Combine TACE and RFA Versus TACE Alone for HCC With PVTT

• Status: Unknown status
• Trial end date: 2019-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether combined radiofrequency ablation and transcatheter chemoembolization (TACE) result in better survival outcomes than TACE alone in patients with HCC and portal vein tumor thrombus.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ming Zhao
• Treatments: Chlorotrianisene; Mitomycin; Mitomycins; Pirarubicin

Criteria

Inclusion Criteria:

• HCC with portal vein tumor thrombus in the first or second branch

• Refused sorafenib or could not tolerate the adverse effect of sorafenib

• A solitary HCC ≤ 5.0 cm in diameter, or multiple HCC ≤ 3 lesions, each ≤ 5.0 cm in diameter

• Eastern Cooperative Oncology Group Performance Status 0-1

• Child-Pugh Score ≤ 8

• A platelet counts of > 60,000/mm3, hemoglobin>8.5 g/dL, prothrombin time prolong <6s

• Albumin >2.8 g/dL, total bilirubin <51.3 umol/L; alanine aminotransferase (ALT) and aspartate transaminase（AST）<5 times of upper limit

• Sign the informed consent.

Exclusion Criteria:

• Presence of extrahepatic metastasis except lymph node metastasis

• The blood supply of tumor lesions is absolutely poor or arterial-venous shunt that TACE can not be performed

• Uncontrolled or refractory ascites, ongoing variceal bleeding or encephalopathy;

• Severe heart, brain or kidney diseases

• Previous or concurrent cancer that is distinct in primary site or histology from HCC

• Pregnant women or lactating women.