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

Primary Purpose

Hepatocellular Carcinoma

Status
Terminated
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
TAI of FOLFOX
Sorafenib
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring Hepatocellular Carcinoma, TACE, TACE failure, TACE refractoriness, TAI, Sorafenib

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cancer Center Sun Yat-sen University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

TAI of FOLFOX

Sorafenib

Arm Description

Retreatment With Transcatheter arterial infusion of oxaliplatin , fluorouracil, and leucovorin

treatment with sorafenib

Outcomes

Primary Outcome Measures

Progression free survival

Secondary Outcome Measures

Number of Adverse Events
All severe adverse events for the entire course of treatment
overall survival

Full Information

First Posted
August 14, 2014
Last Updated
January 9, 2019
Sponsor
Sun Yat-sen University
Collaborators
Kaiping Central Hospital, Guangzhou No.12 People's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02220088
Brief Title
The Efficacy and Safety of Retreatment With TAI for Patients Who Showed TACE-resistant: a Randomized Controlled Trial
Official Title
The Efficacy and Safety of Retreatment With Transcatheter Arterial Infusion (TAI) for Patients Who Showed TACE-resistant: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Terminated
Why Stopped
protocol violation
Study Start Date
December 2014 (Actual)
Primary Completion Date
July 2018 (Actual)
Study Completion Date
July 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
Collaborators
Kaiping Central Hospital, Guangzhou No.12 People's Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
Keywords
Hepatocellular Carcinoma, TACE, TACE failure, TACE refractoriness, TAI, Sorafenib

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
79 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TAI of FOLFOX
Arm Type
Experimental
Arm Description
Retreatment With Transcatheter arterial infusion of oxaliplatin , fluorouracil, and leucovorin
Arm Title
Sorafenib
Arm Type
Active Comparator
Arm Description
treatment with sorafenib
Intervention Type
Procedure
Intervention Name(s)
TAI of FOLFOX
Other Intervention Name(s)
Transcatheter arterial infusion of oxaliplatin , fluorouracil, and leucovorin
Intervention Description
Retreatment with TAI: administration of Oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries
Intervention Type
Drug
Intervention Name(s)
Sorafenib
Intervention Description
Accept sorafenib.
Primary Outcome Measure Information:
Title
Progression free survival
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Number of Adverse Events
Description
All severe adverse events for the entire course of treatment
Time Frame
30 days
Title
overall survival
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ming Shi
Organizational Affiliation
Cancer Center, Sun Yat-set University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cancer Center Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
20724077
Citation
Raoul JL, Sangro B, Forner A, Mazzaferro V, Piscaglia F, Bolondi L, Lencioni R. Evolving strategies for the management of intermediate-stage hepatocellular carcinoma: available evidence and expert opinion on the use of transarterial chemoembolization. Cancer Treat Rev. 2011 May;37(3):212-20. doi: 10.1016/j.ctrv.2010.07.006. Epub 2010 Aug 17.
Results Reference
result
PubMed Identifier
23397536
Citation
Bolondi L, Burroughs A, Dufour JF, Galle PR, Mazzaferro V, Piscaglia F, Raoul JL, Sangro B. Heterogeneity of patients with intermediate (BCLC B) Hepatocellular Carcinoma: proposal for a subclassification to facilitate treatment decisions. Semin Liver Dis. 2012 Nov;32(4):348-59. doi: 10.1055/s-0032-1329906. Epub 2013 Feb 8.
Results Reference
result
PubMed Identifier
23331661
Citation
Park JW, Amarapurkar D, Chao Y, Chen PJ, Geschwind JF, Goh KL, Han KH, Kudo M, Lee HC, Lee RC, Lesmana LA, Lim HY, Paik SW, Poon RT, Tan CK, Tanwandee T, Teng G, Cheng AL. Consensus recommendations and review by an International Expert Panel on Interventions in Hepatocellular Carcinoma (EPOIHCC). Liver Int. 2013 Mar;33(3):327-37. doi: 10.1111/liv.12083. Epub 2013 Jan 18.
Results Reference
result
PubMed Identifier
23316013
Citation
Sieghart W, Hucke F, Pinter M, Graziadei I, Vogel W, Muller C, Heinzl H, Trauner M, Peck-Radosavljevic M. The ART of decision making: retreatment with transarterial chemoembolization in patients with hepatocellular carcinoma. Hepatology. 2013 Jun;57(6):2261-73. doi: 10.1002/hep.26256. Epub 2013 May 3.
Results Reference
result
PubMed Identifier
24251922
Citation
Cheng AL, Amarapurkar D, Chao Y, Chen PJ, Geschwind JF, Goh KL, Han KH, Kudo M, Lee HC, Lee RC, Lesmana LA, Lim HY, Paik SW, Poon RT, Tan CK, Tanwandee T, Teng G, Park JW. Re-evaluating transarterial chemoembolization for the treatment of hepatocellular carcinoma: Consensus recommendations and review by an International Expert Panel. Liver Int. 2014 Feb;34(2):174-83. doi: 10.1111/liv.12314. Epub 2013 Nov 20.
Results Reference
result
PubMed Identifier
24012941
Citation
Hucke F, Sieghart W, Pinter M, Graziadei I, Vogel W, Muller C, Heinzl H, Waneck F, Trauner M, Peck-Radosavljevic M. The ART-strategy: sequential assessment of the ART score predicts outcome of patients with hepatocellular carcinoma re-treated with TACE. J Hepatol. 2014 Jan;60(1):118-26. doi: 10.1016/j.jhep.2013.08.022. Epub 2013 Sep 3.
Results Reference
result
PubMed Identifier
24657396
Citation
Yousuf F, Cross TJ, Palmer D. The ART strategy: sequential assessment of the ART score predicts outcome of patients with hepatocellular carcinoma re-treated with TACE. J Hepatol. 2014 Jul;61(1):175. doi: 10.1016/j.jhep.2014.02.032. Epub 2014 Mar 18. No abstract available.
Results Reference
result

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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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