Neoplasms

All Conditions

Digestive System Diseases

Carcinoma

Carcinoma, Hepatocellular

Liver Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Antineoplastic Agents

All Drugs and Chemicals

Fluorouracil

Cisplatin

Sorafenib

Protein Kinase Inhibitors

Enzyme Inhibitors

Sorafenib will be administered orally at a dose of 400 mg bid for 28 days in a cycle. Cisplatin at the dose of 20 mg/m2 will be administered at day 1 and day8, and fluorouracil at the dose of 330 mg/m2 will be administered continuously at day 1-day 5, and day8-day12 via the implanted catheter system. A cycle is defined as 28 days.

Sorafenib with Low-dose FP

Sorafenib will be administered orally at a dose of 400 mg bid for 28 days in each cycle.A cycle is defined as 28 days.

Masatoshi Kudo, Professor

Kazuomi Ueshima, Dr

Masafumi Ikeda, Dr.

Masatoshi Tanaka, Professor

Takashi Kumada, Dr

Takashi Kumada, Dr.

Junji Kato, Dr.

Takumi Ohmura, Dr.

Chikara Ogawa, Dr.

Katsuya Shiraki, Dr.

Hiromi Ishibashi, Dr.

Keisuke Hino, Dr.

Yasuharu Imai, Dr.

Kazuomi Ueshima, Dr.

Kazuto Nishio, Professor

Hiroaki Nagano, Professor

Junji Furuse, Professor

Namiki Izumi, Dr.

Shigehiro Kokubu, Dr.

Isao Sakaida, Prof

Isao Sakaida, Professor

Fumihiko Kanai, Dr.

Eiichi Tomita, Dr.

Yoshiyuki Kobayashi, Dr.

Hiroshi Aikata, Dr.

Yutaka Sasaki, Professor

Etsuro Hatano, Professor

Hidemori Sakamoto, Dr.

Toru Ishikawa, Dr.

Kouhei Akazawa

Kazuhide Yamamoto, Professor

Ikuo Osaki, Dr.

Tetsuji Takayama, Dr.

Shuntaro Obi, Dr.

Takushi Okusaka, Dr.

The purpose of this study is to evaluate the efficacy of sorafenib in combination with low dose cisplatin /fluorouracil hepatic arterial infusion chemotherapy in patients with advanced hepatocellular carcinoma.

Sorafenib with Low-dose FP Group

Sorafenib will be administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily (bid) for 28 days. Cisplatin at the dose of 20mg/m2 will be administered at day 1 and day8, and fluorouracil at the dose of 330mg/m2 will be administered continuously at day1-day5, and day8-day12 via the implanted catheter system.

Sorafenib Group

Sorafenib will be administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily (bid) for 28 days.

The treatment regimen will be continued until radiographic or symptomatic progression, the development of unacceptable toxicity.

Comparing Efficacy of Sorafenib Versus Sorafenib in Combination With Low-dose FP in Patients With Advanced HCC

Randomized Controlled Trial Comparing Efficacy of Sorafenib Versus Sorafenib In Combination With Low Dose Cisplatin /Fluorouracil Hepatic Arterial InfUSion Chemotherapy in Patients With Advanced Hepatocellular Carcinoma

Ministry of Health, Labour and Welfare, Japan

Kinki University Faculty of Medicine, Department of Gastroenterology and Hepatology

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Comparing Efficacy of Sorafenib Versus Sorafenib in Combination With Low-dose FP in Patients With Advanced HCC	NCT01214343	Advanced Hepato... Carcinoma Carcinoma, Hepa... Liver Neoplasms Neoplasms	Sorafenib with ... Sorafenib	20 Years -	Ministry of Health, Labour and Welfare, Japan
Comparing Efficacy of Sorafenib Versus Sorafenib in Combination With Low-dose FP in Patients With Advanced HCC	NCT01214343	Advanced Hepato... Carcinoma Carcinoma, Hepa... Liver Neoplasms Neoplasms	Sorafenib with ... Sorafenib	20 Years -	Ministry of Health, Labour and Welfare, Japan

Spots Global Cancer Trial Database for hepatic intraarterial infusion chemotherapy