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The Efficacy and Safety of Retreatment With TAI for Patients Who Showed TACE-resistant: a Randomized Controlled Trial

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ClinicalTrials.gov Identifier: NCT02220088
Recruitment Status : Terminated (protocol violation)
First Posted : August 19, 2014
Last Update Posted : January 11, 2019
Sponsor:
Collaborators:
Kaiping Central Hospital
Guangzhou No.12 People's Hospital
Information provided by (Responsible Party):
Shi Ming, Sun Yat-sen University

Brief Summary:
Transarterial chemoembolization (TACE) is considered the gold standard for treating intermediate-stage hepatocellular carcinoma (HCC). However, any treatment guidelines do not specify the criteria for repeating TACE. The study,conducted in Europe ,recently published in the journal of Hepatology shows the ART score of >=2.5 prior the second TACE identifies patients with a dismal prognosis who may not profit from further TACE sessions. However,in clinical practice,we also found some patients who showed TACE-resistant at the beginning of treatment may access to get objective response of retreatment with transcatheter arterial infusion (TAI). So the investigators conduct this prospective,randomized controlled study to find out whether the patient who showed TACE-resistant can obtain survival benefit from retreatment with TAI.

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Procedure: TAI of FOLFOX Drug: Sorafenib Phase 2 Phase 3

Detailed Description:

Transarterial chemoembolization (TACE) is considered the gold standard for treating intermediate-stage hepatocellular carcinoma (HCC). However, intermediate-stage HCC includes a heterogeneous population of patients with varying tumour burdens, liver function (Child-Pugh A or B) and disease aetiology.This suggests that not all patients with intermediate-stage HCC will derive similar benefit from transcatheter arterial infusion (TAI), and that some patients may benefit from other treatment options.

Repetition of TACE is based on evidence suggesting that one cycle of TACE may not be sufficient for effective treatment of intermediate-stage HCC and repeating TACE prolongs survival. However, intermediate-stage HCC patients often have unsatisfactory clinical outcomes with repeated TACE and there is not sufficiently addressed by existing guidelines include the criteria for repeating TACE and recommendations about the number of TACE cycles to be repeated before switching to another or no treatment.The study,recently published in the journal of Hepatology shows the ART score of >=2.5 prior the second TACE identifies patients with a dismal prognosis who may not profit from further TACE sessions.In clinical practice,however, we also found some patients who showed TACE-resistant at the beginning of treatment may access to get objective response of retreatment with TAI. So we conduct this prospective,randomized controlled study to find out whether the patient who showed TACE-resistant can obtain survival benefit from retreatment with TAI.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 79 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Efficacy and Safety of Retreatment With Transcatheter Arterial Infusion (TAI) for Patients Who Showed TACE-resistant: a Randomized Controlled Trial
Actual Study Start Date : December 2014
Actual Primary Completion Date : July 2018
Actual Study Completion Date : July 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: TAI of FOLFOX
Retreatment With Transcatheter arterial infusion of oxaliplatin , fluorouracil, and leucovorin
Procedure: TAI of FOLFOX
Retreatment with TAI: administration of Oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries
Other Name: Transcatheter arterial infusion of oxaliplatin , fluorouracil, and leucovorin

Active Comparator: Sorafenib
treatment with sorafenib
Drug: Sorafenib
Accept sorafenib.




Primary Outcome Measures :
  1. Progression free survival [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Number of Adverse Events [ Time Frame: 30 days ]
    All severe adverse events for the entire course of treatment

  2. overall survival [ Time Frame: 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female patients, > 18 years and <=70 years old diagnosed with HCC according to the European Association for the Study of the Liver (EASL) diagnostic criteria
  • The patient has received 2 session of TACE
  • TACE failure/refractoriness by Liver Cancer Study Group of Japan (LCSGJ) criteria
  • Cirrhotic status of Child-Pugh class A
  • 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:

  • Patients with complete response (CR) after the first TACE did not receive a further TACE session
  • Eastern Cooperative Oncology Group (ECOG) >1
  • 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
  • Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.
  • Serious non-healing wound, ulcer, or bone fracture
  • Evidence of bleeding diathesis.
  • Any other hemorrhage/bleeding event > CTCAE Grade 3 within 4 weeks of first dose of study drug
  • Severe Arterioportal Shunts or Arteriavein Shunts
  • Known metastatic disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02220088


Locations
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China, Guangdong
Cancer Center Sun Yat-sen University
Guangzhou, Guangdong, China, 510060
Sponsors and Collaborators
Sun Yat-sen University
Kaiping Central Hospital
Guangzhou No.12 People's Hospital
Investigators
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Principal Investigator: Ming Shi Cancer Center, Sun Yat-set University
Publications of Results:

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Responsible Party: Shi Ming, Prof., Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT02220088    
Other Study ID Numbers: HCC201408
First Posted: August 19, 2014    Key Record Dates
Last Update Posted: January 11, 2019
Last Verified: December 2018
Keywords provided by Shi Ming, Sun Yat-sen University:
Hepatocellular Carcinoma
TACE
TACE failure
TACE refractoriness
TAI
Sorafenib
Additional relevant MeSH terms:
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Carcinoma, Hepatocellular
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Leucovorin
Fluorouracil
Oxaliplatin
Sorafenib
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antidotes
Protective Agents
Vitamin B Complex
Vitamins
Micronutrients
Nutrients
Growth Substances
Protein Kinase Inhibitors