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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Rutin 40 mg tid. Treatment will be given for 2 cycles (21 days per cycle)
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 200 mg D1 q3w Treatment will be given for 2 cycles (21 days per cycle)
First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
RECRUITINGTumor microenvironment
Immune microenvironment and epigenetic alterations in bladder tumors, including immune cell components.
Time frame: From enrollment to the end of treatment at 6 weeks
Safety and adverse events
The description of adverse events will be coded according to MedDRA terminology and graded according to NCI-CTCAE v5.0.
Time frame: From enrollment to the end of treatment at 6 weeks
Objective remission rate
The proportion of patients with complete response (CR), partial response (PR), stable disease (SD), and progressive disease (PD) after treatment was calculated according to established response evaluation criteria (Response Evaluation Criteria in Solid Tumors \[RECIST\], version 1.1). Definitions: CR (Complete Response): Disappearance of all target lesions with no new lesions. PR (Partial Response): ≥30% decrease in the sum of diameters of target lesions. SD (Stable Disease): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. PD (Progressive Disease): ≥20% increase in the sum of diameters of target lesions and/or appearance of new lesions
Time frame: From enrollment to the end of treatment at 6 weeks
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