OncoMatch/Clinical Trials/NCT06425133
Regorafenib in Combination With Multimodal Metronomic Chemotherapy for Chemo-resistant Metastatic Colorectal Cancers
Is NCT06425133 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies multiple treatments including Regorafenib and Regorafenib + metronomic chemotherapy for metastatic colorectal cancer.
Treatment: Regorafenib · Regorafenib + metronomic chemotherapy — The main objective is to evaluate the impact of a Regorafenib combined with metronomic chemotherapy (capecitabine and cyclophosphamide) and low-dose aspirin compared to standard Regorafenib treatment in patients with metastatic colorectal cancer by assessing progression-free survival.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Other
Cancer type
Colorectal Cancer
Biomarker criteria
Allowed: KRAS wild-type
anti-EGFR (epidermal growth factor receptor) therapy if KRAS (Kirsten rat sarcoma) and NRAS WT (wild type)
Allowed: NRAS wild-type
anti-EGFR (epidermal growth factor receptor) therapy if KRAS (Kirsten rat sarcoma) and NRAS WT (wild type)
Allowed: BRAF V600E
anti-BRAF therapy if BRAF V600E mutated
Allowed: MMR deficient
anti-PD1 (Programmed Death-1) if MSI-H (microsatellite instability) /dMMR (deficient MisMatch Repair) tumor
Disease stage
Metastatic disease required
metastatic colorectal cancer in progression after previous standard treatments
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: fluoropyrimidine (5FU)
progression after previous standard treatments (5FU, CPT11 (Irinotecan), oxaliplatin, anti-VEGF, trifluridine/tipiracil, anti-EGFR therapy if KRAS and NRAS WT, anti-BRAF therapy if BRAF V600E mutated, and anti-PD1 if MSI-H/dMMR tumor, or not considered as candidate for these treatments)
Must have received: topoisomerase inhibitor (irinotecan)
progression after previous standard treatments (5FU, CPT11 (Irinotecan), oxaliplatin, anti-VEGF, trifluridine/tipiracil, anti-EGFR therapy if KRAS and NRAS WT, anti-BRAF therapy if BRAF V600E mutated, and anti-PD1 if MSI-H/dMMR tumor, or not considered as candidate for these treatments)
Must have received: platinum-based chemotherapy (oxaliplatin)
progression after previous standard treatments (5FU, CPT11 (Irinotecan), oxaliplatin, anti-VEGF, trifluridine/tipiracil, anti-EGFR therapy if KRAS and NRAS WT, anti-BRAF therapy if BRAF V600E mutated, and anti-PD1 if MSI-H/dMMR tumor, or not considered as candidate for these treatments)
Must have received: VEGF inhibitor
progression after previous standard treatments (5FU, CPT11 (Irinotecan), oxaliplatin, anti-VEGF, trifluridine/tipiracil, anti-EGFR therapy if KRAS and NRAS WT, anti-BRAF therapy if BRAF V600E mutated, and anti-PD1 if MSI-H/dMMR tumor, or not considered as candidate for these treatments)
Must have received: antimetabolite (trifluridine/tipiracil)
progression after previous standard treatments (5FU, CPT11 (Irinotecan), oxaliplatin, anti-VEGF, trifluridine/tipiracil, anti-EGFR therapy if KRAS and NRAS WT, anti-BRAF therapy if BRAF V600E mutated, and anti-PD1 if MSI-H/dMMR tumor, or not considered as candidate for these treatments)
Must have received: EGFR-targeted therapy
anti-EGFR (epidermal growth factor receptor) therapy if KRAS (Kirsten rat sarcoma) and NRAS WT (wild type)
Must have received: BRAF inhibitor
anti-BRAF therapy if BRAF V600E mutated
Must have received: anti-PD-1 therapy
anti-PD1 (Programmed Death-1) if MSI-H (microsatellite instability) /dMMR (deficient MisMatch Repair) tumor
Cannot have received: VEGF inhibitor (regorafenib)
Previous exposition to regorafenib
Cannot have received: VEGF inhibitor
Exception: bevacizumab and aflibercept allowed
Previous exposition to anti-angiogenic treatment other than bevacizumab and aflibercept
Lab requirements
Blood counts
Haemoglobin ≥ 9 g/dL; ANC ≥ 1.5 x 10^9/L; platelets ≥ 100 x 10^9/L
Kidney function
Cockcroft GFR > 50 ml/min; proteinuria <2+ (dipstick) or ≤1g/24h
Liver function
Total serum bilirubin ≤ 1.5x ULN, alkaline phosphatase < 5x ULN, AST/ALT ≤ 3x ULN (≤ 5x ULN if hepatic lesions present)
Cardiac function
No known cardiac failure of unstable coronaropathy, congestive heart failure ≥ NYHA class 2, recent MI (<6 months), unstable angina, new-onset angina (last 3 months), cardiac arrhythmias requiring anti-arrhythmic therapy (beta-blockers or digoxin permitted), uncontrolled hypertension (SBP ≥ 150 mmHg and/or DBP ≥ 100 mmHg despite optimal management), or history of hypertensive crisis/encephalopathy
Adequate bone marrow, liver and renal functions. See detailed labs in inclusion 6. Cardiac and other organ exclusions in exclusion 13.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT06425133 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior VEGF inhibitor, VEGF inhibitor disqualifies patients from enrollment.
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