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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.

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.

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.

TACE+ systemic Bevacizumab

FOLFIRI+Bevacizumab

TACE

Giammaria Fiorentini, MD

Donatella Sarti, PhD

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

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

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

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

time from first treatment to progression will be computed

CT scan will be performed to assess tomuor response

Number of adverse events will be monitored

Giammaria Fiorentini

Colorectal Neoplasms

Intestinal Neoplasms

Colonic Diseases

Intestinal Diseases

Rectal Diseases

irinotecan liposome 60 mg/m2, iv, for at least 90 minutes LV 400 mg/m2, iv, for at least 2 hours FU 400 mg/m2, iv, followed by FU 2400 mg/m2, iv for at least 46 hours bevacizumab 5mg/kg IV. The above scenario is repeated every two weeks. Patients were treated until disease progression, toxic intolerance, initiation of a new antitumor therapy, withdrawal of knowledge, or investigator judgment that subjects should withdraw from study therapy.

Xinxiang li, PhD

The goal of this prospective clinical trial is to evaluate efficacy and safety of irinotecan liposomes for first-line treatment of advanced colorectal cancer. The primary endpoint is Objective response rate (ORR) per RECIST 1.1. The secondary endpoints are overall survival (OS), progression-free survival (PFS), disease control rate (DCR) and safety based on NCI-CTCAE 5.0

Liposomal Irinotecan Based FOLFIRI With Bevacizumab in First-line Treatment of Advanced Colorectal Cancer

Prospective and Exploratory Study of Liposomal Irinotecan Based FOLFIRI Combined With Bevacizumab in First-line Treatment of Advanced Colorectal Cancer

The proportion of participants in the analyzed population who developed complete (CR) or partial response (PR) according to RECIST 1.1 criteria

From the time of patient admission to the time of subject's death, at the end of the study, if the subject is still alive, the last known date of subject's survival is the deletion date

Time from patient admission to first radiographic disease progression (RECIST 1.1 criteria) or death (whichever occurs first)

The proportion of subjects in the analyzed population who achieved CR, PR, or stable disease (SD) according to RECIST 1.1 criteria

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
TACE Associated to Systemic Bevacizumab for the Treatment of Refractory Liver Metastases From Colorectal Cancer	NCT03732235	Liver Metastasi...	TACE+ systemic ... FOLFIRI+Bevaciz... TACE	18 Years -	International Group of Endovascular Oncology
Liposomal Irinotecan Based FOLFIRI With Bevacizumab in First-line Treatment of Advanced Colorectal Cancer	NCT05969899	Colorectal Canc...	FOLFIRI+Bevaciz...	18 Years - 75 Years	Fudan University

Spots Global Cancer Trial Database for folfiri+bevacizumab