ChiCTR2100046713 版本V1.9 版本创建时间2022/01/08 22:06:07 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：

ChiCTR2100046713 

最近更新日期：

Date of Last Refreshed on：

2022-01-08 22:05:39 

注册时间：

Date of Registration：

2021-05-27 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

评价靶向HER2的自体CAB-T细胞（PM3002注射液）治疗晚期实体瘤的临床试验

Public title：

a study of HER2-CAB-T Cell (chimeric CD3e and anti-CD3 based Bispecific T cell activator engineered T cells) for the treatment of advanced solid tumors

注册题目简写：

English Acronym：

研究课题的正式科学名称：

评价靶向HER2的自体CAB-T细胞（PM3002注射液）在晚期实体瘤受试者中的耐受性、安全性及初步疗效的临床试验

Scientific title：

a Study to Evaluate the Tolerance, Safety, Pharmacokinetics and Preliminary Efficacy of HER2-Targeted CAB-T（PM3002）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：

高嵩 

研究负责人：

许青 

Applicant：

Gao Song 

Study leader：

Xu Qing 

申请注册联系人电话：

Applicant telephone：

+86 21 66302521

研究负责人电话：

Study leader's telephone：

+86 21 66302521

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：

gaosong167@163.com

研究负责人电子邮件：

Study leader's E-mail：

xuqingmd@tongji.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：

上海市静安区延长中路301号2号楼12楼肿瘤内科

研究负责人通讯地址：

上海市静安区延长中路301号2号楼12楼肿瘤内科

Applicant address：

301 Middle Yanchang Road, Jing'an District, Shanghai

Study leader's address：

301 Middle Yanchang Road, Jing'an District, Shanghai

申请注册联系人邮政编码：

Applicant postcode：

200070

研究负责人邮政编码：

Study leader's postcode：

200070

申请人所在单位：

上海市第十人民医院

Applicant's institution：

Shanghai Tenth People's Hospital

研究负责人所在单位：

上海市第十人民医院

Affiliation of the Leader：

Shanghai Tenth People's Hospital

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：

SHSY-IEC-4.1/21-75/02

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：

上海市第十人民医院伦理委员会

Name of the ethic committee：

the Ethics Committee of Shanghai Tenth People's Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

2021-05-11 00:00:00

伦理委员会联系人：

傅近

Contact Name of the ethic committee：

Fu Jin

伦理委员会联系地址：

上海市静安区延长中路301号11号楼2楼

Contact Address of the ethic committee：

301 Middle Yanchang Road, Jing'an District, Shanghai

伦理委员会联系人电话：

Contact phone of the ethic committee：

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：

上海市第十人民医院

Primary sponsor：

Shanghai Tenth People's Hospital

研究实施负责（组长）单位地址：

上海市静安区延长中路301号

Primary sponsor's address：

301 Middle of Yanchang Road, Jing'an District, Shanghai

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

上海

市(区县)：

Country：

China

Province：

Shanghai

City：

单位(医院)：

上海市第十人民医院

具体地址：

静安区延长中路301号

Institution
hospital：

Shanghai Tenth People's Hospital

Address：

301 Middle Yanchang Road, Jing'an District

经费或物资来源：

海南凯博生物科技有限公司

Source(s) of funding：

Hainan Kaibo Biotechnology Co., Ltd

Target disease：

advanced solid tumors

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 探索性研究/预试验 

Study phase：

0

研究设计：

单臂 

Study design：

Single arm 

研究目的：

1.剂量递增阶段主要目的：评价PM3002注射液在晚期HER2阳性的恶性实体瘤受试者中的安全性和耐受性。 2.剂量扩展阶段主要目的：初步评价PM3002注射液在晚期HER2阳性的恶性实体瘤受试者（如乳腺癌、胃癌、尿路上皮癌等）治疗中的DCR与ORR。  

Objectives of Study：

1. The main purpose of the dose escalation stage: to evaluate the safety and tolerability of PM3002 injection in subjects with advanced HER2-positive malignant solid tumors. 2. The main purpose of the dose expansion stage: to initially evaluate the DCR and ORR of PM3002 injection in the treatment of advanced HER2-positive malignant solid tumor subjects (such as breast cancer, gastric cancer, urothelial cancer, etc.).

