Transarterial Chemoembolization (TACE) Plus Bevacizumab for Liver Metastases

NCT ID: NCT06311851

Last Updated: 2025-11-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-01
• Study Completion Date: 2026-04-30

Brief 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.

Conditions

Cancer; Metastatic Cancer; Liver Metastases

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Bevacizumab

Intervention Type: DRUG

Infusion of Bevacizumab-loaded hepaspher through transarterial chemoembolization.

Interventions

Bevacizumab

Infusion of Bevacizumab-loaded hepaspher through transarterial chemoembolization.

Intervention Type: DRUG

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pardis Noor Medical Imaging and Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Shahram Akhlaghpoor

Associate Professor of Vascular and Interventional Radiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Pardis Noor Medical Imaging and Cancer Center

Tehran, Tehran Province, Iran

Site Status: RECRUITING

Countries

Iran

Central Contacts

Shahram Akhlaghpoor, M.D

Role: CONTACT

shahram_ak@yahoo.com

+9802192008808

Facility Contacts

Shahram Akhlaghpoor, M.D.

Role: primary

Other Identifiers

PNCC140201

Identifier Type: -

Identifier Source: org_study_id