HAIC Plus Sorafenib Versus TACE Plus Sorafenibfor Advanced HCC

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the efficacy and safety of hepatic arterial infusion chemotherapy (HAIC) compared with transarterial chemoembolization (TACE) in patients with BCLC stage hepatocellular carcinoma (HCC).

Detailed Description
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Transarterial chemoembolization (TACE) is the most widely used palliative treatment for hepatocellular carcinoma (HCC) patients. Our previous prospective study also revealed that TACE confers a survival benefit to patients with HCC and portal venous tumor thrombus (PVTT). Recently, the results of our preliminary pilot study suggested that, compared with TACE, hepatic arterial infusion chemotherapy (HAIC) may improve the survivals for patitens with BCLC stage C HCC. Thus, the investigators carried out this prospective randomized control study to find out it.

Official Title
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The Efficacy and Safety of Hepatic Arterial Infusion Chemotherapy Plus Sorafenib Compared With Transarterial Chemoembolization Plus Sorafenib in Patients With BCLC C Stage Hepatocellular Carcinoma

Conditions
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Hepatocellular Carcinoma

Intervention / Treatment
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* Procedure: Hepatic arterial infusion chemotherapy
* Procedure: Transarterial chemoembolization
* Drug: TACE regimen
* Drug: HAIC Regimen
* Drug: Oral Sorafenib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The diagnosis of BCLC C stage HCC was based on the diagnostic criteria for HCC used by the European Association for the Study of the Liver (EASL) Patients must have at least one tumor lesion that can be accurately measured according to EASL criteria. with no previous treatment No Cirrhosis or cirrhotic status of Child-Pugh class A only Not amendable to surgical resection ,local ablative therapy and any other cured treatment. The following laboratory parameters: Platelet count ≥ 75,000/µL Hemoglobin ≥ 8.5 g/dL Total bilirubin ≤ 30mmol/L Serum albumin ≥ 30 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: Main portal vein occlusion Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy 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 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

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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HAIC plus sorafenib<br>Procedure/Surgery: Hepatic arterial infusion chemotherapy Drug: HAIC Regimen Drug: Oral Sorafenib | Procedure: Hepatic arterial infusion chemotherapy<br> <br> Drug: HAIC Regimen<br>* Hepatic intra-arterial infusion via the tumor feeding arteries of Oxaliplatin , fluorouracil, and leucovorin<br>Drug: Oral Sorafenib<br>* Oral Sorafenib, 400mg, Bid<br>|
| Active Comparator: TACE plus sorafenib<br>Procedure/Surgery: Transarterial chemoembolization Drug: TACE regimen Drug: Oral Sorafenib | Procedure: Transarterial chemoembolization<br> <br> Drug: TACE regimen<br>* infusion with lipiodol mixed with chemotherapy drugs (EADM , lobaplatin, and MMC ), and embolization with polyvinyl alcohol particles (PVA)<br>Drug: Oral Sorafenib<br>* Oral Sorafenib, 400mg, Bid<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | Overall survival | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progress free survival | Progress free survival | 18 months | 
| Adverse Events | Number of adverse events. Postoperative adverse events were graded based on CTCAE v3.0 | 30 Days | 
| Number of of Patients developed Adverse Events | Number of of patients who developed adverse event. Postoperative adverse events were graded based on CTCAE v3.0 | 30 Days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatic arterial infusion chemotherapy, Transarterial Chemoembolization