[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100602638":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":32,"centralContacts":36,"locations":42,"responsibleParty":60,"collaborators":22,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":22,"eligibilityCriteria":68,"healthyVolunteers":64,"sex":69,"minAge":70,"maxAge":22,"enrollmentInfo":71,"targetDuration":22,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":22,"overallStatus":45,"whyStopped":22,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"Tianjin Medical University Second Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm 1","EXPERIMENTAL","Nab-Paclitaxel 125mg\u002Fm\\^2 IV on day 1 in combination with Tislelizumab 200mg IV on day 1 every 3 weeks for 2-3 cycles and then followed by radical nephroureterectomy (RNU).",[13,14,15],"Drug: Nab-Paclitaxel","Drug: Tislelizumab","Procedure: Radical nephroureterectomy (RNU)",[17,23,27],{"type":18,"name":19,"description":20,"armGroupLabels":21,"otherNames":22},"DRUG","Nab-Paclitaxel","Nab-Paclitaxel 125mg\u002Fm\\^2 IV will be administered on Day 1 every 3 weeks for 2-3 cycles",[9],null,{"type":18,"name":24,"description":25,"armGroupLabels":26,"otherNames":22},"Tislelizumab","Tislelizumab 200mg iv will be administered on Day 1 every 3 weeks for 2-3 cycles.",[9],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":22},"PROCEDURE","Radical nephroureterectomy (RNU)","Radical nephroureterectomy (RNU) will conducted after the completion of neoadjuvant therapy.",[9],[33],{"name":34,"affiliation":5,"role":35},"Hailong Hu, PhD","STUDY_DIRECTOR",[37],{"name":38,"role":39,"phone":40,"phoneExt":22,"email":41},"Hailong Hu","CONTACT","+86 13662096232","Huhailong@tmu.edu.cn",[43],{"facility":44,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"The Second Hospital of Tianjin Medical University","RECRUITING","Tianjin","Outside U.S.","300211","China","CN",{"type":52,"coordinates":53},"Point",[54,55],117.17667,39.14222,{"lat":55,"lon":54},[58,59],{"name":38,"role":39,"phone":40,"phoneExt":22,"email":41},{"name":22,"role":39,"phone":22,"phoneExt":22,"email":41},{"type":61,"investigatorFullName":22,"investigatorTitle":22,"investigatorAffiliation":22,"oldNameTitle":22,"oldOrganization":22},"SPONSOR","100602638","phase-2-neoadjuvant-tislelizumab-in-combination-with-nab-paclitaxel-for-utuc-100602638",false,"NCT07126119","Neoadjuvant Tislelizumab in Combination With Nab-Paclitaxel for UTUC","Neoadjuvant Tislelizumab in Combination With Nab-Paclitaxel for Upper Tract Urothelial Carcinoma: An Open-Label, Single-Center, Single-Arm, Phase II Clinical Trial (TRUCE-U02)","Inclusion Criteria:\n\n1. Males or females aged no less than 18 years old;\n2. UTUC indicated by ureteroscopic biopsy and imageological examination (including CT, MRI, or PET-CT), without evidences of metastasis in chest CT scan and abdominal CT scan (T1-4N0-2M0); High risk disease confirmed in accordance with the EAU guidelines.\n3. Histologically confirmed urothelial carcinoma or urothelial carcinoma as the major pathological component \\>50% in the specimen from ureteroscopic biopsy;\n4. Suitable and planned to receive RNU.\n5. Expected survival time of more than 12 weeks;\n6. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2;\n\n6.Agree to provide blood, urine, and tissue samples (for testing PD-L1 expression, HER-2, tumor mutation burden, etc.); 7.The organ function levels must meet the following requirements: Hematological indicators: Absolute neutrophil count ≥1.5×10\\^9\u002FL, platelet count ≥80×10\\^9\u002FL, hemoglobin ≥6.0 g\u002FdL (can be maintained through symptomatic treatment); Liver function: Total bilirubin ≤1.5 times the upper limit of normal, alanine transaminase and aspartate transaminase ≤2.5 times the upper limit of normal; Renal function: Baseline ECT renography indicates a total renal glomerular filtration rate (GFR) ≥15 ml\u002Fmin.\n\n8.Participants are willing to join the study and be able to sign and comply the protocol.\n\nExclusion Criteria:\n\n1. Concurrent primary malignancies in other sites are excluded, except for those with a history of other malignancies that have been treated and are currently stable.\n2. Confirmed bilateral upper tract urothelial carcinoma (UTUC).\n3. Presence of urothelial carcinoma in bladder is excluded, except for non-muscle-invasive bladder cancer that can be completely resected via transurethral resection of bladder tumor (TURBT).\n4. Received a live attenuated vaccine within 4 weeks before treatment or plan to receive during the study period;\n5. Active, known or suspected history of autoimmune disease;\n6. Known history of primary immunodeficiency;\n7. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation;\n8. Pregnant or breastfeeding female patients;\n9. Untreated acute or chronic active Hepatitis B or Hepatitis C infection. Patients receiving antiviral therapy may be eligible if viral load is under monitored, at the discretion of the physician based on the patient's individual condition;\n10. Receiving immunosuppressive medication within 4 weeks prior to starting treatment, except nasal, inhaled, topical steroids, or systemic corticosteroids at physiological doses (i.e., not exceeding 10 mg\u002Fday of prednisone or equivalent dose of other corticosteroids);\n11. Known or suspected allergy to Tislelizumab or Nab-Paclitaxel;\n12. Active tuberculosis;\n13. Previous treatment with PD-1\u002FPD-L1\u002FCTLA-4 immune checkpoint inhibitors or other immunotherapies;\n14. Participation in another clinical study;\n15. Fertile men or women without effective contraception;\n16. Uncontrolled concurrent illness, including but not limited to:\n\n(1)HIV infection (HIV antibodies positive); (2)Uncontrolled severe infection; (3)Uncontrolled systemic disease (such as severe psychiatric, neurological disorders, epilepsy or dementia, unstable or uncompensated respiratory, cardiovascular, liver, or kidney disease, uncontrolled hypertension \\[i.e., hypertension of CTCAE grade 2 or higher despite treatment\\]); (4)Active hemorrhage or newly developed thrombotic disease. (5)Renal failure with CKD grade 5 and undergoing dialysis treatment.","ALL","18 Years",{"count":72,"type":73},35,"ESTIMATED","INTERVENTIONAL",[76],"PHASE2","This study is designed as an open-label, single-arm, single center, phase II clinical trial, aiming to evaluate the efficacy of neoadjuvant Tislelizumab combined with Nab-Paclitaxel for patients with non-metastatic upper tract urothelial carcinoma (UTC). Patients enrolled will receive 2-3 cycles of Tislelizumab in combination with Nab-Paclitaxel every 3 weeks and then undergo radical nephroureterectomy (RNU). The assessment of efficacy is based on the histology of specimen from RNU, and treatment-related adverse events (TRAEs) will be recorded and evaluated according to CTCAE 5.0.",[79,80,81,82],"Upper Tract Urothelial Carcinoma","Neoadjuvant Therapy","PD-1 Inhibitor","Nab-paclitaxel","2025-08-15",{"date":85,"type":86},"2025-08-17","ACTUAL",{"date":88,"type":86},"2025-07-05",{"date":90,"type":73},"2030-12-30",{"name":5,"class":6},1]