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.自愿参加临床研究完全了解本研究并自愿签署知情同意书愿意遵循并有能力完成所有试验程序；
2.男性或女性年龄18至70岁（含边界值）；
3.经组织学或细胞学证实的HER2 阳性无标准治疗方案或不耐受标准治疗方案或经二线标准治疗后失败或进展的晚期恶性实体瘤受试者（如乳腺癌胃癌卵巢癌结直肠癌等）；
4.既往抗肿瘤治疗所致的所有毒性反应缓解至0-1级（根据NCI CTCAE 5.0版）或至入选/排除标准可接受的水平脱发白癜风等研究者认为对受试者不产生安全性风险的其他毒性除外；
5.所有受试者均需提供肿瘤组织标本需为签署知情同意书前12个月内的合格归档标本或在细胞回输前-9~-12周内采集的新鲜活检标本（不接受骨活检标本）；
6.有充足的器官功能（细胞回输前14天内未接受输血粒细胞集落刺激因子等医学支持的情况下）定义如下血液系统中性粒细胞计数（ANC）≥1.5×109/L 白细胞（WBC）≥3.0×109/L血小板计数（PLT）≥100×109/L血红蛋白（Hb）≥90g/L肝功能总胆红素（TBIL）≤2.0×正常上限（ULN）Gilbert病受试者应≤3×ULN谷草转氨酶（AST）谷丙转氨酶（ALT）≤3×ULN（在剂量扩展阶段肝转移或肝癌受试者可≤5×ULN）碱性磷酸酶（ALP）≤2.5×ULN（骨转移受试者ALP≤5×ULN）肾功能血清肌酐≤1.5×ULN 或 肌酐清除率≥50 ml/min（Cockcroft-Gault公式（[140-年龄]×体重[kg] × [0.85，仅对于女性]）/（72 × 肌酐 (mg/dl)））；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；凝血功能：未接受抗凝治疗者：国际标准化比值（INR）、活化部分凝血活酶时间（APTT）应≤1.5×ULN；肝转移或肝癌受试者应≤2×ULN；
7.体力状况美国东部肿瘤协作组（ECOG）评分为0-1；
8.预期生存期≥12周；
9.根据RECIST 1.1标准，至少存在一个可测量病灶，如既往接受过局部放疗的病灶，只有在放疗后出现明确疾病进展，并且该既往照射病灶不是唯一可测量病灶的情况下，才可以考虑该病灶为可测量病灶；
10.经评估，受试者体内可采集到足够PBMC细胞用以制备回输细胞；
11.经评估，制备的回输细胞数量足够且质量合格，可用于临床回输；
12.有生育能力的女性受试者细胞回输前3天内的血妊娠结果为阴性，且愿意从签署知情同意书起至末次用药结束后6个月内，保持禁欲或采取经医学认可的高效避孕措施（如宫内节育器、避孕套）；
13.男性受试者愿意从签署知情同意书起至末次用药结束后6个月内，保持禁欲或采取经医学认可的高效避孕措施，且在此期间不捐献精子。

