预约演示
更新于：2026-05-07
CREPT-618
更新于：2026-05-07
概要
基本信息
原研机构 |
在研机构 |
非在研机构 |
权益机构- |
最高研发阶段临床1/2期 |
首次获批日期- |
最高研发阶段(中国)临床1期 |
特殊审评- |
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关联
6
项与 CREPT-618 相关的临床试验ChiCTR2600123838
A Clinical Study to Evaluate the Safety and Efficacy of CREPT-618 Injection in Participants with Liver Fibrosis
开始日期2026-04-27 |
NCT07307053
An Open-Label, Single-Arm, Phase I/II Platform Trial of Innovative Therapies and Technologies Primarily in Rare Tumors in China (PLATFORM2) in Patients With Advanced Solid Tumors
The goal of this Phase I/II observational and interventional platform study is to evaluate the safety and efficacy of multiple types of innovative anti-tumor drugs and new technologies in patients with rare solid tumors. The study utilizes multi-dimensional precision screening (including WES, RNAseq, mIHC, and quantitative proteomics) to match patients with specific sub-protocols.
Key questions it aims to answer:
Assess the safety of innovative therapies in rare tumor populations. Evaluate the objective response rate (ORR) and other efficacy metrics. Explore biomarkers related to therapeutic efficacy. Participants: Patients with metastatic or advanced rare solid tumors who have failed standard therapy or have no standard treatment options.
Key questions it aims to answer:
Assess the safety of innovative therapies in rare tumor populations. Evaluate the objective response rate (ORR) and other efficacy metrics. Explore biomarkers related to therapeutic efficacy. Participants: Patients with metastatic or advanced rare solid tumors who have failed standard therapy or have no standard treatment options.
开始日期2026-01-01 |
申办/合作机构 |
ChiCTR2600119918
A Study on the Safety, Tolerability, and Preliminary Efficacy of CREPT-618 in Patients with Metabolic Dysfunction-Associated Steatohepatitis
开始日期2025-12-31 |
申办/合作机构 |
100 项与 CREPT-618 相关的临床结果
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100 项与 CREPT-618 相关的转化医学
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100 项与 CREPT-618 相关的专利（医药）
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1
项与 CREPT-618 相关的新闻（医药）2026-01-28
注册号：
Registration number：
ChiCTR2600117700 最近更新日期：
Date of Last Refreshed on：
2026-01-28 08:12:28 注册时间：
Date of Registration：
2026-01-28 00:00:00 注册号状态：
预注册Registration Status：
Prospective registration注册题目：
CREPT-618联合替雷利珠单抗注射液治疗不可切除肝细胞癌的安全性、耐受性和初步有效性的临床试验Public title：
Clinical trial of safety, tolerability and preliminary efficacy of crept-618 combined with tirelizumab injection in the treatment of unresectable hepatocellular carcinoma注册题目简写：English Acronym：研究课题的正式科学名称：
CREPT-618联合替雷利珠单抗注射液治疗不可切除肝细胞癌的安全性、耐受性和初步有效性的临床试验Scientific title：
Clinical trial of safety, tolerability and preliminary efficacy of crept-618 combined with tirelizumab injection in the treatment of unresectable hepatocellular 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：
樊莲莲
研究负责人：
麦刚 Applicant：
Lianlian.Fan
Study leader：
