An observational study in Metastatic Colorectal Cancer and Colorectal Neoplasms, sponsored by Sanofi. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-30.
Sponsored by Sanofi · Observational
Primary Objective:
-Evaluate the resection rate (R0/R1) in current practice for aflibercept in combination with irinotecan plus 5-fluorouracil (FOLFIRI) in patients treated for metastatic colorectal cancer (mCRC) after failure of an oxaliplatin-containing regimen
Secondary Objectives:
The estimated inclusion period is 45 months. Patient follow-up is 24 months and the total study duration is 69 months. Last patient status (alive or dead) collected before database lock.
5,738 studies on the registry are indexed under Colorectal Neoplasms; 1,483 are open to participants now.
This study's enrollment of 140 is below the median of 250 across 1,253 observational studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Sanofi is the lead sponsor of 1,548 studies on the registry; 88 are open to participants now.
Of its 204 completed or terminated interventional studies of FDA-regulated products, 122 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
The source population for this study will be patients treated with aflibercept in combination with FOLFIRI for metastatic ColoRectal Cancer (mCRC) after failure of an oxaliplatin-containing regimen (including patients pretreated with bevacizumab or anti-estimated glomerular filtration rate (anti-EGFR) and patients treated with oxaliplatin in the adjuvant setting but excluding these already participating in a clinical trial) recruited from particpating sites in France. The study will aim to enroll approximately 140 adult patients treated with aflibercept in combination with FOLFIRI for metastatic colorectal cancer after failure of an oxaliplatin-containing regimen from up to 30 sites.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
Patients with metastatic colorectal cancer and liver metastases treated with FOLFIRI plus aflibercept after failure of an oxaliplatin-based regimen
Drug: Fluorouracil · Drug: Aflibercept · Drug: Irinotecan
Pharmaceutical Form: solution for injection Route of Administration: intravenous (IV), intravenous or intra-arterial infusion
Pharmaceutical Form: concentrate solution for infusion Route of Administration: IV infusion
Also known as: ZALTRAP®
Pharmaceutical Form: solution for injection Route of Administration: IV infusion
Also known as: CAMPTOSAR®
Assessment of resection rate (R0/R1)
R0 /R1 resection rate after aflibercept + FOLFIRI (resection with histological assessment of margin status)
Time frame: Up to 24 months
Overall survival
Defined starting from the date of the first aflibercept administration.
Time frame: Up to 69 months
Progression-free surivival
Defined as the time from the date of the first aflibercept administration to the date of the first event (progression, relapse or death). (Relapse in case of complete response due to chemotherapy or surgery)
Time frame: Up to 69 months
Relapse-free surivial
Defined as the time from the date of the first aflibercept administration to the date of the first event (progression, relapse or death). (Relapse in case of complete response due to chemotherapy or surgery)
Time frame: Up to 69 months
Objective Response
Assessed according to RECIST and CHUN (radiological assessment) criteria in the exploratory analysis.
Time frame: Up to 69 months
Conversion rate
Initially unresectable disease which became resectable after aflibercept + FOLFIRI, with R0/R1 resection).
Time frame: Up to 69 months
Histological response of resected patients via Tumor Regression Grade (TRG)
Histological response of resected patients via TRG
Time frame: Up to 69 months
Histological response of resected patients via Modified Tumor Regression Grade (mTRG)
Histological response of resected patients via mTRG,
Time frame: Up to 69 months
Histoligical response of resected patients via Blazer assessment
Time frame: Up to 69 months
Histological response of resected patients via modified Blazer assessment
Time frame: Up to 69 months
Histological response of resected patients via Sebagh assessment
Time frame: Up to 69 months
Radiological response for all patients using RECIST 1.1 criteria
Time frame: Up to 69 months
Rate of 90-day postoperative complications using DINDO-CLAVIEN classification
Time frame: Up to 69 months
Safety (serious and non-serious adverse events occurring during treatment
Number of patients with serious and non-serious adverse events occurring during treatment
Time frame: Up to 69 months
No study locations are listed for this record.
Plan to share: Yes — Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.