3104 - Comparison of Anlotinib and S-1 Combined with Radiotherapy in the Treatment of Elderly Patients with Inoperable Esophageal Squamous Cell Cancer: An Open-Label, Phase 2, Randomized Controlled Trial

G. Xiang¹, G. Chai², B. Lyu², Z. Li², B. Wang², and L. Zhao³; ¹Department of Radiation Oncology, Xijing Hospital, Air Force Medical University, Xian, China, ²Department of Radiation Oncology, Xijing Hospital, Air Force Medical University, Xian, Shaanxi, China, ³Department of Radiation Oncology, Xijing Hospital, Fourth Military Medical University, Xian, Shaanxi, China

Purpose/Objective(s): Concurrent chemoradiotherapy is one of the standard therapies for inoperable esophageal squamous cell carcinoma (ESCC). However, there is no standard treatment concerning elderly esophageal patients and oral chemotherapy agents including S-1 was often administrated in clinical practice. Anlotinib have been recommended by the guidelines for advanced ESCC in China owing to its superior efficacy and tolerance. This trial was designed to assess the feasibility and efficacy of anlotinib combined with concurrent radiotherapy in elderly patients with locally advanced ESCC. Materials/

Methods: This was a multi-center, prospective, randomized, controlled clinical trial. A total of 76 patients with inoperable ESCC, with clinical stage cT1b-T4b N0-N+ and age ranging from 70-85 years old, ECOG performance status = 2 were planned to be enrolled in anlotinib and S-1 group concurrent with radiotherapy with an allocation ratio of 1:1. Patients in anlotinib group received 2 cycles of anlotinib (12 mg, qd, D1-D14, q3w) and S-1 group received 2 cycles of S-1 (70 mg/m², bid, D1-D14, q3w). Concurrent radiotherapy was administrated at 50-60Gy in on 5 days per week. Primary endpoint was 1-year locoregional recurrence-free survival (LRFS) rate. Secondary endpoints included progression free survival (PFS), objective response rate (ORR), overall survival (OS), disease control rate (DCR) and safety. Based on a two-sided test for two proportions with 5.0% type I error and 80% power to detect an improvement in the rate of 1-year LRFS from 61% to 89%, Considering 10% of patients dropping out, 76 patients will be enrolled in this study.
Results: Not applicable
Conclusion: Not applicable