Nimotuzumab with chemoradiotherapy for newly diagnosed, high-risk, locally advanced squamous cervical cancer (CC11): A prospective single-arm phase II study.

5521 Background: Cervical cancer ranks as the fourth most common cancer, with 32% of cases being locally advanced (stage IIB-IVA, LACC). The standard treatment is concurrent chemoradiotherapy (CCRT) with platinum drugs, but many patients only achieve partial or short-term remission. Nimotuzumab has shown promise in treating LACC, but few studies focus on high-risk cases (FIGO 2018 III-IVA). This study aims to evaluate the efficacy and safety of combining nimotuzumab with CCRT for high-risk LACC. (NCT06771596). Methods: Patients aged 18-75 with confirmed cervical squamous cell carcinoma, an ECOG status of 0-2, and at least one measurable lesion were eligible. All patients received nimotuzumab 400 mg weekly for 4-6 weeks combined with CCRT. CCRT included external beam radiotherapy (45 Gy/1.8Gy/25 fractions) using volumetric modulated arc therapy (VMAT), concurrent with weekly cisplatin (40mg/m 2 for 4-6 weeks), followed by image-guided high-dose-rate brachytherapy, aiming for a cumulative dose ≥87 Gy (EQD2). The primary endpoint was 1-, 2-year progression free survival (PFS) per RECIST 1.1. The secondary endpoints were 1-, 2-year overall survival (OS), objective response rate (ORR), disease control rate (DCR) rate per RECIST v1.1, and safety per CTCAE v5.0. Results: In total, 40 patients were enrolled. The baseline characteristics are shown in the table. 36 (90%) patients had CR, 3 (7.5%) patients had PR, ORR was 97.5% (95% CI: 86.84%-99.94%), and DCR was 97.5% (95% CI: 86.84%-99.94%). The median follow-up time was 21.32 months (95% CI: 20.01~24.34) months, with mPFS and mOS not yet reached. The 1-, 2-year PFS rates were 79.11% (95% CI: 62.53%-88.97%) and 76.29% (95% CI: 59.33%-86.91%), respectively, and 1-, 2-year OS rate were 100% (95% CI: 100%~100%) and 85.27% (95% CI: 64.8%~94.32%). The most common AEs were leukopenia (42.5%), myelosuppression (40%), and anemia (37.5%), all of which were graded 1-2. Conclusions: Nimotuzumab combined with chemoradiotherapy in the treatment of high-risk squamous LACC demonstrated prolonged PFS and favorable safety profile. Clinical trial information: NCT06771596 . Baseline characteristics. Characteristic All patients (n=40) Age (mean ± SD, years) 53.9±11.69 FIGO stage IIIA-IIIB 6(15.0%) IIIC1R-IIIC2R 33(82.5%) IVA 1(2.5%) Tumor differentiation Low differentiation 8(20.0%) Medium differentiation 1(2.5%) Highly differentiation 31(77.5%)