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This is a prospective, randomized study designed to compare the efficacy of transcatheter hepatic artery chemoembolization (TACE) combined with bevacizumab arterial perfusion versus conventional therapy in patients with hepatocellular carcinoma (HCC) invading the portal vein. The study aims to evaluate the effects on tumor load, angiogenesis, and survival outcomes.
Hepatocellular carcinoma (HCC) with portal vein invasion has a poor prognosis and limited therapeutic options. Transcatheter hepatic artery chemoembolization (TACE) is a standard locoregional therapy, but its efficacy can be limited by hypoxia-induced angiogenesis. Bevacizumab, a VEGF inhibitor, can counteract this angiogenic rebound. This study was designed to investigate the potential synergistic effects of combining TACE with bevacizumab arterial perfusion. A total of 180 patients with portal vein-invasive HCC were prospectively recruited and randomized to either the combination therapy group or a conventional therapy control group. The primary objectives were to assess changes in tumor load (size and number), serum angiogenic factors (VEGF and PDGF), and tumor vascular density. Secondary objectives included evaluating safety and comparing progression-free and overall survival between the two groups to establish an evidence-based framework for this treatment strategy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: Observation Group (TACE + Bevacizumab) | Experimental | Patients randomized to this arm received transcatheter hepatic artery chemoembolization (TACE) combined with arterial infusion of bevacizumab. |
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| Active Comparator: Control Group (Conventional Therapy) | Active Comparator | Patients randomized to this arm received conventional therapy for HCC with portal vein invasion, serving as the active control. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bevacizumab Arterial Perfusion plus TACE | Drug | The intervention consists of a combination treatment. Patients undergo transcatheter hepatic artery chemoembolization (TACE), a procedure involving localized delivery of chemotherapy and embolization of the tumor-feeding arteries. This is combined with a targeted arterial perfusion of bevacizumab, a monoclonal antibody that inhibits vascular endothelial growth factor (VEGF). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Tumor Load | Measured by assessing the change in tumor diameter (in cm) and the total number of tumors from baseline. Measurements are performed using Magnetic Resonance Imaging (MRI). | Baseline (before treatment) and 3 months post-treatmen |
| Change in Serum Angiogenic Factors | Measured by the change in serum levels of Vascular Endothelial Growth Factor (VEGF) and Platelet-Derived Growth Factor (PDGF) in pg/mL, as quantified by Enzyme-Linked Immunosorbent Assay (ELISA). | Baseline (before treatment) and at the 3-month post-treatment follow-up |
| Change in Tumor Vascular Density | Measured as the change in the density of blood vessels (vessels/cm²) in the tumor area, evaluated by Dynamic Contrast-Enhanced Magnetic Resonance Imaging (DCE-MRI). | Baseline (before treatment) and 3 months post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | Time from randomization to death from any cause. Reported as median survival in months. | From date of randomization until death, with a median follow-up of 24 months (range 12-36 months) |
| Progression-Free Survival (PFS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Hospital of Hebei Medical University | Shijiazhuang | Hebei | 050023 | China |
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| Conventional Therapy | Procedure | Patients in the control group received conventional therapy, which typically consists of TACE alone for this patient population. This involves the selective catheterization of hepatic arteries supplying the tumor, followed by the infusion of chemotherapeutic agents and an embolic agent to induce tumor necrosis. |
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Time from randomization to disease progression or death from any cause, whichever occurs first. Reported as median survival in months.
| From date of randomization until disease progression or death, assessed at 6-month intervals up to 36 months |
| Incidence of Adverse Events | Number and percentage of participants experiencing treatment-related adverse events, graded according to CTCAE v5.0. | From the start of the first intervention until the 3-month post-treatment follow-up visit |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |