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Chemoembolization of Unresectable Hepatocellular Carcinoma With or Without Lipiodol: Effectiveness and Safety. A Prospective and Randomized Clinical Trial.

Phase 3
18 Years
70 Years
Open (Enrolling)
Hepatocellular Carcinoma

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Trial Information

Chemoembolization of Unresectable Hepatocellular Carcinoma With or Without Lipiodol: Effectiveness and Safety. A Prospective and Randomized Clinical Trial.

TACE is the most widely used therapy in patients with HCC who are considered to be
unsuitable candidates for curative therapy.And the regimen of TACE with anticancer agents
and followed embolic particles has become a standard treatment for unresectable
hepatocellular carcinoma. However, there are variety TACE protocols with different
chemotherapeutic agents(combined or alone),which mixed with lipiodol or not,different
embolic agents(temporary or permanent ) and how these drugs combine. Currently, no standard
protocol exists for TACE. One of the controversy is what's the mechanism of lipiodol. This
disparity in the literature is the effectiveness of the lipiodol is unclear: some study
reveal a regimen contain lipiodol can improves survival ,while the other research consider
there is no any statistical significances in survival,but also aggravate the side effects.
Thus , The purpose of the investigators' study is to prospectively study the efficacy of
lipiodol in transcatheter arterial Chemoembolization with two kinds of regimens for
nonresectable hepatocellular carcinoma based on multivariate analysis of prognostic
factors. The study had a interim analysis to allow the trial to be stopped if significant
differences were detected. The accumulated data were examined when half patient was
enrolled in the clinical trial.

Comparison(s): In patients with HCC who underwent TACE therapy, stratified by whether they
have vascular invasion, we study the differences of survival between two regimens of
transcatheter arterial Chemoembolization.

Eligibility criteria:1-Inclusion Criteria;

Inclusion Criteria:

- Male or female patients > 18 years and <=70 years of age with a diagnosis of HCC

- Adults patients with a diagnosis of HCC which is not amenable to surgical resection
,local ablative therapy and any other cured treatment.

- A diagnosis of HCC based on the diagnostic criteria for HCC used by the European
Association for the Study of the Liver (EASL).

- The patient has not been previously treated with surgery, radiation therapy,
radiofrequency ablation, percutaneous ethanol or acetic acid injection, or

- Patients must have at least one tumor lesion that can be accurately measured
according to EASL criteria

- No serious concurrent medical illness

- Unresectable BCLC stage B disease

- Not pregnant or breast-feeding patients

- Cirrhotic status of Child-Pugh class A only

- No significant renal impairment (creatinine clearance < 30 mL/minute) or patients on

- No current infections requiring antibiotic therapy

- Not on anticoagulation or suffering from a known bleeding disorder

- No unstable coronary artery disease or recent MI

- The following laboratory parameters:

- Platelet count ≥ 60,000/µL

- Hemoglobin ≥ 8.5 g/dL

- Total bilirubin ≤ 1.5 mg/dL Serum albumin ≥ 35 g/L

- ASL and AST ≤ 5 x upper limit of normal

- Serum creatinine ≤ 1.5 x upper limit of normal

- INR ≤ 1.5 or PT/APTT 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:

- Known history of HIV

- History of organ allograft

- Known or suspected allergy to the investigational agents or any agent given in
association with this trial.

- Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy

- Evidence of bleeding diathesis.

- Patients with clinically significant gastrointestinal bleeding within 30 days prior
to study entry.

- Any other hemorrhage/bleeding event > CTCAE Grade 3 within 4 weeks of first dose of
study drug

- Serious non-healing wound, ulcer, or bone fracture

- Known central nervous system tumors including metastatic brain disease

- severe Arterioportal Shunts or Arteriavein Shunts

Type of Study:


Study Design:

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

Outcome Measure:

overall survival

Outcome Time Frame:

1 year

Safety Issue:


Principal Investigator

Ming Shi, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cancer Center, Sun Yat-set University


China: Ministry of Health

Study ID:




Start Date:

November 2010

Completion Date:

November 2014

Related Keywords:

  • Hepatocellular Carcinoma
  • Carcinoma,Hepatocellular
  • Liver Neoplasms
  • Therapeutic
  • Chemoembolization,
  • TACE
  • pharmacokinetics
  • Iodized Oil/administration & dosage
  • polyvinyl alcohol
  • Humans
  • Carcinoma
  • Carcinoma, Hepatocellular