A Prospective Multicenter Non-randomized Controlled Study of Palliative Treatments for Patients With Advanced Hepatocellular Carcinoma
- 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
- Hepatocellular carcinoma with histological diagnose.
- 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.
- 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.