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

Launched by SECOND AFFILIATED HOSPITAL OF GUANGZHOU MEDICAL UNIVERSITY · Apr 29, 2024

Keywords

ClinConnect Summary

This clinical trial, called DEB-TACE+RALOX-HAIC vs DEB-TACE, is exploring a new treatment approach for patients with large hepatocellular carcinoma (HCC), a type of liver cancer that cannot be surgically removed. The researchers are comparing two methods: one that combines a procedure called transarterial chemoembolization with drug-eluting beads (DEB-TACE) and additional chemotherapy delivered directly into the liver (HAIC) using specific drugs, versus DEB-TACE alone. The goal is to see if the combination treatment is more effective and safe for patients with large tumors.

To participate in this study, individuals must be between the ages of 18 and 75 and have confirmed liver cancer that is larger than 7 centimeters. They should also have one or more measurable tumors and a stable liver function score. However, those with certain complications, like advanced liver disease or previous treatments for cancer, may not be eligible. Participants will receive either the combination treatment or the standard treatment and will be monitored closely for any side effects and effectiveness. This trial is currently recruiting patients, and it's important for those interested to discuss with their healthcare provider if they meet the criteria.

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Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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.