其长直径≥10 mm（非淋巴结病灶）或短轴≥15 mm（淋巴结病灶），且病灶适合反复准确测量。如果位于既往接受过照射区域的病灶明确证明出现进展，则该病灶可作为可测量靶病灶。
5.    预期生存时间≥12 周。
6.    美国东部肿瘤协作组（Eastern Cooperative Oncology Group，ECOG）体力状况评分为0或1分。
7.    患者在筛选时具备足够的重要脏器功能（要求筛查前 14 天内未曾输血、未使用造血刺激因子或人体白蛋白制剂），具体定义如下：
a)   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；血红蛋白（Hemoglobin ，Hb）≥90g/L；
b)   肝功能：血清 TBIL ≤1.5 × ULN；肝转移或者已证实患有 Gilbert综合征的患者，TBIL ≤3 × ULN。对于无肝转移的受试者， ALT和 AST≤2.5 × ULN；肝转移的受试者，ALT和 AST≤5 × ULN；
c)    凝血功能 ：活化部分凝血活酶时间（ Activated  partial thromboplastin time ，APTT）和国际标准化比率（International normalized ratio，INR）≤1.5 × ULN（接受抗凝治疗的受试者指标在治疗范围内）；
d)    肾功能：根据 Cockcroft-Gaultg 公式计算的肌酐清除率（Clearance of creatinine ，CCr）≥60 mL/min；
e)    心功能标准：超声心动图（Echocardiography，ECHO）显示左室射血分数（left ventricular ejection fraction，LVEF）大于50%。
8.    育龄期女性患者在首次使用试验药物前7天内的血妊娠试验必须为阴性；有生育能力的合格患者（男性和女性）必须同意在试验期间和末次用药后至少 6个月内与其伴侣一起使用可靠的避孕方法（激素或屏障法或禁欲等）。有生育能力的患者定义为性成熟并且有生物学潜在生育能力。

Inclusion criteria

Subjects must meet all of the following criteria to be eligible for this clinical study:
1. The subject must fully understand the requirements of this study and voluntarily sign a written informed consent form. They must also be able to comply with the study’s medication regimen as well as all related procedures and assessments;
2. Age must be >=18 and <=75 years old, with no gender restriction;
3. Subjects must have locally advanced, recurrent, or metastatic malignant tumors that have failed standard treatment or are not tolerant to it, and for which there is no effective standard treatment option. Histological or cytological confirmation is required;
4. According to RECIST v1.1, the subject must have at least 1 measurable target lesion. At baseline, the lesion must be accurately measurable by computed tomography (CT) or magnetic resonance imaging (MRI) – preferably with intravenous contrast agent. The long diameter of non-lymph node lesions must be ≥10 mm, and the short axis of lymph node lesions must be >=15 mm. The lesion must be suitable for repeated and accurate measurements. If a lesion in a previously irradiated area shows clear progression, it can also be considered a measurable target lesion;
5. The expected survival time must be >=12 weeks;
6. The Eastern Cooperative Oncology Group performance status score must be 0 or 1;
7. Subjects must have adequate function of vital organs at the time of screening. This requires that no blood transfusions, hematopoietic stimulants, or human albumin preparations have been used within 14 days prior to screening. The specific criteria are as follows:
(1) Blood tests: Absolute neutrophil count >=1.5 × 10^9/L; Platelet count >=75 × 10^9/L; Hemoglobin >=90 g/L;
(2) Liver function: Serum TBIL <=1.5 × ULN. For patients with liver metastases or Gilbert’s syndrome, TBIL <=3 × ULN. For subjects without liver metastases, ALT and AST <=2.5 × ULN; for those with liver metastases, ALT and AST <=5 × ULN;
(3) Coagulation function: Activated partial thromboplastin time and International normalized ratio <=1.5 × ULN (for subjects on anticoagulant therapy, these values must be within the therapeutic range).
(4) Renal function: Creatinine clearance rate >=60 mL/min, calculated using the Cockcroft-Gault formula;
(5) Cardiac function: Echocardiography shows left ventricular ejection fraction greater than 50%;
8. Female subjects of childbearing age must have a negative pregnancy test within 7 days before receiving the study drug for the first time. Eligible male and female subjects must agree to use reliable contraceptive methods (hormonal, barrier methods, or abstinence) during the study and for at least 6 months after the last dose of the drug. Eligible subjects are defined as being sexually mature and biologically capable of reproducing.

