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 (Jun 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
Treatments studied
Targeted therapy
Other
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.
Frequently asked questions
Is NCT05462613 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior regorafenib, anti-angiogenic therapy disqualifies patients from enrollment.
Does this trial require MSH2?
Yes, MSH2 microsatellite-stable is a required biomarker for enrollment.
Does this trial require KRAS?
Yes, KRAS known status is a required biomarker for enrollment.
Does this trial require NRAS?
Yes, NRAS known status is a required biomarker for enrollment.
Are patients with BRAF alterations eligible?
No. BRAF V600E is an exclusion criterion.
What disease stage is eligible?
Stage IV is required (metastatic disease required).
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 qualify