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OncoMatch/Clinical Trials/NCT06577194

A Single-Center, Single-Arm Study of Neoadjuvant Short-Course Radiotherapy With IL-2 Followed by Sequential Immunotherapy With CAPOX Combined With PD-1 Antibody and IL-2 for Locally Advanced Rectal Cancer

Is NCT06577194 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Sintilimab + IL-2 Combined with CAPOX for rectal cancer.

Phase 2RecruitingThe First Affiliated Hospital with Nanjing Medical UniversityNCT06577194Data as of May 2026

Treatment: Sintilimab + IL-2 Combined with CAPOXA Single-Center, Single-Arm Study of Neoadjuvant Short-Course Radiotherapy with IL-2 Followed by Sequential Immunotherapy with CAPOX Combined with PD-1 antibody and IL-2 for Locally Advanced Rectal Cancer

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Extracted eligibility criteria

Cancer type

Colorectal Cancer

Tumor Agnostic

Disease stage

Excluded: Stage IV

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

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

Cannot have received: systemic anti-cancer treatment

Previous systemic anti-cancer treatment for colorectal cancer

Cannot have received: anti-PD-1 therapy

Previous treatment with anti-programmed death receptor-1 (PD-1) or its ligand (PD-L1) antibodies

Cannot have received: anti-PD-L1 therapy

Previous treatment with anti-programmed death receptor-1 (PD-1) or its ligand (PD-L1) antibodies

Cannot have received: anti-CTLA-4 therapy

Previous treatment with anti-cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) antibodies

Lab requirements

Blood counts

neutrophil count ≥ 1.5×10^9/L; platelet count ≥ 75×10^9/L

Kidney function

serum creatinine ≤ 1.5× UNL

Liver function

serum total bilirubin ≤ 1.5× upper limit of normal (UNL); aspartate aminotransferase ≤ 2.5× UNL; alanine aminotransferase ≤ 2.5× UNL

Adequate hematological, liver, and kidney functions: neutrophil count ≥ 1.5×10^9/L; platelet count ≥ 75×10^9/L; serum total bilirubin ≤ 1.5× upper limit of normal (UNL); aspartate aminotransferase ≤ 2.5× UNL; alanine aminotransferase ≤ 2.5× UNL; serum creatinine ≤ 1.5× UNL.

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

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