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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

79 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2018-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Efficacy and Safety of HAIC With FOLFOX vs Sorafenib for Patients Who Showed TACE-resistant: a Retrospective Study

NCT05121571

Hepatocellular Carcinoma

COMPLETED NA

TACE Plus Sorafenib Versus TACE Alone for Recurrent Intermediate Hepatocellular Carcinoma

NCT04103398

Hepatocellular Carcinoma Sorafenib Transarterial Chemoembolization

COMPLETED PHASE3

HAIC Versus TACE for Large and Unresectable Hepatocellular Carcinoma Staged BCLC A/B

NCT03048123

Hepatocellular Carcinoma

COMPLETED PHASE2

Study in Asia of the Combination of TACE With Sorafenib in HCC Patients

NCT00990860

Hepatocellular Carcinoma

UNKNOWN PHASE2

HAIC Versus TACE for Large Hepatocellular Carcinoma Staged BCLC A/B.

NCT02973685

HepatoCellular Carcinoma

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hepatocellular Carcinoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

TAI of FOLFOX

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

Group Type EXPERIMENTAL

TAI of FOLFOX

Intervention Type PROCEDURE

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

Sorafenib

treatment with sorafenib

Group Type ACTIVE_COMPARATOR

Sorafenib

Intervention Type DRUG

Accept sorafenib.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

TAI of FOLFOX

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

Intervention Type PROCEDURE

Sorafenib

Accept sorafenib.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Transcatheter arterial infusion of oxaliplatin , fluorouracil, and leucovorin

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No