Gang Mai 申请注册联系人电话：
Applicant telephone：
+86 838 2418820
研究负责人电话：
Study leader's telephone：
+86 838 2418010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：
510791761@qq.com
研究负责人电子邮件：
Study leader's E-mail：
kj2418045@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：
中国四川省德阳市旌阳区泰山北路一段173号
研究负责人通讯地址：
中国四川省德阳市旌阳区泰山北路一段173号Applicant address：
No.173, Section 1, Taishan North Road, Jingyang District, Deyang, Sichuan, China
Study leader's address：
No.173, Section 1, Taishan North Road, Jingyang District, Deyang, Sichuan, China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：
德阳市人民医院Applicant's institution：
People's Hospital of Deyang City研究负责人所在单位：
德阳市人民医院Affiliation of the Leader：
People's Hospital of Deyang City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：
2025-03-054-H01
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：
德阳市人民医院临床试验伦理委员会Name of the ethic committee：
Clinical trial Ethics Committee of Deyang People's Hospital伦理委员会批准日期：
Date of approved by ethic committee：
2025-12-11 00:00:00伦理委员会联系人：
肖雪Contact Name of the ethic committee：
Xiao Xue伦理委员会联系地址：
中国四川省德阳市旌阳区泰山北路一段173号Contact Address of the ethic committee：
No.173, Section 1, Taishan North Road, Jingyang District, Deyang, Sichuan, China伦理委员会联系人电话：
Contact phone of the ethic committee：
+86 838 2312773
伦理委员会联系人邮箱：
Contact email of the ethic committee：
891627253@qq.com研究实施负责（组长）单位：
德阳市人民医院Primary sponsor：
People's Hospital of Deyang City研究实施负责（组长）单位地址：
中国四川省德阳市旌阳区泰山北路一段173号Primary sponsor's address：
No.173, Section 1, Taishan North Road, Jingyang District, Deyang, Sichuan, 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)：
四川
市(区县)：
Country：
China
Province：
Sichuan
City：
单位(医院)：
德阳市人民医院
具体地址：
中国四川省德阳市旌阳区泰山北路一段173号
Institution
hospital：
People's Hospital of Deyang City
Address：
No.173, Section 1, Taishan North Road, Jingyang District, Deyang, Sichuan, China经费或物资来源：
荷芽（北京）医药科技有限责任公司Source(s) of funding：
Heya (Beijing) Pharmaceutical Technology Co., Ltd研究疾病：
肝细胞癌 Target disease：
Hepatocellular 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：
其它 Study phase：
N/A研究设计：
单臂 Study design：
Single arm 研究目的：
评价CREPT-618联合替雷利珠单抗注射液治疗不可切除肝细胞癌受试者的安全性、耐受性。 Objectives of Study：
Objective to evaluate the safety and tolerability of crept-618 combined with tirelizumab injection in the treatment of patients with unresectable hepatocellular carcinoma.药物成份或治疗方案详述：
Description for medicine or protocol of treatment in
detail：
纳入标准：
1.18周岁≤年龄≤75周岁，性别不限；
3.经组织检查确诊的肝细胞癌（HCC）患者；
4.至少有一个可测量病灶（根据RECIST 1.1版要求该可测量病灶螺旋CT扫描长径≥10mm或肿大淋巴结短径≥15mm）， 或经过局部治疗后明确进展（基于RECIST 1.1 标准）的可测量病灶；
5.研究者计划处方或实际处方替雷利珠单抗注射液者；
5.肝细胞癌不可切除，巴塞罗那临床肝癌分期（BCLC分期）B期、C期且中国肝癌临床分期（CNLC分期）Ⅱb、Ⅲa、Ⅲb期；
6.需可提供至少6张白片检测肝癌组织 CREPT 和ASGPR 受体均阳性；或可进行穿刺进行肿瘤组织取材后切片确定CREPT、ASGPR双阳性。H-score为50%以上，染色强度2+；
7.Child-Pugh肝功能评级：A级或较好的B级（≤7分）；
8.入组时预期生存时间大于3个月；
9.入组前1周内ECOG PS评分：0-2分；
10.育龄期女性患者或性伴侣为育龄期女性的男性患者，需在整个治疗期及末次用药后 90天采取有效的避孕措施；
