NCT07213570 STREAM-2: Second-line Treatment With REgorafenib in Advanced RAS-Mutant Colorectal Cancer
| NCT ID | NCT07213570 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | National Cancer Institute, Naples |
| Condition | Colorectal Cancer Metastatic |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-10-16 |
| Primary Completion | 2026-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 60 participants in total. It began in 2025-10-16 with a primary completion date of 2026-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. Written informed consent to study procedures and to correlative studies. 2. Either sex aged ≥ 18. 3. Histologically proven of colorectal adenocarcinoma. 4. Diagnosis of metastatic disease. 5. RAS mutant at initial diagnosis assessed at local centers according with a validated method defined by EMA and known MMR/MSI status. 6. Achieved a PFS in first line \> 6 months with chemotherapy in combination to antiangiogenic treatment OR with one metastatic site at study entry 7. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1 at study entry. 8. Imaging-documented measurable disease, according to RECIST 1.1 criteria. 9. Estimated life expectancy of more than 12 weeks 10. 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. 11. 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. 12. 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). 13. Electrolytes (i.e. magnesium, calcium, sodium and potassium) within laboratory normal range. 14. Known dihydropyrimidine dehydrogenase (DPYD) activity is mandatory. Additional analysis of polymorphisms uridine diphosphate-glycosyltransferase 1 (UGT1A1) enzyme is recommended but not mandatory. Exclusion Criteria: 1. Prior malignancy within five years. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer. 2. Any contraindication to regorafenib. 3. Not received immunotherapy if dMMR or MSI-H. 4. Major surgical intervention within 4 weeks prior to enrollment. 5. Pregnancy and breast-feeding. 6. Any brain metastasis. 7. Evidence of severe or uncontrolled systemic disease or any concurrent condition which in the investigator's opinion makes it undesirable for the patient to participate in the study, or which would jeopardize compliance with the protocol, or would interfere with the results of the study. 8. History of poor co-operation, non-compliance with medical treatment, unreliability or any condition that may impair the patient's understanding of the Informed consent form. 9. Participation in any interventional drug or medical device study within 30 days prior to treatment start. 10. Sexually active males and females (of childbearing potential) unwilling to practice contraception (barrier contraceptive measure or oral contraception) during the study and until 6 months after the last trial treatment. 11. Complete deficiency of activity of dihydropyrimidine dehydrogenase (DPYD)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07213570 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Colorectal Cancer Metastatic. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07213570 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07213570 currently recruiting?
Yes, NCT07213570 is actively recruiting participants. Contact the research team at a.avallone@istitutotumori.na.it for enrollment information.
Where is the NCT07213570 trial being conducted?
This trial is being conducted at Naples, Italy.
Who is sponsoring the NCT07213570 clinical trial?
NCT07213570 is sponsored by National Cancer Institute, Naples. The trial plans to enroll 60 participants.
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