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

NCT02220088 | Terminated Phase 2 DMC

• 1 other identifier: HCC201408
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Carcinoma

Keywords

Hepatocellular Carcinoma; TACE; TACE failure; TACE refractoriness; TAI; Sorafenib

Outcome Measures

Primary Outcomes (1)

• Progression free survival

  1 year

Secondary Outcomes (2)

• Number of Adverse Events

  30 days

• overall survival

  1 year

Study Arms (2)

TAI of FOLFOX

EXPERIMENTAL

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

Procedure: TAI of FOLFOX

Sorafenib

ACTIVE COMPARATOR

treatment with sorafenib

Drug: Sorafenib

Interventions

TAI of FOLFOX PROCEDURE

Retreatment with TAI: administration of Oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries

Also known as: Transcatheter arterial infusion of oxaliplatin , fluorouracil, and leucovorin

TAI of FOLFOX

Sorafenib DRUG

Accept sorafenib.

Sorafenib

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sun Yat-sen University: lead
• Kaiping Central Hospital: collaborator
• Guangzhou No.12 People's Hospital: collaborator

Study Sites (1)

Cancer Center Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

Location

Related Publications (7)

• 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.

  PMID: 20724077 RESULT

• 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.

  PMID: 23397536 RESULT

• 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.

  PMID: 23331661 RESULT

• 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.

  PMID: 23316013 RESULT

• 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.

  PMID: 24251922 RESULT

• 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.

  PMID: 24012941 RESULT

• 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.

  PMID: 24657396 RESULT

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Fluorouracil; Leucovorin; Sorafenib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Pyridines

Study Officials

• Ming Shi

  Cancer Center, Sun Yat-set University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: August 14, 2014
• First Posted: August 19, 2014
• Study Start: December 1, 2014
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: January 11, 2019

Record last verified: 2018-12

Locations

CN (1)