Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT07213570

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

Led by National Cancer Institute, Naples · Updated on 2025-12-17

60

Participants Needed

1

Research Sites

76 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed informed consent for study procedures and correlative studies
  • Age 18 years or older
  • Histologically confirmed colorectal adenocarcinoma
  • Diagnosed with metastatic disease
  • RAS mutation confirmed at diagnosis with known MMR/MSI status
  • Progression-free survival greater than 6 months with first-line chemotherapy plus antiangiogenic treatment or presence of one metastatic site at study entry
  • ECOG performance status of 0 or 1
  • Measurable disease per RECIST 1.1 criteria on imaging
  • Estimated life expectancy over 12 weeks
  • Adequate bone marrow function: ANC 63 1.5 x 10^9/L, platelets 63 100 x 10^9/L, hemoglobin 63 9 g/dL
  • Adequate liver function: total bilirubin 64 1.5 x ULN or 64 2 with biliary stent, AST/ALT 64 5 x ULN
  • Adequate renal function: serum creatinine 64 1.5 mg/dL or creatinine clearance 63 60 mL/min (males) or 63 50 mL/min (females)
  • Electrolytes within normal laboratory range
  • Known dihydropyrimidine dehydrogenase (DPYD) activity; UGT1A1 polymorphism analysis recommended but not mandatory
Not Eligible

You will not qualify if you...

  • History of another cancer within the past five years except treated basal or squamous cell skin cancer or in situ cervical cancer
  • Contraindications to regorafenib
  • Did not receive immunotherapy if dMMR or MSI-H
  • Major surgery within 4 weeks before enrollment
  • Pregnancy or breastfeeding
  • Presence of brain metastases
  • Severe or uncontrolled systemic disease or conditions making study participation unsafe or unreliable
  • History of poor cooperation, non-compliance, or inability to understand informed consent
  • Participation in another interventional drug or device study within 30 days before treatment start
  • Sexually active individuals of childbearing potential unwilling to use contraception during and for 6 months after the study
  • Complete deficiency of DPYD enzyme activity

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Istituto Nazionale Tumori | "Fondazione Pascale"

Naples, Italy, Italy

Actively Recruiting

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Research Team

A

Antonio Avallone, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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