Anlotinib plus camrelizumab and chemotherapy as first-line treatment in patients with advanced esophageal squamous cell carcinoma.

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. 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). 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 0.001) and the mPFS was 16.03, 7.30 months (HR 0.35, 95%CI, 0.19-0.65; P < 0 0.001) in TCAC and TCC groups, respectively. Grade 3 TRAEs were experienced by 12 patients (40.0%) 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. 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.