OncoMatch/Clinical Trials/NCT05571644
Neoadjuvant Treatment With mFOLFOXIRI Plus Cadonilimab (AK104) Versus mFOLFOX6 in Locally Advanced Colorectal Cancer
Is NCT05571644 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including mFOLFOXIRI + Cadonilimab and mFOLFOX6 for colorectal cancer.
Treatment: mFOLFOXIRI + Cadonilimab · mFOLFOX6 · mFOLFOXIRI · mFOLFOXIRI+AK104+fruquintinib — Neoadjuvant chemoradiotherapy (CRT) followed by total mesenteric excision (TME) and adjuvant chemotherapy was the standard of treatment for locally advanced rectal cancer (LARC) in the past two decades. The main obstacles for improving survival benefit of LARC was distant metastasis. Recently, total neoadjuvant therapy (TNT) had been recommended as new preferred option for LARC. Induction chemotherapy with FOLFOXIRI followed by CRT or short-course radiotherapy followed by FOLFOX chemotherapy had improved survival benefit for LARC. Neoadjuvant immunotherapy had also been explored in pMMR patients with CRC. In the NICHE trial, neoadjuvant therapy with 2 dose of nivolumab and 1 dose of ipilimumab led to 29% of pathological response and 13% of pCR. Cadonilimab (AK104) was a PD-1/CTLA-4 bi-specific antibody. Here, we tried to explore the efficacy of Neoadjuvant Treatment With mFOLFOXIRI with or without Cadonilimab (AK104) Versus mFOLFOX6 in LARC.
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Disease stage
Required: Stage T3>5MM, T3-4
Colon cancer was evaluated as T3>5mm or T4 by contrast-enhanced CT... Rectal cancer was graded as T3-4 and/or N+ by pelvic contrast-enhanced MRI... Distant metastasis was excluded
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: systemic antitumor therapy
No previous systemic antitumor therapy for colorectal cancer, including cytotoxic drugs, immunotherapy, molecular targeted therapy, etc.
Cannot have received: anti-PD-1 therapy
Previously received anti-programmed death-1 (PD-1) or its ligand (PD-L1) antibody
Cannot have received: anti-PD-L1 therapy
Previously received anti-programmed death-1 (PD-1) or its ligand (PD-L1) antibody
Cannot have received: anti-CTLA-4 therapy
Previously received...anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) antibodies
Cannot have received: T-cell costimulatory or checkpoint pathway drugs/antibodies
other drugs/antibodies that act on T-cell costimulatory or checkpoint pathways
Lab requirements
Blood counts
hemoglobin ≥90g/l, neutrophil count ≥1.5×109/l, platelet count ≥75×109/l
Kidney function
serum creatinine ≤1.5×unl
Liver function
serum total bilirubin ≤1.5× upper limit of normal value (unl), aspartate transferase ≤2×unl, alanine transferase ≤3×unl
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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