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The Efficacy, Safety, and Patient Reported Outcomes of Different Regimens of Transarterial Chemoembolization in Patients With Hepatocellular Carcinoma

Phase 3
18 Years
75 Years
Not Enrolling
Hepatocellular Carcinoma

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Trial Information

The Efficacy, Safety, and Patient Reported Outcomes of Different Regimens of Transarterial Chemoembolization in Patients With Hepatocellular Carcinoma

Transarterial chemoembolization (TACE) has been recommended as first line non-curative
therapy for non-surgical patients with large/multifocal HCC who do not have vascular
invasion or extrahepatic spread. There has not been any standardized protocol in the choice
of chemotherapeutic agents, dosage, dilution, rate of injection, and time interval between
treatments. Similarly, there is no agreement on the choice of embolizing agents, degree of
embolization, and whether the chemotherapeutic agent should be given together, or before the
embolizing agent.

Comparison(s): In patients with HCC who underwent TACE therapy, stratified by whether they
have vascular invasion and tumor size, we compare efficacy, safety, and patient reported
outcomes (PRO) of different regimens of TACE.

Regimen 1: lipiodol combined chemotherapy with embolization

Regimen 2: lipiodol combined chemotherapy without embolization

Regimen 3: lipiodol single agent chemotherapy with embolization

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

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Outcome Measure:

Overall survival

Outcome Time Frame:

3 years

Safety Issue:


Principal Investigator

Jin-Qing Li, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cancer Center, Sun Yat-set University


China: Ministry of Health

Study ID:




Start Date:

July 2007

Completion Date:

December 2010

Related Keywords:

  • Hepatocellular Carcinoma
  • Antineoplastic Agents
  • administration & dosage
  • Carcinoma, Hepatocellular
  • Chemoembolization, Therapeutic
  • Humans
  • Liver Neoplasms
  • therapy
  • Carcinoma
  • Carcinoma, Hepatocellular