TACE With Immune Agents for Angiogenesis in Hepatocellular Carcinoma

Sponsor
The First Hospital of Hebei Medical University
Study ID
NCT07053202
Status
Completed

Conditions

  • Hepatocellular Carcinoma (HCC)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab — COMBINATION_PRODUCT
    hepatic artery infusion therapy with nivolumab was performed
  • Transarterial Chemoembolization (TACE) — PROCEDURE
    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).

Study Details

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.

Key Dates

Start date
Oct 1, 2021
Status verified
Jun 2025
Primary completion
Nov 1, 2022
Completion
Dec 31, 2023

Study Design

Enrollment
140 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: TACE combined with Nivolumab
    Patients received TACE procedure. Additionally, hepatic artery infusion therapy with nivolumab was performed.
  • Active Comparator: TACE Alone
    Patients received TACE procedure alone.

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: Assessed at 1 month post-treatment, and then approximately every 3 months until disease progression, up to 24 months. ]

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