Clinical trial NCT02817178: Study for Validation of Immunological Biomarkers in Patients With Metastatic Colorectal Cancer
Official title: Prospective Study for Validation of Immunological Biomarkers in Patients With Metastatic Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metastatic Colorectal Cancer
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2016-06-29
Enrollment: 258
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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 OncoImmunology 2012 and unpublished data).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.


Eligibility criteria: 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.

Primary outcomes:
measure: Progression-free survival
timeFrame: date of first progression of the disease (within 3 years after the enrollment in the study)]
Secondary outcomes:
Other outcomes:
Locations:
city: Besançon
country: France
facility: Centre Hospitalier Régional Universitaire de Besançon
city: Besançon
country: France
facility: Polyclinique de Franche-Comté
city: Colmar
country: France
facility: Hôpitaux Civils de Colmar
city: Dijon
country: France
facility: Centre Georges François Leclerc
city: Montbéliard
country: France
facility: Hôpital Nord Franche-Comté
city: Nancy
country: France
facility: Institut de Cancérologie de Lorraine
city: Paris
country: France
facility: Hôpital Européen Georges Pompidou
city: Strasbourg
country: France
facility: Centre Paul Strauss
city: Tours
country: France
facility: Centre Hospitalier Universitaire de Tours
Study officials:
affiliation: CHU DE BESANCON
name: Stefano KIM, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kroemer M, Turco C, Spehner L, Viot J, Idirene I, Bouard A, Renaude E, Deschamps M, Godet Y, Adotevi O, Limat S, Heyd B, Jary M, Loyon R, Borg C. Investigation of the prognostic value of CD4 T cell subsets expanded from tumor-infiltrating lymphocytes of colorectal cancer liver metastases. J Immunother Cancer. 2020 Nov;8(2):e001478. doi: 10.1136/jitc-2020-001478.