advanced hepatocellular carcinoma
Conditions
Interventions
Arm A: Soragenib 800mg/day everyday Patients will continue to receive study treatment of Arm A and B until another criterion for discontinuation or completion is met.
Arm B: New FP treatment
Sponsors
National Hospital Organization Kyushu Cancer Center Department of Hepato-biliary-pancreatology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically or Clinically diagnosed as hepatocellular carcinoma (HCC) by imaging assessment and tumor maker. 2) Unsuitable for local therapy. (Including surgery, radiofrequency ablation, hepatic arterial embolization and percutaneous ethanol injection etc.) 3) Presence of intrahepatic major lesion. 4) Measurable lesion on clinical image studies by CT with contrast or MRI with contrast. 5) No lingering effects of previous therapy. (treatment-free interval: Hepatectomy and local therapy, 2 weeks or more. Hepatic arterial embolization, continuous hepatic arterial infusion and radiotherapy, 4 weeks or more.) 6) Child-Pugh classification A. 7) Performance status of 0 to 1. 8) Preservation of major organ function. (Examination should be performed within 2 weeks prior to the registration.) 9) Age more than 20 years. 10) Willing and able to comply with study procedures. 11) Provision of written informed consent.
Exclusion criteria
Exclusion criteria: Patients will be excluded from the study if they meet any of the following criteria. 1) Having a history of molecular targeted drug or sorafenib. 2) Having a history of any previous systemic therapy. 3) Having clinically meaningful ascites that require a puncture method. 4) History of liver transplant. 5) Having esophageal varices that represent a high bleeding risk. 6) With cardiac infarction, unstable angina, cardiac failure and cerebral vascular disorder within 12 month before registration. 7) History of or current hepatic encephalopathy. 8) With cerebral tumors. 9) Having a dialysis. 10) With a gastrointestinal hemorrhage within 1 month before registration. 11) With a duplicate active cancer. 12) Taking drugs with CYP3A4 (Including rifampicin etc.) 13) Severe arrhythmia of CTCAE v4.0 >= grade 2 and uncontrolled high blood pressure defined in blood pressure guidelines 2014. 14) Having hypersensitivity reaction to any of the treatment components. 15) Taking approved crude drugs for cancer treatment. (Including shosaikoto.) 16) Known human immunodeficiency virus infection (HIV) or acquire immunodeficiency syndrome (AIDS) -related illness. 17) Pregnancy, nursing women. 18) Not eligible because of safety issues judged by investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival, Responsive rate,AE, Down staging rate for Curative treatment | — |
Countries
Japan
Contacts
Public ContactMasaki Kato
Kyushu University Department of Medicine and Bioregulatory Science, Graduate School of Medical Sciences
Outcome results
None listed