Clinical trial NCT03009461: Sorafenib Plus Hepatic Arterial Infusion Versus Sorafenib for HCC with Major Portal Vein Tumor Thrombosis
Official title: Randomized Trial of Sorafenib Plus Hepatic Arterial Infusion with Oxaliplatin and Fluorouracil Versus Sorafenib for Hepatocellular Carcinoma with Major Portal Vein Tumor Thrombosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HepatoCellular Carcinoma
Portal Vein Thrombosis
Keywords: Hepatocellular carcinoma
Portal vein tumor thrombosis
Hepatic arterial infusion chemotherapy
Sorafenib
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2017-01-04
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Overall survival
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Cancer Hospital
state: Beijing
Study officials:
References:
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