eligibility_summary
Eligibility: Adults ≥18 with unresectable/recurrent/metastatic ESCC, HER2 IHC 2+/3+, measurable disease (RECIST), ECOG 0–1, survival ≥12 wks, adequate organ function, LVEF ≥50%, relapse >6 mo after prior (neo)adjuvant if given, contraception, consent. Exclude: recent other cancers, unstable CNS mets, autoimmune disease, serious cardiac disease, active infection/ILD, HIV or active HBV/HCV, allergy to biologics/platinum, systemic steroids, recent live vaccine, pregnancy, safety risks.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Interventions: Disitamab vedotin (RC48), an anti‑HER2 antibody–drug conjugate carrying MMAE (a microtubule‑inhibiting cytotoxin), camrelizumab, an anti–PD‑1 IgG4 monoclonal antibody (immune checkpoint inhibitor), and platinum chemotherapy (cisplatin or nedaplatin), DNA‑crosslinking cytotoxics. Mechanisms: RC48 binds HER2 on tumor cells, is internalized, and releases MMAE to disrupt microtubules, causing mitotic arrest/apoptosis and potential bystander killing. Camrelizumab blocks PD‑1 to reinvigorate exhausted T cells and enhance anti‑tumor immunity. Cisplatin/nedaplatin form DNA crosslinks, driving tumor cell death and may increase tumor immunogenicity. Targets/pathways: HER2/ERBB2 on ESCC cells, PD‑1/PD‑L1 immune checkpoint on T cells, microtubule dynamics, DNA damage/repair pathways. Phase I/II, single‑arm first‑line study in HER2 IHC 2+/3+ ESCC.