Comparison of Two Solvents Used With Chemotherapy Agent for Transarterial Chemoembolization of Hepatocellular Carcinoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Sun Yat-sen University
Sponsor:
Information provided by (Responsible Party):
Shi Ming, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT01259414
First received: December 13, 2010
Last updated: January 2, 2014
Last verified: January 2014
  Purpose

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 administrating drugs can cause a different survival benefit.


Condition Intervention Phase
Hepatocellular Carcinoma
Other: transarterial chemoembolization(TACE)
Other: Transarterial chemoembolization (TACE)
Phase 3

Study Type: 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
Official Title: Comparison of Two Solvents Used With Chemotherapy Agent for Transarterial Chemoembolization of Hepatocellular Carcinoma

Resource links provided by NLM:


Further study details as provided by Sun Yat-sen University:

Primary Outcome Measures:
  • overall survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to progression [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 844
Study Start Date: January 2011
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: group1
chemotherapy drugs dissolved in distilled water and emulsified in lipiodol followed embolization with polyvinyl alcohol particles (PVA)
Other: transarterial chemoembolization(TACE)
TACE with chemotherapy drugs (EADM 50mg, lobaplatin 50mg, and MMC 6mg)dissolved in distilled water and emulsified lipiodol followed embolization with polyvinyl alcohol particles (PVA)
Experimental: group2
chemotherapy drugs dissolved in water-soluble contrast medium and distilled water,then emulsified with lipiodol followed embolization with polyvinyl alcohol particles (PVA)
Other: Transarterial chemoembolization (TACE)
TACE with chemotherapy drugs (EADM 50mg, lobaplatin 50mg, and MMC 6mg)dissolved in water-soluble contrast medium and distilled water,then emulsified with lipiodol followed embolization with polyvinyl alcohol particles (PVA)

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 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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01259414

Contacts
Contact: Ming Shi 86-2087343582 ext 86-2087343582 shiming@mail.sysu.edu.cn
Contact: Rong Ping Guo 86-2087343117 ext 86-2087343117 guorongp@mail.sysu.edu.cn

Locations
China, Guangdong
Cancer Center Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China
Contact: Ming Shi    86-2087343582 ext 86-2087343582    shiming@mail.sysu.edu.cn   
Contact: Ping Rong Guo    86-2087343117 ext 86-2087343117    guorongp@mail.sysu.edu.cn   
Principal Investigator: Ming Shi         
Sponsors and Collaborators
Sun Yat-sen University
Investigators
Principal Investigator: Ming Shi Cancer Center, Sun Yat-set University
  More Information

Publications:

Responsible Party: Shi Ming, Prof., Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT01259414     History of Changes
Other Study ID Numbers: HCC2011A
Study First Received: December 13, 2010
Last Updated: January 2, 2014
Health Authority: China: Ministry of Health

Keywords provided by Sun Yat-sen University:
Carcinoma,Hepatocellular
Liver Neoplasms
Survival analysis
treatment outcome
administration drugs
Chemoembolization,
TACE
polyvinyl alcohol
water-soluble contrast mesium
iopamidol
lipiodol
distilled water

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Carcinoma
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases

ClinicalTrials.gov processed this record on September 22, 2014