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Neo-TACE-HAIC for BCLC B Stage HCC

Not Applicable
Recruiting
Conditions
Hepatocellular Carcinoma
Registration Number
NCT04424043
Lead Sponsor
Sun Yat-sen University
Brief 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.

Detailed Description

Not available

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
280
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Progression-free survival, PFS36 months

PFS was calculated from the date of starting treatment to the date of progression, of disease or death

Secondary Outcome Measures
NameTimeMethod
Overall survival, OS60 months

OS was calculated from the date of starting treatment to the date of death.

Trial Locations

Locations (1)

Sun Yat-sen University Cancer Center

🇨🇳

Guangzhou, Guangdong, China

Sun Yat-sen University Cancer Center
🇨🇳Guangzhou, Guangdong, China
Jiliang Qiu, MD.
Contact
862087343114
qiujl@sysucc.org.cn

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