Health Trials

Transarterial Chemoembolization (TACE) Plus Bevacizumab for Liver Metastases

ConditionsCancerMetastatic CancerLiver Metastases
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorPardis Noor Medical Imaging and Cancer Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Bevacizumab

    Drug

    Infusion of Bevacizumab-loaded hepaspher through transarterial chemoembolization.

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: Bevacizumab Transarterial ChemoembolizationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Overall Survival Rate

Percentage of patients who survived 6 months after inclusion

Time frame
6 months
2

Objective response rate

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

Time frame
6 months

Secondary outcomes

1

Adverse event

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

Time frame
6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Pardis Noor Medical Imaging and Cancer Center

Lead sponsor

Source ClinicalTrials.gov
Apply now