To evaluate the safety of sorafenib as a maintenance therapy after the surgical resection of hepatocellular carcinoma (HCC) with macroscopic vascular invasion (Vp, Vv, B).
Conditions
Interventions
When normal performance status and liver function are restored after the surgical resection of HCC with vascular invasion (#
4 weeks to <
8 weeks after hepatectomy or
2 weeks to <
4 weeks after postoperative TAE), study treatment will be started as follows: 1)Subjects classified as Child-Pugh class A: Start sorafenib at an initial dose of 800 mg/day. 2)Subjects classified a
subsequent treatment will be determined in accordance with the opinions of the subject'
s doctor and his/her wishes.
Sponsors
Tokyo University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)Patients aged > 20 years to < 85 years; (2)Patients with recurrent disease who received prior treatment at least 2 years before surgery; (3)Patients in whom a preoperative diagnosis of HCC was made histologically or clinically (diagnostic imaging and tumor marker diagnosis); (4)Patients with preoperative evidence of macroscopic vascular invasion (Vp, Vv, B); (5)Patients with preoperative evidence of measurable disease on a contrast-enhanced CT or MRI scan; (6)Patients who underwent successful surgical resection of HCC with macroscopic vascular invasion, or those with gross residual disease after surgery who underwent postoperative TAE; (7)Patients without any carry-over effects of prior treatment or adverse reactions (prior to the study, a treatment-free period of > 4 weeks to < 8 weeks is required after surgery; for those with gross residual disease after surgery, a treatment-free period of > 2 weeks to < 4 weeks is required after postoperative TAE); (8)Patients with a Child-Pugh score of >7 (9)Patients with an ECOG performance status (PS) of 0 or 1; (10)Patients with intact function of vital organs (to be confirmed within 2 weeks before the start of study treatment); (a)Neutrophil count:>1,500/uL (b)Serum albumin: >3.0 g/dL (c)Platelets:>50,000/uL (d)Hemoglobin:>7.5 g/dL (e)Total bilirubin: <1.5 mg/dL (f)Serum aspartate aminotransferase (AST), serum alanine aminotransferase (ALT):<200 IU/L (g)Serum creatinine: <1.5 x ULN at the study site (11)Patients who can comply with the study procedures including hospital visits, study treatment, and laboratory tests; and (12)Patients who gave written informed consent prior to the study.
Exclusion criteria
Exclusion criteria: (1)Patients treated with sorafenib or other molecular target drugs within 3 months before surgery; (2)Patients with a history of allergic reaction to sorafenib; (3)Pregnant and breastfeeding women or those who may possibly be pregnant; (4)Patients with serious complications (whether preoperative or postoperative); (5)Patients with distant metastasis; (6)Patients with other active malignancies (e.g., brain tumor); (7)Patients with underlying diseases other than viral hepatitis (e.g., autoimmune hepatitis, alcoholic hepatitis); (8)Patients with moderate or severe renal dysfunction (eGFR < 30 mL/min) including those on dialysis; (9)Patients with asthma; (10)Patients with uncontrolled hypertension or with thromboembolism, ischemic heart disease, unstable angina pectoris, heart failure, or cerebrovascular disorder that may affect the operability of the disease; (11)Patients with clinically relevant ascites (refractory ascites requiring therapeutic paracentesis); (12)Patients with previous liver transplantation; (13) Patients with esophageal varices that may cause bleeding (those who had gastrointestinal bleeding in the past month); (14)Patients with a current or past history of hepatic encephalopathy; (15)Patients under treatment with drugs affecting the activity of CYP3A4 or UGT1A9 (e.g., rifampicin) or drugs that may affect the serum concentration of sorafenib; (16)Patients orally taking crude drugs approved for the treatment of cancer (e.g., Sho-saiko-to); (17)Patients with diseases related to human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS); or (18)Patients considered to be ineligible for participation in the study by the investigator or subinvestigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| incidence of adverse events, hepatic reserve (ICGR-15), hepatic function (ALT, T-cho, T-Bil), and Child-Pugh class and score after the start of treatment with sorafenib | — |
Secondary
| Measure | Time frame |
|---|---|
| progression-free survival (PFS), time to progression (TTP), overall survival (OS) | — |
Countries
Japan
Contacts
Public ContactYosuke Inoue
Tokyo University Hospital Hepato-Biliary-Pancreatic Surgery Division
Outcome results
None listed