OncoMatch/Clinical Trials/NCT06242067
Second-line Treatment of Metastatic Colorectal Cancer
Is NCT06242067 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Other
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)
Demographics
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.
Frequently asked questions
Is NCT06242067 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior irinotecan disqualifies patients from enrollment.
Does this trial require KRAS?
Yes, KRAS wild-type is a required biomarker for enrollment.
Does this trial require NRAS?
Yes, NRAS wild-type is a required biomarker for enrollment.
Does this trial require BRAF?
Yes, BRAF wild-type is a required biomarker for enrollment.
Are patients with MMR alterations eligible?
No. MMR deficient is an exclusion criterion.
Are patients with MSI alterations eligible?
No. MSI high is an exclusion criterion.
Is there an age limit?
Yes. Patients must be 75 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages