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A Randomized Controlled Trial of Hepatectomy With Adjuvant Transcatheter Arterial Chemoembolization Versus Hepatectomy Alone for Stage IIIA Hepatocellular Carcinoma

Phase 3
18 Years
70 Years
Not Enrolling
Hepatocellular Carcinoma, Hepatectomy, Chemoembolization

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Trial Information

A Randomized Controlled Trial of Hepatectomy With Adjuvant Transcatheter Arterial Chemoembolization Versus Hepatectomy Alone for Stage IIIA Hepatocellular Carcinoma

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

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

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

overall survival rates

Outcome Time Frame:

1-, 3-, and 5-year

Safety Issue:


Principal Investigator

GUO Rong-ping, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

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


China: Ministry of Health

Study ID:




Start Date:

January 2002

Completion Date:

December 2007

Related Keywords:

  • Hepatocellular Carcinoma
  • Hepatectomy
  • Chemoembolization
  • hepatocellular carcinoma
  • hepatectomy
  • chemoembolization
  • randomized controlled trial
  • prognosis
  • Carcinoma
  • Carcinoma, Hepatocellular