排除标准：

受试者符合以下任何一项即被排除： 1. SIG001 首次用药前仍在此前抗肿瘤药物治疗的洗脱期内（末次用药后 4 周或 5 个半衰期，以较短者为准）。 2. SIG001 首次用药前 28 天内接受放射治疗； 3. SIG001 首次给药之前 4 周存在既往抗肿瘤治疗引起的急性毒性未恢复至 NCICTCAE 5.0 版本≤1 级或入组标准规定的基线水平（不包括脱发或乏力）。 4. 首次用药前 5 年内患有其他恶性肿瘤（除了得到根治性治疗且无疾病复发证据的非黑色素瘤的皮肤基底细胞癌或鳞状细胞癌、乳腺/宫颈原位癌、浅表膀胱癌等原位癌）。 5. 受试者患有以下任一条定义的心血管疾病： a) 症状性心脏衰竭（纽约心脏病协会心功能分级≥2 级，见附录4）； b) 尽管经标准治疗方案治疗但仍多次观察到不受控制的动脉高压（收缩压≥160mmHg 或舒张压≥100 mmHg）； c) 静息状态，12 导联心电图（12-Electrocardiograph，ECG）检查得出的平均校正 QT 间期（Corrected QT interval ，QTc，采用Fridericia’s 校正公式）> 470 ms（重复 3 次）。各种有临床意义的心律、传导、静息 ECG 形态异常，例如完全性左束支传导阻滞，III 度传导阻滞，II 度传导阻滞，PR 间期> 250 ms 。可能增加 QTc 延长风险或心律失常事件风险的各种因素，例如心力衰竭，低钾血症，先天性长 QT 综合征，家族史中直系亲属有长 QT 综合征或不到 40 岁就不明原因猝死，正在使用任何已知 QT 间期延长的药物； d) 急性冠脉综合征/急性心肌梗死、不稳定型心绞痛、筛选前 6 个月内进行经皮冠状动脉介入手术治疗或冠状动脉搭桥术； e) 具有任何病因的心肌病； f) 具有存在临床意义的心脏瓣膜病； g) 需治疗的房性或室性心律失常史；患有房颤且心室率得到最佳控制的受试者允许入组； h) 筛选前 6 个月内出现短暂性脑缺血发作或卒中。 6. 传染病感染者，包括： a) 急性或者慢性活动性乙型肝炎，定义为乙型肝炎表面抗原（HbsAg）和/或乙型肝炎核心抗体（HbcAb）阳性且乙型肝炎病毒（HBV）DNA≥100 IU/mL； b) 急性或慢性活动性丙型肝炎（HCV），即 HCV 抗体阳性且 HCV- RNA 水平大于中心参考值上限； c) HIV 感染者（HIV 1/2 抗体阳性）； d) 已知的梅毒活动性感染、活动性肺结核。 7. 存在原发性中枢神经系统肿瘤、脑膜转移、脊髓压迫或脑干转移；存在已知的未经治疗的脑转移或有症状或病情不稳定，经治疗病情稳定至少 4 周后可以入组。 8. 未能控制的并发疾病，如： a) 开始研究治疗前 4 周内发生严重感染，包括但不限于因感染、菌血症或重症肺炎并发症而住院治疗；或筛选期存在不可控制的活动性感染，接受预防性抗生素治疗的患者可入组（如预防泌尿道感染或慢性阻塞性肺疾病）； b) 既往有间质性肺病、未完全缓解的放射性肺炎，或基线有急性发作或进行性加重的肺部症状，或存在间质性肺病高风险因素且经研究者评估可能危及受试者安全者； c) 显著的营养不良，如需要静脉补充营养液。在首次给药之前营养不良纠正后稳定 4 周以上者可以入组； d) 肿瘤侵犯周围重要脏器或血管，且经研究者判断可能显著增加治疗风险或影响疗效评估；或存在发生食管气管瘘或食管胸膜瘘风险，或食管、气管腔内支架植入术后≤4 周（允许病情稳定>4 周者入组）； e) 在筛选前 6 个月内有胃肠道穿孔和/或瘘管的病史； f) 伴有未控制的需要反复引流的第三间隙积液，如胸水、腹水、心包积液等（不需要引流积液或停止引流 3 天积液无明显增加的患者可以入组）。 9. 预计在试验治疗期间接受其它抗肿瘤治疗（允许姑息性放疗）。 10. 首次给药前 4 周内参加过临床研究，或拟于试验期间参加其他临床研究。 11. 首次用药前 4 周内使用任何活疫苗治疗。 12. 对 SIG001 或其制剂组分过敏。 13. 妊娠期、哺乳期或计划在研究期间妊娠的女性患者。 14. 已知异体器官移植史和异体造血干细胞移植史。 15. 需排除在给药前 2 年内因自身免疫疾病接受系统性免疫抑制剂治疗的受试者，以下情况除外： a) 吸入、局部外用类固醇或局部类固醇注射（如关节内注射）； b) 全身性皮质类固醇（剂量不超过 10 mg/天泼尼松或其等效药物）； c) 类固醇作为超敏反应的预先用药（例如 CT 扫描预先用药）。 16. 既往有明确的精神障碍史并服用药物进行治疗者。 17. 有药物滥用史或吸毒史者。 18. 研究者认为患者存在其它可能影响研究结果、干扰其参加整个研究过程的因素，包括曾经或现有的身体状况、治疗或实验室检查异常，受试者不愿意遵守研究的各项流程、限制和要求等。

