ChiCTR2600119416 版本V1.4 版本创建时间2026/02/26 16:47:59 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：

 ChiCTR2600119416 

最近更新日期：

Date of Last Refreshed on：

 2026-02-26 16:47:55 

注册时间：

Date of Registration：

 2026-02-26 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

芦康沙妥珠单抗+/-贝伐珠单抗在TROP2高表达腹膜转移癌人群中的疗效及安全性研究

Public title：

Study on the efficacy and safety of Lukang saltuzumab +/- bevacizumab in the population with TROP2 highly expressed peritoneal metastatic cance

注册题目简写：

English Acronym：

研究课题的正式科学名称：

芦康沙妥珠单抗+/-贝伐珠单抗在TROP2高表达腹膜转移癌人群中的疗效及安全性研究

Scientific title：

Study on the efficacy and safety of Lukang saltuzumab +/- bevacizumab in the population with TROP2 highly expressed peritoneal metastatic cance

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：

程瑜蓉 

研究负责人：

严冬 

Applicant：

Yurong Cheng 

Study leader：

Dong Yan 

申请注册联系人电话：

Applicant telephone：

 +86 10 6954 3901

研究负责人电话：

Study leader's
telephone：

+86 10 6954 3901

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：

 cyrgetit@163.com

研究负责人电子邮件：

Study leader's E-mail：

 yd15yt88@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：

中国北京市通州区新华南路82号

研究负责人通讯地址：

中国北京市通州区新华南路82号

Applicant address：

Xinhua South Road 82,Tongzhou District, Beijing,China,101149

Study leader's address：

Xinhua South Road 82,Tongzhou District, Beijing,China,101149

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：

中国北京首都医科大学附属北京潞河医院

Applicant's institution：

Beijing luhe hospital Affiliated to Capital Medical University, Beijing, China

研究负责人所在单位：

中国北京首都医科大学附属北京潞河医院

Affiliation of the Leader：

Beijing luhe hospital Affiliated to Capital Medical University, Beijing, China

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：

 2025-LHKY-080-03

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：

首都医科大学附属北京潞河医院医学伦理委员会

Name of the ethic committee：

Medical Ethics Committee of Beijing Luhe Hospital, Capital Medical University

伦理委员会批准日期：

Date of approved by ethic committee：

 2025-11-27 00:00:00

伦理委员会联系人：

王辉

Contact Name of the ethic committee：

Hui Wang

伦理委员会联系地址：

中国北京市通州区新华南路82号

Contact Address of the ethic committee：

Beijing luhe hospital Affiliated to Capital Medical University, Beijing, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 10 6954 3901

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：

首都医科大学附属北京潞河医院

Primary sponsor：

Beijing luhe hospital Affiliated to Capital Medical University

研究实施负责（组长）单位地址：

中国北京市通州区新华南路82号

Primary sponsor's address：

Beijing luhe hospital Affiliated to Capital Medical University, Beijing, China

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

北京

市(区县)：

Country：

China

Province：

Beijing

City：

单位(医院)：

首都医科大学附属北京潞河医院

具体地址：

中国北京市通州区新华南路82号

Institution
hospital：

Beijing luhe hospital Affiliated to Capital Medical University

Address：

Beijing luhe hospital Affiliated to Capital Medical University, Beijing, China

经费或物资来源：

吴阶平医学基金会

Source(s) of funding：

Wu Jieping Medical Foundation

研究疾病：

腹膜转移癌  

Target disease：

peritoneal metastatic 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：

 II期临床试验 

Study phase：

2

研究设计：

单臂 

Study design：

Single arm 

研究目的：

评估芦康沙妥珠单抗±贝伐珠单抗治疗TROP2高表达腹膜转移癌人群的疗效及安全性  

Objectives of Study：

To evaluate the efficacy and safety of Lukang saltuzumab ± bevacizumab in the treatment of peritoneal metastatic cancer patients with high TROP2 expression

