Comparing Efficacy of Sorafenib Versus Sorafenib in Combination With Low-dose FP in Patients With Advanced HCC
NCT ID: NCT01214343
Last Updated: 2011-06-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
190 participants
INTERVENTIONAL
2010-10-31
2013-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Sorafenib with Low-dose FP
Sorafenib with Low-dose FP
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
Sorafenib
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.
Interventions
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Sorafenib with Low-dose FP
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
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Life expectancy of at least 12 weeks at the pre-treatment evaluation.
3. Advanced hepatocellular carcinoma with histological evidence on a biopsy specimen, or typical findings by dynamic CT or CT during hepatic arteriography/arterioportography.
4. Not suitable for resection or local ablation therapy or transcatheter arterial chemoembolization.
5. ECOG Performance status of 0 or 1.
6. Cirrhotic status of Child-Pugh score ≤ 7.
7. Adequate bone marrow, liver and renal function, as assessed by the following laboratory requirements:
* Hemoglobin ≥8.5 g/dl
* Granulocytes≥1500/μL
* Platelet count ≥50,000 /μL
* PT-INR ≤ 2.3
* Total serum bilirubin ≤ 2 mg/dl
* AST(SGOT) and ALT(SGPT) ≤ 6 × upper limit of normal
* Serum creatinine ≤ 1.5 × upper limit of normal
* Amylase ≤ 2 × upper limit of normal
8. Written Informed Consent must be obtained.
Exclusion Criteria
2. Renal failure
3. Any heart disease as follows
* Congestive heart failure defined as NYHA class III or IV
* Active coronary artery disease or ischemic heart disease such as cardiac infarction within 6 months prior to screening
* Serious cardiac arrhythmia
* Serious hypertension
4. Active clinically serious infections except for HBV and HCV
5. Active chicken pox.
6. Auditory disorder.
7. Known history of HIV infection.
8. Known metastatic or meningeal tumors.
9. Extrahepatic tumor spread which affects patient's prognosis
10. History of seizure disorder.
11. Clinically significant gastrointestinal bleeding within 4 weeks prior to study entry.
12. Embolization or infarction such as transient ischemic disease, deep vein thrombosis, pulmonary embolization.
13. Any history of treatment as follows:
* Treatment with the agent which induces CYP3A4
* Surgical procedure within 4 weeks prior to start of study drug
* History of organ allograft
14. Patients unable to swallow oral medications.
15. Gastrointestinal disease that may affect to the absorption of drug or pharmacokinetics.
16. Medication that may affect to the absorption of drug or pharmacokinetics.
17. Any disease or disorder that may affect the evaluation of study drug.
18. Entry to the other clinical trial within 4 weeks prior to entry to this study.
19. Pregnant or breast-feeding patients.
20. Known allergy to the investigational agent or any agent given in association with this trial.
21. Substance abuse, medical, psychological or social conditions that, in the judgment of the investigator, is likely to interfere with the patient's participation in the study or evaluation of the stuy results.
22. Any condition that is unstable or could jeopardize the safety of the patient and its compliance in the study, in the investigator's judgment.
