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Study identifier: NCT07389265 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

Continuation of Cetuximab Beyond First-Line Progression in Metastatic Colorectal Cancer

Condition: Metastatic Colorectal Cancer (mCRC)  ·  Sponsor: University of Campania Luigi Vanvitelli

PhasePhase 3
Planned participants480
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

The goal of this Phase 3 clinical trial is to evaluate whether continuing cetuximab treatment beyond first-line progression can improve outcomes in patients with metastatic colorectal cancer whose tumors are RAS and BRAF wild-type. The study will compare the effectiveness of chemotherapy given together with cetuximab versus chemotherapy given together with bevacizumab. Researchers aim to determine whether cetuximab continuation improves tumor response, progression-free survival, overall survival, and safety in this patient population. Eligible participants are adults with metastatic colorectal cancer who have previously responded to first-line treatment with chemotherapy combined with an anti-EGFR antibody. Before starting therapy, patients will undergo molecular testing using liquid biopsy to confirm tumor characteristics. They will then receive chemotherapy with either cetuximab or bevacizumab every two weeks, and their disease will be monitored regularly with CT or MRI scans, laboratory tests, and clinical evaluations. During the study, patients will also provide biological samples for translational research. This trial will enroll about 360 patients across sites in Italy and Spain and is designed to provide new evidence on whether cetuximab continuation beyond first-line treatment can offer a meaningful clinical benefit compared with standard therapy.

This description comes directly from the study's public registry record.

Talk to the study team

Fortunato Ciardiello  ·  0815666760  ·  fortunato.ciardiello@unicampania.it

Stefania Napolitano  ·  stefania.napolitano@unicampania.it

Always discuss trial participation with your own doctor first.

Locations (41)

A.O.U. Ospedali RiunitiAncona, ItalyNot Yet Recruiting
AORN S. Giuseppe MoscatiAvellino, ItalyNot Yet Recruiting
Centro di Riferimento Oncologico (C.R.O.) IRCCSAviano, ItalyNot Yet Recruiting
IRCCS Istituto Tumori "Giovanni Paolo II"Bari, ItalyNot Yet Recruiting
Fondazione Poliambulanza Istituto OspedalieroBrescia, ItalyNot Yet Recruiting
Ospedale IRCCS 'Saverio de Bellis'Castellana Grotte, ItalyNot Yet Recruiting
Nome EnteA.R.N.A.S. Garibaldi - P.O. Garibaldi-NesimaCatania, ItalyNot Yet Recruiting
Azienda Ospedaliero-Universitaria Renato DulbeccoCatanzaro, ItalyNot Yet Recruiting
A.O.U. CareggiFlorence, ItalyNot Yet Recruiting
P.O. 'Vito Fazzi'Lecce, ItalyNot Yet Recruiting
Istituto Romagnolo per lo Studio dei Tumori 'Dino Amadori'Meldola, ItalyNot Yet Recruiting
ASST Grande Ospedale Metropolitano NiguardaMilan, ItalyNot Yet Recruiting

+ 29 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT07389265