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.受试者自愿同意参与本研究，并签署知情同意书 2.临床确诊为胃癌、结直肠癌继发性腹膜转移肿瘤患者，既往接受过>=2线的标准治疗后进展 3.收集患者组织样本进行TROP2表达检测，判断为TROP2 高表达（H-score>=100或IHC计算2+和3+的肿瘤细胞比例，要求>75%） 4.80周岁>=年龄>=18周岁，性别不限 5.ECOG体力评分0-1分 6.预计生存时间3个月以上 7.有生育能力的合格受试者（男性和女性）必须同意在试验期间和末次用药后至少90天内与其伴侣一起使用可靠的避孕方法（激素或屏障法或绝对禁欲等）；育龄期的女性受试者在首次使用研究药物前7天内的血妊娠试验必须为阴性，且必须为非哺乳期。同意从筛选期、整个研究期间以及最终研究药品使用后至少3个月内不捐献精子或卵子 8.能够理解试验要求，愿意且能够遵从试验和随访程序安排 9.经含铂标准治疗失败（治疗后疾病进展或治疗毒副作用不可耐受），或无法接含铂受标准治疗（包括标准治疗不耐受、经研究者判断不适合进行标准治疗或拒绝接受标准治疗的患者）的患者 10.足够的骨髓功能储备：（筛选期检查前7天内未接受过输血、集落刺激因子或相似作用的生物制剂治疗） （1）绝对中性粒细胞计数（ANC）>=1.5×10^9/L； （2）血小板计数>=100×10^9/L； （3）血红蛋白>=9.0g/dL。 11.足够的肝功能：（以临床试验中心正常值为准） （1）总胆红素（TBIL）<=1.5×正常值上限（ULN）,若患有Gilbert综合征，则总胆红素<=2×ULN；如直接胆红素（DBIL）提示肝外梗阻，则允许TBIL<=3.0×ULN； （2）非肝脏肿瘤患者且无肝转移时，天冬氨酸转移酶（AST）和丙氨酸氨基转移酶（ALT）<=3×ULN；若为肝肿瘤或肝转移患者，需满足AST和ALT<=5.0×ULN 12.足够的肾功能：（以临床试验中心正常值为准） 肌酐（Cr）<=1.5×ULN且肌酐清除率（Ccr）>=50mL/min（使用Cockcroft-Gault公式） 13.足够的凝血功能： 活化部分凝血活酶时间（APTT） <=1.5×ULN，国际标准化比值（INR）<=1.5xULN 14.足够的心脏功能： （1）入组前28天内通过超声心动图检测左心室射血分数（LVEF）>=50%； （2）美国纽约心脏病学会（NYHA）分级<3级

Inclusion criteria

1. The subjects voluntarily agree to participate in this study and sign the informed consent form. 2. Patients with clinically confirmed secondary peritoneal metastasis of gastric cancer or colorectal cancer who have progressed after receiving >=2 lines of standard treatment. 3. Collect the patient's tissue samples for TROP2 expression detection, and determine as high TROP2 expression (H-score >=100 or IHC calculation of the proportion of tumor cells with 2+ and 3+, requiring >75%). 4. Age>=18 years and <=80 years, gender is not limited. 5. ECOG performance score 0-1. 6. Expected survival time of more than 3 months. 7. Qualified subjects of reproductive age (both male and female) must agree to use reliable contraceptive methods (hormonal or barrier methods or absolute abstinence, etc.) with their partners during the trial and at least 90 days after the last dose of study drug; female subjects of reproductive age must have a negative blood pregnancy test within 7 days before the first use of the study drug and must not be breastfeeding. Agree not to donate sperm or eggs from the screening period, throughout the study period, and at least 3 months after the last use of the study drug. 8. Able to understand the requirements of the trial, willing and able to comply with the trial and follow-up procedures. 9. Patients who have failed platinum-based standard treatment (disease progression after treatment or intolerable treatment toxic and side effects), or are unable to receive platinum-based standard treatment (including intolerant to standard treatment, judged by the investigator as unsuitable for standard treatment, or refusing standard treatment). 10. Adequate bone marrow function reserve: (No blood transfusion, colony-stimulating factor or similar biological agent treatment within 7 days before the screening test) (1) Absolute neutrophil count (ANC) >=1.5×10^9/L; (2) Platelet count >= 100×10^9/L; (3) Hemoglobin >= 9.0g/dL. 11. Adequate liver function: (Based on the normal value of the clinical trial center) (1) Total bilirubin (TBIL) <= 1.5×ULN, if suffering from Gilbert syndrome, then total bilirubin <= 2×ULN; if direct bilirubin (DBIL) indicates extrahepatic obstruction, then TBIL <= 3.0×ULN is allowed; (2) For non-liver tumor patients without liver metastasis, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <= 3×ULN; for liver tumor or liver metastasis patients, AST and ALT <= 5.0×ULN are required. 12. Adequate renal function: (Based on the normal value of the clinical trial center) Creatinine (Cr) <= 1.5×ULN and creatinine clearance rate (Ccr) >= 50mL/min (using the Cockcroft-Gault formula) 13. Adequate coagulation function: Activated partial thromboplastin time (APTT) <= 1.5×ULN, international normalized ratio (INR) <= 1.5×ULN 14. Adequate cardiac function: (1) Left ventricular ejection fraction (LVEF) >= 50% as detected by echocardiography within 28 days before enrollment; (2) New York Heart Association (NYHA) classification < 3.

