[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Peter Black\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":68},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,42],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100525687","phase-2-multicenter-clinical-trial-of-st-02-for-ablation-of-upper-tract-urothelial-carcinoma-100525687",false,"NCT06124976","Multicenter Clinical Trial of ST-02 for Ablation of Upper Tract Urothelial Carcinoma","A Phase 2\u002F3 Multicenter Trial Evaluating the Safety and Efficacy of ST-02 (Mucoadhesive Gemcitabine Suspension) on Ablation of Urothelial Carcinomas in the Upper Urinary Tract","Inclusion Criteria:\n\n* Adult (≥ 18 years) male or female\n* Primary or recurrent low-grade (LG), noninvasive (Ta) Upper Tract Urothelial Carcinoma (UTUC) in the renal pelvis, infundibulum, and\u002For calyces, based on ureteroscopy, biopsy and cytology (disease assessment URS) performed within 8 weeks prior to or during the Screening Visit\n* At least 1 measurable papillary tumor measuring 5-15 mm\n* Low grade tumor(s) in the ipsilateral ureter. Every attempt should be made to ablate this tumor completely, but residual ipsilateral ureteral tumor is not an exclusion criterion.\n* Prior fully ablated low grade bladder tumor(s), without the need for intravesical therapy except for single-dose chemotherapy\n* A life expectancy of greater than 12 months\n* No active untreated urinary tract infection (UTI) as confirmed by urine culture or urinalysis\n* Women of Child bearing potential (WoCBP) and Males who have a WoCBP partner require a negative pregnancy test at the Screening visit and must use two acceptable contraceptives methods until six months post-treatment\n* All sexually active males must agree to use a condom during intercourse, for at least 48 h after each instillation\n* eGFR ≥10 mL\u002Fmin; weekly creatinine monitoring recommended during treatment for participants with eGFR \\\u003C30 mL\u002Fmin or a solitary functional kidney\n\nExclusion Criteria:\n\n* Have received Bacillus Calmette - Guerin (BCG) treatment for UTUC within 6 weeks prior to Visit 1 (D1)\n* Pregnant (positive urine pregnancy test), planning pregnancy during trial, breast-feeding, or of childbearing potential without reliable contraception\n* Unresolved infection requiring active treatment with systemic antimicrobial drugs\n* History of high-grade non-muscle invasive bladder cancer within the past 6 months\n* History of muscle-invasive bladder cancer during the past 2 years\n* Actively being treated or intend to be treated with intravesical or systemic chemotherapy during the duration of the trial\n* Urinary obstruction in the ipsilateral Upper Urinary Tract (UUT)\n* Any contraindicated to gemcitabine or sensitivity to gemcitabine or any of the ST-02 ingredients\n* Currently receiving another investigational agent or involved in a clinical trial with an investigational product within the past 30 days prior to Visit 1 (D1)\n* Active hepatitis B (chronic or acute) or active hepatitis C infection","ALL","18 Years",{"count":19,"type":20},70,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE2","PHASE3","The goal of this prospective clinical trial is to investigate the safety and efficacy of ST-02 (mucoadhesive gemcitabine suspension for pyelocaliceal instillation) to treat Upper Tract Urothelial Carcinoma (UTUC) in participants who have a low-grade tumor.\n\nThe main questions this study aims to answer are:\n\n1. Can ST-02 effectively eradicate UTUC by 3 months?\n2. Is ST-02 safe for patients with UTUC?\n\nParticipants in this study will receive ST-02, a new formulation with gemcitabine once weekly for six weeks. Gemcitabine is known to be an effective drug in treating urothelial carcinoma. This new formulation will be instilled directly into the upper urinary tract (renal pelvis) and will allow the chemotherapeutic to work locally for an extended period of time. The administration process will be retrograde (via a small catheter inserted up into the kidney, under anesthesia) or antegrade (via a nephrostomy, in the clinic) once weekly for six weeks. Safety and efficacy will be monitored for up to a year after the initial response assessment.",[27,28],"Urothelial Carcinoma of the Renal Pelvis and Ureter","Transitional Cell Cancer of the Renal Pelvis and Ureter","RECRUITING","2026-07-30",{"date":32,"type":33},"2026-08-03","ACTUAL",{"date":35,"type":33},"2024-06-19",{"date":37,"type":20},"2028-06",{"name":39,"class":40},"Peter