11.主要器官功能正常（获得实验室检查前 14 天内未给予任何血液成分、细胞生长因子、输注白蛋白制剂纠正治疗），即符合下列标准：（1）血常规：a）血红蛋白≥90g/L；b）中性粒细胞≥1.5×10^9/L；c）血小板计数≥75×10^9/L； （2）肝功能：ALT和AST≤5.0×正常范围上限（ULN），血清白蛋白≥28g/L；总胆红素（ TBIL ）≤2×ULN；碱性磷酸酶（ALP）≤5×ULN； （3）肾功能：血清肌酐（Cr）≤1.5×ULN 或肌酐清除率（Ccr）≥50mL/min； （4）凝血功能：活化部分凝血活酶时间（APTT）、国际标准化比值（INR）、凝血酶原时间（PT）≤1.5×ULN； （5）心脏超声心动图：左室射血分数（LVEF）≥50%；
12.签署书面知情同意书，而且能够遵守方案规定的访视及相关程序。Inclusion criteria
1.18 years old <= age <=75 years old, regardless of gender;
2.Patients with hepatocellular carcinoma (HCC) confirmed by histological examination;
3.At least one measurable lesion (according to RECIST version 1.1, the long diameter of the measurable lesion on spiral CT scan is >= 10mm or the short diameter of the enlarged lymph node is >= 15mm), or the measurable lesion with definite progression after local treatment (based on RECIST 1.1 criteria);
4.The investigator planned to prescribe or actually prescribed tirelizumab injection;
5.Hepatocellular carcinoma was unresectable, Barcelona clinical liver cancer stage (BCLC stage) B, C and China clinical liver cancer stage (CNLC stage) Ⅱ B, Ⅲ a, Ⅲ B;
6.At least 6 white films should be available to detect that both crept and ASGPR receptors are positive in liver cancer tissues; Or the tumor tissue can be obtained by puncture and sectioned to determine the double positive of crept and ASGPR. The H-score was more than 50%, and the staining intensity was 2 +;
7.Child Pugh liver function rating: Grade A or better grade B (<= 7 points);
8.The expected survival time at enrollment was greater than 3 months;
9.ECoG PS score within 1 week before enrollment: 0-2 points;
10.Female patients of childbearing age or male patients whose sexual partners are women of childbearing age should take effective contraceptive measures during the whole treatment period and 90 days after the last medication;
11. Normal major organ function (not given any blood components, cell growth factors, albumin infusion within 14 days before laboratory examination), that is, meeting the following criteria: (1) blood routine: a) hemoglobin >=90g/L; b) neutrophil >=1.5×10^9/L; c) platelet count >=75×10^9/L; (2) Liver function: ALT and AST<=5.0× upper limit of normal range (ULN), serum albumin >=28g/L; Total bilirubin (TBIL) <=2×ULN; Alkaline phosphatase (ALP) <=5×ULN; (3) Renal function: serum creatinine (Cr) <=1.5×ULN or creatinine clearance rate
12.Sign written informed consent, and be able to follow the visit and relevant procedures specified in the plan.排除标准：
1.既往经组织学或细胞学确诊的纤维板层肝细胞癌、肉瘤样肝细胞癌、肝胆管细胞癌、混合型肝癌等；
2.有肝性脑病病史，或有肝移植病史；
3.门静脉癌栓同时累及主干和肠系膜上静脉，或有下腔静脉癌栓或心脏受累者；
4.在首次给药前5年内诊断为其他恶性肿瘤者，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；
5.在首次给药前 4 周内，中度或重度腹水或有临床症状需要引流的胸水、 腹水、心包积液；
6.在首剂研究治疗之前存在既往治疗引起的未恢复至NCI CTCAE 5.0版0级或1级的毒性（不包括脱发、非临床显著性和无症状性实验室异常）；
7.本研究治疗首次给药前4周内接受过系统性抗肿瘤治疗，包括化疗、放疗、生物疗法、细胞因子疗法、免疫疗法或参加过其他治疗性临床研究（观察性临床研究除外）；或首次给药前6周内接受过亚硝基脲药物或丝裂霉素C治疗。以下情况除外： 1）首次给药2周以前或距离其末次用药大于5个半衰期，接受过口服氟尿嘧啶类药物或小分子靶向剂治疗（以较长者为准，不超过28天）； 2）首次给药2周以前接受过中药抗肿瘤治疗； 3）姑息性骨定向放疗。
