[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100607533":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":40,"centralContacts":41,"locations":51,"responsibleParty":70,"collaborators":40,"id":72,"slug":73,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":74,"sex":80,"minAge":81,"maxAge":40,"enrollmentInfo":82,"targetDuration":40,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":94,"overallStatus":109,"whyStopped":40,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":119},{"fullName":5,"class":6},"First Affiliated Hospital of Wenzhou Medical University","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Combination: Toripalimab + Intravesical GEM-MMC","EXPERIMENTAL","Toripalimab IV Q3W starting with the first intravesical cycle, plus sequential intravesical gemcitabine followed by mitomycin C in the same visit. Induction weekly ×6; if no recurrence at first tumour assessment (\\~month 3), monthly maintenance up to 24 months.",[13,14,15],"Drug: Toripalimab","Drug: Gemcitabine (GEM)","Drug: Mitomycin C (MMC)",{"label":17,"type":18,"description":19,"interventionNames":20},"Monotherapy: Toripalimab Alone","ACTIVE_COMPARATOR","Toripalimab IV every 3 weeks (Q3W) up to 24 months or until disease progression, unacceptable toxicity, or withdrawal; no intravesical chemotherapy.",[13],[22,30,36],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DRUG","Toripalimab","PD-1 inhibitor administered intravenously every 3 weeks (Q3W) for up to 24 months. Starts during the first intravesical treatment cycle.",[9,17],[28,29],"JS001","Tuoyi",{"type":23,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"Gemcitabine (GEM)","Intravesical instillation as part of a sequential regimen with mitomycin C: weekly for 6 weeks (induction); if no recurrence at first tumour assessment (\\~month 3), maintenance instillations continue monthly up to 24 months.",[9],[35],"GEM",{"type":23,"name":37,"description":38,"armGroupLabels":39,"otherNames":40},"Mitomycin C (MMC)","Intravesical instillation immediately after intravesical gemcitabine in the same visit (sequential regimen): weekly for 6 weeks (induction); if eligible, monthly maintenance up to 24 months.",[9],null,[42,47],{"name":43,"role":44,"phone":45,"phoneExt":40,"email":46},"Qi Lin, MM","CONTACT","+8615205771010","devillynch@126.com",{"name":48,"role":44,"phone":49,"phoneExt":40,"email":50},"Wei Chen, MD","+8613857771505","wzmuchenwei@163.com",[52],{"facility":53,"status":40,"city":54,"state":55,"zip":56,"country":57,"countryCode":58,"cosmosGeoPoint":59,"geoPoint":64,"contacts":65},"The First Affiliated Hospital of Wenzhou Medical University","Wenzhou","Zhejiang","325000","China","CN",{"type":60,"coordinates":61},"Point",[62,63],120.66682,27.99942,{"lat":63,"lon":62},[66],{"name":67,"role":44,"phone":68,"phoneExt":40,"email":69},"Hang Huang, MD","+8613738301029","Huanghang163@163.com",{"type":71,"investigatorFullName":40,"investigatorTitle":40,"investigatorAffiliation":40,"oldNameTitle":40,"oldOrganization":40},"SPONSOR","100607533","phase-2-toripalimab--sequential-intravesical-gemcitabine-mitomycin-c-for-bcg-unresponsive-intolerant-high-risk-nmibc-open-label-randomized-phase-2-study-100607533",false,"NCT07189793","Toripalimab ± Sequential Intravesical Gemcitabine-Mitomycin C for BCG-Unresponsive\u002F-Intolerant High-Risk NMIBC: Open-Label Randomized Phase 2 Study","Toripalimab With Sequential Intravesical Gemcitabine-Mitomycin C Versus Toripalimab Alone for the Treatment of BCG-Unresponsive\u002F-Intolerant High-Risk Non-Muscle-Invasive Bladder Cancer: An Open-Label, Randomized, Multicenter, Phase 2 Study","OHAI-NMIBC-01","Inclusion Criteria:\n\n1. Age ≥18 years; sex: all; signed written informed consent by the participant or legally authorised representative.\n2. Histologically confirmed high-risk non-muscle-invasive bladder cancer (HR-NMIBC), defined as any T1, high-grade Ta, and\u002For carcinoma in situ (CIS).