Liver Metastasis Colon Cancer
Conditions
Keywords
Liver Metastases, Transarterial chemoembolization, Bevacizumab, Anti-angiogenesis, Irinotecan, Embolics, FOLFIRI
Brief summary
Transarterial chemoembolization (TACE) is an effective, minimally invasive therapy that is widely used for unresectable colorectal cancer liver metastases (CRC-LM) treatment. Chemoembolization, however, induces a hypoxic micro-environment, which increases neo-angiogenesis, and may promote early progression. For this reason, efficacy may be improved by associating TACE with an angiogenesis inhibitor, such as bevacizumab. The use of FOLFIRI associate to Bevacizumab is part of clinical practice and is commonly used for the therapy of patients with CRC-LM both wild type and mutant. This case-control observational study aim to compare patients treated with TACE using Irinotecan-loaded embolics followed by systemic Bevacizumab versus patients treated with FILFIRI+ Bevacizumab
Detailed description
TACE is indicated for the treatment of unresectable CRC\_LM, patients who are refractory to systemic chemotherapy, elderly, or have a poor performance status, and is usually performed using irinotecan (IRI) covalently loaded onto embolics. Although chemoembolization with irinotecan-loaded embolics results in an objective response, this method creates a hypoxic micro-environment. Hypoxia induces and activates the HIF-1 and HIF 2 hypoxia-inducible transcription factors, which promote high-level VEGF expression and subsequent neo-angiogenesis. This may provide a mechanism for early relapse and progression following TACE and strongly support a rational for following TACE therapy with a therapeutic inhibitor of angiogenesis, such as bevacizumab. The use of FOLFIRI associate to Bevacizumab is part of clinical practice and is commonly used for the therapy of patients with CRC-LM both wild type and mutant. This case-control observational study aim to compare patients treated with TACE using Irinotecan-loaded embolics followed by systemic Bevacizumab versus patients treated with FILFIRI+ Bevacizumab
Interventions
DEVICETACE
PEG embolics
antiangiogenic factor
DEVICETACE+ systemic Bevacizumab
PEG embolics
Sponsors
Giammaria Fiorentini
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Written informed consent * \>18 years old; * diagnosed with unresectable CRC-LM (for reasons of anatomy, co-morbidity, patient's wishes, lack of response to standard therapy with intravenous or oral fluoropyrimidine, oxaliplatin, irinotecan or biological agents (bevacizumab, cetuximab, panitumumab); * Eastern Cooperative Oncology Group (ECOG) 0-1; * measurable tumor size by mRECIST \[6\]; * ≤40% liver involvement; * a life expectancy of at least 3 months, * blood biochemistry within the normal range.
Exclusion criteria
* contraindication for angiographic catheterization; * extensive extra-hepatic disease; * pregnancy or breast-feeding, * other severe clinical contraindications (e.g. liver failure, ascites, cardiovascular diseases and/or chronic obstructive pulmonary disease).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| time to progression | 1 year | time from first treatment to progression will be computed |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tumor response | 3 months | CT scan will be performed to assess tomuor response |
| Number of adverse events | 3 motnhs | Number of adverse events will be monitored |
Countries
Italy
Contacts
Primary ContactGiammaria Fiorentini, MD
Backup ContactDonatella Sarti, PhD
Outcome results
None listed