Study of Immune Response and Liver Damage Induced by Chemotherapy for Liver Metastases of Colorectal Cancer

  • STATUS
    Recruiting
  • days left to enroll
    51
  • participants needed
    30
  • sponsor
    Poitiers University Hospital
Updated on 25 January 2021

Summary

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.

Details
Condition Resectable Hepatic Metastases of Colorectal Cancer
Treatment Biopsie liver
Clinical Study IdentifierNCT01673607
SponsorPoitiers University Hospital
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have Resectable Hepatic Metastases of Colorectal Cancer?
Do you have any of these conditions: Do you have Resectable Hepatic Metastases of Colorectal Cancer??
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

Exclusion Criteria

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
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