Abstract CT209: Camrelizumab plus chemotherapy as neoadjuvant treatment for resectable locally advanced esophageal squamous cell carcinoma (LA-ESCC): A single-center, randomized, phase II trial

Abstract Background: Neoadjuvant chemotherapy or chemoradiotherapy followed by surgery poses the standard treatment for resectable LA-ESCC. However, post-surgery recurrence remains a concern. The phase III ESCORT-1st trial demonstrated improved survival outcomes on the addition of camrelizumab to first-line chemotherapy over chemotherapy alone. This study aims to evaluate the efficacy and safety of neoadjuvant camrelizumab plus chemotherapy followed by surgery in resectable LA-ESCC. Methods: In this single-center, open-label, randomized, two-arm, phase II trial, patients with resectable thoracic LA-ESCC (T3-4a or TxN+M0, except T4b) were 1: 1 randomized to two groups for 3 cycles of neoadjuvant therapy, each lasting 3 weeks. Group A was treated with a combination of camrelizumab (200 mg, day 1), paclitaxel (80 mg/m², days 1 and 8), and cisplatin (75 mg/m², day 1). Group B received the same dose of camrelizumab and cisplatin, with albumin-bound paclitaxel (130 mg/m², days 1 and 8) instead. Surgery was scheduled within 3-10 weeks after the completion of neoadjuvant therapy. Adjuvant treatment was determined by the investigators, based on postoperative pathological findings. For biomarker analysis, blood and tissue samples were collected at baseline, after 2 cycles of neoadjuvant therapy, and postoperatively. The primary endpoint was the correlation between biomarkers and pathologic complete response (pCR, defined as ypT0N0). The second endpoints included event-free survival, overall survival, and safety. Clinical trial information: NCT04937673 Results: From June 2021 to April 2023, a total of 40 patients were enrolled: 20 patients in each group. By data cutoff on July 31st 2023, 19 patients in group A had completed 3 cycles of neoadjuvant therapy; 17 underwent surgery, with 2 refusals and 1 COVID-19-related delay. In group B, 17 patients completed neoadjuvant therapy, and surgery was performed on 14 patients with 5 refusals and 1 exclusion by investigators. R0 resection was achieved in 16 (94. 1%) patients from group A and 14 (100. 0%) from group B. In intention-to-treatment (ITT) analysis set, the pCR rate was numerically higher in groups A (30. 0% 95%CI: 11. 9- 54. 3%) compared to group B (10. 0% 95%CI: 1. 2-31. 7%). Similarly, a major pathologic response (tumor residual ≤10%) was observed in 50. 0% (95% CI: 27. 2-72. 8%) of group A and 35. 0% (95% CI: 15. 4-59. 2%) of group B patients. Postoperative complications were reported in 5 (29. 4%) and 4 (28. 6%) patients in groups A and B, respectively. Notably, 1 patient from group A developed grade ≥3 acute renal failure and 1 from group B experienced grade ≥3 pleural effusion requiring drainage. Grade ≥3 TEAEs occurred in 25. 0% patients from group A and 40. 0% from group B. Conclusions: In resectable LA-ESCC patients, neoadjuvant camrelizumab and cisplatin combined with paclitaxel or albumin-bound paclitaxel was well tolerated and showed promising anti-tumor activity. Citation Format: Zhihao Lu, Yanshuo Cao, Liang Dai, Fengxiao Dong, Lin Shen. Camrelizumab plus chemotherapy as neoadjuvant treatment for resectable locally advanced esophageal squamous cell carcinoma (LA-ESCC): A single-center, randomized, phase II trial abstract. In: Proceedings of the American Association for Cancer Research Annual Meeting 2024; Part 2 (Late-Breaking, Clinical Trial, and Invited Abstracts) ; 2024 Apr 5-10; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2024;84 (7Suppl): Abstract nr CT209.