Neo-TACE-HAIC for PVTT-HCC

Not Applicable

Recruiting

• Conditions: Portal Vein Thrombosis; Hepatocellular Carcinoma
• Interventions: Procedure: Surgery alone; Procedure: neo-TACE-HAIC+Surgery

• Registration Number: NCT04181931
• Lead Sponsor: Sun Yat-sen University

Brief Summary

Hepatocellular carcinoma (HCC) patients is a common disease in the East Asia. During the disease course, 20%-50% patients suffered portal vein tumor thrombus (PVTT), which is characterized with poor outcome and low response for treatments. Although BCLC (Barcelona clinical liver cancer) system recommend to palliative targeted treatment, the East Asian countries recommend to resection or transartery chemoembolization (TACE).

Recently, FOLFOX (Oxaliplatin and 5-fluorouracil) based hepatic artery infusion chemotherapy (HAIC) exhibited high response rate for advanced 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 PVTT 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

Study Timeline

• Study First Submitted: 2019-11-25
• Study First Submitted QC: 2019-11-26
• Study First Posted: 2019-12-02
• Study Start: 2019-12-16
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-22
• Last Update Posted: 2020-10-26
• Primary Completion: 2022-12-30
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 320

Inclusion Criteria

• Age 18-75 years;
• Patients with resectable primary hepatocellular carcinoma and portal vein tumor thrombus, which was not located in main portal vein;
• Child-Pugh A or B (7 score) liver function;
• With more than 3 months expected survival;
• The volume of residual liver more than 30%

Exclusion Criteria

• Patients with primary hepatocellular carcinoma and major portal vein tumor thrombus
• With extrahepatic metastasis or unresectable HCC
• Pregnant woman or sucking period;
• With other malignant cancer;
• Received chemotherapy, target therapy or immunosuppressive drugs therapy before this study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
surgery alone	Surgery alone	surgery alone for HCC patients with PVTT
neo-TACE-HAIC with surgery	neo-TACE-HAIC+Surgery	neoadjuvant TACE-HAIC with surgery for HCC patients with PVTT

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