Metastatic Colorectal Cancer
Conditions
Brief summary
The investigators recently identified promiscuous HLA-DR-derived epitopes from the human telomerase reverse transcriptase (TERT) called universal cancer peptides (UCP), to study tumor-specific CD4+ T cell responses. The investigators found high frequency of naturally occuring UCP-specific TH1 cells in long term survival of metastatic colorectal cancer (CRC) previously treated by 5 fluoro-uracil -oxaliplatin (Folfox) +/- bevacizumab regiment (Godet et al. OncoImmunology 2012 and unpublished data). Epitopes-CRC02 is a French prospective multicenter study which will evaluate the post chemotherapy and post surgery modulation of host tumor-specific CD4 TH1 cell responses in metastatic colorectal cancer patients and their correlation with progression-free survival.
Interventions
blood and tumor tissue samples
Sponsors
Centre Hospitalier Universitaire de Besancon
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Performance status ECOG-WHO 0, 1 or 2 * Metastatic colorectal cancer Histologically proved * signed written informed consent
Exclusion criteria
* previous treatment (chemotherapy, targeted therapy, surgery) for metastatic disease * history of autoimmune disease * patients under immunotherapy systemic treatment or immunosuppressive drugs or stopped for less than 6 months to the enrollment in this study. * corticoids ≥ 1mg/kg * acute or chronic infectious disease during treatment or stopped for less than six months * other malignancy within the last 5 years, except for adequately treated carcinoma in situ of the cervix or squamous carcinoma of the skin, or adequately controlled limited basal cell skin cancer. * pregnancy, breast-feeding or absence of adequate contraception for fertile patients * patient with any medical or psychiatric condition or disease which would make the patient inappropriate for entry into this study. * patient under guardianship, curator or under the protection of justice.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival | date of first progression of the disease (within 3 years after the enrollment in the study)] | time interval between the date of initiation of treatment and the date of first progression (local, remote \[extent of the disease by RECIST v1.1\] second cancer) or death from any cause. |
Countries
France
Outcome results
None listed