Sorafenib Plus Hepatic Arterial Infusion Versus Sorafenib for HCC with Major Portal Vein Tumor Thrombosis
Phase 2
Completed
- Conditions
- HepatoCellular CarcinomaPortal Vein Thrombosis
- Interventions
- Procedure: HAIC
- Registration Number
- NCT03009461
- Lead Sponsor
- Peking University
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 64
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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sor-HAIC group HAIC 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. Sor group Sorafenib 400 mg of sorafenib (consisting of two 200-mg tablets) twice daily. Sor-HAIC group Sorafenib 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.
- Primary Outcome Measures
Name Time Method Overall survival 1 year
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Peking University Cancer Hospital
🇨🇳Beijing, Beijing, China