Neoadjuvant Transartery Chemoembolization Plus Artery Infusion Chemotherapy With Surgery Versus Surgery Alone for Hepatocellular Carcinoma Patients With Barcelona Clinic Liver Cancer (BCLC) B Stage: a Randomized Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 280
- Locations
- 1
- Primary Endpoint
- Progression-free survival, PFS
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Progression-free survival, PFS
Time Frame: 36 months
PFS was calculated from the date of starting treatment to the date of progression, of disease or death
Secondary Outcomes
- Overall survival, OS(60 months)
Investigators
Yunfei Yuan
Professor
Sun Yat-sen University