OncoMatch/Clinical Trials/NCT05970705
Regorafenib Combined With TAS-102 Versus Regorafenib Monotherapy in Third or Later Line Therapy of mCRC
Is NCT05970705 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Regorafenib and Trifluridine/Tipiracil for metastatic colorectal cancer.
Treatment: Regorafenib · Trifluridine/Tipiracil — The purpose of this study is to evaluate the clinical benefit of regorafenib combined with TAS-102 compared with regorafenib monotherapy in patients with metastatic colorectal cancer who have failed at least two lines of treatment, to explore the rationality of this combination therapy strategy and to obtain relevant survival and safety data.
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Biomarker criteria
Allowed: BRAF wild-type
Allowed: KRAS wild-type
Allowed: NRAS wild-type
Disease stage
Metastatic disease required
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: fluoropyrimidine-based therapy — first- or second-line
Patients who have failed at least one prior standard first- or second-line therapy, including fluoropyrimidine-based therapy
Must have received: oxaliplatin — first- or second-line
Patients who have failed at least one prior standard first- or second-line therapy, including ... oxaliplatin
Must have received: irinotecan — first- or second-line
Patients who have failed at least one prior standard first- or second-line therapy, including ... irinotecan
Must have received: bevacizumab — first- or second-line
Patients who have failed at least one prior standard first- or second-line therapy, including ... bevacizumab
Cannot have received: small molecule tyrosine kinase inhibitor containing VEGFR (apatinib, fruquintinib, anlotinib, lenvatinib)
Patients who have been treated with small molecule tyrosine kinase inhibitors containing VEGFR (such as apatinib, fruquintinib, anlotinib, and lenvatinib)
Cannot have received: TAS-102
Patients who have been treated with TAS-102
Lab requirements
Blood counts
absolute neutrophil count (anc) ≥1.5 × 109 /l, hemoglobin ≥ 8.0 g/dl, platelet count ≥ 75 × 109 /l
Kidney function
serum creatinine ≤1.5 × uln, and creatinine clearance ≥50 ml/min
Liver function
total bilirubin <1.5 × uln, alt and ast <2.5 × uln (≤5 × uln for patients with liver involvement)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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