Transarterial Chemoembolization (TACE) Plus Bevacizumab for Liver Metastases

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06311851
• Other study ID #: PNCC140201
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: April 1, 2024
• Est. completion date: December 1, 2024

Study information

• Verified date: March 2024
• Source: Pardis Noor Medical Imaging and Cancer Center
• Contact: Shahram Akhlaghpoor, M.D
• Phone: +9802192008808
• Email: shahram_ak[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: December 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Cancer
• Liver Metastases
• Liver Neoplasms
• Metastatic Cancer
• Neoplasm Metastasis

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pardis Noor Medical Imaging and Cancer Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival Rate	Percentage of patients who survived 6 months after inclusion	6 months
Primary	Objective response rate	The percentage of patients who achieved a complete or partial response at some point in their life	6 months
Secondary	Adverse event	Adverse event will be defined as the rate of patients who developed adverse event.	6 months