Chemoembolization With or Without Mixing the Chemotherapy With Lipiodol for Unresectable HCC

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2015 by Sun Yat-sen University
Sponsor:
Information provided by (Responsible Party):
Shi Ming, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT01229839
First received: October 25, 2010
Last updated: December 11, 2015
Last verified: November 2015
  Purpose
TACE is considered the standard treatment for unresectable HCC on the basis of the fact that there are no alternative to curative procedures.But the optimal combined regimen is still unclear. One of the controversy is do the protocol should contain lipiodo and how to executer. The investigators hypothesize that TACE without mixing the chemotherapy with lipiodol is not unacceptably worse than TACE mixing the chemotherapy with lipiodol.

Condition Intervention Phase
Hepatocellular Carcinoma
Other: Embolization
Other: Infusion of anticancer agent
Other: Infusion of mixture of anticancer agent and lipiodol
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Chemoembolization of Unresectable Hepatocellular Carcinoma With or Without Mixing the Chemotherapy With Lipiodol: Effectiveness and Safety. A Prospective and Randomized Clinical Trial.

Resource links provided by NLM:


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

Primary Outcome Measures:
  • overall survival [ Time Frame: 3 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to progression [ Time Frame: 3 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 668
Study Start Date: August 2013
Estimated Study Completion Date: August 2018
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: infusion group
Infusion of anticancer agent followed by Embolization
Other: Embolization
embolization with lipiodol and polyvinyl alcohol particles (PVA)
Other: Infusion of anticancer agent
infusion with chemotherapy drugs (EADM 50mg, lobaplatin 50mg, and MMC 6mg ) desolved in water
Experimental: lipiodol chemotherapy group
Infusion of mixture of anticancer agent and lipiodol followed by Embolization
Other: Embolization
embolization with lipiodol and polyvinyl alcohol particles (PVA)
Other: Infusion of mixture of anticancer agent and lipiodol
infusion of mixture of lipiodol and chemotherapy drugs (EADM 50mg, lobaplatin 50mg, and MMC 6mg)dissolved in water-soluble contrast medium and distilled water

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Eligibility criteria:

Inclusion Criteria:

  • Adults patients with a diagnosis of HCC which is not amenable 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. And the lesion has not been previously treated with TACE, surgery, radiation therapy, radiofrequency ablation, percutaneous ethanol or acetic acid injection, or cryoablation.
  • No serious concurrent medical illness
  • Unresectable BCLC stage B disease
  • No cirrhosis or cirrhotic status of Child-Pugh class A
  • 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
  • Pregnant or breast-feeding patients
  • 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: NCT01229839

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

Publications:

Responsible Party: Shi Ming, Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT01229839     History of Changes
Other Study ID Numbers: HCC_S010 
Study First Received: October 25, 2010
Last Updated: December 11, 2015
Health Authority: China: Ministry of Health

Keywords provided by Sun Yat-sen University:
Carcinoma,Hepatocellular
Liver Neoplasms
Therapeutic
Chemoembolization,
TACE
pharmacokinetics
Iodized Oil/administration & dosage
polyvinyl alcohol
Humans

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Adenocarcinoma
Digestive System Diseases
Digestive System Neoplasms
Liver Diseases
Liver Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Antineoplastic Agents
Ethiodized Oil
Contrast Media
Diagnostic Uses of Chemicals
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on February 07, 2016