Informations générales (source: ClinicalTrials.gov)
(METAHEP)
Interventional
Phase 2
Poitiers University Hospital (Voir sur ClinicalTrials)
janvier 2012
mars 2023
29 juin 2024
The immune response at primary tumor has a major role in the prognosis of colorectal
cancer (CRC). Some studies suggest a prognosis value of cytotoxic T cell and memory T
cells at primary tumor greater than tumoral stage. There is no work in the literature
that has examined the prognosis value of the immune response in liver metastases. To
study immune cells (histology) and inflammatory response (cytokines) in liver metastases
is a challenge to understand the effectiveness of chemotherapy used in this situation.
The chemotherapy used in liver metastases of colorectal cancer also have effects on
non-tumoral liver tumor and therefore can interfere with postoperative complications of
hepatic resection. Sinusoidal dilatation is present in 20% to 80% of patients who
received oxaliplatin before hepatectomy. Steatosis is frequently observed after
administration of 5-FU alone or in combination with irinotecan. This steatosis may also
be accompanied by inflammatory lesions (steatohepatitis), especially after administration
of oxaliplatin or irinotecan and is associated with increased postoperative mortality.
The hepatic toxicity of new biological agents is not well known (cetuximab and
bevacizumab). The mechanisms of chemotherapy-induced toxicities are currently unknown.
The main objective is to analyze the profile of the immune response in liver metastases
of CRC and find the link with the radiological response. Measurements will be made by
quantitative RT-PCR on frozen liver biopsies. Secondary objective is to seek a
correlation between the histological lesions induced by chemotherapy and non-invasive
tests for liver fibrosis. The secondary endpoints are rate of immune cells, histologic
response (percentage of tumor necrosis), disease-free survival, the non-invasive test of
fibrosis, the chemotherapy-induced liver injury, cytokines and circulating angiogenic
factors.
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| Poitiers University Hospital - 86021 - Poitiers - France | David TOUGERON, MD | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
Patient older than 18 years.
- Patients with histologically proven colorectal cancer with resectable or potentially
resectable liver metastases.
- First line chemotherapy alone or combination with intravenous 5FU, oral 5FU
(capecitabine), oxaliplatin, irinotecan, cetuximab, panitumumab or bevacizumab
(LV5FU2, XELODA, FOLFIRI, FOLFOX, XELOX, XELIRI alone or in combination with either
cetuximab or panitumumab or bevacizumab).
- Signature of informed consent.
- Patient affiliated to French Social Security.
Patient older than 18 years.
- Patients with histologically proven colorectal cancer with resectable or potentially
resectable liver metastases.
- First line chemotherapy alone or combination with intravenous 5FU, oral 5FU
(capecitabine), oxaliplatin, irinotecan, cetuximab, panitumumab or bevacizumab
(LV5FU2, XELODA, FOLFIRI, FOLFOX, XELOX, XELIRI alone or in combination with either
cetuximab or panitumumab or bevacizumab).
- Signature of informed consent.
- Patient affiliated to French Social Security.
Patients taking immunosuppressive therapy.
- Lack of measurable tumoral target.
- Patients with a contre-indication of all chemotherapy used: oxaliplatin, irinotecan,
fluorouracil, capecitabine, cetuximab, panitumumab, bevacizumab.
- Patients hospitalized without consent.
- Patients in emergency situations.
- Patients under guardianship.
- Patients deprived of their liberty by judicial or administrative procedure.
- Pregnant or nursing women, women without effective contraception.