Clinical trial NCT01259414: Comparison of Two Solvents Used With Chemotherapy Agent for Transarterial Chemoembolization of Hepatocellular Carcinoma
Official title: Comparison of Two Solvents Used With Chemotherapy Agent for Transarterial Chemoembolization of Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatocellular Carcinoma
Keywords: Carcinoma,Hepatocellular
Liver Neoplasms
Survival analysis
treatment outcome
administration drugs
Chemoembolization,
TACE
polyvinyl alcohol
water-soluble contrast mesium
iopamidol
lipiodol
distilled water
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2010-12-14
Enrollment: 812
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: TACE is considered the standard treatment for unresectable HCC and is widely used as a palliative treatment. However there is no consensus of the protocol of TACE.One of the variation is does the stability of the suspension by emulsified the lipiodol and the contrast medium used to dissolve the anticancer agents really effect the survival.Thus the investigators conduct this prospective,randomized controlled study to find out if the different method of preparing chemotheraputic drugs can cause a different survival benefit.

Detailed description: 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. 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.

Eligibility criteria: Inclusion Criteria:

* Male or female patients \> 18 years and \<=70 years of age with a diagnosis of HCC
* BCLC B stage disease
* Not amendable to surgical resection ,local ablative therapy and any other cured treatment.
* Patients must have at least one tumor lesion that can be accurately measured according to EASL criteria. The lesion has not been previously treated with TACE, surgery, radiation therapy, radiofrequency ablation, percutaneous ethanol or acetic acid injection, or cryoablation.
* No Cirrhosis or cirrhotic status of Child-Pugh class A only
* Not pregnant or breast-feeding patients
* No significant renal impairment (creatinine clearance \< 30 mL/minute) or patients on dialysis
* 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 Arteria vein Shunts

Primary outcomes:
measure: overall survival
timeFrame: 3 year
Secondary outcomes:
measure: Time to progression
timeFrame: 3 year
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Cancer Center Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Cancer Center, Sun Yat-set University
name: Ming Shi
role: PRINCIPAL_INVESTIGATOR
References:
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