Neo-TACE-HAIC for PVTT-HCC

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Hepatocellular Carcinoma, Portal Vein Thrombosis

Intervention / Treatment
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* Procedure: neo-TACE-HAIC+Surgery
* Procedure: Surgery alone


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: neo-TACE-HAIC with surgery<br>neoadjuvant TACE-HAIC with surgery for HCC patients with PVTT | Procedure: neo-TACE-HAIC+Surgery<br>* 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<br>|
| Active Comparator: surgery alone<br>surgery alone for HCC patients with PVTT | Procedure: Surgery alone<br>* hepatic resection remove the liver tumor and portal vein tumor thrombus<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival, OS | OS was calculated from the date of starting treatment to the date of death. | 60 months |