Different Regimens of Transarterial Chemoembolization for Hepatocellular Carcinoma

Study Overview
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Brief Summary
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The purpose of this study is to evaluate efficacy, safety, and patient reported outcomes (PRO) of different regimens of transarterial chemoembolization (TACE) in patients with hepatocellular carcinoma (HCC).

Detailed Description
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Transarterial chemoembolization (TACE) has been recommended as first line non-curative therapy for non-surgical patients with large/multifocal HCC who do not have vascular invasion or extrahepatic spread. There has not been any standardized protocol in the choice of chemotherapeutic agents, dosage, dilution, rate of injection, and time interval between treatments. Similarly, there is no agreement on the choice of embolizing agents, degree of embolization, and whether the chemotherapeutic agent should be given together, or before the embolizing agent. Comparison(s): In patients with HCC who underwent TACE therapy, stratified by whether they have vascular invasion and tumor size, we compare efficacy, safety, and patient reported outcomes (PRO) of different regimens of TACE. Regimen 1: lipiodol combined chemotherapy with embolization Regimen 2: lipiodol combined chemotherapy without embolization Regimen 3: lipiodol single agent chemotherapy with embolization

Official Title
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The Efficacy, Safety, and Patient Reported Outcomes of Different Regimens of Transarterial Chemoembolization in Patients With Hepatocellular Carcinoma

Conditions
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Hepatocellular Carcinoma

Intervention / Treatment
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* Procedure: Transarterial chemoembolization (TACE)
* Procedure: Transarterial chemoembolization (TACE)
* Procedure: Transarterial chemoembolization (TACE)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients with minimal height of 150cm and minimal weight of 50 KG Histological confirmed HCC with no previous treatment With unresectable tumor With solitary or multiple intrahepatic tumor, the diameter of the largest one must larger than 7cm. No significant baseline liver dysfunction. Cirrhotic status of Child-Pugh class A only No significant renal impairment (creatinine clearance < 30 mL/minute) The following laboratory parameters: Platelet count ≥ 60,000/µL Hemoglobin ≥ 8.5 g/dL Total bilirubin ≤ 1.5 mg/dL ASL and AST ≤ 5 x upper limit of normal Serum albumin ≥ 35 g/L Serum creatinine ≤ 1.5 x upper limit of normal INR ≤ 1.5 or a Pt/PTT 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: Avascular tumor Main portal vein obstruction without cavernous transformation Evidence of hepatic decompensation including esophageal or gastric variceal bleeding or hepatic encephalopathy Obstructive jaundice Severe underlying cardiac or renal diseases Known or suspected allergy to the investigational agent or any agent given in association with this trial Pregnant or breast-feeding patients. History of organ allograft Active clinically serious infections Any condition that is unstable or which could jeopardize the safety of the patient and his/her compliance in the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: combined chemotherapy with embolization<br>chemotherapy with lipiodol mixed with EADM 50mg, lobaplatin 50mg, and MMC 6mg, with particle embolization. | Procedure: Transarterial chemoembolization (TACE)<br>* drugs and dosage: chemotherapy with lipiodol mixed with EADM 50mg, lobaplatin 50mg, and MMC 6mg, plus particle embolization.<br>|
| Experimental: combined chemotherapy without embolization<br>chemotherapy with lipiodol mixed with EADM 50mg, lobaplatin 50mg, and MMC 6mg, without particle embolization. | Procedure: Transarterial chemoembolization (TACE)<br>* drugs and dosage: chemotherapy with lipiodol mixed with EADM 50mg, lobaplatin 50mg, and MMC 6mg.<br>|
| Experimental: single agent chemotherapy with embolization<br>chemotherapy with lipiodol mixed with EADM 50mg, plus particle embolization. | Procedure: Transarterial chemoembolization (TACE)<br>* Drugs and dosage:chemotherapy with lipiodol mixed with EADM 50mg, plus particle embolization.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | 3 years | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Antineoplastic Agents, administration & dosage, Carcinoma, Hepatocellular, Chemoembolization, Therapeutic, Humans, Liver Neoplasms, therapy