Neo-TACE-HAIC for PVTT-HCC

  • STATUS
    Recruiting
  • End date
    Dec 30, 2024
  • participants needed
    320
  • sponsor
    Sun Yat-sen University
Updated on 26 January 2021
liver cancer
cancer
fluorouracil
oxaliplatin
folfox
TACE
chemoembolization
hepatic arterial infusion
tumour thrombus

Summary

Hepatocellular carcinoma (HCC) patients is a common disease in the East Asia. During the disease course, 20%-50% patients suffered portal vein tumor thrombus (PVTT), which is characterized with poor outcome and low response for treatments. Although BCLC (Barcelona clinical liver cancer) system recommend to palliative targeted treatment, the East Asian countries recommend to resection or transartery chemoembolization (TACE).

Recently, FOLFOX (Oxaliplatin and 5-fluorouracil) based hepatic artery infusion chemotherapy (HAIC) exhibited high response rate for advanced HCC.

Pilot study showed TACE combined HAIC (TACE-HAIC) had better tumor response, with low progression disease rate.

Whether TACE-HAIC would improve survival for patients with PVTT is need to further to study. A randomized clinical trial compared neo-TACE-HAIC with surgery versus surgery alone is aimed to answer this question.

Details
Condition Adenocarcinoma, Malignant Adenoma, Adenocarcinoma, HEPATIC NEOPLASM, Liver Cancer, HEPATOCELLULAR CARCINOMA, Portal Vein Thrombosis, Liver Cancer, Malignant Adenoma, liver cell carcinoma
Treatment Surgery Alone, neo-TACE-HAIC+Surgery
Clinical Study IdentifierNCT04181931
SponsorSun Yat-sen University
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Age 18-75 years
Patients with resectable primary hepatocellular carcinoma and portal vein tumor thrombus, which was not located in main portal vein
Child-Pugh A or B (7 score) liver function
With more than 3 months expected survival
The volume of residual liver more than 30%

Exclusion Criteria

Patients with primary hepatocellular carcinoma and major portal vein tumor thrombus
With extrahepatic metastasis or unresectable HCC
Pregnant woman or sucking period
With other malignant cancer
Received chemotherapy, target therapy or immunosuppressive drugs therapy before this study
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