Hepatectomy With or Without Transcatheter Arterial Chemoembolization for Stage IIIA Hepatocellular Carcinoma

This study has been completed.
Sponsor:
Collaborator:
Ministry of Health, China
Information provided by:
Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT00652587
First received: March 31, 2008
Last updated: NA
Last verified: March 2008
History: No changes posted
  Purpose

The purpose of this study is to evaluate whether hepatectomy combining with adjuvant transcatheter arterial chemoembolization (TACE) for Stage IIIA hepatocellular carcinoma (HCC) resulting better long-term survival outcome when compared with hepatectomy alone.


Condition Intervention Phase
Hepatocellular Carcinoma
Hepatectomy
Chemoembolization
Procedure: hepatectomy and transcatheter arterial chemoembolization
Procedure: hepatectomy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of Hepatectomy With Adjuvant Transcatheter Arterial Chemoembolization Versus Hepatectomy Alone for Stage IIIA Hepatocellular Carcinoma

Resource links provided by NLM:


Further study details as provided by Sun Yat-sen University:

Primary Outcome Measures:
  • overall survival rates [ Time Frame: 1-, 3-, and 5-year ] [ Designated as safety issue: No ]

Enrollment: 115
Study Start Date: January 2002
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A, LRTACE
hepatectomy with adjuvant transcatheter arterial chemoembolization
Procedure: hepatectomy and transcatheter arterial chemoembolization
partial hepatectomy with adjuvant transcatheter arterial chemoembolization
Other Name: hepatectomy and transcatheter arterial chemoembolization
Active Comparator: B, LR
hepatectomy alone
Procedure: hepatectomy
hepatectomy alone
Other Name: hepatectomy alone

Detailed Description:

Hepatocellular carcinoma (HCC) is one of the most common malignancies in the world, and the prevalence is increasing in the United States. Hepatectomy is still considered as the potentially curative treatment for HCC. Unfortunately, long-term survival after hepatectomy is still unsatisfactory because of the high incidence of tumor recurrence, especially intrahepatic recurrence.

Stage IIIA hepatocellular carcinoma (HCC) include multiple tumors more than 5 cm or tumor involving a major branch of the portal or hepatic vein(s) in the International Union Against Cancer (UICC) TNM staging for liver tumors, sixth edition 2002. Until now there are controversies in the management of Stage IIIA HCC. According to the Barcelona -Clinic-Liver-Cancer (BCLC) proposal, Stage IIIA HCC represented as intermediate or advanced disease. The European Association for Study of the Liver (EASL) and the American Association for the Study of Liver Diseases (AASLD) recommended randomized controlled trials of chemoembolization or new agents for such stage of disease. Whereas in Asian areas, such as China or Japan, partial hepatectomy or reductive surgery (with or without adjuvant therapy) was performed for multiple advanced HCC or tumor with a major branch of the portal or hepatic vein(s) invasion, although no prospective study to assess the therapeutic efficacy and safety. On the other hand, transcatheter arterial chemoembolization (TACE) is the most widely used primary treatment for unresectable HCC. It was also used as the optional treatment of relapsed disease. However, the efficacy of TACE used as adjuvant therapy following hepatectomy remains controversial. Neither are there large randomized controlled trials to address this field. Therefore, a randomized controlled trial was performed in our cancer center to compare hepatectomy with adjuvant TACE and hepatectomy alone for the Stage IIIA HCC.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female patients > 18 years and <=70 years of age
  • Patients who have an ECOG PS of 0 or 1.
  • a preoperative diagnosis of HCC with no previous treatment;
  • compensated cirrhosis with Child-Pugh class A, B or no cirrhosis;
  • multiple tumors more than 5 cm or tumor involving a major branch of the portal or hepatic vein(s) on preoperative investigations, and on intraoperative ultrasound and gross examination of the liver during the surgery;
  • on exploration and intraoperative ultrasound the tumor could safely be resected without grossly remaining tumors, and the patient was judged to have adequate liver functional reserve to survive the operation.

Exclusion Criteria:

  • Patient compliance is poor
  • 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; or
    • 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
  • Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry
  • Distantly extrahepatic metastasis
  • History of organ allograft
  • Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
  • Known or suspected allergy to the investigational agent or any agent given in association with this trial
  • Any condition that is unstable or which could jeopardize the safety of the patient and his/her compliance in the study
  • Pregnant or breast-feeding patients. Women of childbearing potential must have a negative pregnancy test performed within seven days prior to the start of study drug. Both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial.
  • Excluded therapies and medications, previous and concomitant:

    • Prior use of any systemic anti-cancer treatment for HCC, eg. chemotherapy, immunotherapy or hormonal therapy (except that hormonal therapy for supportive care is permitted). Antiviral treatment is allowed, however interferon therapy must be stopped at least 4 weeks prior randomization.
    • Prior use of systemic investigational agents for HCC
    • Autologous bone marrow transplant or stem cell rescue within four months of start of study drug
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00652587

Locations
China, Guangdong
Department of Hepatobilliary Surgery, Cancer Center, Sun Yat-sen University
Guangzhou, Guangdong, China, 510060
Sponsors and Collaborators
Sun Yat-sen University
Ministry of Health, China
Investigators
Principal Investigator: GUO Rong-ping, MD Department of Hepatobilliary Surgery, Cancer Center, Sun Yat-sen University
  More Information

Publications:

Responsible Party: Cancer Center, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT00652587     History of Changes
Other Study ID Numbers: HCC_001
Study First Received: March 31, 2008
Last Updated: March 31, 2008
Health Authority: China: Ministry of Health

Keywords provided by Sun Yat-sen University:
hepatocellular carcinoma
hepatectomy
chemoembolization
randomized controlled trial
prognosis

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases

ClinicalTrials.gov processed this record on August 27, 2014