Pilot Study on Rutin Combined With Tislelizumab and GC (Gemcitabine and Cisplatin) as Neoadjuvant Therapy for Platinum-refractory Muscle-invasive Bladder Cancer

Condition(s) studied

Investigational drug(s) / intervention(s)

Rutin: Rutin 40 mg tid. Treatment will be given for 2 cycles (21 days per cycle)

Gemcitabine, Cisplatin: Cisplatin 100 mg/m² D2 q3w, and Gemcitabine 1000 mg/m² D1, D8 q3w. Treatment will be given for 2 cycles (21 days per cycle)

Tislelizumab: Tislelizumab 200 mg D1 q3w Treatment will be given for 2 cycles (21 days per cycle)

Study summary

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.

Eligibility

Primary outcome measure(s)

• Tumor microenvironment — From enrollment to the end of treatment at 6 weeks
  Immune microenvironment and epigenetic alterations in bladder tumors, including immune cell components.

Trial sites (1)

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