Toripalimab combined with definitive chemoradiotherapy for locally advanced cervical squamous cell carcinoma patients (TRACE): A single-arm, phase I/II trial

• DOI: 10.1007/s00262-024-03823-1
• Publication Date: 2024-10-03T01:01:16Z
• Authors: Dan Ou; Rong Cai; Wei-Xiang Qi; Can Cui; Lu Cao; Shu-Bei Wang; Huan Li; Tao Ma; Ying Miao; Cheng Xu; Gang Cai; Wei-Guo Cao; Yun-Sheng Gao; Jia-Yi Chen; Hao-Ping Xu
• Keywords: Adult; Research; Antineoplastic Combined Chemotherapy Protocols; Carcinoma, Squamous Cell; Humans; Uterine Cervical Neoplasms; Female; Chemoradiotherapy; Middle Aged; Antibodies, Monoclonal, Humanized; Aged

This phase I/II trial (ChiCTR2000032879) assessed the safety and efficacy of toripalimab combined with chemoradiotherapy for locally advanced cervical squamous cell carcinoma.Twenty-two patients, regardless of their programmed death ligand-1 (PD-L1) status, received toripalimab combined with concurrent chemoradiotherapy (CCRT). CCRT included cisplatin (40 mg/m2, once weekly for 5 weeks), radiotherapy (45-50.4 Gy/25-28 Fx, 5 fractions weekly), followed by brachytherapy (24-30 Gy/3-5 Fx) and toripalimab (240 mg, intravenous) on days 1, 22 and 43 during CCRT. The primary endpoints were safety and 2-year progression-free survival (PFS). The secondary endpoints included 2-year local control (LC), local regional control and overall survival (OS).All patients successfully completed CCRT and toripalimab treatment. Grade III and higher adverse events (AEs) were observed in 11 patients (11/22, 50%), and no patient experienced grade V AEs. The objective response rate (ORR) was 100%. At the data cutoff (June 30, 2023), the median follow-up was 31.8 months (9.5 to 37.8 months). The 2-year PFS rate was 81.8%. The 2-year LC and local regional control rates were both 95.5%, and the 2-year OS rate was 90.9%.Toripalimab combined with CCRT achieved good tolerance and showed promising anti-tumor effects in patients with locally advanced cervical cancer.