20 Years
ALL
No
Sponsors
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Ministry of Health, Labour and Welfare, Japan
OTHER_GOV
Responsible Party
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Kinki University Faculty of Medicine, Department of Gastroenterology and Hepatology
Principal Investigators
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Masatoshi Kudo, Professor
Role: STUDY_CHAIR
Kinki University Faculty of Medicine, Department of Gastroenterology and Hepatology
Locations
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Chiba University Hospital
Chiba, Chiba, Japan
National Cancer Center Hospital East
Kashiwa, Chiba, Japan
Kurume University Medical Center
Kurume, Fukuoka, Japan
Gifu Municipal Hospital
Gifu, Gifu, Japan
Ogaki Municipal Hospital
Ōgaki, Gifu, Japan
Hiroshima City Hospital
Hiroshima, Hiroshima, Japan
Hiroshima University Hospital
Hiroshima, Hiroshima, Japan
Sapporo Medical University
Sapporo, Hokkaido, Japan
Sapporo-Kosei General Hospital
Sapporo, Hokkaido, Japan
Japanese Red Cross Takamatsu Hospital
Takamatsu, Kagawa-ken, Japan
Kumamoto University Hospital
Kumamoto, Kumamoto, Japan
Kyoto University Hospital
Kyoto, Kyoto, Japan
Mie University Hospital
Tsu, Mie-ken, Japan
Center for Gastroenterological and Hepatological Diseases
Miyazaki, Miyazaki, Japan
National Hospital Organization Nagasaki Medical Center
Ohmura, Nagasaki, Japan
Saiseikai Niigata Dai-ni Hospital
Niigata, Niigata, Japan
Niigata University Medical and Dental Hospital
Niigata, Niigata, Japan
Kawasaki Medical School Hospital
Kurashiki, Okayama-ken, Japan
Okayama University Hospital
Okayama, Okayama-ken, Japan
Ikeda Municipal Hospital
Ikeda, Osaka, Japan
Osaka Red Cross Hospital
Osaka, Osaka, Japan
Kinki University Hospital
Ōsaka-sayama, Osaka, Japan
Osaka University Hospital
Suita, Osaka, Japan
The University of Tokushima Faculty of Medicine
Tokushima, Tokushima, Japan
Kyorin University Hospital
Mitaka, Tokyo, Japan
Musashino Red Cross Hospital
Musashino, Tokyo, Japan
Juntendo University Nerima Hospital
Nerima City, Tokyo, Japan
Kyoundo Hospital
Tokyo, Tokyo, Japan
National Cancer Center Hospital
Tokyo, Tokyo, Japan
Yamaguchi University Hospital
Ube, Yamaguchi, Japan
Countries
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Central Contacts
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Facility Contacts
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Fumihiko Kanai, Dr.
Role: primary
Masafumi Ikeda, Dr.
Role: primary
Masatoshi Tanaka, Professor
Role: primary
Eiichi Tomita, Dr.
Role: primary
Takashi Kumada, Dr
Role: primary
Yoshiyuki Kobayashi, Dr.
Role: primary
Hiroshi Aikata, Dr.
Role: primary
Junji Kato, Dr.
Role: primary
Takumi Ohmura, Dr.
Role: primary
Chikara Ogawa, Dr.
Role: primary
Yutaka Sasaki, Professor
Role: primary
Etsuro Hatano, Professor
Role: primary
Katsuya Shiraki, Dr.
Role: primary
Hidemori Sakamoto, Dr.
Role: primary
Hiromi Ishibashi, Dr.
Role: primary
Toru Ishikawa, Dr.
Role: primary
Kouhei Akazawa
Role: primary
Keisuke Hino, Dr.
Role: primary
Kazuhide Yamamoto, Professor
Role: primary
Yasuharu Imai, Dr.
Role: primary
Ikuo Osaki, Dr.
Role: primary
Hiroaki Nagano, Professor
Role: primary
Tetsuji Takayama, Dr.
Role: primary
Junji Furuse, Professor
Role: primary
Namiki Izumi, Dr.
Role: primary
Shigehiro Kokubu, Dr.
Role: primary
Shuntaro Obi, Dr.
Role: primary
Takushi Okusaka, Dr.
Role: primary
Isao Sakaida, Prof
Role: primary
References
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Kudo M, Ueshima K, Yokosuka O, Ogasawara S, Obi S, Izumi N, Aikata H, Nagano H, Hatano E, Sasaki Y, Hino K, Kumada T, Yamamoto K, Imai Y, Iwadou S, Ogawa C, Okusaka T, Kanai F, Akazawa K, Yoshimura KI, Johnson P, Arai Y; SILIUS study group. Sorafenib plus low-dose cisplatin and fluorouracil hepatic arterial infusion chemotherapy versus sorafenib alone in patients with advanced hepatocellular carcinoma (SILIUS): a randomised, open label, phase 3 trial. Lancet Gastroenterol Hepatol. 2018 Jun;3(6):424-432. doi: 10.1016/S2468-1253(18)30078-5. Epub 2018 Apr 7.
Ueshima K, Kudo M, Tanaka M, Kumada T, Chung H, Hagiwara S, Inoue T, Yada N, Kitai S. Phase I/II Study of Sorafenib in Combination with Hepatic Arterial Infusion Chemotherapy Using Low-Dose Cisplatin and 5-Fluorouracil. Liver Cancer. 2015 Dec;4(4):263-73. doi: 10.1159/000367751. Epub 2015 Oct 21.
Other Identifiers
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SILIUS Phase III trial
Identifier Type: -
Identifier Source: org_study_id
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