Clinical trial · Interventional
Hyperthermic Intravesical Chemotherapy (HIVEC) in BCG-Non-Responsive High-Grade NMIBC Patients
Hyperthermic Intravesical Chemotherapy (HIVEC) In Patients With BCG-Non Responsive Or Intolerant High-Grade BCG-Infiltrating Non-Muscle-Infiltrating Bladder Cancer And Not Eligible For Radical Cystectomy: Phase II Study (SMG-Bladder 01).
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a Phase II, prospective, single-arm, open-label clinical study evaluating hyperthermic intravesical chemotherapy (HIVEC) with Mitomycin C in patients with high-grade, non-muscle-invasive bladder cancer (NMIBC) who are BCG-non-responsive or BCG-intolerant and are ineligible for, or refuse, radical cystectomy. Mitomycin C is an approved medicinal product used within routine clinical practice and administered with a CE-marked recirculation device (BRS Combat system) that maintains the solution at approximately 43°C for 60 minutes. The treatment schedule consists of 6 weekly induction instillations followed by 9 monthly maintenance instillations. The co-primary objectives are to describe the safety and toxicity profile of HIVEC, including treatment discontinuations due to procedure-related toxicity, and to estimate the 12-month recurrence-free survival (12moRFS). Secondary objectives include characterizing patterns of non-muscle-invasive and muscle-invasive recurrences, bladder cancer-specific survival, overall survival, and quality of life. Approximately 50 patients will be enrolled in this single-center pilot study to generate exploratory safety and efficacy data in this high-risk population and to support the design of future randomized trials
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
| Carcinoma in Situ of Bladder | Bladder Urothelial Carcinoma In Situ | ALIAS | 0.90 |
| Carcinoma, Transitional Cell, Bladder | Carcinoma | ONTOLOGY_EXACT | 0.85 |
| Non Muscle Invasive Bladder Cancer | — | UNRESOLVED | — |
| Urinary Bladder Neoplasms | Bladder Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hyperthermic Intravesical Chemotherapy (HIVEC) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- HIVEC Treatment Arm
- description
- Participants will receive Hyperthermic Intravesical Chemotherapy (HIVEC) with Mitomycin C according to the study protocol (induction + maintenance schedule). Mitomycin C is an approved medicinal product used within routine clinical practice. HIVEC is performed using a CE-marked recirculation system that maintains the solution at a controlled therapeutic temperature.
- interventionNames
- Procedure: Hyperthermic Intravesical Chemotherapy (HIVEC)
Primary outcomes (2)
- measure
- Treatment-Related Adverse Events (AEs)
- timeFrame
- Up to 12 months
- description
- Incidence, type, timing, and severity of adverse events graded according to NCI CTCAE v5.0. Includes local and systemic toxicities related to hyperthermic intravesical chemotherapy and the proportion of patients who discontinue treatment due to toxicity.
- measure
- 12-Month Recurrence-Free Survival (RFS)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥ 18 years. * Histologically confirmed high-grade non-muscle-invasive bladder cancer (NMIBC), including Ta, T1, and/or carcinoma in situ (CIS). * BCG-unresponsive or BCG-intolerant disease according to international definitions (persistent or recurrent high-grade NMIBC after adequate BCG therapy). * Patient is ineligible for, or refuses, radical cystectomy. * Candidate for hyperthermic intravesical chemotherapy (HIVEC) according to clinical judgment. * ECOG Performance Status 0-2. * Adequate organ function according to institutional standards. * Ability and willingness to comply with study procedures and follow-up schedule. * Written informed consent obtained. Exclusion Criteria: * Muscle-invasive bladder cancer (≥ T2) or metastatic disease. * Active urinary tract infection at baseline. * Previous treatment with HIVEC or other intravesical hyperthermia systems. * Known hypersensitivity to Mitomycin C or contraindications to intravesical chemotherapy. * Active uncontrolled bleeding or gross hematuria preventing intravesical instillation. * Upper urinary tract urothelial carcinoma. * Pregnant or breastfeeding women. * Any medical or psychological condition that, in the investigator's judgment, could interfere with study participation or compromise patient safety.
References
Publications (0)
Data not yet available