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OncoMatch/Clinical Trials/NCT06884670

Assessment of Efficacy and Safety of PD-1 Monoclonal Antibody Combined With IL-2 and CapeOX in Neoadjuvant Therapy for Locally Advanced Rectal Cancer Prior to Surgery: A Prospective, Multi-center, Randomized Controlled Study

Is NCT06884670 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Interleukin-2 and Tislelizumab for rectal cancer.

Phase 2RecruitingThe First Affiliated Hospital with Nanjing Medical UniversityNCT06884670Data as of May 2026

Treatment: Interleukin-2 · Tislelizumab · Oxaliplatin · CapecitabineThe objective is to evaluate whether the neoadjuvant combination of tislelizumab (a PD-1 inhibitor) with interleukin-2 (IL-2) chemotherapy can significantly increase the Objective Response Rate (ORR) and the Pathological Complete Response rate (pCR) in patients with locally advanced rectal cancer who have Microsatellite Stable/Proficient Mismatch Repair (MSS/pMMR) status.

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Extracted eligibility criteria

Cancer type

Colorectal Cancer

Disease stage

Required: Stage ANY T WITH N+

Excluded: Stage IV

Clinical stage T3-T4 or any T with node-positive (N+) disease: locally advanced; Patients with metastatic disease (Stage IV) [excluded]

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

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

Cannot have received: systemic anticancer therapy

Patients who have previously received systemic anticancer therapy for colorectal cancer

Cannot have received: anti-PD-1/PD-L1/CTLA-4 antibody

have been treated with PD-1, PD-L1, or CTLA-4 antibodies

Lab requirements

Blood counts

Kidney function

Liver function

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

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