Sorafenib Plus Hepatic Arterial Infusion Versus Sorafenib for HCC With Major Portal Vein Tumor Thrombosis

Study Overview
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Brief Summary
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According to the Barcelona clinic liver cancer (BCLC) staging treatment guideline, sorafenib is recommended for Hepatocellular Carcinoma (HCC) with Portal Vein Tumor Thrombosis (PVTT), but HCC with major PVTT (in the main trunk or 1st-order branches of the portal vein) did not benefit much from sorafenib in previous studies. There is no established standard treatment for HCC patients with major PVTT, the investigators conducted a randomized, phase 2 study to investigate the survival benefit of sorafenib plus Hepatic arterial infusion chemotherapy (HAIC) with Oxaliplatin and Fluorouracil versus sorafenib for Hepatocellular Carcinoma with Major Portal Vein Tumor Thrombosis.

Official Title
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Randomized Trial of Sorafenib Plus Hepatic Arterial Infusion With Oxaliplatin and Fluorouracil Versus Sorafenib for Hepatocellular Carcinoma With Major Portal Vein Tumor Thrombosis

Conditions
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HepatoCellular Carcinoma, Portal Vein Thrombosis

Intervention / Treatment
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* Procedure: HAIC
* Drug: Sorafenib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient must have histologically or clinically confirmed hepatocellular carcinoma. HCC with major PVTT (in the main trunk or 1st-order branches of the portal vein) Child A class Patient's Eastern Cooperative Oncology Group (ECOG) performance status must be =< 2 (Karnofsky >= 60%) Absolute neutrophil count >= 1,500/mcL Platelets >= 100,000/mcL Hemoglobin >= 90g/L Total bilirubin =< 2 X institutional upper limit of normal Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase [SGPT]) =< 2.5 X institutional upper limit of normality Creatinine =< 1.5 X institutional upper limit of normal Albumin >= 30g/L Patient must be able to understand and willing to sign a written informed consent document Exclusion Criteria: Patients who have had prior chemotherapy with Oxaliplatin or Fluorouracil or sorafenib. Patient who is receiving any other investigational agents Patient who have a diagnosis of hepatic encephalopathy Patients who have a diagnosis of sclerosing cholangitis. Patients who have a diagnosis of Gilbert's disease. Patients who have clinical ascites Patient must not have any uncontrolled concurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, uncontrolled diabetes mellitus and hypertension, or psychiatric illness/social situations that would limit compliance with study requirements No other malignancy except localized basal cell or squamous cell skin cancer in the past 5 years Patient who is pregnant or lactating Patient Allergic to Iodine contrast medium Uncontrolled severe coagulation disorders (INR < 1.5 in patients not on warfarin therapy)

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: Sor-HAIC group<br>400 mg of sorafenib (consisting of two 200-mg tablets) twice daily. hepatic arterial chemotherapy consisted of infusions of oxaliplatin (35 mg/m2 for 2 hours), followed by 5-fluorouracil (600 mg/m2 for 22 hours) on day1-3 every 4 weeks. | Procedure: HAIC<br>* Intra-arterial chemotherapy consisted of infusions of oxaliplatin (35 mg/m2 for 2 hours), followed by 5-fluorouracil (600 mg/m2 for 22 hours) on day1-3 every 4 weeks. For each cycle, leucovorin calcium 200 mg/m2 was intravenously administered for 2 hours from beginning of 5-fluorouracil infusion.<br>Drug: Sorafenib<br>* 400 mg of sorafenib (consisting of two 200-mg tablets) twice daily.<br>|
| Active Comparator: Sor group<br>400 mg of sorafenib (consisting of two 200-mg tablets) twice daily. | Drug: Sorafenib<br>* 400 mg of sorafenib (consisting of two 200-mg tablets) twice daily.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatocellular carcinoma, Portal vein tumor thrombosis, Hepatic arterial infusion chemotherapy, Sorafenib