TACE Associated to Systemic Bevacizumab for the Treatment of Refractory Liver Metastases From Colorectal Cancer

Liver Metastasis Colon Cancer Clinical Trial

— EMBOBEVA  

Official title:

Observational Study on Transarterial Chemoembolization With Irinotecan-loaded Embolics Associated With Systemic Bevacizumab for the Treatment of Refractory Liver Metastases From Colorectal Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03732235
• Other study ID #: EMBOBEVA
• Status: Recruiting
• Start date: October 1, 2018
• Est. completion date: December 2021

Study information

• Verified date: February 2019
• Source: International Group of Endovascular Oncology
• Contact: Giammaria Fiorentini, MD
• Phone: +390721364005
• Email: g.fiorentini[@]alice.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2021
• Est. primary completion date: October 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Liver Metastasis Colon Cancer
• Liver Neoplasms
• Neoplasm Metastasis
• Neoplasms, Second Primary

Intervention

Device:
• TACE+ systemic Bevacizumab
PEG embolics

Drug:
• FOLFIRI+Bevacizumab
antiangiogenic factor

Device:
• TACE
PEG embolics

Locations

Country	Name	City	State
Italy	Azienda Ospedaliera Ospedali Riuniti Marche Nord, Presidio Ospedaliero San Salvatore	Pesaro	PU

Sponsors (1)

Lead Sponsor	Collaborator
Giammaria Fiorentini

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	time to progression	time from first treatment to progression will be computed	1 year
Secondary	Tumor response	CT scan will be performed to assess tomuor response	3 months
Secondary	Number of adverse events	Number of adverse events will be monitored	3 motnhs