Inclusion criteria

1. Volunteer to participate in clinical research, fully understand this research and voluntarily sign an informed consent form, willing to follow and have the ability to complete all trial procedures;
2. No gender limit, aged from 18 to 70 years (including boundary value);
3. HER2 positive confirmed by histology or cytology has no standard treatment plan or intolerance to standard treatment plan
or subjects with advanced malignant solid tumors who failed or progressed after second-line standard treatment (such as breast cancer, gastric cancer, ovarian cancer, colorectal cancer, etc.);
4. All toxic reactions caused by previous anti-tumor treatments are alleviated to grade 0-1 (according to NCI CTCAE version 5.0) or to a level acceptable for inclusion/exclusion criteria, alopecia, vitiligo, and other toxicities considered by researchers that do not pose a safety risk to the subjects are excluded;
5. All subjects are required to provide tumor tissue specimens, which must be qualified archived specimens within 12 months before signing the informed consent form or fresh biopsy specimens collected within 9-12 weeks before cell reinfusion (Bone biopsy specimens are not accepted);
6. Sufficient organ function (without receiving medical support such as granulocyte colony stimulating factor transfusion within 14 days before cell reinfusion) is defined as follows: blood system neutrophil count (ANC) >= 1.5x10^9/L, white blood cell (WBC) ) >=3.0x10^9/L, platelet count (PLT) >=100x10^9/L, hemoglobin (Hb) >=90g/L, liver function total bilirubin (TBIL) <=2.0xupper limit of normal (ULN), Gilbert disease subjects should be <= 3xULN, aspartate aminotransferase (AST) alanine aminotransferase (ALT)<=3xULN (in the dose expansion phase liver metastasis or liver cancer subjects may be <=5xULN), alkaline phosphatase (ALP) <=2.5xULN (Subjects with bone metastasis ALP<=5xULN), renal function serum creatinine <= 1.5 x ULN or creatinine clearance >= 50 ml/min (Cockcroft-Gault formula: ([140-age] x weight [kg] x [0.85, for women only])/(72 x creatinine (mg /dl))); qualitative urine protein <= 1+; if qualitative urine protein >= 2+, a 24-hour urine protein quantitative test is required, if 24-hour urine protein quantitative <1 g, then it is acceptable; coagulation function: not accepted anticoagulant therapy, International normalized ratio (INR) and activated partial thromboplastin time (APTT) should be <=1.5xULN; subjects with liver metastasis or liver cancer should be <=2xULN;
7. Physical fitness score of the Eastern Cooperative Oncology Group (ECOG) of the United States is 0-1;
8. Expected survival period >= 12 weeks;
9. According to the RECIST 1.1 standard, there is at least one measurable lesion, a lesion that has received local radiotherapy in the past can only be considered as a measurable lesion if there is clear disease progression after radiotherapy and the previously irradiated lesion is not the only measurable lesion;
10. After evaluation, enough PBMC cells can be collected from the subject to prepare reinfusion cells;
11. After evaluation, the number of prepared reinfusion cells is sufficient and the quality is qualified, which can be used for clinical reinfusion;
12. Female subjects with fertility had negative blood pregnancy results within 3 days before the cell reinfusion, and were willing to maintain abstinence or take medically approved high-efficiency contraceptive measures (such as intrauterine devices, condoms) from the time of signing the informed consent form to 6 months after the end of the last medication;
13. Male subjects are willing to maintain abstinence or take medically-approved high-efficiency contraceptive measures within 6 months from the signing of the informed consent form to the end of the last medication, and do not donate sperm during this period.