Black","OTHER",8,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":50,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":21,"phases":53,"briefSummary":54,"conditions":55,"keywords":57,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":64,"leadSponsor":66,"locationsCount":67},"100557364","phase-2-neo-blast-neoadjuvant-therapy-for-bladder-cancer-followed-by-active-surveillance-vs-treatment-100557364","NCT06537154","NEO-BLAST: Neoadjuvant Therapy for Bladder Cancer Followed by Active Surveillance vs Treatment","Active Surveillance Versus Definitive Local Therapy for Patients Showing Clinical Complete Response Following Neoadjuvant Therapy for Muscle Invasive Bladder Cancer","NEO-BLAST","Inclusion Criteria:\n\n* Male or female \\>18 years\n* Primary urothelial or predominantly (\\>50%) urothelial carcinoma of the bladder with histologic evidence of muscularis propria invasion.\n* Clinical stage T2-T4aN0M0 (Radiographic lymphadenopathy greater than 1.5 cm in short axis by imaging must be proven by biopsy to be free of cancer)\n* No concomitant multifocal carcinoma in situ; a single focus is allowed.\n* ECOG performance status 0, 1, or 2.\n* Participants must be able to undergo pelvis MRI.\n* Medically appropriate candidate for radical cystectomy (assessed by uro-oncologist) or chemo-radiation (assess by radiation-oncologist and medical-oncologist)\n* Participants must be candidate to received standard of care (SOC) neoadjuvant systemic treatment at time of enrolment (assessed by medical-oncologist): 4 or more cycles of cisplatin-based chemotherapy (gemcitabine\u002Fcisplatin (GC) or methotrexate\u002Fvinblastine\u002FAdriamycin\u002Fcisplatin (MVAC) or dose-dense MVAC (ddMVAC). If SOC evolves from the time of trial design and enrolment, eligibility to any SOC NAT (for example immunotherapy and\u002For antibody drug conjugate, as per NCCN guideline) will be allowed.\n* Adequate bladder function and\u002For absence of significant urethral stricture to allow cystoscopic surveillance, as evaluate by urologist.\n\nExclusion Criteria:\n\n* Any component of small cell or plasmacytoid histology.\n* Prior systemic chemotherapy or immunotherapy (an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways) or antibody-drug conjugate (NECTIN-4, HER2 or other) : Participants who have received any previous systemic therapy for urothelial carcinoma or cytotoxic chemotherapy, immunotherapy or other targeted therapy for another malignancy within 2 year of study entry are ineligible.\n* No available bladder tumor tissue from prior TURBT for tumor sequencing.\n* Prior or concurrent malignancy of any other site EXCEPT for non-melanoma skin cancer OR low risk malignancy not requiring treatment (such as prostate cancer Grade Group 1 under adequate surveillance, carcinoma in situ of the breast, cervix, etc.) AND unless free of disease for ≥ 5 years. Other cancers at low risk of recurrence may be allowed after review by principal investigator.\n* Prior radiation therapy for bladder cancer.\n* Participants who have received experimental agents within 4 weeks of study entry.\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection (defined by current oral or intravenous antibiotic therapy), symptomatic congestive heart failure (NYHA \\>2), unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Pregnancy. People of childbearing potential must have a negative serum pregnancy test before general anesthesia procedure and MRI\n* No concurrent treatment on another clinical trial; supportive care trials or non-therapeutic trials (e.g., quality of life) are allowed.","19 Years",{"count":52,"type":20},688,[23,24],"Invasive bladder cancer is managed with neoadjuvant therapy followed by bladder removal (cystectomy). Research shows that approximately 40% of patient will have no remaining cancer left in their bladder after completion of the initial systemic treatment, and perhaps could have avoided the surgery. However, currently physicians lack the ability to identify these patients.\n\nThe investigators believe that by using advanced imaging (MRI), bladder biopsies and novel biomarkers that detect tumor DNA in blood, they can better identify participants without any remaining cancer after chemotherapy. This will make active surveillance of these participants safer. In this study, participants without evidence of residual cancer will be randomized to active surveillance vs conventional bladder treatment (bladder removal, or chemo-radiation of the bladder). This study will be a pilot randomized control trial (RCT), and if successful, it will transition to a larger phase 3 RCT.",[56],"Muscle-Invasive Bladder Carcinoma",[58,59],"Muscle invasive bladder urothelial carcinoma","Bladder Cancer","2025-07-28",{"date":62,"type":33},"2025-07-30",{"date":60,"type":33},{"date":65,"type":20},"2030-12-31",{"name":39,"class":40},1,""]