eligibility_summary
Adults ≥18, HER2+ (IHC ≥1+) measurable disease, fit for TURBT/RC, ineligible for or refusing cisplatin (CrCl <60 with PS0–1, PS2 if RC-eligible, or ≥G2 hearing loss/neuropathy). Adequate organ function (LVEF ≥50%, Hb ≥9, ANC ≥1.5, Plt ≥100, bili ≤1.5×ULN). Contraception, compliance required. Exclude: drug allergy, unresolved >G1 AEs, recent major surgery/vaccine, active HIV/TB/HBV/HCV, other cancer ≤5y, CNS mets, uncontrolled disease, immunosuppression, NYHA III, pregnancy/lactation.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT06341400 tests perioperative RC48-ADC (disitamab vedotin) plus toripalimab in cisplatin-ineligible muscle-invasive bladder cancer. RC48-ADC is a HER2-targeted antibody–drug conjugate (ADC) carrying MMAE, a microtubule-disrupting cytotoxin. Mechanism: binds HER2 on urothelial tumor cells (IHC ≥1+), internalizes, releases MMAE to inhibit microtubules and induce apoptosis, with potential ADCC. Toripalimab is a humanized anti–PD-1 monoclonal antibody (immune checkpoint inhibitor) that blocks PD-1 on T cells to restore antitumor immunity. Targeted cells/pathways: HER2-expressing bladder cancer cells, microtubule dynamics via MMAE, and the PD-1/PD-L1 axis in the tumor microenvironment, reactivating cytotoxic T cells. Used as neoadjuvant and adjuvant therapy to improve pCR, with biomarker analyses planned.