OncoMatch/Clinical Trials/NCT07213570
STREAM-2: Second-line Treatment With REgorafenib in Advanced RAS-Mutant Colorectal Cancer
Is NCT07213570 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Other
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.
Frequently asked questions
Is NCT07213570 currently recruiting?
Yes, this trial is currently recruiting patients.
Is prior treatment required for enrollment?
Yes. Patients must have previously received chemotherapy in combination to antiangiogenic treatment.
Does this trial require KRAS?
Yes, KRAS mutation is a required biomarker for enrollment.
Does this trial require NRAS?
Yes, NRAS mutation is a required biomarker for enrollment.
Does this trial require MMR?
Yes, MMR status known is a required biomarker for enrollment.
Are patients with DPYD alterations eligible?
No. DPYD complete deficiency of activity is an exclusion criterion.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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