Department of Radiation Oncology, Fudan University Shanghai Cancer Center, Shanghai, China.
Department of Oncology, Shanghai Medical College of Fudan University, Shanghai, China.
BMJ Open. 2024 Feb 2;14(2):e079442. doi: 10.1136/bmjopen-2023-079442.
The preliminary result of the TORCH trial has shown a promising complete response (CR) for managing locally advanced rectal cancer with neoadjuvant short-course radiotherapy (SCRT) combined with chemotherapy and PD-1 inhibitor. For locally advanced colon cancer (LACC) with bulky nodal disease and/or clinically T4, neoadjuvant chemotherapy followed by colectomy with en bloc removal of regional lymph nodes is the suggested treatment. However, the CR rate is less than 5%. TORCH-C will aim to investigate neoadjuvant SCRT combined with chemotherapy and PD-1 inhibitor in LACC.
TORCH-C is a randomised, prospective, multicentre, double-arm, open, phase II trial of SCRT combined with chemotherapy and immunotherapy in LACC with microsatellite stable (MSS) patients and cT4 or bulky nodes. Eligible patients will be identified by the multidisciplinary team. 120 patients will be randomised 1:1 to the intervention or control arm. The patients in the control arm will receive four cycles of capecitabine plus oxaliplatin (CAPOX). The patients in the intervention arm will receive SCRT, followed by four cycles of CAPOX and PD-1 inhibitor (serplulimab). Both arms will receive curative surgery, followed by four cycles of CAPOX. The primary endpoint is pathological complete regression.TORCH-C (TORCH-colon) trial aims to investigate whether the combination of immunotherapy and chemoradiotherapy improves the treatment effect in LACC with MSS. TORCH-C will establish the TORCH platform, a key part of our long-term strategy to develop neoadjuvant treatment for colorectal cancer.
This study was approved by the Ethics Committee of Fudan University Shanghai Cancer Center (approval number: 2211265-12).
NCT05732493.
TORCH 试验的初步结果表明，新辅助短程放疗（SCRT）联合化疗和 PD-1 抑制剂治疗局部进展期直肠癌有很好的完全缓解（CR）前景。对于伴有大淋巴结疾病和/或临床 T4 的局部进展期结肠癌（LACC），建议行新辅助化疗，然后行结肠癌切除术，并整块切除区域淋巴结。然而，CR 率小于 5%。TORCH-C 旨在研究新辅助 SCRT 联合化疗和 PD-1 抑制剂治疗局部进展期结肠癌。
TORCH-C 是一项随机、前瞻性、多中心、双臂、开放、Ⅱ期试验，研究 SCRT 联合化疗和免疫治疗微卫星稳定（MSS）患者和 cT4 或大淋巴结的 LACC。多学科团队将确定符合条件的患者。将 120 例患者随机分为 1:1 组，分别进入干预组和对照组。对照组患者接受 4 周期卡培他滨联合奥沙利铂（CAPOX）治疗。干预组患者接受 SCRT，然后接受 4 周期 CAPOX 和 PD-1 抑制剂（serplulimab）治疗。两组患者均接受根治性手术，然后接受 4 周期 CAPOX 治疗。主要终点为病理完全缓解。TORCH-C（TORCH-结肠）试验旨在研究免疫治疗联合放化疗是否能提高 MSS 局部进展期结肠癌的治疗效果。TORCH-C 将建立 TORCH 平台，这是我们开发结直肠癌新辅助治疗长期策略的关键部分。
本研究已获得复旦大学附属肿瘤医院伦理委员会批准（批准文号：2211265-12）。
NCT05732493。
