eligibility_summary
Adults 18–75 with unresectable/recurrent/metastatic ESCC, no prior systemic therapy or relapse >6 mo post adjuvant/radical, measurable disease, ECOG 0–1, >3 mo survival, adequate organs/marrow/cardiac/coag, contraception. Exclude prior EGFR/PD-1/PD-L1/CTLA-4, obstruction/bleeding/fistula risk, recent major surgery, liver mets >50%, uncontrolled CV, infection, renal/hepatic disease, diabetes, CNS mets or significant effusions/ascites, ILD, autoimmune/immunosuppression, pregnancy, other serious illness.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase II, open-label, single-arm trial in China testing: 1) Nimotuzumab—humanized anti-EGFR IgG1 monoclonal antibody, blocks EGFR ligand binding, inhibiting RAS/RAF/MEK/ERK and PI3K/AKT signaling and can trigger ADCC. 2) Sintilimab—anti-PD-1 IgG4 monoclonal antibody, immune checkpoint inhibitor that blocks PD-1/PD-L1 to restore T-cell function. 3) Nab-paclitaxel—taxane antimicrotubule chemotherapeutic, stabilizes microtubules to arrest mitosis. 4) Cisplatin—platinum DNA crosslinker, causes DNA damage and apoptosis. Targets/pathways: EGFR on ESCC tumor cells, PD-1 on T cells (reinvigorating CD8+ cytotoxic T cells), NK cell-mediated ADCC, tumor microtubule dynamics, DNA damage/repair and apoptosis pathways. Maintenance: nimotuzumab + sintilimab after 4–6 cycles of TP chemotherapy.