PTC-guided Neoadjuvant Therapy For Muscle-invasive Bladder Cancer

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorThe Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • PTC guided individualized neoadjuvant therapy

Treatment groups

35 Participants
are divided into 1 treatment group