Neo-TACE-HAIC for BCLC B Stage HCC (Neoconcept)

  • STATUS
    Recruiting
  • End date
    Dec 30, 2025
  • participants needed
    280
  • sponsor
    Sun Yat-sen University
Updated on 19 February 2024
cancer
oxaliplatin
carcinoma
fluorouracil
folfox regimen
hepatocellular carcinoma
TACE
liver cancer
chemoembolization
hepatic arterial infusion

Summary

Hepatocellular carcinoma (HCC) patients is a common disease in the East Asia. Although BCLC (Barcelona clinical liver cancer) system recommend to transarterial chemoembolization (TACE) for BCLC B stage patients, increasing studies suggested that hepatic resection provided survival benefit for those patients. However, a relative high recurrence risk leads surgeons to investigate the value of preoperative treatment.

Recently, FOLFOX (Oxaliplatin and 5-fluorouracil) based hepatic artery infusion chemotherapy (HAIC) exhibited high response rate for unresectable 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 BCLC B stage 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, Adenocarcinoma, HEPATIC NEOPLASM, liver cancer, HEPATOCELLULAR CARCINOMA, liver cancer
Age 18years - 75years
Treatment neo-TACE-HAIC+Surgery, Surgery alone
Clinical Study IdentifierNCT04424043
SponsorSun Yat-sen University
Last Modified on19 February 2024

Eligibility

Yes No Not Sure

Inclusion Criteria

Age 18-75 years
BCLC B stage and tumor number <=4
Patients with resectable primary hepatocellular carcinoma
Child-Pugh A or B (7 score) liver function
The volume of residual liver more than 30%

Exclusion Criteria

With unresectable HCC
Pregnant woman or sucking period
With other malignant cancer
Received anti-HCC therapy before this study
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