OncoMatch/Clinical Trials/NCT05462613
Regorafenib With Low-dose Chemotherapies and Aspirin Followed by Standard Chemotherapies in Metastatic Colorectal Cancer
Is NCT05462613 recruiting? Yes, currently enrolling (May 2026). This Phase 2/3 trial studies multiple treatments for metastatic colorectal cancer.
Treatment: Regorafenib · Metronomic chemotherapies · Aspirin · Bevacizumab · FOLFIRI or FOLFOX — This study evaluates the interest of regorafenib in combination of metronomic chemotherapies and low-dose aspirin as a 2 months induction therapy before chemotherapy initiation in the second-line metastatic colorectal carcinoma
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Biomarker criteria
Required: MSH2 microsatellite-stable
patients eligible should have microsatellite-stable (MSS) status
Required: KRAS known status
a known RAS (Retrovirus Associated Sequences) status
Required: NRAS known status
a known RAS (Retrovirus Associated Sequences) status
Excluded: BRAF V600E
absence of BRAF V600E (B(Raf gene, val600-to-glu) mutation
Disease stage
Required: Stage IV
Metastatic disease required
metastatic colorectal cancer in progression after a first line of chemotherapy
Performance status
ECOG-WHO 0–1
Prior therapy
Must have received: cytotoxic chemotherapy (FOLFOX, FOLFIRI, FOLFIRINOX, FOLFOXIRI) — first-line metastatic
Patients must have been treated for their metastatic disease with one of the following regimens as first-line therapy: FOLFOX, FOLFIRI, FOLFIRINOX, FOLFOXIRI
Cannot have received: regorafenib (regorafenib)
Previous exposure to regorafenib
Cannot have received: anti-angiogenic therapy
Exception: bevacizumab
Previous exposure to other anti-angiogenic treatment than bevacizumab
Lab requirements
Blood counts
Haemoglobin ≥ 9 g/dL; absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L; platelets ≥ 100 x 10^9/L
Kidney function
Cockcroft glomerular filtration rate > 50 ml/min; Proteinuria <2+ (dipstick urinalysis) or ≤1g/24hour
Liver function
Total serum bilirubin ≤ 1.5 times upper normal value (ULN), serum alkaline phosphatase < 5 times ULN, aminotransferases (AST/ALT) ≤ 3 × ULN in absence of hepatic metastasis or ≤ 5 if presence of hepatic lesions
Adequate bone marrow, liver and renal functions.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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