8.控制不佳的急性或者慢性活动性乙型肝炎或丙型肝炎感染者；
9.伴有已知活动性中枢神经系统转移（CNS）和/或癌性脑膜炎：既往接受过治疗的脑转移受试者可以参加研究，前提是临床稳定至少 2 周，没有新的或扩大的脑转移证据，且研究药物给药前14天停用类固醇。这个定义中稳定的脑转移应该在研究药物首次给药前确定。无症状性脑转移受试者（即没有神经系统症状，不需要皮质类固醇，且无病变＞1.5cm）可以参加，但需要作为疾病部位定期进行脑部影像学检查；
10.筛选前 6个月内发生过门静脉高压导致的食管或胃底静脉曲张出血事件。首次给药前3个月内已知内镜检查存在重度静脉曲张。有门静脉高压证据，经研究者评估出血风险高；
11.筛选前 3 个月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；有严重出血倾向或凝血功能障碍，或正在接受溶栓治疗；
12.筛选前 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）；
13.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>500 ms（使用Fridericia法计算）；
14.筛选前 6 个月内有胃肠道穿孔和/或瘘管、腹腔脓肿、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；
15.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；
16.处于活动期或临床控制不佳的严重感染。如活动性肺结核(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；人免疫缺陷病毒（HIV）感染者（HIV 1/2抗体阳性），已知的梅毒感染需要治疗者；以及在首次给药前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；
17.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；
18.首次给药4 周内或研究期间需要使用免疫抑制药物，排除以下情况： 1) 喷鼻、吸入性或其他途径的局部糖皮质激素； 2) 生理剂量的系统性糖皮质激素（即不超过10 mg/天泼尼松或等效剂量的其他糖皮质激素）； 3) 因预防过敏反应或治疗哮喘、慢性阻塞性肺疾病等疾病的呼吸困难症状临时（≤7 天）使用糖皮质激素；
19.已知对试验用药物或已知成分过敏者；
20.首次给药前4周之内或计划在研究期间接受减毒活疫苗；
21.妊娠或哺乳的女性患者；
22.任何其他疾病，代谢紊乱或实验室检查异常，研究者认为患者不适合接受研究药物治疗，或将影响研究结果的解读，或使患者处于高风险状况，或影响资料及样品的收集。Exclusion criteria：
1.Fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, hepatocholangiocarcinoma, mixed liver cancer, etc. previously confirmed by histology or cytology;
2.Have a history of hepatic encephalopathy or liver transplantation;
3.Patients with portal vein tumor thrombus involving both the main trunk and superior mesenteric vein, or with inferior vena cava tumor thrombus or cardiac involvement;
4.Other malignant tumors diagnosed within 5 years before the first administration do not include skin basal cell carcinoma, skin squamous cell carcinoma and / or carcinoma in situ that has undergone radical resection;
5.Moderate or severe ascites or pleural effusion, ascites and pericardial effusion with clinical symptoms requiring drainage within 4 weeks before the first administration;
6.Before the first dose of study treatment, there was toxicity caused by previous treatment that did not return to NCI CTCAE version 5.0 grade 0 or 1 (excluding alopecia, non clinically significant and asymptomatic laboratory abnormalities);
7.Received systemic anti-tumor treatment within 4 weeks before the first administration of this study treatment, including chemotherapy, radiotherapy, biotherapy, cytokine therapy, immunotherapy or participated in other therapeutic clinical studies (except observational clinical studies); Or received nitrosourea drugs or mitomycin C treatment within 6 weeks before the first administration. Except for the following cases: 1) having received oral fluorouracil drugs or small molecule targeted agents 2 weeks before the first administration or more than 5 half lives from the last Administration (whichever is longer, no more than 28 days); 2) ; 3) Palliative bone directed radiotherapy.
