OncoMatch/Clinical Trials/NCT06242067
Second-line Treatment of Metastatic Colorectal Cancer
Is NCT06242067 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Trifluridine/tipiracil for metastatic colorectal cancer.
Treatment: Trifluridine/tipiracil — The goal of this multicenter, single-arm, observational cohort study is to investigate the efficacy and safety of irinotecan in combination with trifluridine-tipiracil and bevacizumab in colorectal cancer with prior oxaliplatin and fluoropyrimidine-based chemotherapy (including 5-FU/capecitabine/S-1) exposure in the metastatic setting or within 12 months of recurrence.
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Biomarker criteria
Required: KRAS wild-type
Patients with KRAS/NRAS/BRAF wild-type and not treated with cetuximab in the first line.
Required: NRAS wild-type
Patients with KRAS/NRAS/BRAF wild-type and not treated with cetuximab in the first line.
Required: BRAF wild-type
Patients with KRAS/NRAS/BRAF wild-type and not treated with cetuximab in the first line.
Excluded: MMR deficient
Patients with dMMR/MSI-H (deficient mismatch repair/microsatellite instability-high) status
Excluded: MSI high
Patients with dMMR/MSI-H (deficient mismatch repair/microsatellite instability-high) status
Disease stage
Metastatic disease required
metastatic or recurrent adenocarcinoma of the colon or rectum; At least one measurable metastatic lesion, as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: fluoropyrimidine (5-fluorouracil, capecitabine) — first-line
Prior treatment with a fluoropyrimidine (5-fluorouracil [5-FU] or capecitabine)
Must have received: oxaliplatin (oxaliplatin) — first-line
Prior treatment with ... oxaliplatin
Must have received: VEGF inhibitor (bevacizumab) — first-line
Prior treatment with ... bevacizumab or cetuximab targeted therapy as the first-line regimen.
Must have received: EGFR-targeted therapy (cetuximab) — first-line
Prior treatment with ... cetuximab targeted therapy as the first-line regimen.
Cannot have received: irinotecan (irinotecan)
First-line treatment with irinotecan
Lab requirements
Blood counts
Absolute neutrophil count ≥ 1.5×10^9/L; Platelet count ≥ 100×10^9/L; Hemoglobin ≥ 90g/L (no history of blood transfusion within 7 days)
Kidney function
Creatinine clearance ≥ 60 ml/min (Cockcroft-Gault formula)
Liver function
Bilirubin ≤ 1.5 x ULN; AST/ALT ≤2.5 x ULN or ≤5 x ULN if with hepatic metastases; AKP ≤2.5 x ULN or ≤5 x ULN if with hepatic metastases
Cardiac function
QTc interval < 450 ms for men and < 470 ms for women (Fridericia formula); NYHA class III or IV cardiac insufficiency or LVEF < 50% excluded
Adequate organ function: bone marrow, kidney, liver function ... see full text for details
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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