Exclusion criteria：

Subjects will be excluded if they meet any of the following criteria: 1. SIG001 is administered during the washout period following previous antineoplastic therapy (4 weeks or 5 half-lives after the last dose, whichever is shorter); 2. Received radiotherapy within 28 days prior to the first dose of SIG001; 3. Acute toxicity resulting from previous antineoplastic therapy had not resolved to NCICTCAE 5.0 version grade ≤1 or to the baseline level specified in the inclusion criteria 4 weeks before the first dose of SIG001 (excluding hair loss or fatigue); 4. Had a history of other malignant tumors within 5 years prior to the first dose (except for non-melanoma skin basal cell carcinoma or squamous cell carcinoma that has been cured with no evidence of recurrence, breast/cervical carcinoma in situ, superficial bladder carcinoma, and other in situ cancers); 5. Subjects with any of the following cardiovascular diseases: (1) Symptomatic heart failure (New York Heart Association functional class >=2, see Appendix 4); (2) Uncontrolled hypertension despite standard treatment (systolic blood pressure >=160 mmHg or diastolic blood pressure >=100 mmHg); (3) Resting mean corrected QT interval > 470 ms on a 12-lead electrocardiogram (QTc, using Fridericia’s correction formula) on three repeated measurements. Various clinically significant arrhythmias, conduction abnormalities, and resting ECG abnormalities, such as complete left bundle branch block, third-degree block, second-degree block, and PR interval > 250 ms. Factors that may increase the risk of QTc prolongation or arrhythmic events, such as heart failure, hypokalemia, congenital long QT syndrome, a family history of long QT syndrome or sudden death before age 40, and use of medications known to prolong QTc; (4) Acute coronary syndrome/acute myocardial infarction, unstable angina pectoris, percutaneous coronary intervention or coronary artery bypass grafting within 6 months prior to screening; (5) Any cause of cardiomyopathy; (6) Clinically significant valvular heart disease; (7) History of atrial or ventricular arrhythmias that require treatment; subjects with atrial fibrillation and well-controlled ventricular rate may be enrolled; (8) Transient ischemic attack or stroke within 6 months prior to screening; 6. Subjects with infectious diseases, including; (1) Acute or chronic active hepatitis B, defined as positive for hepatitis B surface antigen (HbsAg) and/or hepatitis B core antibody (HbcAb) with HBV DNA >=100 IU/mL; (2) Acute or chronic active hepatitis C, i.e., positive for HCV antibodies with HCV-RNA levels above the upper limit of the central reference range; (3) HIV-infected individuals (positive for HIV 1/2 antibodies); (4) Active syphilis or active pulmonary tuberculosis; 7. Subjects with primary central nervous system tumors, meningeal metastases, spinal cord compression, or brainstem metastases; those with untreated brain metastases or symptomatic/stable conditions can be enrolled after at least 4 weeks of stable treatment; 8. Uncontrolled comorbidities, such as: (1) Severe infections within 4 weeks prior to study initiation, including hospitalization due to infection, bacteremia, or severe pneumonia; subjects with uncontrolled active infections during screening can be enrolled if they receive prophylactic antibiotics (e.g., for urinary tract infections or chronic obstructive pulmonary disease); (2) History of interstitial lung disease, unresolved radiation pneumonitis, acute episodes or progressive worsening of pulmonary symptoms at baseline, or factors that increase the risk of interstitial lung disease and pose a safety risk to the subject as assessed by the investigator; (3) Severe malnutrition requiring intravenous nutrition; subjects whose malnutrition has been corrected and stabilized for more than 4 weeks prior to the first dose can be enrolled; (4) Tumors invading vital organs or blood vessels, which may significantly increase treatment risk or affect efficacy assessment; subjects with a risk of esophagotracheal fistula or esophagothoracic fistula, or those within 4 weeks of esophageal or tracheal stent placement (subjects with stable conditions for more than 4 weeks can be enrolled); (5) History of gastrointestinal perforation and/or fistula within 6 months prior to screening; (6) Presence of uncontrolled effusions requiring repeated drainage, such as pleural effusion, ascites, pericardial effusion, etc. (Subjects without the need for drainage or with no significant increase in effusion volume after 3 days of drainage cessation can be enrolled). 9. Subjects who are expected to receive other antineoplastic treatments during the study period (palliative radiotherapy is allowed); 10. Subjects who have participated in clinical studies within 4 weeks prior to the first dose or plan to participate in other clinical studies during the study period; 11. Subjects who have received live vaccines within 4 weeks prior to the first dose; 12. Allergy to SIG001 or its components; 13. Pregnant women, lactating women, or women who plan to become pregnant during the study period; 14. History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; 15. Subjects who have received systemic immunosuppressive therapy for autoimmune diseases within 2 years prior to dosing are excluded, except in the following cases: (1) Inhaled, topical, or intramuscular steroid use; (2) Systemic corticosteroids (dose not exceeding 10 mg/day of prednisone or equivalent); (3) Steroids used as premedication for hypersensitivity reactions (e.g., premedication for CT scans). 16. Subjects with a history of mental disorders and those taking medication for treatment; 17. Subjects with a history of drug abuse or substance use; 18. Subjects who, in the judgment of the investigator, have other factors that may affect the study results or interfere with their participation in the entire study, including past or current health conditions, treatment or laboratory test abnormalities, and those who are unwilling to comply with the study procedures and requirements.

