Hepatocellular Carcinoma
Conditions
Keywords
Carcinoma,Hepatocellular, Liver Neoplasms, Therapeutic, Chemoembolization,, TACE, pharmacokinetics, Iodized Oil/administration & dosage, polyvinyl alcohol, Humans
Brief summary
TACE is considered the standard treatment for unresectable HCC on the basis of the fact that there are no alternative to curative procedures.But the optimal combined regimen is still unclear. One of the controversy is do the protocol should contain lipiodo and how to executer. The investigators hypothesize that TACE without mixing the chemotherapy with lipiodol is not unacceptably worse than TACE mixing the chemotherapy with lipiodol.
Interventions
OTHEREmbolization
embolization with lipiodol and polyvinyl alcohol particles (PVA)
OTHERInfusion of anticancer agent
infusion with chemotherapy drugs (EADM 50mg, lobaplatin 50mg, and MMC 6mg ) desolved in water
OTHERInfusion of mixture of anticancer agent and lipiodol
infusion of mixture of lipiodol and chemotherapy drugs (EADM 50mg, lobaplatin 50mg, and MMC 6mg)dissolved in water-soluble contrast medium and distilled water
Sponsors
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Eligibility criteria: Inclusion Criteria: * Adults patients with a diagnosis of HCC which is not amenable to surgical resection ,local ablative therapy and any other cured treatment. * Patients must have at least one tumor lesion that can be accurately measured according to EASL criteria. And the lesion has not been previously treated with TACE, surgery, radiation therapy, radiofrequency ablation, percutaneous ethanol or acetic acid injection, or cryoablation. * No serious concurrent medical illness * Unresectable BCLC stage A-B disease * No cirrhosis or cirrhotic status of Child-Pugh class A * No significant renal impairment (creatinine clearance \< 30 mL/minute) or patients on dialysis * No current infections requiring antibiotic therapy * Not on anticoagulation or suffering from a known bleeding disorder * No unstable coronary artery disease or recent MI * 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
* Known history of HIV * History of organ allograft * Pregnant or breast-feeding patients * Known or suspected allergy to the investigational agents or any agent given in association with this trial. * Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy * Evidence of bleeding diathesis. * Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry. * Any other hemorrhage/bleeding event \> CTCAE Grade 3 within 4 weeks of first dose of study drug * Serious non-healing wound, ulcer, or bone fracture * Known central nervous system tumors including metastatic brain disease * severe Arterioportal Shunts or Arteriavein Shunts
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall survival | 3 year |
Secondary
| Measure | Time frame |
|---|---|
| Time to progression | 3 year |
Countries
China
Outcome results
None listed