Multimodality Therapy for Palliative Resectable Hepatocellular Carcinoma With Intrahepatic Vessels Invasion

NCT00501813 | Unknown Phase 3 DMC

• 1 other identifier: hcc-002
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the effects of different multimodality therapy strategies (initial hepatectomy followed by transcatheter hepatic arterial chemoembolization and/or local regional treatments compare with transcatheter hepatic arterial chemoembolization combined local regional treatments without hepatectomy)in the treatment of palliative resectable hepatocellular carcinoma with intrahepatic vessels invasion.

Conditions

Hepatocellular Carcinoma

Keywords

Hepatocellular carcinoma; Intrahepatic vessels invasion; Hepatectomy; Transcatheter arterial chemoembolization; Local regional treatment

Outcome Measures

Primary Outcomes (1)

• Overall survival rate

  1-, 3- and 5-year

Secondary Outcomes (1)

• Quality of live

  1- and 3- month

Study Arms (2)

surgery

ACTIVE COMPARATOR

initial palliative hepatectomy followed by TACE and/or local regional treatment

Procedure: Hepatectomy

no surgery

EXPERIMENTAL

TACE combined with local regional treatment without hepatectomy

Procedure: TACE combined with local regional therapies without hepatectomy

Interventions

Hepatectomy PROCEDURE

irregular Hepatectomy

surgery

TACE combined with local regional therapies without hepatectomy PROCEDURE

TACE combined with RFA, MCT, PEI, and so on.

Also known as: TACE combined with local regional treatment without hepatectomy

no surgery

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients \> 18 years and \<=70 years of age.
• Patients with palliative resectable HCC (all macroscopic tumor tissue can be removed), which have been histologically or cytologically documented. Documentation of original biopsy for diagnosis is acceptable if tumor tissue is unavailable at screening.
• Patients must have at least one lesion that meets both of the following criteria:
• The lesion can be accurately measured in at least one dimension according to RECIST (Section 10.7).
• The lesion has not been previously treated with local therapy (such as surgery, radiation therapy, hepatic arterial therapy, chemoembolization, radiofrequency ablation, percutaneous ethanol injection or cryoablation).
• Patients must have the tumor in the liver with intrahepatic vessels(portal vein/hepatic vein/bile duct) invasion, but all the tumor can be macroscopically removed.
• Patients who have an ECOG PS of 0 or 1.
• Cirrhotic status of Child-Pugh class A only. Child-Pugh status should be calculated based on clinical findings and laboratory results during the screening period.

You may not qualify if:

• Patient compliance is poor.
• The blood supply of tumor lesions is absolutely poor or arterial-venous shunt that TACE can not be performed.
• The vessels invasion beyond the following extent:
• the main branch of portal vein;
• the inferior vena cava;
• the common hepatic duct.
• Previous or concurrent cancer that is distinct in primary site or histology from HCC, EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (Ta, Tis \& T1). Any cancer curatively treated \> 3 years prior to entry is permitted.
• History of cardiac disease:
• congestive heart failure \> New York Heart Association (NYHA) class 2;
• active coronary artery disease (myocardial infarction more than 6 months prior to study entry is permitted);
• cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers, calcium channel blocker or digoxin;
• uncontrolled hypertension (failure of diastolic blood pressure to fall below 90 mmHg, despite the use of 3 antihypertensive drugs).
• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead
• Ministry of Health, China: collaborator

Study Sites (1)

Department of Hepatobilliary Surgery, Cancer Center, Sun Yat-sen University,

Guangzhou, Guangdong, 86-20, China

RECRUITING

Related Publications (8)

• Arii S, Yamaoka Y, Futagawa S, Inoue K, Kobayashi K, Kojiro M, Makuuchi M, Nakamura Y, Okita K, Yamada R. Results of surgical and nonsurgical treatment for small-sized hepatocellular carcinomas: a retrospective and nationwide survey in Japan. The Liver Cancer Study Group of Japan. Hepatology. 2000 Dec;32(6):1224-9. doi: 10.1053/jhep.2000.20456.

  PMID: 11093728 BACKGROUND

• Mise K, Tashiro S, Yogita S, Wada D, Harada M, Fukuda Y, Miyake H, Isikawa M, Izumi K, Sano N. Assessment of the biological malignancy of hepatocellular carcinoma: relationship to clinicopathological factors and prognosis. Clin Cancer Res. 1998 Jun;4(6):1475-82.

  PMID: 9626465 BACKGROUND

• Shi M, Zhang CQ, Zhang YQ, Liang XM, Li JQ. Micrometastases of solitary hepatocellular carcinoma and appropriate resection margin. World J Surg. 2004 Apr;28(4):376-81. doi: 10.1007/s00268-003-7308-x. Epub 2004 Mar 17.

  PMID: 15022021 BACKGROUND

• Ikai I, Arii S, Kojiro M, Ichida T, Makuuchi M, Matsuyama Y, Nakanuma Y, Okita K, Omata M, Takayasu K, Yamaoka Y. Reevaluation of prognostic factors for survival after liver resection in patients with hepatocellular carcinoma in a Japanese nationwide survey. Cancer. 2004 Aug 15;101(4):796-802. doi: 10.1002/cncr.20426.

  PMID: 15305412 BACKGROUND

• Lau 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 BACKGROUND

• Llovet 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 BACKGROUND

• Bruix 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 BACKGROUND

• Lopez 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 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Hepatectomy

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Digestive System Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Jin-Qing Li, MD

  Department of Hepatobilliary Surgery, Cancer Center, Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

• Rong-Ping Guo, MD

  Department of Hepatobilliary Surgery, Cancer Center, Sun Yat-sen University

  STUDY DIRECTOR

Central Study Contacts

shi ming, MD

CONTACT

86-2087343582; shiming@mail.sysu.edu.cn

Min-Shan Chen, MD

CONTACT

86-2087343117; Chminsh@mail.sysu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 13, 2007
• First Posted: July 16, 2007
• Study Start: October 1, 2006
• Primary Completion: December 1, 2009
• Study Completion: July 1, 2010
• Last Updated: July 30, 2010

Record last verified: 2010-01

Locations

CN (1)