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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.

Phase 2RecruitingFudan UniversityNCT05970705Data as of May 2026

Treatment: Regorafenib · Trifluridine/TipiracilThe 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.

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Extracted 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

Min 1 prior line

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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