Comparison of Two Solvents Used With Chemotherapy Agent for Transarterial Chemoembolization of Hepatocellular Carcinoma
18 Years
70 Years
Both
Hepatocellular Carcinoma
Trial Information
Comparison of Two Solvents Used With Chemotherapy Agent for Transarterial Chemoembolization of Hepatocellular Carcinoma
Transcatheter arterial chemoembolization is currently the mainstays of palliative treatments
worldwide for patients with unresectable HCC. However there is no standard protocol exists
for TACE currently. One of the controversy is does the way of emulsified the anticancer
agents and lipiodol to get a high stability suspension really effect the survival rates.
Anticancer drugs play important role in survival benefit from our RCTs research (not
released). Many studies have innovated different methods to get a high stability suspension
of lipiodol and anticancer drugs ,because they think lipiodol can selectively retained in
HCC and used as a drug-carrying which allow a slow release of the anticancer drug from
lipiodol microdroplets. Thus ,A stability suspension might get a maximize tumor drug
uptake,which can caused a more tumor necrosis, and minimize systemic drug levels ,which get
a less toxicity, hence survival benefit. While the other researcher think a stability
emulsion can't get a positive effect ,such as pharmacokinetic and systematic toxicity of the
anticancer drugs, tumor response, biologic response and so on.
In conclude, there is no consensus in the method of combining the drugs. The variation of
the regime is great. Because there is no hard-evidence proved which protocol is better than
other by survival benefit.Thus, the investigators conduct the clinical trial with two arms
,which one is a traditional and classical regime administrated by us while the other is a
more stability suspension approved by many researchers, to prospectively study does the
stability suspension really effect the patient's survival based on multivariate analysis of
prognostic factors . The study had two interim analysis to allow the trial to be stopped if
significant differences were detected. The accumulated data were examined when one third
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.
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
cryoablation.
- 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
dialysis
- 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:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
overall survival
Outcome Time Frame:
1 year
Safety Issue:
No
Principal Investigator
Ming Shi
Investigator Role:
Principal Investigator
Investigator Affiliation:
Cancer Center, Sun Yat-set University
Authority:
China: Ministry of Health
Study ID:
HCC2011A
NCT ID:
NCT01259414
Start Date:
January 2011
Completion Date:
January 2017
Related Keywords:
- Hepatocellular Carcinoma
- Carcinoma,Hepatocellular
- Liver Neoplasms
- Survival analysis
- treatment outcome
- administration drugs
- Chemoembolization,
- TACE
- polyvinyl alcohol
- water-soluble contrast mesium
- iopamidol
- lipiodol
- distilled water
- Carcinoma
- Carcinoma, Hepatocellular
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