OncoMatch/Clinical Trials/NCT06992648
Trifluridine/Tipiracil Plus Regorafenib vs Trifluridine/Tipiracil Plus Bevacizumab for Refractory Metastatic Colorectal Cancer
Is NCT06992648 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including Trifluridine/Tipiracil + Regorafenib and Trifluridine/tipiracil + bevacizumab for colorectal cancer metastatic.
Treatment: Trifluridine/Tipiracil + Regorafenib · Trifluridine/tipiracil + bevacizumab — The goal of this clinical trial is to demonstrate the non-inferiority of trifluridine/tipiracil + regorafenib vs trifluridine/tipiracil + bevacizumab in terms of progression free survival in patients with refractory metastatic colorectal cancer(mCRC) patients. It will also try to estimate the effect of trifluridine/tipiracil + regorafenib vs trifluridine/tipiracil + bevacizumab in terms of OS, ORR, and DCR in patients with refractory mCRC. Other secondary objectives are to compare the safety and tolerance, and the impact on QoL of trifluridine/tipiracil + regorafenib vs trifluridine/tipiracil + bevacizumab in patients with refractory mCRC.
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Biomarker criteria
Required: KRAS wild-type
Required: NRAS wild-type
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: fluoropyrimidine — advanced
Prior treatment regimens for the treatment of advanced colorectal cancer must have included a fluoropyrimidine
Must have received: irinotecan — advanced
Prior treatment regimens for the treatment of advanced colorectal cancer must have included ... irinotecan
Must have received: oxaliplatin — advanced
Prior treatment regimens for the treatment of advanced colorectal cancer must have included ... oxaliplatin
Must have received: anti-VEGF monoclonal antibody — advanced
Prior treatment regimens for the treatment of advanced colorectal cancer must have included ... an anti-VEGF monoclonal antibody
Must have received: anti-EGFR monoclonal antibody — advanced
Prior treatment regimens for the treatment of advanced colorectal cancer must have included ... an anti-EGFR monoclonal antibody for RAS wildtype patients
Cannot have received: trifluridine/tipiracil
Prior trifluridine/tipiracil ... for the treatment of advanced colorectal cancer
Cannot have received: tyrosine kinase inhibitor
Prior ... TKI regimens for the treatment of advanced colorectal cancer
Lab requirements
Blood counts
Absolute neutrophil count ≥1.5×10^9/L; Platelet count ≥75×10^9/L; Hemoglobin≥90g/L (7 days without transfusion)
Kidney function
Creatinine clearance ≥60 mL/min, assessed using the Cockcroft & Gault formula
Liver function
Total serum bilirubin <1.5×ULN (unless Gilbert disease confirmed); AST (SGOT) and ALT (SGPT) ≤ 2.5×ULN (≤ 5×ULN if due to liver metastasis)
Has adequate organ function as defined by the following laboratory values obtained within 7 days prior to randomization: Absolute neutrophil count ≥1.5×10^9/L; Platelet count ≥75×10^9/L; Hemoglobin≥90g/L (7 days without transfusion); Creatinine clearance ≥60 mL/min, assessed using the Cockcroft & Gault formula; Total serum bilirubin <1.5×ULN (unless Gilbert disease confirmed); AST (SGOT) and ALT (SGPT) ≤ 2.5×ULN (unless if liver function abnormalities are due to underlying liver metastasis, AST (SGOT) and ALT (SGPT) ≤ 5×ULN); Urine protein <1+ on urinalysis or 24-hour urine protein <1g; International Normalized Ratio (INR) or Prothrombin Time (PT) ≤1.5×ULN (For patients receiving anti-coagulant therapy the adequate therapeutic levels of PT should be confirmed).
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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