Sorafenib Alone Versus Sorafenib Combined With HAIC for Advanced HCC

• Status: Completed
• Trial end date: 2018-08-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-sen University
• Collaborators: First Affiliated Hospital, Sun Yat-Sen University; Guangzhou No.12 People's Hospital; Kaiping Central Hospital; The First Affiliated Hospital of University of South China
• Treatments: Fluorouracil; Leucovorin; Niacinamide; Oxaliplatin; Sorafenib

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