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

• Status: Terminated
• Trial end date: 2018-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-sen University
• Collaborators: Guangzhou No.12 People's Hospital; Kaiping Central Hospital
• Treatments: Fluorouracil; Leucovorin; Oxaliplatin; Sorafenib

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