OncoMatch

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 (Jun 2026). This Phase 2 trial studies multiple treatments including PD-1 antibody and Capecitabine for rectal cancer.

Phase 2RecruitingFudan UniversityNCT06455124Data as of Jun 2026Location: China

Treatment: PD-1 antibody · Capecitabine · OxaliplatinThis 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.

Check if I qualify

Extracted eligibility criteria

Treatments studied

Chemotherapy

CapecitabineOxaliplatin

Other

PD-1 antibody

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

Demographics

Ages ≤ 75

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.

Frequently asked questions

Is NCT06455124 currently recruiting?

Yes, this trial is currently recruiting patients.

Can patients have received prior systemic therapy?

No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.

Does this trial require MMR?

Yes, MMR proficient is a required biomarker for enrollment.

Are patients with DPYD alterations eligible?

No. DPYD deficiency is an exclusion criterion.

What disease stage is eligible?

Stage PT1 or PT2 is required.

Is there an age limit?

Yes. Patients must be 75 years or younger.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

Check if I qualify