Sorafenib Alone Versus Sorafenib Combined With HAIC for Advanced HCC
- Conditions
- Hepatocellular Carcinoma
- Interventions
- Registration Number
- NCT02774187
- Lead Sponsor
- Sun Yat-sen University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 247
-
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
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Eastern Cooperative Oncology Group performance status of 0 to 2
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with no previous treatment
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No Cirrhosis or cirrhotic status of Child-Pugh class A only
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Not amendable to surgical resection ,local ablative therapy and any other cured treatment.
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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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sorafenib combined with HAIC Folfox Protocol Sorafenib combined with Hepatic arterial infusion chemotherapy with Folfox Protocol Sorafenib combined with HAIC Hepatic arterial infusion chemotherapy Sorafenib combined with Hepatic arterial infusion chemotherapy with Folfox Protocol Sorafenib alone Sorafenib Sorafenib alone Sorafenib combined with HAIC Sorafenib Sorafenib combined with Hepatic arterial infusion chemotherapy with Folfox Protocol
- Primary Outcome Measures
Name Time Method Overall survival 6 months Overall survival
- Secondary Outcome Measures
Name Time Method Time to progression 6 months Time to progression
Number of of Patients developed Adverse Events 30 days Number of of patients who developed adverse event. Postoperative adverse events were graded based on CTCAE v3.0
Adverse Events 30 days Number of adverse events. Postoperative adverse events were graded based on CTCAE v3.0
Trial Locations
- Locations (5)
The Kaiping Center's Hospital
🇨🇳Kaiping, Guangdong, China
Cancer Center Sun Yat-sen University
🇨🇳Guangzhou, Guangdong, China
Guangzhou Twelfth People 's Hospita
🇨🇳Guangzhou, Guangdong, China
First Affiliated Hospital of University Of South China
🇨🇳Hengyang, Hunan, China
The First Affiliated Hospital of Sun Yat-sen University
🇨🇳Guangzhou, Guangdong, China