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Short-Course Radiotherapy Combined With CapeOx and PD-1 Inhibitor Following Local Excision in High-Risk Early Rectal
Jingwen Wang1,2,3,4, Yan Wang1,2,3,4, Zhiyuan Zhang1,2,3,4
1Department of Radiation Oncology, Fudan University Shanghai Cancer Center, Shanghai, China.
Clinical Medicine Insights. Oncology
|August 9, 2026
Summary
This study evaluates a new treatment combining radiotherapy, chemotherapy, and immunotherapy for early rectal cancer patients after local excision. The goal is to reduce local recurrence while preserving organ function.
Area of Science:
- Oncology
- Rectal Cancer Research
- Adjuvant Therapy
Background:
- Local excision (LE) offers organ preservation for early rectal cancer but carries a risk of local recurrence, especially with high-risk features.
- Completion total mesorectal excision (TME) may be refused or medically unfeasible for some patients.
- Adjuvant strategies combining radiotherapy, chemotherapy, and immunotherapy are being explored for microsatellite-stable (MSS) rectal cancer.
Purpose of the Study:
- To evaluate the efficacy and safety of combining radiotherapy, chemotherapy, and immunotherapy as an adjuvant organ-preservation strategy.
- To assess this strategy in patients with high-risk pathological features after LE who are not candidates for or decline completion TME.
Main Methods:
- A prospective, multi-center, single-arm, hypothesis-generating phase II trial (TORCH-LE).
- Enrolled 60 patients with MSS early rectal cancer and high-risk features post-LE.
- Administered short-course radiotherapy (SCRT), capecitabine and oxaliplatin (CapeOx), and toripalimab (PD-1 inhibitor).
Main Results:
- The primary endpoint is 3-year local recurrence-free survival (LRFS), with an expected benchmark of 95%.
- Secondary endpoints include 3-year disease-free survival (DFS), overall survival (OS), treatment-related adverse events, and quality of life.
- Follow-up involves regular imaging and endoscopic surveillance.
Conclusions:
- The TORCH-LE trial investigates a novel adjuvant treatment for early rectal cancer patients unsuitable for completion TME.
- The combination of SCRT, chemotherapy, and immunotherapy aims to reduce recurrence risk and preserve rectal function.
- Findings are exploratory and may support personalized organ-preserving approaches and future randomized trials.
