Palliative Treatments for Patients With Advanced Hepatocellular Carcinoma (HCC)

This is a prospective non-randomized controlled study. Patients with advanced hepatocellular carcinoma (BCLC C stage) who underwent palliative resection or TACE followed with Sorafenib or treated by sorafenib alone will be included. The patients will be divided to group A (palliative resection plus sorafenib), group B (palliative TACE plus sorafenib), and group C (sorafenib alone). The sample size will be about 200 cases altogether.

Inclusion criteria

• Male or female patients > 18 years of age.
• Diagnosed to have advanced HCC (BCLC C stage).
• Patients who have a life expectancy of at least 12 weeks.
• Patients whose primary tumor can be resected.

Definition of resectable in this study:

• Tumor number <=2.
• If number of tumors >= 3, then all tumors were located in the same lobe.
• Without tumor invasion of the main trunk of the portal vein, or hepatic duct, or caval vein.
• Hepatocellular carcinoma with histological diagnose or clinical diagnose according to AASLD.
• No major post-operative complication.
• Patients who have an ECOG PS of 0, or 1.
• Cirrhotic status of Child-Pugh class A only.
• The following laboratory parameters:

Platelet count > 60 x 109/L Hemoglobin > 8.5 g/dL Albumin > 3.5 g/dL Total bilirubin < 25μmol/L Alanine transaminase (ALT) and AST < 2.5 x upper limit of normal Serum creatinine <1.5 x the upper limit of normal Prothrombin time (PT)<3 seconds above control.

• Patients who give written informed consent.

Exclusion criteria

• Previous or concurrent cancer that is distinct in primary site or histology from HCC.
• History of cardiac disease.
• Active clinically serious infections (> grade 2 National Cancer Institute [NCI]-Common Terminology Criteria for Adverse Events [CTCAE] version 3.0)
• Known history of human immunodeficiency virus (HIV) infection
• Known Central Nervous System tumors including metastatic brain disease.
• Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.
• History of organ allograft.
• Known or suspected allergy to the investigational agent or any agent given in association with this trial.
• Pregnant or breast-feeding patients.
• Any condition that is unstable or which could jeopardize the safety of the patient and his/her compliance in the study.
• Excluded therapies and medications, previous and concomitant: Systemic chemotherapy and target drug other than sorafenib. Antiviral treatment is allowed.
• Radiotherapy except for which done for bone metastases palliatively.