eligibility_summary
Inclusion: adults ≥18 with histologically confirmed non‑metastatic MIBC (cT2–T4a, N0–1, M0), survival ≥12 weeks, no prior systemic therapy/radiation, eligible for radical cystectomy + PLND, HER2 IHC 1+/2+/3+, ECOG 0–1, adequate organ function, contraception, adherence. Exclusion: prior antitumor therapy, major surgery/live vaccine <4 wks, HBV/HCV/HIV, NYHA III HF, active infection, uncontrolled HTN/DM/ILD/COPD, autoimmune Tx <2 yrs, other recent cancers, pregnancy/lactation, noncompliance.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Interventions: RC48-ADC (disitamab vedotin), an anti-HER2 antibody–drug conjugate carrying MMAE (a microtubule inhibitor), and AK104 (cadonilimab), a bispecific immune checkpoint antibody targeting PD‑1 and CTLA‑4. Mechanisms: RC48-ADC binds HER2 on tumor cells, is internalized, and releases MMAE to disrupt tubulin, causing cell-cycle arrest/apoptosis, Fc functions may add ADCC against HER2+ cells. AK104 simultaneously blocks PD‑1 and CTLA‑4 to reinvigorate effector T cells and diminish Treg-mediated suppression, boosting antitumor immunity. Targets/pathways: HER2 receptor on bladder cancer cells, microtubule cytoskeleton, PD‑1/PD‑L1 axis and CTLA‑4 checkpoint on T cells in the tumor microenvironment. Setting: perioperative (neoadjuvant/adjuvant) therapy for HER2-expressing MIBC.