Neo-TACE-HAIC for BCLC B Stage HCC
- 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
-
• 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%
-
• 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
Name Time Method Progression-free survival, PFS 36 months PFS was calculated from the date of starting treatment to the date of progression, of disease or death
- Secondary Outcome Measures
Name Time Method Overall survival, OS 60 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, ChinaJiliang Qiu, MD.Contact862087343114qiujl@sysucc.org.cn