排除标准：

1.严重过敏性疾病史严重药物（含未上市的试验药物）过敏史或已知对本方案建议使用药物（含预处理药物）的任何成分过敏；
2.既往接受过基因治疗或细胞治疗或肿瘤疫苗者；
3.既往接受过冠状动脉重建术者；
4.既往接受抗HER2治疗曾出现与治疗药物相关的严重不良事件或导致停药的不良事件；
5.具有重大出凝血障碍或其他明显出血风险证据：
（1） 既往有颅内出血或脊髓内出血病史；
（2）肿瘤病灶侵犯大血管且具有明显出血风险者；
（3）细胞回输前6个月内，发生过血栓形成或栓塞事件；
（4）细胞回输前1个月内，出现过临床显著的咯血或肿瘤出血；
（5）细胞回输前2周内，使用过出于治疗目的的抗凝治疗（低分子量肝素除外）；
（6）细胞回输前10天内，使用过抗血小板药物治疗，如阿司匹林（>325 mg/天）、氯吡格雷（>75 mg/天）、双嘧达莫、噻氯匹定或西洛他唑等；
6.在细胞回输前接受过以下治疗或药物：
（1）细胞回输前28天内，有未愈合的伤口、溃疡或骨折；
（2）细胞回输前28天内，接种过减毒活疫苗；
（3）细胞回输前28天内，接受过化疗、生物治疗、内分泌治疗、免疫治疗等抗肿瘤治疗（回输前符合方案要求使用的治疗除外），或任何未上市试验药物的治疗；以下情况也需排除：细胞回输前6周内接受过亚硝基脲或丝裂霉素C治疗，细胞回输前2周或药物的5个半衰期内（以时间长者为准）接受过口服氟尿嘧啶类和小分子靶向药物治疗，细胞回输前2周内接受过有抗肿瘤适应症的中药治疗；
（4）细胞回输前2周内，接受过皮质类固醇，或预计在采血、细胞采集或细胞回输过程中可能需要皮质类固醇治疗，以下情况除外：短时间（≤7天）、剂量不高于10 mg/d强的松或等价剂量的皮质类固醇用于预防或治疗非自身免疫性状况，局部、鼻内、眼内、关节腔内或吸入用皮质类固醇；
7.已知具有软脑膜转移，或无法控制的或有症状的中枢神经系统转移，表现为出现临床症状、脑水肿、脊髓压迫和/或进展性生长，有中枢神经系统转移或脊髓压迫病史的受试者，如明确接受过治疗且在细胞回输前停用抗惊厥药和类固醇8周后经研究者判定临床表现稳定，则可以接受；
8.存在任何形式的原发性免疫缺陷；
9.存在任何活动性自身免疫病，或有自身免疫病病史且预期复发（包括但不局限于：全身性红斑狼疮、类风湿性关节炎、自身免疫性肝炎、葡萄膜炎、肠炎、肝炎、垂体炎、血管炎、肾炎、甲状腺功能亢进、甲状腺功能降低、需要支气管扩张剂进行医学干预的哮喘受试者。以下情况除外：1型糖尿病；无需全身治疗的皮肤病[如白癜风、银屑病、脱发]；只需接受激素替代治疗的甲状腺功能减退症；童年期已完全缓解的哮喘，成年后无需任何干预；或其他预计在无外部触发因素的状态下病情不会复发者）；
10.细胞回输前5年内，曾患有其他活动性恶性肿瘤，可进行局部治疗且已治愈的恶性肿瘤除外（如皮肤基底细胞或鳞状细胞癌、浅表性或非侵袭性膀胱癌、宫颈原位癌、乳腺导管内原位癌、甲状腺乳头状癌等）；
11.细胞回输前6个月内，出现以下情况：心肌梗死、严重/不稳定型心绞痛、有临床意义的心律失常且需要临床干预者、脑血管意外/卒中、短暂性脑缺血发作、蛛网膜下出血、美国纽约心脏病学会（NYHA）分级≥II级的心功能不全；
12.目前存在无法控制的胸腔、心包、腹腔积液；
13.细胞回输前，存在：
（1） 先天性长QT综合征；
（2）使用心脏起搏器；
（3）左室射血分数（LVEF）<50%；
（4）QTcF间期>480 msec（QTcF=QT/（RR^0.33））；
（5）心肌肌钙蛋白I或T >2.0 ULN；
（6）控制不佳的糖尿病（空腹血糖≥13.3 mM）；
（7）控制不佳的高血压（收缩压≥160 mmHg和/或舒张压≥100 mmHg）；
（8）第一秒用力呼气容积（FEV1）≤60% 或 需辅助使用氧疗者；
14.在筛选期间或细胞回输前，出现不明原因的发热>38.5°C（经研究者判断，因肿瘤原因导致的发热可以入组）；
15.已知有异体器官移植史或异体造血干细胞移植史；
16.已知有酒精滥用、精神类药物滥用或吸毒史；
17.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；
18.已知患有获得性免疫缺陷综合征（艾滋病）；
19.已知存在严重的活动性病毒、细菌感染，或未控制的全身性真菌感染；
20.病毒学检查结果（HIV、CMV、HSV、HPV、EBV、梅毒）阳性；
21.HBsAg阳性或HBcAb阳性，且HBV-DNA > 200 IU/mL；或HCV-Ab阳性，且HCV-RNA高于研究中心检测下限；
22.经研究者判断，受试者基础病情可能会增加其接受试验药物治疗的风险，或是对于出现的毒性反应及不良事件的解释造成混淆的；
23.预期在治疗期间需要接受任何其他形式的抗肿瘤药物治疗；
24.处于孕期或哺乳期的女性；
25.其它研究者认为不适合参加本研究的情况。

