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

NCT03732235 | Unknown DMC

• 1 other identifier: EMBOBEVA
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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

Conditions

Liver Metastasis Colon Cancer

Keywords

Liver Metastases; Transarterial chemoembolization; Bevacizumab; Anti-angiogenesis; Irinotecan; Embolics; FOLFIRI

Outcome Measures

Primary Outcomes (1)

• time to progression

  time from first treatment to progression will be computed

  1 year

Secondary Outcomes (2)

• Tumor response

  3 months

• Number of adverse events

  3 motnhs

Study Arms (3)

TACE+ systemic Bevacizumab

TACE was performed, using 2 ml of LifePearl® with 100 micron diameter (Terumo Europe NV, Leuven, Belgium) loaded with Irinotecan (100 mg), diluted in 5 ml of non-ionic contrast solution and 5 ml of distilled water, infused at fixed speed of 1ml/minute for a median time of 12 minutes (range 8-16 minutes). A second TACE was performed after 30 days if needed according to physician choice. Bevacizumab (5 mg/kg) therapy was initiated 15 days after first round of TACE and was repeated every two weeks, for a total of 8 cycles.

Device: TACE+ systemic Bevacizumab

FOLFIRI+Bevacizumab

FOLFIRI consists of 5-FU administered as a 48-hour continuous infusion to a total dose of 3,200 mg/m2 without a bolus, leucovorin 200 mg/m2, irinotecan 165 mg/m2 Bevacizumab (5 mg/kg) therapy was repeated every two weeks, for a total of 8 cycles.

Drug: FOLFIRI+Bevacizumab

TACE

TACE was performed, using 2 ml of LifePearl® with 100 micron diameter (Terumo Europe NV, Leuven, Belgium) loaded with Irinotecan (100 mg), diluted in 5 ml of non-ionic contrast solution and 5 ml of distilled water, infused at fixed speed of 1ml/minute for a median time of 12 minutes (range 8-16 minutes). A second TACE was performed after 30 days if needed according to physician choice.

Device: TACE

Interventions

TACE+ systemic Bevacizumab DEVICE

PEG embolics

TACE+ systemic Bevacizumab

FOLFIRI+Bevacizumab DRUG

antiangiogenic factor

FOLFIRI+Bevacizumab

TACE DEVICE

PEG embolics

TACE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This was a prospective observational single center study.that involved CRC-LM patients treated with TACE, using irinotecan-loaded PEG embolics (LIFIRI), followed by the intravenous administration of bevacizumab. This group was compared to CRC-LM patients treated with FOLFIRI+Bevacizumab. CRC-LM patients were instructed by physician about the study procedures and after signing informed consent choose the type of theratment TACE+bevacizumab or FOLOFIRI+bevacizumab

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Giammaria Fiorentini: lead

Study Sites (1)

Azienda Ospedaliera Ospedali Riuniti Marche Nord, Presidio Ospedaliero San Salvatore

Pesaro, PU, 61122, Italy

RECRUITING

Related Publications (1)

• Fiorentini G, Sarti D, Nardella M, Inchingolo R, Nestola M, Rebonato A, Guadagni S. Chemoembolization Alone or Associated With Bevacizumab for Therapy of Colorectal Cancer Metastases: Preliminary Results of a Randomized Study. In Vivo. 2020 Mar-Apr;34(2):683-686. doi: 10.21873/invivo.11824.

  PMID: 32111770 DERIVED

Central Study Contacts

Giammaria Fiorentini, MD

CONTACT

+390721364005; g.fiorentini@alice.it

Donatella Sarti, PhD

CONTACT

+390721364018; d.sarti@fastwebnet.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: October 30, 2018
• First Posted: November 6, 2018
• Study Start: October 1, 2018
• Primary Completion: October 1, 2021
• Study Completion: December 1, 2021
• Last Updated: February 21, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 1 year
• Access Criteria: request by email to Principal Investigator

Locations

IT (1)