# Short-course Radiotherapy Combined With CapeOx and PD-1 Inhibitor After Local Excision for High-risk Early Rectal Cancer (TORCH-LE)

Source: https://onco.cc/trials/nct06455124/  
OnCo record `nct06455124` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A phase 2 trial of capecitabine and fOLFOX (5-FU, leucovorin, oxaliplatin) in colorectal cancer, run by Fudan University, now recruiting.

## Summary

Short-course Radiotherapy Combined With CapeOx and PD-1 Inhibitor After Local Excision for High-risk Early Rectal Cancer (TORCH-LE) is a phase 2, interventional study registered as NCT06455124 by Fudan University, with a registry enrolment figure of 60 participants, started 2024-05-08 and due to reach its primary completion in 2026-06-30. Interventions recorded: Radiation; PD-1 antibody; Capecitabine; Oxaliplatin. Conditions listed: Rectal Cancer. Primary outcome: 3y LRFS. Colorectal eligibility wording from the registry: "pT1 after local excision of the primary rectal cancer, with at least one of the high-risk features including margin positivity/very close margin (\<1mm) at time of local excision, depth of invasion \>1 mm or SM3 invasion (submucosal invasion to the lower third of the submucosal level), high grade or". Sites: China. No results are recorded here; the registry entry is the source.

## Fields

- Kind: Trial
- Status: recruiting
- Last checked: 2026-09-24
- Tags: ctgov-ingest; colorectal-deep-dive
- Registry id: NCT06455124
- Phase: 2
- Setting: Short-course Radiotherapy Combined With CapeOx and PD-1 Inhibitor After Local Excision for High-risk Early Rectal Cancer (TORCH-LE)
- Sponsor: Fudan University
- Enrolled: 60

## Sources

- ClinicalTrials.gov NCT06455124: https://clinicaltrials.gov/study/NCT06455124

## Connected records

- cancers: [Rectal cancer](https://onco.cc/cancers/rectal-cancer/)
- technologies: [Cytotoxic chemotherapy](https://onco.cc/technologies/cytotoxic-chemotherapy/), [IMRT / IGRT (modern external beam)](https://onco.cc/technologies/imrt-igrt/), [Platinum agents](https://onco.cc/technologies/platinum/)
- drugs: [Capecitabine](https://onco.cc/drugs/capecitabine/), [FOLFOX (5-FU, leucovorin, oxaliplatin)](https://onco.cc/drugs/folfox/)
- terms: [Colorectal cancer trials open today (registry snapshot)](https://onco.cc/terms/colorectal-trials-open-today/)

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JSON: https://onco.cc/api/v1/entities/nct06455124.json