Prospective Study for Validation of Immunological Biomarkers in Patients With Metastatic Colorectal Cancer
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 258
- Locations
- 9
- Primary Endpoint
- Progression-free survival
Study Overview
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 OncoImmunology 2012 and unpublished data).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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
Additional biological samples
Additional blood samples will be realized specifically to the study at baseline, at 1 month, at 3 months, and 1 month after surgery (if applicable).
Peripheral Blood Mononuclear Cell (PBMC) and plasma will be collected. Tissue tumor is collected during surgery if applicable.
Intervention: Additional biological samples (Other)
Outcomes
Primary Outcomes
Progression-free survival
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported