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

NCT01673607 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2021-09-29

No results posted yet for this study

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.

Conditions

  • Resectable Hepatic Metastases of Colorectal Cancer

Interventions

PROCEDURE

Biopsie liver

Sponsors & Collaborators

  • Poitiers University Hospital

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-11
Primary Completion
2021-12-31
Completion
2023-03-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01673607 on ClinicalTrials.gov