Role of DEB-TACE Versus c-TACE in Treatment of HCC

• Status: Not yet recruiting
• Trial end date: 2023-01-30
• Target enrollment: 0
• Participant gender: All

Summary

Hepatocellular carcinoma (HCC) is listed as the sixth most common cancer worldwide and the third most frequent cause of cancer-related mortality. The majority of HCC cases occurs stem from chronic liver disease and cirrhosis.

Hepatocellular carcinoma accounts for approximately 70% to 90% of all primary liver cancers. Trans-arterial Chemoembolization is the most widely utilized and is considered the first-line treatment recommended for patients staged as intermediate HCC (Barcelona Clinic Liver Cancer stage B). If applied correctly, TACE can produce survival benefits without adversely affecting hepatic functional reserve.

Two TACE techniques have been used since 2004, conventional TACE (c-TACE) and TACE with drug-eluting beads (DEB-TACE). Conventional TACE was evidenced first to treat intermediate stage HCC patients.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sohag University
• Treatments: Doxorubicin; Liposomal doxorubicin

Criteria

Inclusion Criteria:

• - Child-Pugh A or B cirrhosis.

• ECOG performance status (PS) Grade 2 or below.

• BCLC stage B or C.

• No serious concurrent medical illness.

• Radiologically or histologically proven HCC (an alpha-fetoprotein level > 500 ug/ml in the presence of radiological findings suggestive of HCC in a patient with chronic HBV or HCV infection is considered eligible).

• Unresectable and locally advanced disease without extra-hepatic disease.

• Nodular tumor morphology with measurable lesion on CT with less than 50% involvement of liver by HCC.

• Size of largest tumor is less than or equal to 15cm in largest dimension.

• Number of main tumor is less than or equal to 5, excluding associated small satellite lesions.

• Patent main portal vein.

Exclusion Criteria:

• - Child-Pugh C cirrhosis (evidence of poor liver function).

• History of significant concurrent medical illness such as ischemic heart disease or heart failure.

• Serum creatinine level > 2 mg/dL.

• Presence of extrahepatic metastasis.

• Predominantly infiltrative lesion.

• Diffuse tumor morphology with extensive lesions involving both lobes.

• Hepatic artery thrombosis.

• Thrombosis of the main portal vein.

• Tumor invasion of portal branch of contralateral lobe.