Chemoembolization With or Without Mixing the Chemotherapy With Lipiodol for Unresectable HCC

Study Overview
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Brief Summary
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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.

Official Title
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Chemoembolization of Unresectable Hepatocellular Carcinoma With or Without Mixing the Chemotherapy With Lipiodol: Effectiveness and Safety. A Prospective and Randomized Clinical Trial.

Conditions
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Hepatocellular Carcinoma

Intervention / Treatment
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* Other: Embolization
* Other: Infusion of anticancer agent
* Other: Infusion of mixture of anticancer agent and lipiodol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: infusion group<br>Infusion of anticancer agent followed by Embolization | Other: Embolization<br>* embolization with lipiodol and polyvinyl alcohol particles (PVA)<br>Other: Infusion of anticancer agent<br>* infusion with chemotherapy drugs (EADM 50mg, lobaplatin 50mg, and MMC 6mg ) desolved in water<br>|
| Experimental: lipiodol chemotherapy group<br>Infusion of mixture of anticancer agent and lipiodol followed by Embolization | Other: Embolization<br>* embolization with lipiodol and polyvinyl alcohol particles (PVA)<br>Other: Infusion of mixture of anticancer agent and lipiodol<br>* infusion of mixture of lipiodol and chemotherapy drugs (EADM 50mg, lobaplatin 50mg, and MMC 6mg)dissolved in water-soluble contrast medium and distilled water<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival |  | 3 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to progression |  | 3 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Carcinoma,Hepatocellular, Liver Neoplasms, Therapeutic, Chemoembolization,, TACE, pharmacokinetics, Iodized Oil/administration & dosage, polyvinyl alcohol, Humans