DEB-TACE+HAIC vs. HAIC for Large HCC

Launched by SECOND AFFILIATED HOSPITAL OF GUANGZHOU MEDICAL UNIVERSITY · Feb 22, 2022

Keywords

ClinConnect Summary

This clinical trial, known as DEB-TACE+HAIC vs. HAIC, is studying a new treatment approach for patients with large unresectable hepatocellular carcinoma (HCC), which is a type of liver cancer that cannot be surgically removed. The trial is comparing two treatment methods: one that combines transarterial chemoembolization using special drug-eluting beads (DEB-TACE) with hepatic artery infusion chemotherapy (HAIC), against HAIC alone. This research aims to find out which method is more effective and safe for patients.

To be eligible for this trial, participants should be adults between the ages of 65 and 74 and have confirmed HCC with at least one tumor that is larger than 7 cm. They should have a good level of liver function and be in relatively good health overall. Participants can expect to receive either of the treatment options and will be monitored closely for any side effects or changes in their condition. It’s important to note that individuals with certain complications, like severe liver issues or other health conditions that could affect treatment, may not be able to participate. If you or a loved one are considering joining this trial, it could provide access to new treatment options that may improve outcomes for this challenging disease.

Gender

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Eligibility 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.