Sorafenib Alone Versus Sorafenib Combined With HAIC for Advanced HCC

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy and safety of sorafenib combined with hepatic arterial infusion chemotherapy (HAIC) compared with sorafenib Alone in patients with hepatocellular carcinoma (HCC) with major portal venous tumor thrombus (PVTT).

Detailed Description
-----------------
The results of our preliminary pilot study suggested that sorafenib combined with hepatic arterial infusion chemotherapy (HAIC) may improve the survivals for advanced stage HCC. Thus, the investigators carried out this prospective randomized control study to find out it.

Official Title
-----------------
Sorafenib Alone Versus Sorafenib Combined With Hepatic Arterial Chemoinfusion for Advanced HCC With Portal Vein Tumor Thrombosis: a Multicentre Randomised Controlled Trial

Conditions
-----------------
Hepatocellular Carcinoma

Intervention / Treatment
-----------------
* Drug: Sorafenib
* Procedure: Hepatic arterial infusion chemotherapy
* Drug: Folfox Protocol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The diagnosis of 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. portal vein tumor thrumbus confirmed in two image techniques Eastern Cooperative Oncology Group performance status of 0 to 2 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: 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. Known central nervous system tumors including metastatic brain disease

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

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sorafenib combined with HAIC<br>Sorafenib combined with Hepatic arterial infusion chemotherapy with Folfox Protocol | Drug: Sorafenib<br>* administration of Sorafenib<br>Procedure: Hepatic arterial infusion chemotherapy<br>* administration of Oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries<br>* Other names: HAIC;Drug: Folfox Protocol<br>* Oxaliplatin , fluorouracil, and leucovorin<br>* Other names: Oxaliplatin , fluorouracil, and leucovorin;|
| Active Comparator: Sorafenib alone<br>Sorafenib alone | Drug: Sorafenib<br>* administration of Sorafenib<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | Overall survival | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to progression | Time to progression | 6 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
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hepatocellular Carcinoma, Hepatic arterial infusion chemotherapy, Sorafenib