OncoMatch/Clinical Trials/NCT06455124

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

Is NCT06455124 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including PD-1 antibody and Capecitabine for rectal cancer.

Phase 2RecruitingFudan UniversityNCT06455124Data as of May 2026

Treatment: PD-1 antibody · Capecitabine · Oxaliplatin — This is a single arm phase II study to explore the 3y LRFS and safety for high-risk early rectal cancer after local excision with short-course radiotherapy and chemo-immunotherapy.

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Extracted eligibility criteria

Cancer type

Colorectal Cancer

Biomarker criteria

Required: MMR proficient

microsatellite repair status is MSS/pMMR

Excluded: DPYD deficiency

DPD deficiency

Disease stage

Required: Stage PT1, PT2

Grade: high gradepoorly differentiated

pT1 after local excision ... with at least one of the high-risk features including ... high grade or poorly differentiated ... or pT2 tumor

Prior therapy

No prior treatment (treatment-naive required)

Max 0 prior lines

Cannot have received: anti-cancer therapy

without previous anti-cancer therapy or immunotherapy

Cannot have received: immunotherapy

without previous anti-cancer therapy or immunotherapy

Lab requirements

Blood counts

neutrophils≥1.5×10^9/l, hb≥90g/l, plt≥100×10^9/l

Kidney function

cr≤ 1 uln

Liver function

alt/ast ≤2.5 uln

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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