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NCT Number: NCT06311851

Transarterial Chemoembolization (TACE) Plus Bevacizumab for 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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Pardis Noor Medical Imaging and Cancer Center

Tehran, Tehran Province, 021, Iran

Location status: Recruiting

Location contact

Shahram Akhlaghpoor, M.D.

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Bevacizumab

Drug

Infusion of Bevacizumab-loaded hepaspher through transarterial chemoembolization.

Primary outcomes

  1. Overall Survival Rate

    Time frame: 6 months

    Percentage of patients who survived 6 months after inclusion

  2. Objective response rate

    Time frame: 6 months

    The percentage of patients who achieved a complete or partial response at some point in their life

Secondary outcomes

  1. Adverse event

    Time frame: 6 months

    Adverse event will be defined as the rate of patients who developed adverse event.

Study contacts

Contact information is provided by the study sponsor or research team.

Shahram Akhlaghpoor, M.D

CONTACT

[email protected]

+9802192008808

Sponsors and collaborators

Lead sponsor

Pardis Noor Medical Imaging and Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 15, 2024
Registry last updated
Nov 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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