Neoadjuvant chemoradiotherapy plus sequential tislelizumab followed by surgery for esophageal carcinoma (CRISEC study): A single-arm, bicentric, phase 2 trial.

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Tác giả: Fengjun Cao, Lei Huang, Ke Jiang, Cui Liu, You Qin, Yue Qu, Buhai Wang, Xiaolin Wang, Jielin Wei, Lu Wen, Bian Wu, Guangqin Xiao, Shijie Xing, Jinsong Yang, Kunyu Yang, Zhanjie Zhang, Zhigang Zuo

Ngôn ngữ: eng

Ký hiệu phân loại: 627.12 Rivers and streams

Thông tin xuất bản: Ireland : Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology , 2025

Mô tả vật lý:

Bộ sưu tập: NCBI

ID: 233386

BACKGROUND AND PURPOSE: To explore the efficacy and safety of neoadjuvant chemoradiotherapy (NCRT) plus sequential tislelizumab followed by surgery for esophageal squamous cell carcinoma (ESCC). MATERIALS AND METHODS: This single-arm, bicentric, phase 2 trial enrolled patients with resectable or potentially resectable thoracic ESCC to receive neoadjuvant radiotherapy (41.4 Gy in 23 fractions) with concurrent chemotherapy (albumin-bound paclitaxel, 50-100 mg/m RESULTS: Of the 30 patients enrolled from January 2021 to October 2022, 24 (80.0 %) completed planned surgery and gained R0 resection (100 %). Among the 24 patients, nine (37.5 %) achieved pCR and 21 (87.5 %) achieved MPR. Ten patients (35.7 %) developed grade 3-4 toxicities during tislelizumab therapy, including lymphopenia (32.1 %), neutropenia (3.6 %), and thrombocytopenia (3.6 %). Grade 5 hematemesis occurred in two patients and both were attributed to aortic invasion. Three patients (12.5 %) developed grade 3 postoperative complications, including pulmonary infection (8.3 %) and hoarseness (4.2 %). After a median follow-up of 35.4 months, the 2-year OS and DFS rates were 83.3 % and 79.2 %, respectively. CONCLUSION: Sequential tislelizumab after NCRT in ESCC is safe and feasible. Further study is warranted to validate the efficacy of this combination mode.
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