Exclusion criteria：

1. History of severe allergic disease history of allergies to serious drugs (including unmarketed test drugs) or known allergies to any component of the drugs recommended for this program (including pretreatment drugs);
2. Patients who have received gene therapy or cell therapy or tumor vaccine in the past;
3. Patients who have undergone coronary artery reconstruction in the past;
4. Past anti-HER2 treatment has experienced serious adverse events related to the treatment drug or adverse events leading to discontinuation of the drug;
5. Evidence of major coagulopathy or other obvious risk of bleeding:
(1) Past history of intracranial hemorrhage or intraspinal hemorrhage;
(2) Tumor lesions invade large blood vessels and have obvious bleeding risk;
(3) Thrombosis or embolism occurred within 6 months before the cell reinfusion;
(4) Clinically significant hemoptysis or tumor hemorrhage occurred within 1 month before the cell reinfusion;
(5) Anticoagulant therapy for therapeutic purposes (except low molecular weight heparin) has been used within 2 weeks before cell reinfusion;
(6) Within 10 days before cell reinfusion, have used antiplatelet drugs, such as aspirin (>325 mg/day), clopidogrel (>75 mg/day), dipyridamole, ticlopidine or siroline Tazol, etc.;
6. Have received the following treatments or drugs before cell reinfusion:
(1) There are unhealed wounds, ulcers or fractures within 28 days before the cell reinfusion;
(2) Inoculated with live attenuated vaccine within 28 days before cell reinfusion;
(3) Within 28 days before cell reinfusion, have received chemotherapy, biological therapy, endocrine therapy, immunotherapy and other anti-tumor treatments (except for the treatments that meet the requirements of the plan before reinfusion), or treatment of any unmarketed trial drug; the following conditions also need to exclude: received nitrosourea or mitomycin C treatment within 6 weeks before cell reinfusion, received oral fluorouracil and small molecule targeted drug treatment 2 weeks before cell reinfusion or within 5 half-lives of the drug (whichever is the longer), and received Chinese medicine with anti-tumor indications within 2 weeks before cell reinfusion treat;
(4) Within 2 weeks before cell reinfusion, have received corticosteroids, or it is expected that corticosteroid treatment may be required during blood collection, cell collection or cell reinfusion, except for the following situations: short time (<=7 days),
doses not higher than 10 mg/d of prednisone or equivalent doses of corticosteroids are used to prevent or treat non-autoimmune conditions, corticosteroids for topical, intranasal, intraocular, intra-articular or inhaled use;
7. Known to have metastasis to the pia mater, or uncontrollable or symptomatic central nervous system metastasis, manifested as clinical symptoms, cerebral edema, spinal cord compression and/or progressive growth, and a history of central nervous system metastasis or spinal cord compression Subjects who have clearly received treatment and stopped anticonvulsants and steroids for 8 weeks before cell reinfusion are determined by the investigator to have stable clinical manifestations, they can be accepted;
8. There is any form of primary immunodeficiency;
9. There is any active autoimmune disease, or a history of autoimmune disease and expected recurrence (including but not limited to: systemic lupus erythematosus, rheumatoid arthritis, autoimmune hepatitis, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism, and asthma subjects who require bronchodilators for medical intervention. Except for the following: type 1 diabetes; skin diseases that do not require systemic treatment [such as vitiligo, psoriasis , hair loss]; hypothyroidism that only needs hormone replacement therapy; asthma that has been completely relieved in childhood without any intervention in adulthood; or other patients who are expected to not relapse without external triggers);
10. Within 5 years before cell reinfusion, have had other active malignant tumors, except for malignant tumors that can be treated locally and have been cured (such as skin basal cell or squamous cell carcinoma, superficial or non-invasive bladder cancer, cervical carcinoma in situ, ductal carcinoma in situ of the breast, papillary thyroid carcinoma, etc.);
11. Within 6 months before cell reinfusion, the following conditions occurred: myocardial infarction, severe/unstable angina pectoris, clinically significant arrhythmia requiring clinical intervention, cerebrovascular accident/stroke, transient ischemic attack, subarachnoid hemorrhage, cardiac insufficiency with New York College of Cardiology (NYHA) grade >= Grade II ;
12. There are currently uncontrollable pleural, pericardial, and abdominal effusions;
13. Before cell reinfusion, there are:
(1) Congenital long QT syndrome;
(2) Use a pacemaker;
(3) Left ventricular ejection fraction (LVEF) <50%;
(4) QTcF interval>480 msec (QTcF=QT/(RR^0.33));
(5) Cardiac troponin I or T >2.0 ULN;
(6) Poorly controlled diabetes (fasting blood glucose >= 13.3 mM);
(7) Poorly controlled hypertension (systolic blood pressure >=160 mmHg and/or diastolic blood pressure >=100 mmHg);
(8) Forced expiratory volume in the first second (FEV1) <=60% or those who need to use oxygen therapy;
14. During the screening period or before the cell reinfusion, fever of unknown origin> 38.5°C (according to the judgment of the investigator, fever caused by tumor can be included in the group);
15. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
16. Known history of alcohol abuse, psychotropic drug abuse or drug abuse;
17. Have a clear history of neurological or mental disorders, such as epilepsy, dementia, schizophrenia, etc.;
18. Known to have acquired immunodeficiency syndrome (AIDS);
19. There are known severe active viral, bacterial infections, or uncontrolled systemic fungal infections;
20. Virological examination results (HIV, CMV, HSV, HPV, EBV, syphilis) are positive;
21. HBsAg positive or HBcAb positive, and HBV-DNA> 200 IU/mL; or HCV-Ab positive, and HCV-RNA is higher than the lower detection limit of the research center;
22. According to the judgment of the investigator, the subjects basic medical condition may increase the risk of receiving experimental drug treatment, or cause confusion in the interpretation of toxic reactions and adverse events;
23. Expect to receive any other form of anti-tumor drug treatment during the treatment period;
24. Patients who are pregnant or breastfeeding;
25. Other researchers think it is not suitable to participate in this study.

