Transarterial Chemoembolization (TACE) Plus Bevacizumab for Liver Metastases

An Open-Label Pilot Study to Evaluate Efficacy and Safety of Bevacizumab Via Transarterial Chemoembolization (TACE) in Patients With Liver Metastases

Trans arterial chemoembolization (TACE) has emerged as a treatment option for chemotherapy-refractory diseases in Liver metastases. By delivering chemotherapy agents directly to the tumor site, TACE can maximize local drug concentrations and reduce systemic adverse reactions. Bevacizumab is a monoclonal antibody that functions as an angiogenesis inhibitor. It works by slowing the growth of new blood vessels by inhibiting vascular endothelial growth factor A (VEGF-A). The application of Bevacizumab during TACE has not been reported. In this study, we will evaluate the the overall survival (OS)、efficacy, and safety of the application of Bevacizumab during TACE in patients with Liver Metastases by designing an open, single-arm phase II clinical study.

Study Overview

• Status: Not yet recruiting
• Conditions: Cancer; Metastatic Cancer; Liver Metastases
• Intervention / Treatment: Drug: Bevacizumab

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Shahram Akhlaghpoor, M.D; Phone Number: +9802192008808; Email: shahram_ak@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Confirmation of metastatic liver cancer via histological examination or a characteristic imaging profile on dynamic computed tomography (CT) scan or magnetic resonance imaging (MRI) without indications for surgical resection
• Eastern cooperative oncology group performance status (ECOGPS) of 0 or 1
• Liver function categorized as Child-Pugh class A or B
• Stable non-hepatic metastases, such as skeletal, pulmonary, or lymph node metastases
• Hepatic tumor burden below 70%
• Expected survival duration exceeding six months
• Laboratory findings meeting specific criteria, including platelet count >50×109 /L, hemoglobin >8.0 g/dL, ANC count ≥1.5 × 109/L, bilirubin <51 mmol/L, alanine and aspartate aminotransferase <3 times the upper limit of the normal range, and serum creatinine <1.5 times the upper limit of the normal range.

Exclusion Criteria:

• Active infection
• Presence of severe comorbidities, such as hepatic encephalopathy, refractory ascites, and esophageal variceal bleeding
• Prior liver resection
• Previous TACE therapy received at other healthcare facilities
• Poor performance status (ECOGPS > 1)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Bevacizumab Transarterial Chemoembolization; The procedure commences with local disinfection and anesthesia, followed by a percutaneous right femoral artery puncture, performed using a modified Seldinger technique. A 5-F Simmons Ⅰ catheter was introduced through a vascular sheath and positioned in the common hepatic artery with the guidance of digital subtraction angiography to identify the tumor-supplying vessels. A 2.8-F microcatheter catheter was advanced into the vessel supplying the hepatic tumor. In cases of bilobar disease, the initial treatment focus was on the lobe with the greatest tumor burden, with the contralateral lobe addressed in a subsequent TACE session scheduled 4-6 weeks apart. In the standard TACE protocol ( hepaspheres are loaded with Irinotecan at 50 mg for colon metastases and Idarubicin at 10 mg for breast metastases), Bevacizumab 50 mg-loaded hepaspheres was added. The procedure was monitored under fluoroscopy until arterial flow stasis was achieved.

Drug: Bevacizumab; Infusion of Bevacizumab-loaded hepaspher through transarterial chemoembolization.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival Rate	Percentage of patients who survived 6 months after inclusion	6 months
Objective response rate	The percentage of patients who achieved a complete or partial response at some point in their life	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse event	Adverse event will be defined as the rate of patients who developed adverse event.	6 months

Collaborators and Investigators

• Sponsor: Pardis Noor Medical Imaging and Cancer Center

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: March 6, 2024
• First Submitted That Met QC Criteria: March 13, 2024
• First Posted (Actual): March 15, 2024

Study Record Updates

• Last Update Posted (Actual): April 1, 2024
• Last Update Submitted That Met QC Criteria: March 28, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms; Neoplasms by Site; Digestive System Neoplasms; Liver Diseases; Neoplastic Processes; Neoplasm Metastasis; Liver Neoplasms; Physiological Effects of Drugs; Antineoplastic Agents; Antineoplastic Agents, Immunological; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Bevacizumab
• Other Study ID Numbers: PNCC140201

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No