Status:
COMPLETED
Hepatectomy With or Without Transcatheter Arterial Chemoembolization for Stage IIIA Hepatocellular Carcinoma
Lead Sponsor:
Sun Yat-sen University
Collaborating Sponsors:
Ministry of Health, China
Conditions:
Hepatocellular Carcinoma
Hepatectomy
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
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...
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 t...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
115 Patients enrolled
Trial Details
Trial ID
NCT00652587
Start Date
January 1 2002
End Date
December 1 2007
Last Update
April 3 2008
Active Locations (1)
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1
Department of Hepatobilliary Surgery, Cancer Center, Sun Yat-sen University
Guangzhou, Guangdong, China, 510060