Randomized phase II study of sorafenib and hepatic arterial infusion chemotherapy with cisplatin versus sorafenib for advanced hepatocellular carcinoma.

Conditions

advanced hepatocellular carcinoma

Fushimi C, Tada Y, Takahashi H, Nagao T, Ojiri H, Masubuchi T, Matsuki T, Miura K, Kawakita D, Hirai H, Hoshino E, Kamata S, Saotome T.

2018-04-01142 citations

10.1093/annonc/mdx771

Sorafenib plus hepatic arterial infusion chemotherapy with cisplatin versus sorafenib for advanced hepatocellular carcinoma: randomized phase II trial.

Ikeda M, Shimizu S, Sato T, Morimoto M, Kojima Y, Inaba Y, Hagihara A, Kudo M, Nakamori S, Kaneko S, Sugimoto R, Tahara T, Ohmura T, Yasui K, Sato K, Ishii H, Furuse J, Okusaka T.

2016-08-29128 citations

10.1093/annonc/mdw323

Sorafenib plus intra-arterial cisplatin versus sorafenib alone in patients with advanced hepatocellular carcinoma: A randomized phase II trial.

Masafumi Ikeda, Satoshi Shimizu, Tosiya Sato, Manabu Morimoto, Yoshitaka Inaba et al. (18 authors)

Journal of Clinical Oncology2015-05-203 citations

10.1200/jco.2015.33.15_suppl.4076

Interventions

The combination chemotherapy of sorafenib with transcatheter arterial infusion of cisplatin. Sorafenib 400mg bid. 6 courses of transcatheter arterial infusion of cisplatin every 4-6 weeks Sorafeni

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Advanced hepatocellular carcinoma with histological evidence or typical computed tomographic scans, angiographic findings and elevated serum AFP/PIVKA-II level 2) No indication for surgical resection, liver transplantation, local ablation therapy or transarterial chemoembolization 3) No prior chemotherapy 4) Aged 20-79 years old 5) HCCs in the Liver, with or with extrahepatic tumors which not affect patient's prognosis 6) ECOG Performance Status 0-1 7) Adequate organ function a) Neutrophil>=1500 /mm3 b) Hb>= 8.5 g/dL c) PLT>= 60000 /mm3 d) T-Bil<= 2.0 mg/dL e) Albumin>= 2.8 g/dL f) AST<= within 5 times of normal limit g) ALT<= within 5 times of normal limit h) Cre<= 1.2 mg/dl i) Creatinin cliarance >= 60ml/min 8) Child-Pugh score 5-7 points 9) Adequate indication for hepatic arterial infusion chemotherapy 10) Interval of at least 4 weeks between last treatment and start of present treatment 11) Life expectancy of at least 8 weeks 12) Written informed consent

Exclusion criteria

Exclusion criteria: 1) Refractory pleural effusion or ascites 2) Encephalopacy 3) Concurrent disease a) Serious hypertension b) Severe heart disease c) Acute myocardial infarction within 6 months orior to inclusion d) Active double cancer e) Severe mental disorder f) Allergic reaction to iodine contrast material g) Severe drug allergy 4) Pregnant and lactating females; females of childbearing age unless using effective contraception 5) Inadequate for administration orally 6) Concomitant treatment with drugs inductors of CYP3A4 7) Inadequate physical condition,as diagnosed by primary physician

Design outcomes

Primary

Measure	Time frame
Overall survival	—

Secondary

Measure	Time frame
Time to progression Advrese events Sever advrese events Response rate	—

Countries

Japan

Contacts

Public ContactSatoshi Shimizu

National Cancer Center Hospital East Department of Hepatobiliary and Pancreatic Oncology

sashimiz@east.ncc.go.jp0471-33-1111

Outcome results

None listed