This study investigates the clinical efficacy and safety of transarterial chemoembolization (TACE) combined with the immune agent nivolumab compared to TACE alone for treating hepatocellular carcinoma (HCC). The study aims to determine if the combination therapy can more effectively inhibit tumor angiogenesis, improve clinical benefit rates, and prolong survival, while maintaining a high safety profile.
Hepatocellular carcinoma (HCC) is a common malignancy with high mortality. While TACE is a standard treatment, it can paradoxically stimulate tumor angiogenesis. Immune checkpoint inhibitors have shown promise in HCC, but single-agent efficacy is limited. This study was designed to evaluate whether combining TACE with hepatic arterial infusion of an immune agent (nivolumab) could improve outcomes by inhibiting tumor angiogenesis and enhancing anti-tumor immune responses. Patients diagnosed with unresectable HCC (BCLC stages A, B, C; Child-Pugh A or B) were randomized to receive either TACE alone (control group) or TACE combined with hepatic arterial infusion of nivolumab (study group). The study assessed objective response rate (ORR), disease control rate (DCR), changes in angiogenesis factors (VEGF, VEGFR-2, Ang-2) and tumor markers (CEA, AFP, CA199) before and one month after treatment. Adverse reactions, overall survival (OS), and progression-free survival (PFS) were also evaluated.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
140
hepatic artery infusion therapy with nivolumab was performed
Seldinger technique for femoral artery puncture. Catheterization to celiac trunk/hepatic artery. Infusion of a mixture of idarubicin, raltitrexed, iodized oil, and contrast agent (approx. 8 mL). Embolization with microspheres (300-500 μm and 500-700 μm).
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Objective Response Rate (ORR)
Percentage of patients achieving Complete Remission (CR) or Partial Remission (PR) based on RECIST 1.1 criteria. ORR = \[(CR + PR) / total cases\] × 100%.
Time frame: Assessed at 1 month post-treatment, and then approximately every 3 months until disease progression, up to 24 months.
Disease Control Rate (DCR)
Percentage of patients achieving CR, PR, or Stable Disease (SD) based on RECIST 1.1 criteria. DCR = \[(CR + PR + SD) / total cases\] × 100%.
Time frame: Assessed at 1 month post-treatment, and then approximately every 3 months until disease progression, up to 24 months.
Level of Vascular Endothelial Growth Factor (VEGF)
Serum level of Vascular Endothelial Growth Factor (VEGF) measured by ELISA.
Time frame: Baseline (one day before treatment) and 1 month after treatment.
Level of VEGF Receptor-2 (VEGFR-2)
Serum level of VEGF Receptor-2 (VEGFR-2) measured by ELISA.
Time frame: Baseline (one day before treatment) and 1 month after treatment.
Level of Angiopoietin-2 (Ang-2)
Serum level of Angiopoietin-2 (Ang-2) measured by ELISA.
Time frame: Baseline (one day before treatment) and 1 month after treatment.
Level of Carcinoembryonic Antigen (CEA)
Serum level of Carcinoembryonic Antigen (CEA) measured by ELISA.
Time frame: Baseline (one day before treatment) and 1 month after treatment.
Level of Alpha-fetoprotein (AFP)
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Serum level of Alpha-fetoprotein (AFP) measured by ELISA.
Time frame: Baseline (one day before treatment) and 1 month after treatment.
Level of Carbohydrate Antigen 199 (CA199)
Serum level of Carbohydrate Antigen 199 (CA199) measured by ELISA.
Time frame: Baseline (one day before treatment) and 1 month after treatment.
Overall Survival (OS)
Time from randomization to death from any cause.
Time frame: From randomization until death or end of study, whichever comes first, up to December 2023 (median follow-up 13.87 months).
Progression-Free Survival (PFS)
Time from randomization to disease progression (as per RECIST 1.1) or death from any cause.
Time frame: From randomization until disease progression or death, whichever comes first, up to December 2023 (median follow-up 13.87 months).
Incidence of Adverse Reactions
Adverse reactions evaluated using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Time frame: From the first day of treatment until 30 days after the last treatment administration, monitored up to 24 months.