8.Poorly controlled patients with acute or chronic active hepatitis B or C infection;
9.With known active central nervous system metastasis (CNS) and / or cancerous meningitis: subjects with brain metastasis who have received previous treatment can participate in the study, provided that they are clinically stable for at least 2 weeks, have no evidence of new or expanded brain metastasis, and discontinue steroids 14 days before study drug administration. Stable brain metastases in this definition should be determined before the first administration of the study drug. Subjects with asymptomatic brain metastases (i.e. no neurological symptoms, no corticosteroids, and no lesions > 1.5cm) can participate, but they need to have brain imaging examinations regularly as the disease site;
10.Bleeding events of esophageal or gastric varices caused by portal hypertension occurred within 6 months before screening. The presence of severe varicose veins on endoscopy was known within 3 months before the first administration. There was evidence of portal hypertension, and the investigator assessed that the risk of bleeding was high;
11.Any life-threatening bleeding event occurred 3 months before screening, including the need for blood transfusion treatment, surgery or local treatment, and continuous drug treatment; Have severe bleeding tendency or coagulation dysfunction, or are receiving thrombolytic therapy;
12.Arterial and venous thromboembolic events within 6 months before screening, including history of myocardial infarction, unstable angina pectoris, cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis or any other serious thromboembolism. Implantable venous port or catheter-derived thrombosis, or superficial venous thrombosis, except those with stable thrombus after conventional anticoagulation treatment. ;
13.Symptomatic congestive heart failure (New York Heart Association functional class II-IV), symptomatic or poorly controlled arrhythmias. History of congenital long QT syndrome or corrected QTc >500 ms during screening (calculated using the Fridericia method);
14.Screening for history of gastrointestinal perforation and/or fistula, abdominal abscess, intestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), extensive intestinal resection (partial colectomy or extensive small bowel resection with concurrent chronic diarrhea), Crohn's disease, ulcerative colitis, or long-term chronic diarrhea within the previous 6 months;
15.Previous and current history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, drug-related pneumonia, severe impairment of lung function and other lung diseases;
16.Severe infection in active phase or poor clinical control. For example, patients with active pulmonary tuberculosis (TB), who are receiving anti TB treatment or have received anti TB treatment within 1 year before the first administration; Patients with human immunodeficiency virus (HIV) infection (HIV 1 / 2 antibody positive) and known syphilis infection who need treatment; And severe infection within 4 weeks before the first administration, including but not limited to hospitalization due to infection, bacteremia or severe pneumonia complications;
17.Active autoimmune disease requiring systemic treatment (such as the use of disease modifying drugs, corticosteroids or immunosuppressants) occurred within 2 years before the first administration. Alternative therapies (such as thyroxine, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency) are permitted. Known history of primary immunodeficiency. Patients with positive autoimmune antibody only need to confirm whether there is autoimmune disease according to the judgment of the investigator;
