OncoMatch/Clinical Trials/NCT06425133
Regorafenib in Combination With Multimodal Metronomic Chemotherapy for Chemo-resistant Metastatic Colorectal Cancers
Is NCT06425133 recruiting? Yes, currently enrolling (May 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
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.
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