eligibility_summary
Adults ≥18 with non‑metastatic MIBC (cT2–T4aN0–1M0 or cT1–4aN1M0, pelvic cN1 only), cisplatin‑unfit/refusing, RC/PLND‑eligible, TURBT ≤12 wks with tissue. Variant histology allowed except any neuroendocrine, ECOG 0–2, adequate marrow/renal/hepatic/coag labs, contraception, agree to surgery. Exclude: unresectable/metastatic, medically unfit, recent systemic/radiation, active infection or HBV/HCV, active IBD, major surgery ≤3 wks, serious cardiac dz, invasive upper‑tract/urethral UC, conflicting cancers/trials, pregnancy/lactation, SG allergy, prior topo‑1, organ transplant, Gilbert’s, prohibitive meds.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase II single-arm neoadjuvant trial in non-urothelial muscle-invasive bladder cancer testing sacituzumab govitecan (Trodelvy), an antibody–drug conjugate. Drug type/mechanism: a humanized monoclonal antibody (sacituzumab) targets TROP-2 on tumor cells and delivers SN-38 (govitecan), a cytotoxic topoisomerase I inhibitor (camptothecin derivative). Binding to TROP-2 enables internalization and intracellular release of SN-38, inhibiting Topo I, causing DNA damage and tumor cell death. After 3 cycles, patients undergo radical cystectomy and pelvic lymph node dissection. Targets: TROP-2–expressing bladder cancer cells, topoisomerase I/DNA replication pathway.