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OncoMatch/Clinical Trials/NCT05201430

Neoadjuvant FOLFOXIRI Versus CapeOX Chemotherapy for Local Advanced Rectal Cancer

Is NCT05201430 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including FOLFOXIRI and CapeOX for rectal cancer.

Phase 3RecruitingFudan UniversityNCT05201430Data as of May 2026

Treatment: FOLFOXIRI · CapeOXThis is a phase III randomized controlled trial comparing the efficacy and safety of FOLFOXIRI versus CapeOX as neoadjuvant regimen in treating patients with middle and upper locally advanced (MRI T3-4 or N+) rectal cancer. This study aims to optimize the neoadjuvant therapy for patients with anus-preserving resectable locally advanced rectal cancer, so as to improve the prognosis of them. It remains unclear about whether FOLFOXIRI or CapeOX neoadjuvant chemotherapy is more effective for locally advanced rectal cancer.

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Extracted eligibility criteria

Cancer type

Colorectal Cancer

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

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

Cannot have received: systemic chemotherapy

no previous systemic chemotherapy, radiotherapy or local excision for treating rectal cancer

Cannot have received: radiotherapy

no previous systemic chemotherapy, radiotherapy or local excision for treating rectal cancer

Cannot have received: local excision

no previous systemic chemotherapy, radiotherapy or local excision for treating rectal cancer

Lab requirements

Blood counts

neutrophil count ≥ 1.5×10^9/l, platelet count ≥ 100×10^9 /l, hemoglobin ≥ 80 g/l

Kidney function

serum creatinine ≤ 110 umol/l

Liver function

serum bilirubin ≤ 24umol/l, alanine aminotransferase and aspartate aminotransferase ≤ 60 u/l

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

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