Different Regimens of Transarterial Chemoembolization for Hepatocellular Carcinoma

The purpose of this study is to evaluate efficacy, safety, and patient reported outcomes (PRO) of different regimens of transarterial chemoembolization (TACE) in patients with hepatocellular carcinoma (HCC).

Sex

All

Minimum age

18 Years

Maximum age

75 Years

Inclusion Criteria:

* Adult patients with minimal height of 150cm and minimal weight of 50 KG
* Histological confirmed HCC
* with no previous treatment
* With unresectable tumor
* With solitary or multiple intrahepatic tumor, the diameter of the largest one must larger than 7cm.
* No significant baseline liver dysfunction. Cirrhotic status of Child-Pugh class A only
* No significant renal impairment (creatinine clearance \< 30 mL/minute)
* The following laboratory parameters:

  * Platelet count ≥ 60,000/µL
  * Hemoglobin ≥ 8.5 g/dL
  * Total bilirubin ≤ 1.5 mg/dL
  * ASL and AST ≤ 5 x upper limit of normal
  * Serum albumin ≥ 35 g/L
  * Serum creatinine ≤ 1.5 x upper limit of normal
  * INR ≤ 1.5 or a Pt/PTT within normal limits
  * Absolute neutrophil count (ANC) \> 1,500/mm3
* Ability to understand the protocol and to agree to and sign a written informed consent document

Exclusion Criteria:

* Avascular tumor
* Main portal vein obstruction without cavernous transformation
* Evidence of hepatic decompensation including esophageal or gastric variceal bleeding or hepatic encephalopathy
* Obstructive jaundice
* Severe underlying cardiac or renal diseases
* Known or suspected allergy to the investigational agent or any agent given in association with this trial
* Pregnant or breast-feeding patients.
* History of organ allograft
* Active clinically serious infections
* Any condition that is unstable or which could jeopardize the safety of the patient and his/her compliance in the study

• BACKGROUNDBruix J, Sherman M; Practice Guidelines Committee, American Association for the Study of Liver Diseases. Management of hepatocellular carcinoma. Hepatology. 2005 Nov;42(5):1208-36. doi: 10.1002/hep.20933. No abstract available. PMID 16250051
• BACKGROUNDBREEDIS C, YOUNG G. The blood supply of neoplasms in the liver. Am J Pathol. 1954 Sep-Oct;30(5):969-77. No abstract available. PMID 13197542
• BACKGROUNDLlovet JM, Bruix J. Systematic review of randomized trials for unresectable hepatocellular carcinoma: Chemoembolization improves survival. Hepatology. 2003 Feb;37(2):429-42. doi: 10.1053/jhep.2003.50047. PMID 12540794
• BACKGROUNDOno Y, Yoshimasu T, Ashikaga R, Inoue M, Shindou H, Fuji K, Araki Y, Nishimura Y. Long-term results of lipiodol-transcatheter arterial embolization with cisplatin or doxorubicin for unresectable hepatocellular carcinoma. Am J Clin Oncol. 2000 Dec;23(6):564-8. doi: 10.1097/00000421-200012000-00006. PMID 11202797
• BACKGROUNDLau WY, Yu SC, Lai EC, Leung TW. Transarterial chemoembolization for hepatocellular carcinoma. J Am Coll Surg. 2006 Jan;202(1):155-68. doi: 10.1016/j.jamcollsurg.2005.06.263. Epub 2005 Oct 19. No abstract available. PMID 16377509
• BACKGROUNDLopez PM, Villanueva A, Llovet JM. Systematic review: evidence-based management of hepatocellular carcinoma--an updated analysis of randomized controlled trials. Aliment Pharmacol Ther. 2006 Jun 1;23(11):1535-47. doi: 10.1111/j.1365-2036.2006.02932.x. PMID 16696801
• BACKGROUNDLai CL, Wu PC, Chan GC, Lok AS, Lin HJ. Doxorubicin versus no antitumor therapy in inoperable hepatocellular carcinoma. A prospective randomized trial. Cancer. 1988 Aug 1;62(3):479-83. doi: 10.1002/1097-0142(19880801)62:33.0.co;2-l. PMID 2839280