drugset / Trial / NCT07213570

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

NCT07213570

Phase 2 Recruiting 60 enrolled National Cancer Institute, Naples
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2025-10-16
Primary completion
2026-10
Completion
2027-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Regorafenib Small molecule 160 mg Oral
Comparator Aflibercept Protein / enzyme biologic
Comparator Bevacizumab Monoclonal antibody
Comparator Capecitabine Small molecule
Comparator Irinotecan Small molecule
Comparator LFA Unknown
Comparator Oxaliplatin Small molecule
Comparator fluorouracil Small molecule

Indications