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Trial Title:
Transarterial Chemoembolization (TACE) Plus Bevacizumab for Liver Metastases
NCT ID:
NCT06311851
Condition:
Cancer
Metastatic Cancer
Liver Metastases
Conditions: Official terms:
Neoplasm Metastasis
Liver Neoplasms
Bevacizumab
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Bevacizumab
Description:
Infusion of Bevacizumab-loaded hepaspher through transarterial chemoembolization.
Arm group label:
Bevacizumab Transarterial Chemoembolization
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.
Criteria for 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)
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Start date:
April 1, 2025
Completion date:
December 1, 2025
Lead sponsor:
Agency:
Pardis Noor Medical Imaging and Cancer Center
Agency class:
Other
Source:
Pardis Noor Medical Imaging and Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06311851