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RECRUITING
NCT06397235
PHASE2

DEB-TACE+RALOX-HAIC vs DEB-TACE for Large HCC

Sponsor: Second Affiliated Hospital of Guangzhou Medical University

View on ClinicalTrials.gov

Summary

This study is conducted to evaluate the efficacy and safety of transarterial chemoembolization with drug-eluting beads (DEB-TACE) combined with hepatic artery infusion chemotherapy (HAIC) with oxaliplatin and raltitrexed (RALOX-HAIC) versus DEB-TACE alone for unresectable large hepatocellular carcinoma (HCC).

Official title: DEB-TACE in Combination With or Without RALOX-based HAIC for Unresectable Large Hepatocellular Carcinoma: A Randomized, Controlled Trial

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

130

Start Date

2024-05-01

Completion Date

2028-04-30

Last Updated

2025-02-20

Healthy Volunteers

No

Interventions

DRUG

DEB-TACE+HAIC

CalliSpheres (100-300 µm) loaded with pirarubicin for transarterial chemombolization: Typically, one vial of the beads was loaded with 60 mg pirarubicin. If blushed tumors is still visible after the embolization with one vial of beads, regular microspheres (8spheres) with diameters of 100-700 μm are additionally injected. RALOX-based regimen for hepatic arterial infusion chemotherapy: oxaliplatin, 85 mg/m2 infusion for 2 hours; Raltitrexed, 3 mg/m2 infusion for 0.5 hour.

DRUG

DEB-TACE

CalliSpheres (100-300 µm) loaded with pirarubicin for transarterial chemombolization: Typically, one vial of the beads was loaded with 60 mg pirarubicin. If blushed tumors is still visible after the embolization with one vial of beads, regular microspheres (8spheres) with diameters of 100-700 μm are additionally injected.

Locations (1)

The Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China