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OncoMatch/Clinical Trials/NCT06718543

Neoadjuvant Short-Course Radiotherapy With or Without Chemotherapy and AK112 in Locally Advanced Rectal Cancer

Is NCT06718543 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including AK112 with SCRT and CapeOX and AK112 with SCRT for rectal cancer.

Phase 2Recruitingfan liNCT06718543Data as of May 2026

Treatment: AK112 with SCRT and CapeOX · AK112 with SCRTThis phase II multicenter, randomized study evaluates the safety and efficacy of neoadjuvant short-course radiotherapy (SCRT) sequentially combined with AK112 (Envafolimab) with or without chemotherapy in patients with locally advanced rectal cancer (LARC). The study also aims to identify biomarkers predicting tumor response and develop efficacy prediction models.

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Extracted eligibility criteria

Cancer type

Colorectal Cancer

Disease stage

Required: Stage T3-4NXM0, TXN1-2M0 (MRI assessment)

Clinical baseline stage T3-4NxM0 or TxN1-2M0 by MRI assessment

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: surgery

No prior treatment for rectal cancer, including surgery

Cannot have received: radiotherapy

No prior treatment for rectal cancer, including ... radiotherapy

Cannot have received: chemotherapy

No prior treatment for rectal cancer, including ... chemotherapy

Cannot have received: immunotherapy

No prior treatment for rectal cancer, including ... immunotherapy

Cannot have received: targeted therapy

No prior treatment for rectal cancer, including ... targeted therapy

Lab requirements

Blood counts

Normal organ function

Kidney function

Normal organ function

Liver function

Normal organ function

Normal organ function

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

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