A Study of On-treatment ctDNA Changes in Chemo-refractory Colorectal Cancer Patients
COPERNIC is an international, multicentre, single-arm study. Chemo-refractory mCRC subjects who meet all eligibility criteria will be treated with standard systemic chemotherapy (the decision about the treatment regimen being made by the treating physician) and undergo tumour assessment by standard imaging (either CT scan or MRI scan) at baseline and every 8 or 12 weeks until evidence of tumour progression. Response to treatment will be assessed by the local investigators according to the RECIST criteria version 1.1. Blinded, independent central review of the imaging scan will be carried out, this having no impact on treatment decisions thatwhich will remain the prerogative of the treating physician. Serial blood samples from study subjects will be collected at pre-defined time points for ctDNA testing. Also, archived tumour tissue from each subject will be collected. Prospective and retrospective ctDNA analyses on blood samples will be carried out, and dynamics of ctDNA will be correlated with treatment outcomes prognosis.
• Age ≥ 18 years old
• Male or female
• ECOG performance status ≤2
• Must have histologically or cytologically verified colorectal cancer adenocarcinoma
• Inoperable locally advanced or metastatic disease
• Presence of measurable disease (by RECIST criteria version 1.1) on baseline CT scan of the thorax/abdomen/pelvis or CT scan of the thorax and MRI of the abdomen/pelvis
• At least two prior systemic treatments for advanced/metastatic colorectal cancer including oxaliplatin and irinotecan-based therapy (adjuvant or neoadjuvant systemic chemotherapy will be considered if tumour progression was documented within 6 month of the last chemotherapy dose)
• Candidate for standard third-line or subsequent lines of therapy as per decision of the treating physician
• Life expectancy of at least 3 months
⁃ Women of childbearing potential must have a negative serum pregnancy test done within 28 days prior to enrolment.
⁃ Effective contraception is in place for women of childbearing potential.
⁃ Completion of all necessary screening procedures within 28 days prior to enrolment.
⁃ Availability of archived tumour tissue
⁃ Signed Informed Consent form (ICF) obtained prior to any study related procedure.
⁃ Inclusion criterion applicable to FRANCE only
⁃ Affiliated to the French Social Security System