Rutin with tislelizumab and chemotherapy for bladder cancer not responding to platinum
Tests rutin with tislelizumab and GC chemotherapy in adults with muscle-invasive bladder cancer.
Plain-language title generated from the registry record
Registry title: Pilot Study on Rutin Combined With Tislelizumab and GC (Gemcitabine and Cisplatin) as Neoadjuvant Therapy for Platinum-refractory Muscle-invasive Bladder Cancer
Key facts
- Where
- Chongqing, ChinaSee the site
- Phase
- Phase 1
Where in China
- First Affiliated Hospital of Chongqing Medical UniversityChongqing, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- First Affiliated Hospital of Chongqing Medical University
- Trial code
- NCT06916494
- Record updated
- 10 April 2025
- Original description
This trial aims to evaluate the efficacy, safety, and biological mechanisms of rutin combined with tislelizumab and GC(Gemcitabine and Cisplatin) in platinum-refractory muscle-invasive bladder cancer patients. Key research questions include:Read full original descriptionShow less
A Single-Arm, Open-Label, Multicenter Pilot Study：Rutin Combined With Tislelizumab and GC (Gemcitabine and Cisplatin) for Platinum-refractory Muscle-Invasive Bladder Cancer
This trial aims to evaluate the efficacy, safety, and biological mechanisms of rutin combined with tislelizumab and GC(Gemcitabine and Cisplatin) in platinum-refractory muscle-invasive bladder cancer patients. Key research questions include:
1. Whether rutin regulates epigenetic mechanisms in tumor cells from platinum-refractory bladder cancer patients and modulates the tumor immune microenvironment. 2. Evaluating the safety and adverse events of the combination treatment in platinum-refractory bladder cancer patients. 3. Assessing the disease control rate in platinum-refractory bladder cancer patients receiving this therapy.
Patients with MIBC who exhibit no response (stable disease or progressive disease) after two cycles of neoadjuvant GC chemotherapy will receive two cycles of rutin combined with tislelizumab and GC. Safety and adverse events will be assessed after each cycle of combinational treatment. Therapeutic response will be evaluated by contrast-enhanced MRI, and surgical decisions (transurethral resection, partial cystectomy, or radical cystectomy) will be made by two senior urologists. Epigenetic alterations and the changes in immune microenvironment will be analyzed post-treatment.
Inclusion: Patients with cT2-cT4N0M0 muscle-invasive bladder cancer (MIBC); No response after 2 cycles of GC neoadjuvant chemotherapy; No prior use of systemic immunotherapy or target therapy; Tumor is measurable according to New response evaluation criteria in solid tumours: Revised RECIST guideline; ECOG (ZPS, 5-point scale) 0-1.
Exclusion: Patients with severe cardiac, cerebral, hepatic, or renal disease; Patients with mental illness and those without insight and unable to express exactly; Combined with malignant tumors of other organs; Systemic infectious diseases; Age less than 18 years; Severely malnourished patients.