Neo-TACE-HAIC for PVTT-HCC (NeoconceptC)

Sun Yat-sen University

Status: Enrolling

Conditions: Hepatocellular Carcinoma; Portal Vein Thrombosis

Treatments: Procedure: Surgery alone; Procedure: neo-TACE-HAIC+Surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT04181931

B2019-170

Details and patient eligibility

About

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.

Enrollment: 320 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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320 participants in 2 patient groups

neo-TACE-HAIC with surgery

Experimental group

Description:

neoadjuvant TACE-HAIC with surgery for HCC patients with PVTT

Treatment:

Procedure: neo-TACE-HAIC+Surgery

surgery alone

Active Comparator group

Description:

surgery alone for HCC patients with PVTT

Treatment:

Procedure: Surgery alone