Recruiting nowPhase 2Randomised
What this trial is trying to do
The trial asks whether reusing cetuximab, an antibody that blocks the EGFR growth signal, with irinotecan chemotherapy can shrink metastatic colorectal cancers after earlier treatments have stopped working. It compares this rechallenge approach with trifluridine/tipiracil plus bevacizumab, which blocks tumour blood-vessel growth.
The researchers expect the cetuximab–irinotecan combination might produce more tumour responses than trifluridine/tipiracil plus bevacizumab in this selected group. The main measure is objective response rate—the proportion of patients whose tumours shrink on scans—with progression-free survival, overall survival, side effects and quality of life also assessed.
Worth knowing: This is an open-label phase 2 trial, and its main outcome is tumour response rather than survival; the supplied description does not state which molecular features are required for eligibility.
Written from the trial's own registry entry to explain what the researchers are testing and why. Nothing here is a result — this trial has not reported one — and it is not a view on whether the treatment works or on whether it would suit you.
| Registry number | NCT07381764 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Phase 2 |
| Design | randomised, open label |
| Taking part | 150 people (planned) |
| Who can join | aged 18 Years and over |
| Run by | Gruppo Oncologico Italia Meridionale |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Drug Erbitux (Cetuximab)
- Drug Bevacizumab
- Drug Irinotecan
- Drug Trifluridine/tipiracil
What it is measuring
Objective Response Rate (ORR)
This is the trial's main question — the one it is designed and sized to answer. Anything else it reports is a secondary finding, and secondary findings are far more likely to be chance.
Phase 2. Tests whether the treatment works well enough to be worth a larger trial. Usually too small to prove it changes survival.
How the researchers describe it
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.
Written by the trial’s sponsor, quoted from its ClinicalTrials.gov record.
What this trial is looking for
- (K/N)RAS mutated
- Not yet treated
- Already treated
Read automatically from the criteria below, to make the list searchable. It is a summary of what the text mentions, not a decision about whether you qualify — and where the two disagree, the criteria are right and this is wrong.
Who the trial is looking for
Inclusion Criteria
1. Male or female aged ≥18 years
2. Eastern Cooperative Oncology Group Performance Status (ECOG-PS) ≤1
3. Diagnosis of histologically or cytologically confirmed colorectal cancer.
4. At least one measurable lesion according to RECIST1.1
5. KRAS/NRAS/BRAFV600E wt status of primary CRC or related metastasis (local laboratory assessment).
6. Progression to previous first-line anti-EGFR-containing therapy producing at least a partial response ≥ 6 months.
7. Received and progressed to an anti-EGFR and irinotecan free second-line treatment.
8. Have an anti-EGFR free interval of at least 4 months.
9. Refractory to previous 5-fluorouracil/capecitabine, irinotecan, oxaliplatin, bevacizumab.
10. RAS/BRAF/EGFR/PIK3CAex20/MAP2K1/MET WT and HER2 not amplified ctDNA at FoundationOne CDx test at baseline.
11. Life expectancy of at least 3 months.
12. Adequate hematological function defined by white blood cell (WBC) count ≥ 2.5 × 109/L with absolute neutrophil count (ANC) ≥ 1.5 × 109/L, lymphocyte count ≥ 0.5 × 109/L, platelet count ≥ 100 × 109/L, and hemoglobin ≥ 9 g/dL (may have been transfused).
13.
This is an extract. Whether you qualify is decided by the trial team against the full criteria, not by reading this page. Read the full eligibility criteria
Where it is running
Running at 26 sites. Listed in: Italy.
Individual hospitals, and whether each is currently open, are listed on the registry record. Sites open and close throughout a trial.
Worth asking your oncology team
Being listed here is not a recommendation, and no one page can tell you whether a trial is right for you. These are the questions it raises.
- Is this trial open at a hospital I could realistically travel to?
- Given my stage, my previous treatment and my tumour's molecular profile, would I be eligible?
- What would I be giving up by joining — is the comparison arm the treatment I would otherwise be having?
- What is already known about the safety of what is being tested?
The source
Registry record NCT07381764, registered by Gruppo Oncologico Italia Meridionale on ClinicalTrials.gov, a public database run by the US National Library of Medicine. The details on this page come from that record and are only ever as current as the sponsor has kept it.
This is a listing of a registered clinical trial, reproduced for information. It is not a recommendation, this site has no connection to the trial or its sponsor, and being listed here says nothing about whether the treatment works. Talk to your own oncology team before pursuing any trial.
This article summarises published research for general information. It is not medical advice, and it is not a substitute for a conversation with your own oncology team, who know your case. Do not start, stop, or change any treatment or supplement on the basis of what you read here.