Borderline resectable Hepatocellular carcinoma Induction therapy
Conditions
Interventions
Lenvatinib and intra-arterial cisplatin, Surgical resection
Sponsors
Ikeda Masafumi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically or clinically confirmed hepatocellular carcinoma (except for mixed type). 2) Presence of vascular invasion. (Vascular invasion refers to portal vein tumor thrombosis, hepatic vein tumor thrombus, and bile duct tumor thrombus.) 3) Technically resectable HCC 4) Age >=18 years and = 1,500 /mm3 Hb>= 8.5 g/dL PLT>= 75,000 /mm3 Liver T-Bil= 2.8 g/dL AST= 50 ml/min Coagulation International normalized ratio (PT-INR)<= 2.3 9) Child-Pugh score 5-6 points. 10) Controllable blood pressure by the use of antihypertensive agents with no more than three drugs 11) Procedural cisplatin hepatic arterial infusion chemotherapy is expected to be feasible. 12) Written informed consent has been obtained from the patient.
Exclusion criteria
Exclusion criteria: 1) Extrahepatic metastases. 2) Previously treated with lenvatinib or cisplatin for hepatocellular carcinoma. 3) Moderate or greater ascites or pleural effusion unresponsive to treatment. 4) When the proteinuria is 2+ or more in the urinary protein qualitative test, 24-hour urine collection is carried out, and the urinary protein is recognized over 1 g/24 hour. (However, substitution by urinary protein/creatinine ratio is allowed.) 5) Hepatic encephalopathy 6) The following serious complications Uncontrolled hypertension despite treatment (diastolic pressure exceeds 100 mmHg) Difficult-to-control heart failure despite treatment; angina; arrhythmias Poorly controlled diabetes despite treatment Myocardial infarction within 6 months of onset Active double cancers (synchronous double cancers, metachronous double cancers within 3 years of disease-free interval) Serious psychiatric disorder History of hypersensitivity to iodine-containing drugs or contrast media. Serious drug allergy 7) Bleeding or thrombotic disease or a history of gastrointestinal bleeding or active hemoptysis within 28 days before enrollment. 8) Pregnant, breastfeeding, or possibly or intentionally pregnant, or wish to raise a child. 9) Difficult oral intake. 10) HIV positive. 11) Complicated by active infection requiring treatment (except for hepatitis virus). 12) Complicated by pulmonary fibrosis or interstitial pneumonia. 13) Treatment for blood conditions (including blood transfusions, blood products or hematopoietic factors products such as Granulocyte-Colony Stimulating Factor: G-CSF) in the 14 days prior to enrollment. 14) The investigator judges it inappropriate to conduct the study safely.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Resection rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate, progression-free survival, overall survival, R0 resection rate, tumor-necrosis response (EVANS classification); incidence adverse event; and serious complications of surgical resection; treatment outcomes by preoperative circulating tumor DNA (ctDNA), perioperative ctDNA monitoring | — |
Contacts
Public ContactKazuo Watanabe
Saitama Prefectural Hospital Organization
Outcome results
None listed