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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Poitiers University Hospital
Sponsor:
Information provided by (Responsible Party):
Poitiers University Hospital
ClinicalTrials.gov Identifier:
NCT01673607
First received: February 13, 2012
Last updated: April 3, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention Phase
Resectable Hepatic Metastases of Colorectal Cancer
Procedure: Biopsie liver
Phase 2

Study Type: Interventional

Resource links provided by NLM:


Further study details as provided by Poitiers University Hospital:

Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Criteria

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.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01673607

Contacts
Contact: David TOUGERON, MD 33.5.49.44.37.51 david.tougeron@chu-poitiers.fr

Locations
France
Poitiers University Hospital Recruiting
Poitiers, France, 86021
Contact: David TOUGERON, MD    33.5.49.44.37.51    david.tougeron@chu-poitiers.fr   
Sponsors and Collaborators
Poitiers University Hospital
  More Information

No publications provided

Responsible Party: Poitiers University Hospital
ClinicalTrials.gov Identifier: NCT01673607     History of Changes
Other Study ID Numbers: METAHEP
Study First Received: February 13, 2012
Last Updated: April 3, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Colorectal Neoplasms
Neoplasm Metastasis
Liver Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplastic Processes
Pathologic Processes
Liver Diseases

ClinicalTrials.gov processed this record on August 21, 2014