OncoMatch/Clinical Trials/NCT05201430
Neoadjuvant FOLFOXIRI Versus CapeOX Chemotherapy for Local Advanced Rectal Cancer
Is NCT05201430 recruiting? Yes, currently enrolling (Jun 2026). This Phase 3 trial studies multiple treatments including FOLFOXIRI and CapeOX for rectal cancer.
Treatment: FOLFOXIRI · CapeOX — This 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Colorectal Cancer
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
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.
Frequently asked questions
Is NCT05201430 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.
Check if I qualifyRelated pages