Affiliation:
1. Fudan University Shanghai Cancer Center
Abstract
Abstract
Background The preliminary result of the TORCH trial has showed promising complete response (CR) for managing locally advanced rectal cancer (LARC) with neoadjuvant short-couse 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 short-couse radiotherapy combined with chemotherapy and PD-1 inhibitor in LACC.Methods TORCH-C is a randomized, 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 multidisplinary team. 120 patients will be randomized 1:1 to the intervention or control arm. The patients in the control arm will receive 4 cycles of capecitabine plus oxaliplatin (CAPOX). The patients in the intervention arm will receive SCRT, followed by 4 cycles of CAPOX and PD-1 inhibitor (Serplulimab). Both arms will receive curative surgery, followed by 4 cycles of CAPOX. The primary endpoint is pathologic complete regression (pCR).Discussion TORCH-C 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 (CRC).Trial registration: The trial has been registered in ClinicalTrials.gov on Feburary 16, 2023 (Registration No. NCT05732493).
Publisher
Research Square Platform LLC