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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 (Jun 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 Jun 2026Location: China

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

Treatments studied

Other

Sintilimab + IL-2 Combined with CAPOX

Cancer type

Colorectal Cancer

Tumor Agnostic

Disease stage

Excluded: Stage IV

Performance status

ECOG 0–1(Restricted strenuous activity)

Demographics

Ages ≤ 75

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.

Frequently asked questions

Is NCT06577194 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.

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.

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