[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100548002":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":32,"responsibleParty":55,"collaborators":20,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":20,"eligibilityCriteria":64,"healthyVolunteers":60,"sex":65,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":20,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":20,"overallStatus":35,"whyStopped":20,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"Sun Yat-sen University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental: Neoadjuvant Therapy TIP (Paclitaxel + Ifosfamide + Cisplatin) & Toripalimab","EXPERIMENTAL","Drug: Toripalimab 240mg, ivgtt, d1 Drug: Paclitaxel 175 mg\u002Fm2, ivgtt, d1 Drug: Cisplatin 25mg\u002Fm2·d, ivgtt, d1-3 Drug: Ifosfamide 1.2g\u002Fm2·d, ivgtt, d1-3",[13],"Drug: Paclitaxel + Ifosfamide + Cisplatin & Toripalimab",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Paclitaxel + Ifosfamide + Cisplatin & Toripalimab","Paclitaxel + Ifosfamide + Cisplatin \\& Toripalimab",[9],null,[22,28],{"name":23,"role":24,"phone":25,"phoneExt":26,"email":27},"Hui Han","CONTACT","13002018798","+86","hanhui@sysucc.org.cn",{"name":29,"role":24,"phone":30,"phoneExt":26,"email":31},"Ting Xue","18243057370","xueting1@sysucc.org.cn",[33],{"facility":34,"status":35,"city":36,"state":37,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"Sun Yat-sen University Cancer Center","RECRUITING","Guangzhou","Guangdong","510060","China","CN",{"type":42,"coordinates":43},"Point",[44,45],113.25,23.11667,{"lat":45,"lon":44},[48,51,53],{"name":49,"role":24,"phone":50,"phoneExt":20,"email":27},"Hui Han PhD","0086-13002018798",{"name":52,"role":24,"phone":20,"phoneExt":20,"email":20},"Ting Xue Dr.",{"name":49,"role":54,"phone":20,"phoneExt":20,"email":20},"PRINCIPAL_INVESTIGATOR",{"type":54,"investigatorFullName":56,"investigatorTitle":57,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"ZHOU FANGJIAN","Director","100548002","phase-2-tip-regimen-combined-with-triplizumab-neoadjuvant-therapy-for-locally-advanced-penile-cancer-100548002",false,"NCT06415318","TIP Regimen Combined With Triplizumab Neoadjuvant Therapy for Locally Advanced Penile Cancer","A Single-center, Single-arm Clinical Study of TIP(Paclitaxel + Ifosfamide + Cisplatin) Regimen Combined With Triplizumab Neoadjuvant Therapy for Locally Advanced Penile Cancer","Inclusion Criteria:\n\n1. Squamous cell carcinoma confirmed by histology or cytology;\n2. Clinical Stage is Locally advanced penile cancer (T4, any N stage; or any T stage, N3);\n3. No prior chemotherapy for newly diagnosed or relapsed patients or the time from the last chemotherapy to relapse should be longer than 12 months;\n4. There is at least one measurable lesion according to the solid tumor efficacy evaluation standard RECIST1.1;\n5. the Eastern Cooperative Oncology Group (ECOG) scored 0-2;\n6. Blood marrow function: Hemoglobin(Hb) \\>\u002F= 80g\u002FL; White blood cell count \\>\u002F= 3.0x10\\^9\u002FL; Neutrophil count \\>\u002F= 1.5x10\\^9\u002FL; Platelet count \\>\u002F = 100x10\\^9\u002FL;\n7. Liver function: AST, ALT, ALP \\\u003C\u002F= 2.5 ULN; Total bilirubin \\\u003C\u002F= 1.5 ULN;\n8. Estimated survival \\>\u002F= 12 months;\n9. No prior serious disease history of a systemic organ;\n10. The participant understands this study procedure and signs the informed consent.\n\nExclusion Criteria:\n\n1. Peripheral neuropathy degree \\>\u002F=2 (affecting patient's function);\n2. Previously received any other experimental drug treatment within 4 weeks before enrollment;\n3. Patients with other cancer at present, or have other malignant tumor histories within the past 5 years. Except for (1) Cured skin non-malignant melanoma; (2) Curable tumor, including low-risk prostate cancer (T1a, Gleason score\\\u003C6, PSA\\\u003C0.5ng\u002Fml), superficial bladder cancer and so on; (3) Other solid tumors have received radical treatment, and no recurrence or metastasis has been found at least 5 years;\n4. Other serious or poorly controlled concomitant diseases, including but not limited to (1) Severe or acute attack disease history of cardiovascular, liver, respiratory, kidney, blood, endocrine or neuropsychiatric system within 6 months; (2) Active infection history and needed antibiotic treatment within 2 weeks before enrollment; (3) Congestive heart failure (grade III-IV); (4) Unstable angina pectoris or myocardial infarction history within 6 months","MALE","18 Years","75 Years",{"count":69,"type":70},25,"ESTIMATED","INTERVENTIONAL",[73],"PHASE2","Primary Objective: To evaluate the efficacy and safety of TIP (paclitaxel + ifosfamide + cisplatin) combined with Toripalimab as a neoadjuvant treatment in locally advanced penile cancer",[76],"Penile Cancer","2025-04-16",{"date":79,"type":80},"2025-04-22","ACTUAL",{"date":82,"type":80},"2024-05-31",{"date":84,"type":70},"2027-12-01",{"name":5,"class":6},1]