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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 (Jun 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 Jun 2026Location: China

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

Treatments studied

Other

AK112 with SCRT and CapeOXAK112 with SCRT

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)

Demographics

Ages ≤ 80

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.

Frequently asked questions

Is NCT06718543 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.

What disease stage is eligible?

Stage T3-4NXM0 or TXN1-2M0 is required.

Is there an age limit?

Yes. Patients must be 80 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.

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