Hepatocellular carcinoma Chemotherapy
Conditions
Interventions
Lenvatinib and intra-arterial cisplatin
Molecular targeted agent, hepatic arterial infusion chemotherapy
Sponsors
Ikeda Masafumi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Advanced hepatocellular carcinoma (HCC) confirmed histologically or by the typical findings of a hypervascular tumor on computed tomography or angiography 2)Not applicable for surgical resection, liver transplantation, local ablative therapy or TACE 3)No prior systemic chemotherapy for HCC 4)Age 20-79 years old 5)Presence of intrahepatic tumors affecting the prognosis, irrespective of the presence of extrahepatic tumors 6)Presence of measurable lesions 7)Eastern Cooperative Oncology Group Performance Status 0-1 8)Adequate organ functions 9)Child-Pugh score 5-6 10)Controlled hypertension with 3 or less antihypertensive drugs 11)Hepatic arterial infusion chemotherapy with CDDP technically feasible 12)Interval of 4 weeks or more from the last treatment for HCC 13)Life expectation of 12 weeks or over at least 14)Written informed consent
Exclusion criteria
Exclusion criteria: 1)Prior treatment with sorafenib, lenvatinib or cisplatin (including combined use with TACE) 2)Refractory moderate pleural effusion or ascites 3)Urinary protein excretion of 1 g or over on quantitative examination of a 24-hour urine sample, if qualitative examination for proteinuria reveals a result of 2+ or greater. 4)Hepatic encephalopathy 5)Serious complications 6)Hemorrhagic or thrombotic disease, or history of gastrointestinal bleeding or active hemoptysis. 7)Pregnant or lactating woman; woman of childbearing age unless using effective contraception 8)Oral intake impossible 9)Brain or meningeal metastasis 10)Active infection, excluding hepatitis viral infection 11)HIV-positive 12)Pulmonary fibrosis or interstitial pneumonitis 13)History of blood transfusion or intake of blood-forming medicines, such as G-CSF, within 14 days prior to enrollment 14)Unsatisfactory general condition for participation in the study as judged by the primary physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate (modified RECIST as assessed by independent radiological review committees) | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival, time to progression, overall survival, adverse events, response rate (RECIST1.1 as assessed by independent radiological review committees), response rate (modified RECIST as assessed by each investigators) and serious adverse events. | — |
Contacts
Public ContactMasafumi Ikeda
National Cancer Center Hospital East
Outcome results
None listed