NCT07053202

TACE With Immune Agents for Angiogenesis in Hepatocellular Carcinoma

Clinical Study on TACE Combined With Immune Agents for Inhibiting Tumor Angiogenesis in Hepatocellular Carcinoma

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 140 (actual)
• Sponsor: The First Hospital of Hebei Medical University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Hepatocellular Carcinoma (HCC)

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Nivolumab	hepatic artery infusion therapy with nivolumab was performed
PROCEDURE	Transarterial Chemoembolization (TACE)	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).

Timeline

• Start date: 2021-10-01
• Primary completion: 2022-11-01
• Completion: 2023-12-31
• First posted: 2025-07-08
• Last updated: 2025-07-08

Locations

1 site across 1 country: China