Hepatocellular carcinoma
Conditions
Interventions
To evaluate the safety and efficacy of sorafenib therapy after TACE in patients with unresectable hepatocellular carcinoma who have PD within 6 months after prior TACE as assessed according to the mod
Sponsors
Kagoshima University Medical and Dental Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Male or female aged 20 years or older at the time of enrollment 2) Patients who have provided written consent to participate in this study 3) Patients with histologically or clinically (based on diagnostic imaging and tumor markers) diagnosed hepatocellular carcinoma 4) Patients not indicated for hepatectomy, liver transplant, or percutaneous local treatment (i.e., radiofrequency ablation, ethanol injection) 5) Patients assessed as having progressive disease (PD) according to the modified RECIST criteria within 6 months following prior TACE 6) Patients who had a measurable lesion as specified by the modified RECIST criteria on computed tomographic arteriography (CTA) or computed tomographic arterial portography (CTAP) obtained immediately before the index TACE 7) Patients who completed TACE appropriately 8) Patients without any residual adverse effects of TACE 9) Patients in Child-Pugh Class A 10) Patients with an ECOG Performance Status (PS) score of 0 or 1 11) Patients with adequate functions of major organs
Exclusion criteria
Exclusion criteria: 1) Patients previously treated with sorafenib or other molecular-targeting therapy 2) Patients previously treated with systemic chemotherapy 3) Patients with clinically significant ascites (refractory ascites requiring paracentesis) 4) Patients with extra-hepatic metastases at the time of the index TACE (Chest CT must be performed for confirmation.) 5) Patients with vascular invasion of Vp3/4 and Vv2/3 at the time of the index TACE 6) Patients with diffuse lesions at the time of the index TACE 7) Patients with a history of liver transplant 8) Patients with potential bleeding from esophageal varices 9) Patients who experienced any of the following within 12 months prior to enrollment in this study 10) Patients with a current or past history of hepatic encephalopathy 11) Patients with a brain tumor 12) Patients undergoing dialysis 13) Patients who had gastrointestinal hemorrhage within the past month 14) Patients with multiple active cancers 15) Patients receiving CYP3A4 inducers (e.g., rifampicin) 16) Patients with serious comorbidities (NCI-CTCAE Ver. 4 Grade 2 or greater arrhythmia, uncontrolled hypertension) 17) Patients with a history of serious hypersensitivity to sorafenib 18) Patients taking oral herbal medicine approved for the treatment of cancer (e.g., Shosaikoto) 19) Patients with disorders related to human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS) 20) Pregnant or breastfeeding patients 21) Other patients judged by the principal investigator or a co-investigator to be inappropriate to participate in this stud
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to progression | — |
Countries
Japan
Contacts
Public ContactTsutomu Tamai
Kagoshima University Medical and Dental Hospital Department of Gastroenterology
Outcome results
None listed