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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

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