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Transarterial Chemoembolization With or Without Lipiodol Chemotherapy in Patient With Unresectable Hepatocellular Carcinoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 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: August 3, 2013
Last verified: August 2013
  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 lipiodol can achieve a better survival but less side effects for advanced stage HCC. Thus, the investigators carried out this prospective control study to find out if the survivals for patients after TACE without lipiodol better than TACE with an emulsion of anticancer drugs in lipiodol.


Condition Intervention Phase
Hepatocellular Carcinoma
Other: Procedure:Transarterial embolization
Other: Procedure/Surgery: Transarterial infusion chemotherapy
Other: Transarterial lipiodol chemotharepy
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 Lipiodol Chemotherapy: 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: 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: November 2010
Estimated Study Completion Date: November 2016
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: infusion group
chemotherapy drugs infusion followed embolization with lipiodol and polyvinyl alcohol particles (PVA)
Other: Procedure:Transarterial embolization
embolization with lipiodol and polyvinyl alcohol particles (PVA)
Other: Procedure/Surgery: Transarterial infusion chemotherapy
infusion with chemotherapy drugs (EADM 50mg, lobaplatin 50mg, and MMC 6mg ) desolved in water
Experimental: lipiodol chemotherapy group
Injection of chemotherapy drugs mixed with lipiodol followed embolization with lipiodol and polyvinyl alcohol particles (PVA)
Other: Procedure:Transarterial embolization
embolization with lipiodol and polyvinyl alcohol particles (PVA)
Other: Transarterial lipiodol chemotharepy
infusion of mixture of lipiodol and chemotherapy drugs (EADM 50mg, lobaplatin 50mg, and MMC 6mg)dissolved in water-soluble contrast medium and distilled water

Detailed Description:

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

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

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 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: 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: HCC008010
Study First Received: October 25, 2010
Last Updated: August 3, 2013
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
Ethiodized Oil
Antineoplastic Agents
Contrast Media
Diagnostic Uses of Chemicals
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014