Status:
TERMINATED
The Efficacy and Safety of Retreatment With TAI for Patients Who Showed TACE-resistant: a Randomized Controlled Trial
Lead Sponsor:
Sun Yat-sen University
Collaborating Sponsors:
Kaiping Central Hospital
Guangzhou No.12 People's Hospital
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
PHASE3
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...
Detailed Description
Transarterial chemoembolization (TACE) is considered the gold standard for treating intermediate-stage hepatocellular carcinoma (HCC). However, intermediate-stage HCC includes a heterogeneous populati...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2018
Estimated Enrollment :
79 Patients enrolled
Trial Details
Trial ID
NCT02220088
Start Date
December 1 2014
End Date
July 1 2018
Last Update
January 11 2019
Active Locations (1)
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1
Cancer Center Sun Yat-sen University
Guangzhou, Guangdong, China, 510060