Status:
NOT_YET_RECRUITING
Toripalimab ± Sequential Intravesical Gemcitabine-Mitomycin C for BCG-Unresponsive/-Intolerant High-Risk NMIBC: Open-Label Randomized Phase 2 Study
Lead Sponsor:
First Affiliated Hospital of Wenzhou Medical University
Conditions:
Urinary Bladder Neoplasms
Carcinoma, Transitional Cell
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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...
Detailed Description
Rationale and Objectives. A substantial proportion of HR-NMIBC patients are BCG-unresponsive or BCG-intolerant and face early high-grade recurrence and consideration of cystectomy. This trial evaluate...
Eligibility Criteria
Inclusion
- Age ≥18 years; sex: all; signed written informed consent by the participant or legally authorised representative.
- Histologically confirmed high-risk non-muscle-invasive bladder cancer (HR-NMIBC), defined as any T1, high-grade Ta, and/or carcinoma in situ (CIS).
- BCG-intolerant (unable to continue BCG because of severe adverse reactions) or meeting at least one definition of BCG treatment failure:
- Persistent or recurrent CIS within 12 months after completion of adequate BCG (with or without concomitant NMIBC);
- Recurrent high-grade Ta/T1 within 6 months after completion of adequate BCG;
- High-grade T1 at the first evaluation after BCG induction (\~3 months);
- Ta high-grade and/or CIS present or recurrent at \~3 months after receiving ≥5 BCG instillations.
- Adequate BCG, for the purposes of this protocol, is defined as receipt of at least 5 of 6 induction instillations (maintenance not required).
- ECOG performance status 0-2.
- Adequate organ function per protocol laboratory criteria.
- No intravesical chemotherapy or immunotherapy between the most recent cystoscopy/TURBT and study start; a single immediate postoperative intravesical chemotherapy at the time of the most recent cystoscopy/TURBT is allowed during screening per local practice.
- Willing and able to comply with study procedures.
Exclusion
- Muscle-invasive bladder cancer (T2-T4).
- Low-grade (LG) recurrence during or after BCG therapy.
- Concomitant upper tract urothelial carcinoma, or lymph-node/distant metastasis.
- Indwelling ureteral stent or known vesicoureteral reflux.
- Contraindications to intravesical instillation, including within 2 weeks after TURBT, bladder perforation, symptomatic urinary tract infection, or gross haematuria.
- Known hypersensitivity or contraindication to gemcitabine, mitomycin C, or toripalimab.
- Systemic chemotherapy, small-molecule targeted therapy, or radiotherapy within 2 weeks before first study treatment.
- Prior immune checkpoint inhibitor therapy.
- Pregnant, planning pregnancy, or breastfeeding women.
- Ongoing acute or chronic systemic infection, or history of active tuberculosis.
- Other malignancy requiring active treatment.
- Any condition that, in the investigator's judgment, makes participation not in the patient's best interest or could confound study results.
- Study Population Adults with BCG-unresponsive or BCG-intolerant HR-NMIBC treated at participating centres in China.
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2028
Estimated Enrollment :
106 Patients enrolled
Trial Details
Trial ID
NCT07189793
Start Date
October 1 2025
End Date
October 1 2028
Last Update
September 24 2025
Active Locations (1)
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1
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China, 325000