RCT of TAE Simultaneously Combined Thermal Ablation for Large Hepatocellular Carcinoma

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This study intends to evaluate the efficacy and safety of Transarterial embolization (TAE) simultaneously combined with thermal ablation for large hepatocellular carcinoma (HCC). Half participants will receive TAE simultaneously combined with thermal ablation and the other half receive TACE sequentially combined with thermal ablation, which is a conventional treatment for HCC patients.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-sen University
• Collaborators: First Affiliated Hospital, Sun Yat-Sen University; Guangdong General Hospital; Guangdong Provincial People's Hospital; Sixth Affiliated Hospital, Sun Yat-sen University; Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University; Third Affiliated Hospital, Sun Yat-Sen University

Criteria

Inclusion Criteria:

• Age between 18 to 70 years with estimated survival over 3 months

• Number of tumors < 3

• Diameter of tumor between 5cm to 15cm

• No portal vein trunk tumoral thrombus or inferior vena cava tumoral thrombus

• With arteriovenous fistula or arterioportal shunt fistula that can be completely embolized

• Child-Pugh class A or B/Child score > 7;ECOG score < 2

• Tolerable coagulation function or reversible coagulation disorders

• Laboratory examination test: WBC≥3.0×10E9/L; Hb≥3.0×10E9/L; PLT ≥50×10E9/L; INR < 2.3 or PT< 16.5s; Cr ≤ 145.5 umul/L

• Signed informed consent before recruiting

Exclusion Criteria:

• Diffused HCC

• With portal vein trunk tumoral thrombus

• With inferior vena cava tumoral thrombus or hepatic vein tumor thrombus

• With lymphatic metastasis or extra hepatic metastasis

• Child-Pugh class C and can't be improved by expectant treatment

• Untreatable coagulation disorders, severe hemogram abnormal and bleeding tendency

• Massive intractable ascites

• ECOG score > 2