OncoMatch/Clinical Trials/NCT07213570
STREAM-2: Second-line Treatment With REgorafenib in Advanced RAS-Mutant Colorectal Cancer
Is NCT07213570 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including standard second line treatment, at discretion of the investigator and Regorafenib (BAY73-4506) for colorectal cancer metastatic.
Treatment: standard second line treatment, at discretion of the investigator · Regorafenib (BAY73-4506) — The investigators hypothesize that patients with mCRC RAS-mutant eligible for a second line treatment with good prognostic features, identified as single metastatic site, long progression free survival (PFS) in first line treatment, might benefit from a personalized approach, with less intensive treatment with regorafenib as part of a continuum-of-care strategy aimed at ensuring quality of life and extending survival.
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Biomarker criteria
Required: KRAS mutation
RAS mutant at initial diagnosis assessed at local centers according with a validated method defined by EMA
Required: NRAS mutation
RAS mutant at initial diagnosis assessed at local centers according with a validated method defined by EMA
Required: MMR status known
known MMR/MSI status
Required: DPYD activity known
Known dihydropyrimidine dehydrogenase (DPYD) activity is mandatory
Excluded: DPYD complete deficiency of activity
Complete deficiency of activity of dihydropyrimidine dehydrogenase (DPYD) [excluded]
Disease stage
Metastatic disease required
Diagnosis of metastatic disease. Imaging-documented measurable disease, according to RECIST 1.1 criteria.
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: chemotherapy in combination to antiangiogenic treatment — first line
Achieved a PFS in first line > 6 months with chemotherapy in combination to antiangiogenic treatment OR with one metastatic site at study entry
Lab requirements
Blood counts
ANC ≥ 1.5 x 10^9/L; platelet count ≥ 100 x 10^9/L; hemoglobin ≥ 9 g/dL
Kidney function
serum creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 60 mL/min in males and ≥50 mL/min in females (Cockroft-Gault formula)
Liver function
total bilirubin ≤ 1.5 x ULN or ≤ 2 (in case of biliary stent); AST/ALT ≤ 5 X ULN
Adequate bone marrow hematological function: absolute neutrophil count (ANC) ≥ 1.5 x 109/L and platelet count ≥ 100 x 109/L and hemoglobin ≥ 9 g/dL. Adequate liver function: total bilirubin ≤ 1.5 x upper limit of normal (ULN) or ≤ 2 (in case of biliary stent) and aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 5 X ULN. Adequate renal function: serum creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 60 mL/min in males and ≥50 mL/min in females (calculated according to Cockroft-Gault formula). Electrolytes (i.e. magnesium, calcium, sodium and potassium) within laboratory normal range.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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