Transarterial Chemoembolization (TACE) Plus Bevacizumab for Liver Metastases

Phase

1/2

Condition

Liver Cancer

Digestive System Neoplasms

Metastatic Cancer

Treatment

Bevacizumab

Clinical Study ID

NCT06311851

PNCC140201

Ages 18-80
All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Confirmation of metastatic liver cancer via histological examination or acharacteristic imaging profile on dynamic computed tomography (CT) scan or magneticresonance 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 andaspartate aminotransferase <3 times the upper limit of the normal range, and serumcreatinine <1.5 times the upper limit of the normal range.

Exclusion

Exclusion Criteria:

Active infection
Presence of severe comorbidities, such as hepatic encephalopathy, refractoryascites, and esophageal variceal bleeding
Prior liver resection
Previous TACE therapy received at other healthcare facilities
Poor performance status (ECOGPS > 1)

Study Design