研究实施时间：

Study execute time：

从 From 2026-01-30 00:00:00至 To 2028-02-29 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2026-02-24 00:00:00 至 To 2027-06-01 00:00:00

干预措施：

Interventions：

组别：	剂量递增研究组	样本量：	36
Group：	Dose-escalation study group	Sample size：	36
干预措施：	静脉输注给药。剂量递增研究采用 BOIN 设计进行剂量递增。方案剂量递增的起始剂量为 0.15 mg/kg Q2W，剂量递增比例为 167% 、150% 、80% 、94.4% 、71.4%，直到 6 mg/kg。	干预措施代码：
Intervention：	Intravenous administration. The dose-escalation study was conducted using a BOIN design. The starting dose in the escalation regimen was 0.15 mg/kg Q2W. The dose increases were at rates of 167%, 150%, 80%, 94.4%, and 71.4%, respectively, until a dose of 6 mg/kg was reached.	Intervention code：

组别：	剂量扩展研究组	样本量：	30
Group：	Dose Expansion Study Group	Sample size：	30
干预措施：	将根据剂量递增研究的安全性和有效性数据，选择至少 2 个剂量级别，进行静脉输注给药。	干预措施代码：
Intervention：	At least 2 dosage levels will be selected for intravenous administration based on the safety and efficacy data from the dose-escalation studies.	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	中国	省(直辖市)：	北京市	市(区县)：
Country：	China	Province：	Beijing	City：
单位(医院)：	北京大学肿瘤医院	单位级别：	三甲
Institution hospital：	Peking University Cancer Hospital	Level of the institution：	Grade A tertiary hospital

测量指标：

Outcomes：

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

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

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

指标中文名：	心电图数据	指标类型：	主要指标
Outcome：	Electrocardiogram data	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	实验室检查结果：血常规，血生化，凝血功能，尿常规，甲状腺功能	指标类型：	主要指标
Outcome：	Laboratory test results: Complete blood count, blood biochemistry, coagulation function, urinalysis, thyroid function tests	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	血妊娠检测结果	指标类型：	主要指标
Outcome：	Blood pregnancy test results	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	ECHO数据	指标类型：	主要指标
Outcome：	ECHO data	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	PK/PD/ADA参数	指标类型：	主要指标
Outcome：	PK/PD/ADA parameters	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	肿瘤组织活检（可选）结果	指标类型：	次要指标
Outcome：	Tumor tissue biopsy (optional) result	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	肿瘤评估	指标类型：	次要指标
Outcome：	Tumor assessment	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	不良事件和合并用药	指标类型：	主要指标
Outcome：	Adverse events and concomitant medications	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：	血液	组织：
Sample Name：	Blood	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:

公开/Public

盲法：
Blinding：
试验完成后的统计结果（上传文件）：	点击下载
Calculated Results after the Study Completed(upload file)：	download

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）：	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：	研究者必须准确记录保存数据，保证所有的研究数据得到充分的记录，并能够被准确核实。源文件是自受试者 CRF 中采集的原始文件、数据和记录，包括但不限于医院记录、临床和办公室图表、实验室和药房记录、日记卡、缩微胶片、影像学资料和来往信件。如果 CRF 是所在研究中心的原始记录文件，则CRF 可被视为源数据（例如没有其他书面或电子数据记录的情况下）。建立EDC系统对数据进行管理。
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	Researchers must accurately record and store data to ensure that all research information is properly documented and can be verified accurately. Source documents include the original files, data, and records obtained from participants’ CRFs. These may comprise hospital records, clinical and office charts, laboratory and pharmacy records, diaries, microfiche films, imaging materials, and correspondence. If the CRF constitutes the original record at the research site, it can be considered source data (especially in the absence of other written or electronic records). An EDC system is established to manage the data.
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：	2026-02-10 17:29:36