RecruitingPhase 2NCT07213570

STREAM-2: Second-line Treatment With REgorafenib in Advanced RAS-Mutant Colorectal Cancer

Regorafenib as Second-line Treatment of Patients With RAS-mutant Advanced Colorectal Cancer: a Multicentre, Phase 2 Study

Sponsor

National Cancer Institute, Naples

Enrollment

60 participants

Start Date

Oct 16, 2025

Study Type

INTERVENTIONAL

Conditions

Colorectal Cancer Metastatic

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study (called STREAM-2) is testing a drug called regorafenib as a second-line treatment for people with metastatic colorectal cancer (cancer that has spread) that has a specific genetic mutation called RAS. It is for people whose cancer progressed after their first treatment. **You may be eligible if...** - You are 18 or older and have metastatic colorectal cancer confirmed by biopsy - Your cancer has a RAS mutation - You have already received first-line chemotherapy combined with a blood vessel-blocking drug, and your cancer was controlled for more than 6 months; or you have only one site of spread - You are reasonably functional (ECOG performance status 0 or 1) - Your blood counts, liver, and kidney function are adequate - Your cancer can be measured on scans **You may NOT be eligible if...** - You had another cancer within the past 5 years (some skin cancers are exceptions) - You have brain metastases - You have a known severe reaction to regorafenib - You are pregnant or breastfeeding - You are not able or willing to use contraception during the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGstandard second line treatment, at discretion of the investigator

Combination treatment may include: 5FU/LFA, capecitabine, oxaliplatin, irinotecan, bevacizumab, aflibercept

DRUGRegorafenib (BAY73-4506)

Regorafenib will be administered following a dose-escalation strategy: starting dose 80 mg/day orally with weekly escalation, per 40 mg increment up to 160 mg/day regorafenib); if no significant drug-related adverse events occurred for 21 days of a 28-day cycle. The following cycle will be administered at highest tolerated dose from cycle 1 (up to 160 mg), as per current guidelines and clinical practice. Treatment will continue until disease progression, unacceptable toxic effects, motivated decision to stop the treatment by the treating physician, or refusal or withdrawal of consent by the patient. Every cycle will be administered every 28 days (four weeks) +/- 3 days.