Neo-TACE-HAIC for PVTT-HCC

Hepatocellular Carcinoma Clinical Trial

— NeoconceptC  

Official title:

Neoadjuvant Transartery Chemoembolization Plus Artery Infusion Chemotherapy With Surgery Versus Surgery Alone for Hepatocellular Carcinoma Patients With Portal Vein Tumor Thrombus: a Randomized Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04181931
• Other study ID #: B2019-170
• Status: Recruiting
• Phase: N/A
• Start date: December 16, 2019
• Est. completion date: December 30, 2024

Study information

• Verified date: October 2020
• Source: Sun Yat-sen University
• Contact: Jiliang Qiu, MD.
• Phone: 862087343114
• Email: qiujl[@]sysucc.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 320
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma
• Portal Vein Thrombosis
• Thrombosis

Intervention

Procedure:
• neo-TACE-HAIC+Surgery
transartery chemoembolization with lipiodol and EADM, FOLFOX (Oxa 85mg/m2 2h+CF 400mg/m2 2h+5FU 400mg/m2 10min+5FU 1200mg/m2 23h)-based artery infusion chemotherapy, followed by hepatic resection
• Surgery alone
hepatic resection remove the liver tumor and portal vein tumor thrombus

Locations

Country	Name	City	State
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival, PFS	PFS was calculated from the date of starting treatment to the date of progression, of disease or death.	36 months
Secondary	Overall survival, OS	OS was calculated from the date of starting treatment to the date of death.	60 months