eligibility_summary
Include: MIBC T2–T4aN0M0, mixed UC ok except small cell/neuroendocrine, no prior systemic tx, declines/ineligible for radiosens chemo and/or cystectomy, ECOG ≤2, adequate organ/marrow and bladder function, TURBT and CT/MRI staging ≤60 d with no T4b or N1–3, no extravesical UC in past 24 mo. Exclude: investigational therapy ≤4 wks, prior pelvic RT or systemic/RT for (N)MIBC (intravesical ok), bilateral hydronephrosis or poor bladder function, SG allergy, uncontrolled illness, pregnant/breastfeeding.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 1 single-arm study of sacituzumab govitecan (Trodelvy) plus adaptive image-guided radiotherapy for bladder preservation in localized muscle-invasive bladder cancer. Drug/intervention: Sacituzumab govitecan is an antibody–drug conjugate (humanized anti–Trop-2 IgG1 linked to SN-38, a topoisomerase I inhibitor), given IV on days 1 and 8 of 21-day cycles (one cycle before, two cycles during radiation). Adaptive external-beam radiotherapy is individualized to daily anatomy. Mechanism: ADC binds Trop-2 on urothelial tumor cells, internalizes, and releases SN-38 to inhibit topoisomerase I, inducing DNA damage and apoptosis, SN-38 may radiosensitize, enhancing radiation-induced DNA breaks. Targets: Trop-2–expressing epithelial bladder cancer cells, topoisomerase I and DNA damage/repair pathways.