[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100514959":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":19,"locations":20,"responsibleParty":45,"collaborators":19,"id":47,"slug":48,"hasResults":49,"nctId":50,"briefTitle":51,"officialTitle":51,"acronym":19,"eligibilityCriteria":52,"healthyVolunteers":49,"sex":53,"minAge":54,"maxAge":55,"enrollmentInfo":56,"targetDuration":19,"studyType":59,"phases":60,"briefSummary":62,"conditions":63,"keywords":19,"overallStatus":23,"whyStopped":19,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":74},{"fullName":5,"class":6},"Peking University Cancer Hospital & Institute","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"[ Lu-177]-Catalase","EXPERIMENTAL","Participants received \\[ Lu-177\\]-Catalase intratumoral injection",[13],"Drug: [ Lu-177]-Catalase",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","\\[ 177Lu\\]-Catalase is administered by intratumoral puncture every four weeks, and the specific dose is related to the size of the tumor",[9],null,[21],{"facility":22,"status":23,"city":24,"state":25,"zip":26,"country":27,"countryCode":28,"cosmosGeoPoint":29,"geoPoint":34,"contacts":35},"Zhi Yang","RECRUITING","Beijing","Beijing Municipality","100142","China","CN",{"type":30,"coordinates":31},"Point",[32,33],116.39723,39.9075,{"lat":33,"lon":32},[36,41],{"name":37,"role":38,"phone":39,"phoneExt":19,"email":40},"Zhi Yang, PhD","CONTACT","01088196196","pekyz@163.com",{"name":42,"role":38,"phone":43,"phoneExt":19,"email":44},"Xiaoyi GUO, PhD","01088196495","2216392114@bjmu.edu.cn",{"type":46,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100514959","early-phase-1-clinical-application-of-lutetium-177lu-catalase-in-tumor-radionuclide-therapy-100514959",false,"NCT05985278","Clinical Application of Lutetium [177Lu]-Catalase in Tumor Radionuclide Therapy","Inclusion Criteria:\n\n1. Male or female patients, aged 18-70 years; ECOG score 0 or 1;\n2. Patients with advanced malignant tumors, such as liver cancer, ovarian cancer, prostate cancer, and so on, clearly diagnosed by pathology and\u002For cytology;\n3. Patients with advanced solid tumors who have failed or cannot tolerate standard treatment;\n4. Expected survival of more than 3 months;\n5. According to the solid tumor efficacy evaluation criteria , the patient had at least one measurable or evaluable tumor lesion with the longest diameter ≥10 mm at baseline (in the case of lymph nodes, the short diameter ≥15 mm). This lesion is suitable for intratumoral injection (the length of the lesion is at least 1 cm or equal).\n6. Blood routine and liver and kidney function meet the following criteria: Blood routine: WBC≥4.0×109L or neutrophil ≥1.5×109L, PLT≥100×109\u002FL, Hb≥90g\u002FL; PT or APTT≤1.5ULN; Liver and kidney function: T-Bil≤1.5×ULT(upper limit of normal),ALT\u002FAST≤2.5ULN or ≤5×ULT(subjects with liver metastasis), ALP≤2.5ULN(ALP≤ 4.5ULN if there is bone metastasis or liver metastasis); BUN≤1.5×ULT, SCr≤1.5×ULT;\n7. Women must use effective contraception during the study period and for 6 months after the study (effective contraception means sterilization, intrauterine hormone devices, condoms, contraceptives\u002Fpills, abstinence or partner vasectomy, etc.); Men should consent to subjects who must use contraception during the study period and for 6 months after the end of the study period;\n8. Can understand and voluntarily sign informed consent, compliance is good\n\nThe Exclusion Criteria:\n\n1. Severe abnormal liver and kidney function;\n2. Pregnant, pregnant and lactating women;\n3. Can not lie flat for half an hour;\n4. Refuse to join the clinical investigator;\n5. Suffering from claustrophobia or other mental illness;\n6. Other conditions deemed unsuitable for participation in the trial by the investigator","ALL","18 Years","70 Years",{"count":57,"type":58},10,"ESTIMATED","INTERVENTIONAL",[61],"EARLY_PHASE1","The purpose of this study is to evaluate the retention in tumour and distribution behavior of \\[Lu-177\\]-Catalase after intratumoral injection,and preliminary evaluation the efficacy and safety of \\[Lu-177\\]-Catalase.",[64],"Advanced Malignant Neoplasm","2023-08-02",{"date":67,"type":68},"2023-08-14","ACTUAL",{"date":70,"type":68},"2023-07-06",{"date":72,"type":58},"2026-06-15",{"name":5,"class":6},1]