Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2025-12-25 @ 3:45 AM
NCT ID:
NCT07053202
Brief 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.
Study:
NCT07053202
Study Brief:
Protocol Section:
NCT07053202