排除标准：

1.在给药前5年内患有其他恶性肿瘤（已通过局部治疗治愈的肿瘤除外，例如皮肤基底细胞癌、皮肤鳞状细胞癌、宫颈原位癌等） 2.在研究药物首次使用前3周内接受过化疗，或首次给药前4周内接受过放疗、放射性粒子植入（除外为缓解疼痛的骨放射性粒子植入及局部放疗为首次使用研究药物前2周内）、含靶向拓扑异构酶Ⅰ的任何药物治疗，包括抗体偶联药物（antibody-drug conjugate，ADC）治疗 3.已知患有脑膜转移、脑干转移、脊髓转移和/或压迫、活动性或未经局部治疗的中枢神经系统（CNS）转移受试者。对于既往接受过局部治疗的脑转移受试者，如果在用药前至少4周临床稳定并且至少14天内无需使用糖皮质激素或抗惊厥药物可允许入组 4.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、经激素替代治疗稳定的甲状腺功能减退等） 5.根据研究者判断，无法控制的系统性疾病： （1）控制不佳的糖尿病（连续两次空腹血糖>=10mmol/L）； （2）控制不佳的高血压（收缩压>160mmHg和/或舒张压>100mmHg）； （3）存在有临床症状或需要反复引流的胸腔积液、心包积液或腹水（>1次/周） 6.存在需要类固醇治疗的（非感染性）间质性肺病（ILD）或非感染性肺炎病史，目前有ILD或非感染性肺炎，或筛选时存在无法经影像学检查排除的可疑ILD或非感染性肺炎 7.患有活动性慢性炎症性肠病、胃肠道梗阻、严重溃疡、胃肠穿孔、腹腔脓肿或急性胃肠道出血的受试者 8.患有在过去两年内需要系统性治疗的活动性自身免疫性疾病，系统性治疗包括改善病情药物、免疫抑制剂、全身皮质类固醇给药（>10mg/天泼尼松或等效药物）等。激素替代治疗，如甲状腺素、胰岛素、或针对肾上腺或垂体功能不全的生理性皮质类固醇替代治疗不认为是一种系统性治疗；给药前2周内接受>10mg/天泼尼松的全身皮质类固醇治疗或其他免疫抑制药物的受试者 9.已知的活动性肺结核。怀疑有活动性肺结核的受试者，需进行临床检查排除 10.已知异体器官移植史和异体造血干细胞移植史 11.活动性乙型肝炎[乙肝表面抗原（HBsAg）阳性，须进行HBV-DNA检测；HBV-DNA>=500IU/mL或高于检测值下限，以较高者为准]或丙型肝炎（丙肝抗体阳性，且HCV-RNA高于检测值下限）。注：对于HBsAg阳性的受试者，要求在研究治疗期间接受抗乙肝病毒治疗 12.人类免疫缺陷病毒（HIV）检查阳性或存在获得性免疫缺陷综合征（艾滋病）病史；已知活动性梅毒感染 13.已知对研究药物或其任何成分过敏，已知对其他生物制剂产生严重超敏反应的病史 14.给药前4周内进行过大型手术者或预计在研究期间需要进行大手术者 15.给药前4周内发生严重感染，包括但不限于伴有需要住院治疗的并发症、败血症或严重肺炎；给药前2周内存在需要接受全身系统性抗感染治疗的活动性感染 16.给药前2周内接受过非特异性免疫调节治疗[包括但不限于干扰素、白介素2（IL-2）]、获批抗肿瘤适应症的中成药制剂等 17.给药前30天内接种了活疫苗，或计划在研究期间接种活疫苗 18.给药前的筛选过程中，病情快速恶化，例如体能状态的明显变化等 19.妊娠期或者哺乳期妇女 20.患有非恶性肿瘤导致的局部或全身性疾病，或肿瘤继发的疾病或症状，并可导致较高医学风险和/或生存期评价的不确定性，如肿瘤类白血病反应、恶病质表现等 21.研究者认为干扰研究药物的评价或受试者安全性或研究结果解析的任何状况或其他研究者认为不宜参加本研究的状况

