NCT07189793View on ClinicalTrials.gov

Toripalimab ± Sequential Intravesical Gemcitabine-Mitomycin C for BCG-Unresponsive/-Intolerant High-Risk NMIBC: Open-Label Randomized Phase 2 Study

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

106

Participants

Timeline

Start Date

October 31, 2025

Primary Completion Date

October 31, 2027

Study Completion Date

October 31, 2028

Conditions
Urinary Bladder NeoplasmsCarcinoma, Transitional CellCarcinoma in Situ of BladderNon-Muscle-Invasive Bladder Cancer
Interventions
DRUG

Toripalimab

PD-1 inhibitor administered intravenously every 3 weeks (Q3W) for up to 24 months. Starts during the first intravesical treatment cycle.

DRUG

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.

DRUG

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.

Trial Locations (1)

325000

The First Affiliated Hospital of Wenzhou Medical University, Wenzhou

All Listed Sponsors
lead

First Affiliated Hospital of Wenzhou Medical University

OTHER

NCT07189793 - Toripalimab ± Sequential Intravesical Gemcitabine-Mitomycin C for BCG-Unresponsive/-Intolerant High-Risk NMIBC: Open-Label Randomized Phase 2 Study | Biotech Hunter | Biotech Hunter