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Trial result

Camrelizumab (PD-1) + nimotuzumab (EGFR mAb) delivers 32.6% ORR in 2L advanced ESCC

Trial ID
NCT03766178 on ClinicalTrials.gov
Cancer type
Esophageal Cancer
Published in
New in Oncology - September 24, 2026

Camrelizumab is an anti–PD-1 immune checkpoint inhibitor combined with nimotuzumab, an anti-EGFR monoclonal antibody, tested in a Chinese multicenter single-arm Phase II second-line study in advanced esophageal squamous cell carcinoma (ESCC) after progression on first-line therapy (n=46; NCT03766178); neither camrelizumab nor nimotuzumab is currently FDA approved in the US. Confirmed ORR was 32.6% with DCR 82.6%; median PFS was 9.13 months and median OS was 12.62 months, with similar ORR in immunotherapy-naïve vs ICI-pretreated patients (32.0% vs 33.3%); EGFR amplification correlated with higher ORR (47.1% vs 24.0%) and longer OS (13.17 vs 9.99 months). TRAEs occurred in 80.4% with grade ≥3 TRAEs in 8.7%—numerically lower high-grade toxicity than historical chemotherapy controls in this setting (e.g., ATTRACTION-3 chemo grade 3–4 TRAEs 63%; nivolumab mOS 10.9 vs chemo 8.4 months) and with OS in the ballpark/slightly above PD-1 monotherapy benchmarks (ATTRACTION-3 mOS 10.9 months; KEYNOTE-181 ESCC ORR 16.7% with pembrolizumab vs 7.4% with chemo).

Take home

If this holds up in a randomized trial, PD-1 + EGFR blockade could become a credible 2L option even after prior ICI exposure (a real unmet need), but the single-arm design plus small biomarker subsets (EGFR amp/MUC16/NOTCH3/MTAP) mean the “who benefits” story still needs hard confirmation.

Source: Read the original publication

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