Exclusion criteria：

1. Patients with other malignant tumors within 5 years before drug administration (except for those cured by local treatment, such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and cervical carcinoma in situ, etc.) 2. Patients who have received chemotherapy within 3 weeks before the first use of the study drug, or radiotherapy, radioactive particle implantation (except for bone radioactive particle implantation for pain relief and local radiotherapy within 2 weeks before the first use of the study drug), or any drug treatment targeting topoisomerase I, including antibody-drug conjugate (ADC) treatment within 4 weeks before the first administration. 3. Patients with known leptomeningeal metastasis, brainstem metastasis, spinal cord metastasis and/or compression, active or untreated central nervous system (CNS) metastasis. For patients with previously treated brain metastases, if they are clinically stable for at least 4 weeks before medication and do not require glucocorticoids or anticonvulsants for at least 14 days, they may be eligible for inclusion. 4. Patients with adverse reactions from previous anti-tumor treatment that have not recovered to CTCAE 5.0 grade <= 1 (except for toxicities judged by the investigator to have no safety risk, such as alopecia and stable hypothyroidism treated with hormone replacement therapy, etc.) 5. According to the investigator's judgment, patients with uncontrolled systemic diseases: (1) Poorly controlled diabetes (fasting blood glucose >= 10 mmol/L for two consecutive times); (2) Poorly controlled hypertension (systolic blood pressure > 160 mmHg and/or diastolic blood pressure > 100 mmHg); (3) Presence of symptomatic or untreated pleural effusion, pericardial effusion or ascites (more than once a week) 6. Patients with a history of (non-infectious) interstitial lung disease (ILD) or non-infectious pneumonia requiring steroid treatment, currently having ILD or non-infectious pneumonia, or having suspicious ILD or non-infectious pneumonia that cannot be excluded by imaging examination at screening 7. Patients with active chronic inflammatory bowel disease, gastrointestinal obstruction, severe ulcers, gastrointestinal perforation, abdominal abscess or acute gastrointestinal bleeding 8. Patients with active autoimmune diseases requiring systemic treatment within the past two years, systemic treatment including disease-modifying drugs, immunosuppressants, systemic corticosteroid administration (> 10 mg/day prednisone or equivalent drugs), etc. Hormone replacement therapy, such as thyroid hormone, insulin, or physiological corticosteroid replacement therapy for adrenal or pituitary insufficiency, is not considered systemic treatment; patients who have received systemic corticosteroid treatment (> 10 mg/day prednisone) or other immunosuppressive drugs within 2 weeks before administration 9. Known active pulmonary tuberculosis. Patients suspected of having active pulmonary tuberculosis need to undergo clinical examination to rule it out 10. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation 11. Active hepatitis B [positive hepatitis B surface antigen (HBsAg), HBV-DNA testing is required; HBV-DNA >= 500 IU/mL or higher than the lower limit of detection, whichever is higher] or hepatitis C (positive hepatitis C antibody, and HCV-RNA higher than the lower limit of detection). Note: For HBsAg-positive patients, antiviral treatment for hepatitis B is required during the study treatment period 12. Positive human immunodeficiency virus (HIV) test or history of acquired immune deficiency syndrome (AIDS); known active syphilis infection 13. Known allergy to the study drug or any of its components, or a history of severe hypersensitivity reactions to other biological agents 14. Patients who have undergone major surgery within 4 weeks before administration or are expected to undergo major surgery during the study period 15. Patients who have experienced severe infection within 4 weeks before administration, including but not limited to those with complications requiring hospitalization, sepsis or severe pneumonia; 16. Active infection requiring systemic anti-infective treatment within 2 weeks before administration of the drug. 17. Received non-specific immunomodulatory treatment [including but not limited to interferon, interleukin-2 (IL-2)], or traditional Chinese medicine preparations approved for anti-tumor indications within 2 weeks before administration of the drug. 18. Received live vaccines within 30 days before screening, or planned to receive live vaccines during the study period. 19. Pregnant or lactating women. 20. Suffering from local or systemic diseases caused by non-malignant tumors, or diseases or symptoms secondary to tumors, which may lead to higher medical risks and/or uncertainties in survival evaluation, such as tumor leukemia-like reaction, cachexia, etc. 21. Any condition that the investigator believes may interfere with the evaluation of the study drug or the safety of the subject or the interpretation of the study results, or any other condition that the investigator deems inappropriate for participation in this study.

