Study for Validation of Immunological Biomarkers in Patients With Metastatic Colorectal Cancer

Metastatic Colorectal Cancer Clinical Trial

— Epitopes-CRC02  

Official title:

Prospective Study for Validation of Immunological Biomarkers in Patients With Metastatic Colorectal Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02817178
• Other study ID #: Epitopes-CRC02
• Status: Completed
• Phase: N/A
• Start date: March 2013
• Est. completion date: July 6, 2020

Study information

• Verified date: May 2022
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 OncoImmunology 2012 and unpublished data).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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 258
• Est. completion date: July 6, 2020
• Est. primary completion date: June 11, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Metastatic Colorectal Cancer

Intervention

Other:
• Additional biological samples
blood and tumor tissue samples

Locations

Country	Name	City	State
France	Centre Hospitalier Régional Universitaire de Besançon	Besançon
France	Polyclinique de Franche-Comté	Besançon
France	Hôpitaux Civils de Colmar	Colmar
France	Centre Georges François Leclerc	Dijon
France	Hôpital Nord Franche-Comté	Montbéliard
France	Institut de Cancérologie de Lorraine	Nancy
France	Hôpital Européen Georges Pompidou	Paris
France	Centre Paul Strauss	Strasbourg
France	Centre Hospitalier Universitaire de Tours	Tours

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival	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.	date of first progression of the disease (within 3 years after the enrollment in the study)]