研究实施时间：

Study execute time：

从 From 2021-06-07 00:00:00至 To 2036-12-30 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2021-06-07 00:00:00 至 To 2023-03-30 00:00:00  

干预措施：

Interventions：

组别：

剂量递增组

样本量：

15

Group：

Dose escalation group

Sample size：

干预措施：

PM3002注射液

干预措施代码：

Intervention：

PM3002 injection

Intervention code：

组别：

剂量扩展组

样本量：

20

Group：

Dose expansion group

Sample size：

干预措施：

PM3002注射液

干预措施代码：

Intervention：

PM3002 injection

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 上海 

市(区县)：

  

Country：

China 

Province：

Shanghai 

City：

 

单位(医院)：

上海市第十人民医院 

单位级别：

三甲 

Institution
hospital：

Shanghai Tenth People's Hospital

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

首次给药后28天内剂量限制性毒性的发生

指标类型：

主要指标

Outcome：

Occurrence of dose-limiting toxicity within 28 days after the first administration

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

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：

测量方法：

Measure time point of outcome：

Measure method：

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：

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

 使用后保存  

说明

Fate of sample：

Preservation after use  

Note：

标本中文名：

尿液

组织：

Sample Name：

Urine

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：

粪便

组织：

Sample Name：

Excrement

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：

肿瘤组织切片

组织：

Sample Name：

Tumor tissue section

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 70 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）：

非随机

Randomization Procedure (please state who generates the random number sequence and by what method)：

Non-randomized

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：

N/A

Blinding：

N/A

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

是否共享原始数据：

IPD sharing

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）：

未说明 请阅读网页注册指南中关于“原始数据共享”的内容。

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

Not stated

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：

EDC

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

EDC

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：

  2021-05-27 04:00:23