研究实施时间：

Study execute time：

从 From 2026-02-25 00:00:00至 To 2026-10-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2026-02-26 00:00:00 至 To 2026-10-31 00:00:00

干预措施：

Interventions：

组别：

A组

样本量：

 10

Group：

Group A

Sample size：

干预措施：

芦康沙妥珠单抗+贝伐珠单抗

干预措施代码：

Intervention：

Lukang saltuzumab + bevacizumab

Intervention code：

组别：

B组

样本量：

 10

Group：

Group B

Sample size：

干预措施：

芦康沙妥珠单抗

干预措施代码：

Intervention：

Lukang saltuzumab

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(区县)：

  

Country：

China

Province：

Beijing

City：

单位(医院)：

 首都医科大学附属北京潞河医院 

单位级别：

 三级 

Institution
hospital：

Beijing luhe hospital Affiliated to Capital Medical University

Level of the institution：

Tertiary

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

Type：

Primary indicator

测量时间点：

受试者在给药后1年内，首次肿瘤评估的影像学检查将在第6周(+7天)进行，后续每6周——8周进行1次肿瘤评估，1年之后每8周——12周进行1次肿瘤评估，直至影像学疾病进展(经研究者确认)

测量方法：

实体瘤疗效评价标准,v1.1

Measure time point of outcome：

The first imaging examination for tumor assessment of the subjects within one year after administration will be conducted on the 6th week (+7 day), followed by tumor assessment every 6 to 8 weeks. After one year, tumor assessment will be conducted every 8 to 12 weeks until the imaging disease progresses (confirmed by the investigator).

Measure method：

Response Evaluation Criteria in Solid Tumors,v1.1

指标中文名：

疾病控制率

指标类型：

主要指标

Outcome：

Disease Control Rate

Type：

Primary indicator

测量时间点：

受试者在给药后1年内，首次肿瘤评 估的影像学检查将在第6周(+7天)进行，后续每6周——8周进 行1次肿瘤评估，1年之后每8周——12周进行1次肿瘤评估，直至影像学疾病进展(经研究者确认)

测量方法：

实体瘤疗效评价标准,v1.1

Measure time point of outcome：

The first imaging examination for tumor assessment of the subjects within one year after administration will be conducted on the 6th week (+7 day), followed by tumor assessment every 6 to 8 weeks. After one year, tumor assessment will be conducted every 8 to 12 weeks until the imaging disease progresses (confirmed by the investigator).

Measure method：

Response Evaluation Criteria in Solid Tumors,v1.1

指标中文名：

无进展生存期

指标类型：

主要指标

Outcome：

Progression Free Survival

Type：

Primary indicator

测量时间点：

从随机化开始至肿瘤进展或任何原因导致死亡（以先发生者为准）的时间。

测量方法：

研究者判断

Measure time point of outcome：

From the start of randomization to tumor progression or death due to any cause (whichever occurs first).

Measure method：

Researchers' judgment

指标中文名：

不良事件

指标类型：

主要指标

Outcome：

Adverse Event

Type：

Primary indicator

测量时间点：

所有不良事件病例客观记录，SAE 24小时内报告

测量方法：

不良事件,5.0

Measure time point of outcome：

All adverse event cases are objectively recorded and reported by SAE within 24 hours

Measure method：

Common Terminology Criteria for Adverse Events,5.0

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：

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 80 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：

Blinding：

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：

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：

  2026-02-26 16:46:47