ctDNA-guided anti-EGFR retreatment in metastatic colorectal cancer
Assessing the Efficacy and Safety of ctDNA-driven Selection for Anti-EGFR Retreatment in a Real World Metastatic Colorectal Cancer Patients Cohort
This project will see if using a ctDNA blood test to pick people with metastatic colorectal cancer for anti‑EGFR retreatment leads to better treatment outcomes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 250 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Niguarda Hospital Academic / other |
| Locations | 1 site (Milan, Italia) |
| Trial ID | NCT07536113 on ClinicalTrials.gov |
What this trial studies
This is a retrospective, observational, international multicenter effort to collect clinical, molecular and outcome data from MSS, RAS/BRAF wild‑type metastatic colorectal cancer patients who were screened by ctDNA within the MEN1611‑02 protocol. The study compiles archival tissue and liquid biopsy molecular profiles (RAS/BRAF/PIK3CA), timing of sample collection, patient demographics, ECOG performance status, metastasis sites, prior treatments and the first treatment given after the ctDNA draw. Responses will be recorded using RECIST v1.1 and outcomes will include response rate, disease control rate, duration of response, progression‑free survival, time‑to‑treatment failure and overall survival. Analyses will compare real‑world outcomes for patients selected or not selected for anti‑EGFR retreatment based on ctDNA findings.
Who should consider this trial
Good fit: Adults (≥18) with MSS, RAS/BRAF wild‑type metastatic colorectal cancer who were screened by ctDNA within the MEN1611‑02 program and have available outcome data after the ctDNA draw.
Not a fit: Patients without ctDNA screening or without outcome data after the ctDNA draw, those enrolled and treated within the MEN1611‑02 interventional trial, or patients with non‑wild‑type RAS/BRAF or MSI‑high tumors would not be candidates for inclusion or likely to benefit from this analysis.
Why it matters
Potential benefit: If successful, this work could help clinicians use a simple blood test to identify patients likely to benefit from anti‑EGFR retreatment, avoiding ineffective therapy and tailoring care.
How similar studies have performed: Smaller studies and emerging clinical reports have shown promise for ctDNA‑guided anti‑EGFR rechallenge, but the approach remains exploratory and not yet definitively proven.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria 1. Patients diagnosed with MSS RAS and BRAF wild-type (on solid tissue) mCRC and screened by ctDNA within the MEN1611-02 clinical trial; 2. Informed consent signature from alive patient; 3. Availability of clinical data detailing the outcome to the first treatment received by patients following the blood draw for ctDNA analysis performed as per screening procedures within the MEN1611-02 clinical trial; 4. Signed informed consent for molecular screening within the MEN1611-02 clinical trial. 5. Age ≥ 18. Exclusion criteria 1. No data available detailing the outcome to the first treatment received by patients following the blood draw for ctDNA analysis performed as per screening procedures within the MEN1611-02 clinical trial. 2. Patients enrolled and treated within the MEN1611-02 clinical trial.
Where this trial is running
Milan, Italia
- ASST GOM Niguarda — Milan, Italia, Italy (Recruiting)
Study contacts
- Principal investigator: Salvatore Siena, MD — ASST Niguarda Hospital
- Study coordinator: Salvatore Siena, MD
- Email: salvatore.siena@ospedaleniguarda.it
- Phone: +39026444
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.