Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT04776655

Study in mCRC Patients RAS/BRAF wt Tissue and RAS Mutated LIquid BIopsy to Compare FOLFIRI Plus CetuxiMAb or BevacizumaB

Led by Azienda USL Reggio Emilia - IRCCS · Updated on 2025-10-02

280

Participants Needed

4

Research Sites

261 weeks

Total Duration

On this page

Sponsors

A

Azienda USL Reggio Emilia - IRCCS

Lead Sponsor

I

Istituto Di Ricerche Farmacologiche Mario Negri

Collaborating Sponsor

AI-Summary

What this Trial Is About

This study is a prospective, randomized phase III, to evaluate if in patients with mCRC RAS/BRAF wild type on tumor tissue and RAS mutations on liquid biopsy, treating in first line with antibody anti-VEGF (bevacizumab) plus chemotherapy (FOLFIRI) is superior in terms of PFS compared to standard treatment with antibody anti-EGFR (cetuximab) plus FOLFIRI, and then in patients RAS/BRAF wild type on tumor tissue who develop RAS mutations on liquid biopsy after the beginning of the first line treatment with cetuximab plus FOLFIRI, in the absence of a clinical or radiological progression disease, to anticipate a change of treatment with bevacizumab plus FOLFIRI further impacts on the PFS.

CONDITIONS

Official Title

Study in mCRC Patients RAS/BRAF wt Tissue and RAS Mutated LIquid BIopsy to Compare FOLFIRI Plus CetuxiMAb or BevacizumaB

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Provide written informed consent
  • Male or female 18 years of age or older
  • Histologically confirmed colorectal adenocarcinoma with RAS/BRAF wild type on tumor tissue
  • Unresectable metastatic colorectal cancer not previously treated with chemotherapy for metastatic disease
  • Left-sided colorectal cancer
  • Suitable for first-line chemotherapy
  • Life expectancy greater than 3 months
  • At least one measurable disease site per RECIST criteria version 1.1
  • ECOG performance status 0, 1, or 2
  • Adequate bone marrow, liver, and kidney function before starting treatment
  • If known, DPD status must be wild type; no restrictions if unknown
  • Women of childbearing potential must have a negative pregnancy test within 24 hours before starting treatment
  • Willingness of subjects and partners to use effective contraception during the trial and for specified months after treatment
Not Eligible

You will not qualify if you...

  • Prior chemotherapy for metastatic disease, except adjuvant treatment completed at least 6 months before randomization
  • Contraindications to Cetuximab, Bevacizumab, Irinotecan, 5-FU, or folinic acid
  • Radiotherapy within 4 weeks before randomization
  • Serious, non-healing wounds, ulcers, or bone fractures
  • Bleeding disorders or coagulopathy
  • Uncontrolled hypertension or history of hypertensive crisis/encephalopathy
  • Additional malignancy within the last 5 years except certain skin or cervical cancers
  • Active untreated brain metastases or carcinomatous meningitis
  • Active infection needing systemic therapy or disseminated intravascular coagulation
  • History of HIV infection
  • Positive test for hepatitis B or C indicating acute or chronic infection
  • Chronic daily high-dose aspirin use (>325 mg/day)
  • Previous venous thromboembolism greater than NCI CTCAE Grade 3
  • History of abdominal fistula, gastrointestinal perforation, abscess, or active bleeding within 6 months
  • Current or recent therapeutic anticoagulant treatment within 10 days prior to study start
  • Major surgery, open biopsy, or significant injury within 28 days before study start
  • Severe hypersensitivity to any monoclonal antibody
  • Significant concomitant disease that prevents study participation as judged by investigator

AI-Screening

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Trial Site Locations

Total: 4 locations

1

Ospedale San Salvatore

Coppito, L'Aquila, Italy, 67100

Actively Recruiting

2

Ospedale Civile di Guastalla

Guastalla, Reggio Emilia, Italy, 42016

Actively Recruiting

3

AUSL/IRCCS di Reggio Emilia

Reggio Emilia, Reggio Emilia, Italy, 42123

Actively Recruiting

4

Azienda ULSS 3 Serenissima

Mirano, VE, Italy, 30035

Actively Recruiting

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Research Team

C

Carmine Pinto, MD

CONTACT

A

Angela Damato, 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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