Short-Course Radiotherapy Combined With CapeOx and PD-1 Inhibitor Following Local Excision in High-Risk Early Rectal Cancer: Study Protocol for a Prospective Phase II Trial (TORCH-LE)
Jingwen Wang, Yan Wang, Zhiyuan Zhang, Yaqi Wang, Ruiyan Wu, Shujuan Zhou, Wang Yang, Yajie Chen, Menglong Zhou, Hui Zhang, Fan Xia, Xinxiang Li, Zhen Zhang, Juefeng Wan, Lijun ShenBackground
Local excision (LE) has emerged as an organ-preserving option for patients with early rectal cancer, but high-risk pathological features significantly increase the risk of local recurrence. When completion total mesorectal excision (TME) is refused or medically unfeasible, combining radiotherapy, chemotherapy, and immunotherapy offers an adjuvant organ-preservation strategy in microsatellite-stable (MSS) rectal cancer.
Objectives
The TORCH-LE trial aims to evaluate the efficacy and safety of combining radiotherapy, chemotherapy, and immunotherapy as an adjuvant organ-preservation strategy for patients with high-risk pathological features after local excision (LE) who refuse or are unfit for completion TME.
Design
This is a prospective, multi-center, single-arm, hypothesis-generating phase II trial.
Methods and Analysis
A total of 60 patients with MSS early rectal cancer who have high-risk features following LE will be enrolled. All participants will receive short-course radiotherapy (SCRT; 25 Gy in 5 fractions), followed by four cycles of capecitabine and oxaliplatin (CapeOx) plus the PD-1 inhibitor toripalimab. The primary endpoint is the 3-year local recurrence-free survival (LRFS) rate, with an expected benchmark of 95% (target two-sided 95% CI: 85.6%–98.9%). Secondary endpoints include 3-year disease-free survival (DFS) rate, overall survival (OS) rate, treatment-related adverse events, and quality of life. Follow-up will include regular imaging and endoscopic surveillance.
Discussion
The TORCH-LE trial explores a novel adjuvant treatment strategy for early rectal cancer patients with high-risk features who are not eligible for or decline completion TME. By combining SCRT, chemotherapy, and immunotherapy, the study seeks to reduce recurrence risk while preserving rectal function. Given the single-arm design, findings should be considered exploratory and hypothesis-generating. The findings may support a more personalized organ-preserving approach and provide a rationale for future randomized trials.