This study evaluates Patient-derived Tumor-like Cell Clusters (PTC)-guided individualized neoadjuvant therapy in patients with muscle-invasive bladder cancer who are candidates for radical cystectomy.
Histologically confirmed muscle-invasive urothelial carcinoma of the bladder, with clinical stage cT2-4aN0M0.
Medically suitable for radical cystectomy as assessed by the multidisciplinary team.
Expected survival of at least 18 months.
Estimated glomerular filtration rate (eGFR) ≥60 mL/min.
Non-urothelial carcinoma histology, or mixed histology with a predominant non-urothelial component, such as small cell carcinoma or adenocarcinoma.
Evidence of distant metastatic disease on imaging.
Uncontrolled or clinically significant comorbid illness, including but not limited to uncontrolled infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina, clinically significant arrhythmia, interstitial lung disease, severe chronic gastrointestinal disease associated with diarrhea, or psychiatric/social conditions that may limit compliance or increase study risk.
Known hypersensitivity or allergy to any study treatment, or history of autoimmune disease.
Single group
PTC guided individualized neoadjuvant therapy
DrugFresh tumor tissue will be collected before neoadjuvant treatment to generate Patient-derived Tumor-like Cell Clusters (PTC) for ex vivo drug sensitivity testing. Based on the PTC results, each participant will receive an individualized neoadjuvant regimen selected from gemcitabine plus cisplatin, disitamab vedotin (RC48), enfortumab vedotin, toripalimab, or their protocol-defined combinations. Treatment will be administered for up to 4 cycles before radical cystectomy and pelvic lymph node dissection.
Pathological Complete Response (pCR) Rate
Pathological complete response is defined as the proportion of participants with no residual viable tumor in the bladder and no pathological lymph node involvement, defined as ypT0N0, based on pathological assessment of surgical specimens obtained after radical cystectomy and pelvic lymph node dissection.
Pathological Downstaging (pDS) Rate
Pathological downstaging is defined as the proportion of participants with pathological stage lower than ypT2N0, including ypT0N0, based on surgical pathology after radical cystectomy and pelvic lymph node dissection.
Progression-Free Survival (PFS)
Progression-free survival is defined as the time from enrollment to disease progression or death from any cause, whichever occurs first.
Overall Survival (OS)
Overall survival is defined as the time from enrollment to death from any cause.
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Treatment-emergent adverse events are defined as adverse events occurring after initiation of study treatment, assessed according to CTCAE version 5.0.
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