Cancer, Liver Metastases, Metastatic Cancer
Conditions
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.
Interventions
DRUGBevacizumab
Infusion of Bevacizumab-loaded hepaspher through transarterial chemoembolization.
Sponsors
Pardis Noor Medical Imaging and Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival Rate | 6 months | Percentage of patients who survived 6 months after inclusion |
| Objective response rate | 6 months | The percentage of patients who achieved a complete or partial response at some point in their life |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse event | 6 months | Adverse event will be defined as the rate of patients who developed adverse event. |
Countries
Iran
Outcome results
None listed