DEB-TACE+HAIC vs. HAIC for Large HCC

• Status: Recruiting
• Trial end date: 2026-02-09
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Second Affiliated Hospital of Guangzhou Medical University
• Collaborators: Affiliated Hospital of Guangdong Medical University; First Affiliated Hospital, Sun Yat-Sen University; First People's Hospital of Foshan; Hainan General Hospital; Jiangmen Central Hospital; Maoming People's Hospital; Zhongshan City People's Hospital

Criteria

Inclusion Criteria:

• Patients with HCC confirmed by histology/cytology or diagnosed clinically.

• The maximum HCC lesion > 7 cm.

• Unresectable HCC evaluated by the surgeon team.

• At least one measurable intrahepatic target lesion.

• Patients without cirrhosis, or with cirrhosis but the liver function of Child-Pugh Class A.

• ECOG score of performance status ≤ 1 point.

• Adequate organ and bone marrow function; the blood biochemical examination: platelet count ≥75×10^9/L, leukocyte >3.0×10^9/L, ASL and AST≤5×ULN, creatinine≤1.5×ULN, INR<1.5 or PT/APTT normal range.

• Life expectancy of at least 3 months.

Exclusion Criteria:

• Accompanied with tumor thrombus involving the main portal vein or bilateral first-order branch of portal vein.

• Accompanied with vena cava tumor thrombus.

• Extrahepatic metastasis.

• Previous treatment with TACE, HAIC, liver transplantation, resection, ablation, radiotherapy, or systemic therapy.

• Decompensated liver function, including: ascites, bleeding from gastroesophageal varices, and hepatic encephalopathy.

• Those with organs (heart and kidneys) dysfunction who cannot tolerate TACE or HAIC treatment.

• History of other malignancies.

• Uncontrollable infection.

• History of HIV.

• Allergic to the drugs involved in the research.

• Patients with gastrointestinal bleeding within 30 days, or other bleeding> CTCAE grade 3.

• History of organ or cells transplantation.

• Those with bleeding tendency.