Organ Preservation via Immunotherapy-Based Total Neoadjuvant Therapy in Early Low Rectal Cancer (TORCH-E): A Multicenter, Open-label, Single-Arm, Phase II Study

作者：Fan Xia, Yajie Chen, Di Zhou, Juefeng Wan, Lijun Shen, Yaqi Wang, Jinluan Li, Hui Zhang, Yan Wang, Wang Yang, Menglong Zhou, Ruiyan Wu, Shujuan Zhou, Yikuan Chen, Dakui Luo, Wenchao Gu, Peng Lian, Junjie Peng, Fangqi Liu, Yiqun Sun, Lei Wang, Sanjun Cai, Zhen Zhang, Xinxiang Li · 发表于：Clinical Cancer Research · 年份：2025 · DOI：10.1158/1078-0432.ccr-25-0975 · 被引用次数：4 · 研究领域：Colorectal Cancer Surgical Treatments、Colorectal and Anal Carcinomas、Bladder and Urothelial Cancer Treatments

PURPOSE: Organ preservation (OP) can be preferred in low-lying rectal cancer to reduce morbidity from radical surgery. Immunotherapy-based total neoadjuvant therapy (iTNT) showed remarkable tumor regression and facilitated OP in locally advanced rectal cancer. This study evaluated the efficacy and safety of iTNT, comprising short-course radiotherapy followed by CAPOX and toripalimab, in enabling OP for early low rectal cancer. PATIENTS AND METHODS: TORCH-E was a multicenter, single-arm phase II trial enrolling patients with T2-3bN0 rectal adenocarcinoma ≤5 cm from the anal verge. Patients received short-course radiotherapy (25 Gy/5 Fx) followed by four cycles of CAPOX plus toripalimab. Good responders were eligible for watch-and-wait (WW) or local excision (LE), and total mesorectal excision was recommended for poor responders or those with high-risk features after LE. The primary endpoint was complete response (CR), including clinical CR with WW and pathologic CR. Secondary endpoints included OP rate, adverse effects, and quality of life. RESULTS: From December 2022 to March 2024, 33 patients were enrolled, with 75.8% staged as T3. After iTNT, 16 patients achieved clinical CR and adopted WW. Pathologic CR was observed in eight of eight LE and five of nine patients who underwent total mesorectal excision. The most common grade 3 to 4 adverse event was thrombocytopenia (27.3%). After a median follow-up of 24.1 months, four local regrowths and one metastatic recurrence occurred...