Safety Evaluation of the Maintenance treatment of Sorafenib in Hepatocellular carcinoma patients with Tumor thrombus after palliative surgery
- Conditions
- 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).
- Registration Number
- JPRN-UMIN000005910
- Lead Sponsor
- Tokyo University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 12
Not provided
(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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method progression-free survival (PFS), time to progression (TTP), overall survival (OS)