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

Sun Yat-sen University

Status and phase

Terminated

Phase 3

Phase 2

Conditions

Hepatocellular Carcinoma

Treatments

Procedure: TAI of FOLFOX

Drug: Sorafenib

Study type

Interventional

Funder types

Other

Identifiers

NCT02220088

HCC201408

Details and patient eligibility

About

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.

Full 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.

Enrollment

79 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No 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