Trial · NCT04776655
Study in mCRC Patients RAS/BRAF wt Tissue and RAS Mutated LIquid BIopsy to Compare FOLFIRI Plus CetuxiMAb or BevacizumaB
NCT04776655, Phase 3, Active not recruiting, Azienda USL Reggio Emilia - IRCCS
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study in mCRC Patients RAS/BRAF wt Tissue and RAS Mutated LIquid BIopsy to Compare FOLFIRI Plus CetuxiMAb or BevacizumaB. Trials, record NCT04776655. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04776655
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study in mCRC Patients RAS/BRAF wt Tissue and RAS Mutated LIquid BIopsy to Compare FOLFIRI Plus CetuxiMAb or BevacizumaB
- NCT number
- NCT04776655
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 280 participants, estimated
- Lead sponsor
- Azienda USL Reggio Emilia - IRCCS
- Conditions
- Colorectal Cancer, Metastatic Colorectal Cancer, RAS Mutation
- Interventions
- Bevacizumab, Cetuximab, 5-FU, Irinotecan, Calcium levofolinate
- First posted
- 2021-03-02
- Last updated
- 2026-07-24
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression free survival (PFS) in patients with RASmut at liquid biopsy and RASwt on tissue. | From the date of randomization to the date of first progression or death for any cause, whichever occurs first, assessed up to 36 months | The primary objective of the study is to assess whether the combination of bevacizumab plus chemotherapy is superior to cetuximab plus chemotherapy in terms of progression free survival (PFS) in patients with RASmut at liquid biopsy and RASwt on tissue. |
| Secondary | Overall survival (OS) | up to 36 months | Overall survival (OS) defined as the time from start of treatment to the date of death for any cause or, for living patients, the date of last contact. |
| Secondary | Objective response rate (ORR) | up to 36 months | Objective Response Rate (ORR), defined as the percentage of patients with a complete (CR) or partial response (PR) as best response during treatment as determined by RECIST 1.1. |
| Secondary | Prevalence of RAS mutation | up to 36 months | Percentage of RAS mut patients on the total of patients who undergone to liquid biopsy at the first and second evaluations. |
| Secondary | Patients Safety | up to 36 months | The maximum toxicity grade experienced by each patient, for each toxicity, according to NCI-CTCAE v. 5.0; the number of patients experiencing grade 3-4 toxicity for each toxicity; type, frequency and nature of SAEs; patients with at least a SAE; patients with at least a SADR; patients with at least a SUSAR. |
| Secondary | Compliance | up to 36 months | The compliance to treatment will be described presenting number of administered cycles; frequency and reasons for drug discontinuation and treatment modifications. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04776655
GET https://conductscience.org/api/trials/v1/NCT04776655/registered