RecruitingPhase 1NCT06916494

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

A Single-Arm, Open-Label, Multicenter Pilot Study:Rutin Combined With Tislelizumab and GC (Gemcitabine and Cisplatin) for Platinum-refractory Muscle-Invasive Bladder Cancer


Sponsor

First Affiliated Hospital of Chongqing Medical University

Enrollment

10 participants

Start Date

May 1, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This pilot study is testing a new treatment approach combining rutin (a plant-based compound), the immunotherapy drug tislelizumab, and standard chemotherapy (gemcitabine and cisplatin) as pre-surgery treatment for patients with muscle-invasive bladder cancer that did not respond to chemotherapy alone. **You may be eligible if...** - You have been diagnosed with muscle-invasive bladder cancer (stage cT2 to cT4, no lymph node or distant spread) - Your cancer did not respond to 2 cycles of standard gemcitabine/cisplatin chemotherapy - You have not previously received immunotherapy or targeted therapy - Your general health status is good (ECOG 0-1) - Your cancer is measurable on imaging **You may NOT be eligible if...** - You are under 18 years of age - You have serious heart, brain, liver, or kidney conditions - You have severe malnutrition - You have another active cancer - You have an active systemic infection Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRutin

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

DRUGGemcitabine, 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)

DRUGTislelizumab

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


Locations(1)

First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

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NCT06916494


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