Anlotinib Plus Camrelizumab And Chemotherapy As First-Line Treatment In Patients With Advanced Esophageal Squamous Cell Carcinoma

Purpose Advanced esophageal squamous cell carcinoma (ESCC) patients exhibit a ~ 50% objective response rate (ORR) and median progression-free survival (mPFS) of just 5–7 months when undergoing first-line immune-chemotherapeutic treatment, underscoring pronounced unmet clinical need. We assessed the efficacy and safety of Anlotinib plus Camrelizumab and chemotherapy for advanced, unresectable, or metastatic ESCC. Patients and methods This is an open-label, investigator-initiated, phase 2, non-randomized clinical trial enrolled patients from August 3, 2020, to August 10, 2022. Patients with treatment-naive unresectable stage III or IV ESCC received treatment which was patient-selected, including chemotherapy + camrelizumab + Anlotinib (TCAC group) or chemotherapy + Camrelizumab (TCC group) induction therapy for 4–6 cycles, followed by maintenance therapy. The primary endpoint was ORR, while secondary endpoints included mPFS, median overall survival (mOS), disease control rate (DCR), and treatment-related adverse events (TRAEs). Results 30 patients were included in each group. Over a median 14.5-month follow-up period, the ORR was 90.0%, 43.3%( P  < 0 .001) and the mPFS was 16.03, 7.30 months (HR 0.35, 95%CI, 0.19–0.65; P  < 0 .001) in TCAC and TCC groups, respectively. Grade 3 TRAEs were experienced by 12 (40.0%) patients in TCAC group, including decreased neutrophil counts (5 [16.7%]), decreased white blood cell counts (4 [13.3%]), reduced platelet counts (3 [10%]), and hypertension (2 [6.7%]). No patients experienced grade 4–5 TRAEs. Conclusion The combination of Anlotinib plus Camrelizumab and chemotherapy had promising efficacy among patients with advanced ESCC in this study, which may be a promising first-line treatment regimen. Trial registration Registered with ClinicalTrials.gov, NCT04471480. 15/07/2020