\n3. BCG-intolerant (unable to continue BCG because of severe adverse reactions) or meeting at least one definition of BCG treatment failure:\n\n   1. Persistent or recurrent CIS within 12 months after completion of adequate BCG (with or without concomitant NMIBC);\n   2. Recurrent high-grade Ta\u002FT1 within 6 months after completion of adequate BCG;\n   3. High-grade T1 at the first evaluation after BCG induction (\\~3 months);\n   4. Ta high-grade and\u002For CIS present or recurrent at \\~3 months after receiving ≥5 BCG instillations.\n\n   Adequate BCG, for the purposes of this protocol, is defined as receipt of at least 5 of 6 induction instillations (maintenance not required).\n4. ECOG performance status 0-2.\n5. Adequate organ function per protocol laboratory criteria.\n6. No intravesical chemotherapy or immunotherapy between the most recent cystoscopy\u002FTURBT and study start; a single immediate postoperative intravesical chemotherapy at the time of the most recent cystoscopy\u002FTURBT is allowed during screening per local practice.\n7. Willing and able to comply with study procedures.\n\nExclusion Criteria:\n\n1. Muscle-invasive bladder cancer (T2-T4).\n2. Low-grade (LG) recurrence during or after BCG therapy.\n3. Concomitant upper tract urothelial carcinoma, or lymph-node\u002Fdistant metastasis.\n4. Indwelling ureteral stent or known vesicoureteral reflux.\n5. Contraindications to intravesical instillation, including within 2 weeks after TURBT, bladder perforation, symptomatic urinary tract infection, or gross haematuria.\n6. Known hypersensitivity or contraindication to gemcitabine, mitomycin C, or toripalimab.\n7. Systemic chemotherapy, small-molecule targeted therapy, or radiotherapy within 2 weeks before first study treatment.\n8. Prior immune checkpoint inhibitor therapy.\n9. Pregnant, planning pregnancy, or breastfeeding women.\n10. Ongoing acute or chronic systemic infection, or history of active tuberculosis.\n11. Other malignancy requiring active treatment.\n12. Any condition that, in the investigator's judgment, makes participation not in the patient's best interest or could confound study results.\n\nStudy Population Adults with BCG-unresponsive or BCG-intolerant HR-NMIBC treated at participating centres in China.","ALL","18 Years",{"count":83,"type":84},106,"ESTIMATED","INTERVENTIONAL",[87],"PHASE2","This open-label, randomised, multicentre, phase 2 study (OHAI-NMIBC-01) compares toripalimab plus sequential intravesical gemcitabine followed by mitomycin C (GEM→MMC) with toripalimab alone in adults with BCG-unresponsive or BCG-intolerant high-risk non-muscle-invasive bladder cancer (HR-NMIBC). Two prespecified cohorts are analysed: (1) CIS cohort (CIS with\u002Fwithout Ta\u002FT1) and (2) non-CIS cohort (high-risk Ta\u002FT1 without CIS). In the combination arm, intravesical GEM→MMC is given weekly for 6 weeks (induction) and, for patients without recurrence at the first tumour assessment (\\~month 3), monthly maintenance continues up to 24 months or until progression\u002Funacceptable toxicity; toripalimab IV every 3 weeks starts during the first intravesical cycle and continues up to 24 months or until progression\u002Funacceptable toxicity. The monotherapy arm receives toripalimab IV every 3 weeks up to 24 months or until progression\u002Funacceptable toxicity. Cystoscopy and urine cytology are performed every 3 months; imaging every 24 weeks. Primary endpoints are 3-month complete response (CR) rate in the CIS cohort and median recurrence-free survival (RFS) in the non-CIS cohort. Secondary endpoints include landmark CR, PFS and OS, RFS\u002FHG-RFS landmarks in the non-CIS cohort, and safety (CTCAE v5.0). Exploratory analyses will assess outcomes by protocol-defined PD-L1 status. Approximately 106 participants will be enrolled at multiple sites in China.",[90,91,92,93],"Urinary Bladder Neoplasms","Carcinoma, Transitional Cell","Carcinoma in Situ of Bladder","Non-Muscle-Invasive Bladder Cancer",[95,96,97,98,99,100,101,102,103,104,105,106,24,107,108],"NMIBC","High-Risk NMIBC","BCG-Unresponsive","BCG-Intolerant","BCG Failure","Carcinoma in Situ (CIS)","Intravesical Therapy","Ta","T1","Gemcitabine","Mitomycin C","GEM-MMC","PD-1 Inhibitor","Bladder-Sparing","NOT_YET_RECRUITING","2025-09-17",{"date":112,"type":113},"2025-09-24","ACTUAL",{"date":115,"type":84},"2025-10",{"date":117,"type":84},"2028-10",{"name":5,"class":6},1]