18.Immunosuppressive drugs need to be used within 4 weeks of the first administration or during the study, and the following cases are excluded: 1) local glucocorticoids by nasal spray, inhalation or other routes; 2) Physiological doses of systemic glucocorticoids (i.e. no more than 10 mg/ day prednisone or equivalent doses of other glucocorticoids); 3) Temporary (<= 7 days) use of glucocorticoids for the prevention of allergic reactions or the treatment of dyspnea symptoms of asthma, chronic obstructive pulmonary disease and other diseases;
19.Known allergy to test drugs or known ingredients;
20.Received live attenuated vaccine within 4 weeks before the first dose or planned during the study;
21.Pregnant or lactating female patients;
22.For any other disease, metabolic disorder or abnormal laboratory test, the investigator believes that the patient is not suitable for the treatment of study drug, or will affect the interpretation of the study results, or put the patient in a high-risk condition, or affect the collection of data and samples.研究实施时间：
Study execute time：
从
From
2026-01-31 00:00:00至
To
2026-12-31 00:00:00
征募观察对象时间：
Recruiting time：
从
From
2026-01-31 00:00:00
至
To
2026-12-31 00:00:00干预措施：
Interventions：
组别：
剂量组2
样本量：
3
Group：
Dose group 2
Sample size：
干预措施：
1.0mg/kg
干预措施代码：
Intervention：
1.0mg/kg
Intervention code：
组别：
剂量组1
样本量：
1
Group：
Dose group 1
Sample size：
干预措施：
0.5mg/kg
干预措施代码：
Intervention：
0.5mg/kg
Intervention code：
组别：
剂量组3
样本量：
6
Group：
Dose group 3
Sample size：
干预措施：
1.5mg/kg
干预措施代码：
Intervention：
1.5mg/kg
Intervention code：研究实施地点：
Countries of recruitment and research settings：
国家：
中国
省(直辖市)：
四川
市(区县)：
Country：
China
Province：
Sichuan
City：
单位(医院)：
德阳市人民医院
单位级别：
三级甲等
Institution
hospital：
People's Hospital of Deyang City
Level of the institution：
Tertiary A
国家：
中国
省(直辖市)：
贵州
市(区县)：
Country：
China
Province：
Guizhou
City：
单位(医院)：
遵义医科大学附属医院
单位级别：
三级甲等
Institution
hospital：
Affiliated Hospital of Zunyi Medical University
Level of the institution：
Tertiary A测量指标：
Outcomes：
指标中文名：
安全性评估
指标类型：
主要指标
Outcome：
Safety assessment
Type：
Primary indicator
测量时间点：
末次给药后的第28±7天、第90±7天内
测量方法：
描述性统计报告AE发生率、严重程度及与药物的相关性。
Measure time point of outcome：
Within 28 ± 7 days and 90 ± 7 days after the last Administration
Measure method：
Descriptive statistics were used to report the incidence, severity and correlation with drugs of AES.
指标中文名：
药代动力学
指标类型：
次要指标
Outcome：
Pharmacokinetics
Type：
Secondary indicator
测量时间点：
测量方法：
Measure time point of outcome：
Measure method：
指标中文名：
免疫原性
指标类型：
次要指标
Outcome：
Immunogenicity
Type：
Secondary indicator
测量时间点：
测量方法：
Measure time point of outcome：
Measure method：
指标中文名：
有效性评估
指标类型：
次要指标
Outcome：
Evaluation of effectiveness
Type：
Secondary indicator
测量时间点：
测量方法：
Measure time point of outcome：
Measure method：
指标中文名：
药效学
指标类型：
次要指标
Outcome：
Pharmacodynamics
Type：
Secondary 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)：
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
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：
本研究采用电子数据采集系统（EDC）进行数据管理。Data collection and Management (A
standard data collection and management system
include a CRF and an electronic data capture：
In this study, electronic data acquisition system (EDC) was used for data management.数据与安全监察委员会：
Data and Safety Monitoring Committee：
无/No注册人：
Name of Registration：
2026-01-28 08:12:15
临床1期临床结果
100 项与 CREPT-618 相关的药物交易
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研发状态
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 晚期恶性实体瘤 | 临床2期 | - | 2026-01-01 | |
| 转移性实体瘤 | 临床2期 | - | 2026-01-01 | |
| 局部晚期肝细胞癌 | 临床1期 | 中国 | 2025-09-15 | |
| 原发性胆汁性胆管炎 | 临床阶段不明 | 中国 | 2025-09-30 |
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临床结果
临床结果
适应症
分期
评价
查看全部结果
| 研究 | 分期 | 人群特征 | 评价人数 | 分组 | 结果 | 评价 | 发布日期 |
|---|
No Data | |||||||
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