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
Second Affiliated Hospital of Guangzhou Medical University
130 participants
May 1, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria7
- HCC confirmed by histology/cytology or diagnosed clinically.
- At least one measurable intrahepatic target lesion.
- The largest tumor size \> 7 cm.
- Tumor recurrence after curative treatment (hepatectomy or ablation) is eligible for enrollment.
- Child-Pugh score 5-7.
- ECOG performance status ≤ 1.
- Adequate organ and hematologic function with platelet count ≥75×10\^9/L, leukocyte \>3.0×10\^9/L, Neutrophil count ≥1.5×10\^9/L, ASL and AST≤5×ULN, creatinine clearance≤1.5×ULN, and prolongation of prothrombin time ≤4 seconds.
Exclusion Criteria11
- Macrovascular invasion or extrahepatic metastasis.
- Diffuse HCC.
- Decompensated liver function, including: ascites, bleeding from gastroesophageal varices, and hepatic encephalopathy.
- Previous palliative treatments, including TACE, transcatheter arterial embolization, HAIC, radiation therapy, systemic therapy.
- Organ (heart and kidneys) dysfunction, unable to tolerate TACE or HAIC treatment.
- History of other malignancies.
- Uncontrollable infection.
- History of HIV.
- Gastrointestinal bleeding within 30 days, or other bleeding\> CTCAE grade 3.
- History of organ or cells transplantation.
- Pregnant or lactating patients.
Interventions
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.
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)
View Full Details on ClinicalTrials.gov
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NCT06397235