Transarterial Chemoembolization (TACE) Plus Bevacizumab for Liver Metastases

NCT06311851 | Recruiting Phase 1

• 1 other identifier: PNCC140201
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Adverse event

  6 months

Study Arms (1)

Bevacizumab Transarterial Chemoembolization

EXPERIMENTAL

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

Interventions

Bevacizumab DRUG

Infusion of Bevacizumab-loaded hepaspher through transarterial chemoembolization.

Bevacizumab Transarterial Chemoembolization

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Pardis Noor Medical Imaging and Cancer Center: lead

Study Sites (1)

Pardis Noor Medical Imaging and Cancer Center

Tehran, Tehran Province, 021, Iran

RECRUITING

MeSH Terms

Conditions

Neoplasms; Neoplasm Metastasis

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

Shahram Akhlaghpoor, M.D

CONTACT

+9802192008808; shahram_ak@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Vascular and Interventional Radiology

Study Record Dates

• First Submitted: March 6, 2024
• First Posted: March 15, 2024
• Study Start: June 1, 2025
• Primary Completion: March 30, 2026
• Study Completion: April 30, 2026
• Last Updated: November 25, 2025

Record last verified: 2025-06

Locations

IR (1)