Viewing Study NCT06536127



Ignite Creation Date: 2024-10-26 @ 3:36 PM
Last Modification Date: 2024-10-26 @ 3:36 PM
Study NCT ID: NCT06536127
Status: RECRUITING
Last Update Posted: None
First Post: 2024-07-29

Brief Title: Prospective Monocentric Study Evaluating the Circulating NK Cells Phenotype and the ImmunoScore in Patients With Non Metastatic Rectal Cancer
Sponsor: None
Organization: None

Study Overview

Official Title: Prospective Monocentric Study Evaluating the Circulating NK Cells Phenotype and the ImmunoScore in Patients With Non Metastatic Rectal Adenocarcinoma Treated With Preoperative Radiochemotherapy With or Without Initial Chemotherapy
Status: RECRUITING
Status Verified Date: 2024-07
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: No
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: IMMUNOREC
Brief Summary: Until 2020 the standard treatment for rectal cancer was a combination of radiotherapy and concomitant chemotherapy based on IV or oral 5FU with a low complete response rate

The randomised phase 3 PRODIGE 23 trial evaluated a regimen of FOLFIRINOX chemotherapy prior to neoadjuvant RTCT with 3-year disease-free survival as the primary endpoint Patients in the PRODIGE 23 arm had significantly better 3-year disease-free survival 76 versus 69 p0034 and 3-year metastasis-free survival 79 versus 72 p0017 than patients in the standard arm and the complete histological response rate to neoadjuvant treatment ypT0N0 doubled from 12 in the standard arm to 28 in the PRODIGE 23 arm

The main benefit of surgical de-escalation is to improve patients quality of life The main obstacle to the non-surgical management of these patients with a complete response after RTCT was the impact on survival in the event of local recurrence Habr-Gama et al showed that the WW strategy combined with close follow-up resulted in excellent disease control in the event of local recurrence with organ conservation in almost 80 of patients

The selection of patients eligible for this non-surgical treatment Wait and Watch WW remains the main issue which is why some physicians are still reluctant to adopt it

The immune cells known to be involved in the anti-tumour response are T lymphocytes B lymphocytes and Natural Killers NK These cells play a crucial role in the initiation development and progression of cancers They are naturally considered as potential targets for immunotherapy but also as biological markers

In several tumour types particularly colorectal cancers it has been shown that a CD8 lymphocyte infiltrate in the tumour is associated with a better prognosis NK cells have also been studied in the circulating blood of colorectal cancer patients and have been shown to be predictive of 3-year survival These results suggest that prognosis may depend more on the quality of the anti-tumour immune response than on clinical parameters

The prognosis of adenocarcinoma of the rectum is essentially estimated by TNM uicc staging It needs to be better estimated in order to adapt treatments to the risk of relapse The beneficial effect of the immune response developed by the patient against colorectal tumours is certainly an important area of research

The INSERM U1183 unit is developing a technology for analysing blood NK cells and their phenotype including those acquired by trogocytosis WO2016005548 The aim of our study will be to compare the phenotype of circulating NK cells in patients with rectal cancer before during and after treatment and to study the relationship with relapse-free survival and the rate of complete clinical response in non-operated patients and histological response in operated patients

A clinically applicable immunological test called Immunoscore quantifies the density of two types of immune cells in the tumour and its invasion front total T lymphocytes CD3 and killer lymphocytes cytotoxic CD8 The aim of the international study published in The Lancet was to assess the prognostic value of the Immunoscore test in patients with colon cancer Given the major performance of this test in colorectal cancer researchers are currently evaluating the Immunoscore test in rectal cancer and studying its ability to predict response to neoadjuvant treatment in rectal cancer El sissy et al reported very encouraging results on the predictive value of the test for rectal tumours in complete response after radio-chemotherapy
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None