Who is sponsoring NCT07381764?

NCT07381764 is sponsored by Gruppo Oncologico Italia Meridionale.

What drugs are being tested in NCT07381764?

Interventions in NCT07381764: Erbitux (Cetuximab), Bevacizumab, Irinotecan, Trifluridine/tipiracil.

What condition does NCT07381764 study?

NCT07381764 studies Metastatic Colorectal Cancer (CRC).

Is NCT07381764 still recruiting?

NCT07381764 is currently not yet recruiting. Last updated 2 February 2026.

Last reviewed 2026-02-02 · How we verify

NCT07381764: ROMANCE - GOIM

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

ROMANCE: "Irinotecan Plus Cetuximab Rechallenge Versus Trifluridine/Tipiracil Plus Bevacizumab in Molecularly Selected Metastatic Colorectal Cancer"

Not yet recruiting Phase 2 Last updated 2 February 2026

What this trial tests

Phase 2 trial testing Erbitux (Cetuximab) in Metastatic Colorectal Cancer (CRC) in 150 participants. Not yet recruiting.

Timeline

30 March 2026

Primary endpoint
30 March 2031

30 March 2031

Quick facts

Lead sponsor	Gruppo Oncologico Italia Meridionale
Phase	Phase 2
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	150
Start date	30 March 2026
Primary completion	30 March 2031
Estimated completion	30 March 2031
Sites	26 locations across Italy

Drugs / interventions tested

Erbitux (Cetuximab) — full drug profile →
Bevacizumab (Bevacizumab-Bvzr) — full drug profile →
Irinotecan (irinotecan) — full drug profile →
Trifluridine/tipiracil

Conditions studied

Metastatic Colorectal Cancer (CRC) — all drugs for Metastatic Colorectal Cancer (CRC) →

Sponsor

Gruppo Oncologico Italia Meridionale — full company profile →

Who can join

18 and older, any sex, with Metastatic Colorectal Cancer (CRC). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study is a phase II, open-label, multicenter clinical trial designed to evaluate two different treatment options for patients with metastatic colorectal cancer whose disease has progressed after standard therapies. The study compares a rechallenge treatment using irinotecan plus cetuximab with the current standard of care, trifluridine/tipiracil plus bevacizumab, as third-line therapy. Patients enrolled in the study are selected based on specific molecular characteristics of their cancer, identified through circulating tumor DNA analysis from a blood sample. The main purpose of the study is to determine whether the rechallenge with irinotecan and cetuximab leads to a higher tumor response rate compared with trifluridine/tipiracil plus bevacizumab. Secondary objectives include evaluating progression-free survival, overall survival, safety, and quality of life. Patients will be randomly assigned to one of the two treatment groups and will receive treatment until disease progression, unacceptable side effects, or withdrawal of consent. Tumor response will be assessed using standard imaging techniques according to RECIST criteria.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other recruiting trials for Metastatic Colorectal Cancer (CRC)

Currently open trials in the same condition.

NCT07228832 — Phase III Study of Ivonescimab or Bevacizumab Combined With FOLFOX in Patients With Metastatic Colorectal Cancer · Phase 3 · recruiting
NCT07167446 — Neuroprotective Potential of Cannabidiol (CBD) in Preventing Oxaliplatin (Ox)-Induced Neuropathy · EARLY_PHASE1 · recruiting
NCT07309289 — NALIRIFOX Plus Targeted Therapy Versus FOLFOX Plus Targeted Therapy as First-line Treatment for Metastatic Colorectal Ca · Phase 3 · recruiting
NCT06958419 — Node-Sparing Short-Course Radiotherapy Plus Chemotherapy, Bevacizumab and PD-1 Inhibitor in Metastatic pMMR/MSS Colorect · Phase 2, PHASE3 · recruiting
NCT06856187 — Second-line Standard Treatment Sequential TAS-102 and Bevacizumab Combined With Local Treatment in Advanced Colorectal C · Phase 2 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT07381764 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Gruppo Oncologico Italia Meridionale
Last refreshed: 2 February 2026

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07381764.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing