RecruitingPhase 2NCT06397235

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

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

Sponsor

Second Affiliated Hospital of Guangzhou Medical University

Enrollment

130 participants

Start Date

May 1, 2024

Study Type

INTERVENTIONAL

Conditions

Hepatocellular Carcinoma Non-resectable

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).

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study compares two liver cancer treatment strategies: standard DEB-TACE (drug-releasing beads delivered through blood vessels to block and treat the tumor) alone versus DEB-TACE combined with HAIC (chemotherapy pumped directly into the hepatic artery) plus raloxifene — a drug usually used for osteoporosis but being repurposed here — for people with large liver cancer tumors. **You may be eligible if...** - You have large hepatocellular carcinoma (liver cancer, tumor ≥5 cm) - You have not received prior treatment for this cancer (or limited prior treatment) - Your liver is still adequately functional - You are at least 18 years old **You may NOT be eligible if...** - Your cancer has spread outside the liver to distant organs - You have very poor liver function (advanced cirrhosis) - You have a blockage in the main portal vein - You have contraindications to raloxifene (history of blood clots, for example) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDEB-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.

DRUGDEB-TACE