Resectable Hepatic Metastases of Colorectal CancerPhase 2METAHEPNCT01673607
Study of Immune Response and Liver Damage Induced by Chemotherapy for Liver Metastases of Colorectal Cancer
A Phase 2 study testing Biopsie liver in people with Resectable Hepatic Metastases of Colorectal Cancer, run by Poitiers University Hospital at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Resectable Hepatic Metastases of Colorectal Cancer
- What is being tested?
- Biopsie liver
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 11 Jan 2012to 31 Mar 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Poitiers University Hospital
Poitiers, 86021
David TOUGERON, MD, 33.5.49.44.37.51, david.tougeron@chu-poitiers.fr
About this study
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.
- Being tested
- Biopsie liver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biopsie liverProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2012 (estimated)
- Study start11 Jan 2012
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Resectable Hepatic Metastases of Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01673607
- Sponsor's protocol ID
- METAHEP
- Acronym
- METAHEP
- Status last verified
- Sep 2021
- First submitted
- 13 Feb 2012
- Last updated
- 29 Sep 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Immune Response and Liver Damage Induced by Chemotherapy for Liver Metastases of Colorectal Cancer
- ClinicalTrials.gov ID
- NCT01673607
- Acronym / sponsor ID
- METAHEP / METAHEP
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- 11 Jan 2012 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Mar 2023 (estimated)
- First posted
- 28 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biopsie liver | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2021.
Related trials for Resectable Hepatic Metastases of Colorectal Cancer
Not yet recruitingPhase 1/2
The QL1706 Combined With Chemotherapy and Either Cetuximab or Bevacizumab in Potentially Resectable Colorectal Cancer Patients With Liver Metastases
Colorectal Cancer Metastatic to Liver
Not yet recruitingPhase 2
HRX215, A First Generation MKK4 Inhibitor Drug, for the Treatment of Patients With Colorectal Liver Metastasis After Undergoing a Portal Vein Embolization
Metastatic Colorectal Carcinoma, Metastatic Malignant Neoplasm in the Liver
Active, not recruiting
Living Donor Liver Transplantation for Unresectable Colorectal Cancer Liver Metastases
Colorectal Cancer, Liver Metastases
RecruitingPhase 1/2
Neoadjuvant Dupilumab and Toripalimab in MSS CRC Subjects With Resectable Liver Metastases
Metastatic Colorectal Cancer, Liver Metastases
RecruitingObservational study
Living Donor Liver Transplant for Unresectable Colorectal Liver Metastases
Colorectal Cancer Metastatic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Biopsie liver in people with Resectable Hepatic Metastases of Colorectal Cancer, run by Poitiers University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact David TOUGERON, MD (33.5.49.44.37.51, david.tougeron@chu-poitiers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2021.