A phase II trial of neoadjuvant chemotherapy combined with anti-angiogenesis therapy and immunotherapy for resectable stageII-IIIB esophageal squamous cell carcinoma.

• DOI: 10.1200/jco.2025.43.16_suppl.e16124
• Publication Date: 2025-05-28T16:24:35Z
• Authors: Yupeng Cai; Xing Yuan; Yu Du; Jiayang Fan; Yu Tong; Zhiming Chen; Zhizhi Wang; Siyang Feng; Shaobin Li; Di Lu; Kaican Cai
• Keywords: Neoadjuvant Therapy

e16124 Background: It has been proven that neoadjuvant therapy plays a vital part in the of resectable esophageal squamous cell carcinoma (ESCC). Several studies have shown adding immunotherapy to chemo (-radiation) can effectively improve R0 resection rate and even prognosis. Toripalimab widely used clinical practice advanced staged carcinoma. Anti-angiogenesis also an important role treating ESCC. Moreover, there few attempting add anti-angiogenesis chemotherapy for ESCC, but no results reported so far. This study aims explore safety efficacy combined with ESCC patients. Methods: prospective, single-center, single-arm, phase 2 trial recruits treatment-naive patients Twenty-five are planned be enrolled this study. Eligible those stage II IIIB from cT2N1-2M0 cT3N0-2M0, which pathologically diagnosed. They will receive 240mg plus Anlotinib 12mg (q.o.d. two weeks) (albumin-bound paclitaxel 200-260mg/m2 Carboplatin 200-400mg/m2) every three weeks four cycles. After 4-6weeks, radical surgery surgery, administered year depending on patients’ will. The primary endpoint is pCR, secondary endpoints include ORR, DCR, DFS OS. Results: In first study, 4 achieved allowing progress second phase. On basis Simon's Two-Stage design, 10 cT3N0-2M0 were recruited Nanfang Hospital, Southern Medical University November 1, 2023, June 25, 2024. analysis evaluated all (n = 10), pCR (40%,) mPR (20%). Evaluating by RECIST1.1 standard, ORR was 90% (9/10, 95% CI, 59.59-98.21) DCR 100% (10/10, 72.25-100), while 5(50%) (40%) CR PR respectively, 1 (10%) patient got SD. individual pathological not completely consistent imaging evaluation results. Among stage, 8 (80%) had treatment-related adverse events (TRAEs). More than 10% incidence included paresthesia 5), oral hemorrhage 2), leukopenia 2). G3-4 TRAEs dysphagia Conclusions: exhibited notable manageable profile Clinical information: NCT05996484 .