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Clinical Trials/NCT04424043
NCT04424043RecruitingNot Applicable

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

Sun Yat-sen University1 site in 1 country280 target enrollmentStarted: July 8, 2020Last updated:
Conditions

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

Sponsor
Sun Yat-sen University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Yunfei Yuan

Professor

Sun Yat-sen University

Study Sites (1)

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