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
1 other identifier
interventional
190
1 country
30
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Oct 2010
Typical duration for phase_3
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2010
CompletedFirst Submitted
Initial submission to the registry
October 4, 2010
CompletedFirst Posted
Study publicly available on registry
October 5, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2013
CompletedJune 15, 2011
October 1, 2010
2.9 years
October 4, 2010
June 14, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall survival
Overall survival is defined as the time from randomization to death due to any cause
Secondary Outcomes (4)
Time to progression
TTP is defined as the time from randomization to radiological progression.
Progression Free Survival
PFS is defined as the time from randomization to radiological progression or death due to any cause
Change of tumor marker
Every 4-6 weeks
Biomarker predicting the efficacy
Pre and after treatment
Study Arms (2)
Sorafenib with Low-dose FP
EXPERIMENTALSorafenib
ACTIVE COMPARATORInterventions
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 will be administered orally at a dose of 400 mg bid for 28 days in each cycle.A cycle is defined as 28 days.
Eligibility Criteria
You may qualify if:
- Years and older.
- Life expectancy of at least 12 weeks at the pre-treatment evaluation.
- Advanced hepatocellular carcinoma with histological evidence on a biopsy specimen, or typical findings by dynamic CT or CT during hepatic arteriography/arterioportography.
- Not suitable for resection or local ablation therapy or transcatheter arterial chemoembolization.
- ECOG Performance status of 0 or 1.
- Cirrhotic status of Child-Pugh score ≤ 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
- +1 more criteria
You may not qualify if:
- Previous malignancy (except for cervical carcinoma in situ, adequate treated basal cell carcinoma, or superficial bladder tumors \[Ta, Tis and T1\], early gastric cancer, or other malignancies curatively treated \> 3 years prior to entry
- Renal failure
- 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
- Active clinically serious infections except for HBV and HCV
- Active chicken pox.
- Auditory disorder.
- Known history of HIV infection.
- Known metastatic or meningeal tumors.
- Extrahepatic tumor spread which affects patient's prognosis
- History of seizure disorder.
- Clinically significant gastrointestinal bleeding within 4 weeks prior to study entry.
- +14 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (30)
Chiba University Hospital
Chiba, Chiba, 260-8677, Japan
National Cancer Center Hospital East
Kashiwa, Chiba, 277-8577, Japan
Kurume University Medical Center
Kurume, Fukuoka, 839-0863, Japan
Gifu Municipal Hospital
Gifu, Gifu, 500-8513, Japan
Ogaki Municipal Hospital
Ōgaki, Gifu, 503-8502, Japan
Hiroshima City Hospital
Hiroshima, Hiroshima, 730-8518, Japan
Hiroshima University Hospital
Hiroshima, Hiroshima, 734-8551, Japan
Sapporo Medical University
Sapporo, Hokkaido, 060-8556, Japan
Sapporo-Kosei General Hospital
Sapporo, Hokkaido, 060-8556, Japan
Japanese Red Cross Takamatsu Hospital
Takamatsu, Kagawa-ken, 760-0017, Japan
Kumamoto University Hospital
Kumamoto, Kumamoto, 860-8556, Japan
Kyoto University Hospital
Kyoto, Kyoto, 606-8507, Japan
Mie University Hospital
Tsu, Mie-ken, 514-8507, Japan
Center for Gastroenterological and Hepatological Diseases
Miyazaki, Miyazaki, 880-0003, Japan
National Hospital Organization Nagasaki Medical Center
Ohmura, Nagasaki, 856-8562, Japan
Saiseikai Niigata Dai-ni Hospital
Niigata, Niigata, 950-1104, Japan
Niigata University Medical and Dental Hospital
Niigata, Niigata, 951-8520, Japan
Kawasaki Medical School Hospital
Kurashiki, Okayama-ken, 701-0192, Japan
Okayama University Hospital
Okayama, Okayama-ken, 700-8558, Japan
Ikeda Municipal Hospital
Ikeda, Osaka, 563-8510, Japan
Osaka Red Cross Hospital
Osaka, Osaka, 543-8555, Japan
Kinki University Hospital
Ōsaka-sayama, Osaka, 589-8511, Japan
Osaka University Hospital
Suita, Osaka, 565-0871, Japan
The University of Tokushima Faculty of Medicine
Tokushima, Tokushima, 770-8503, Japan
Kyorin University Hospital
Mitaka, Tokyo, 181-8611, Japan
Musashino Red Cross Hospital
Musashino, Tokyo, 180-8610, Japan
Juntendo University Nerima Hospital
Nerima City, Tokyo, 177-0033, Japan
Kyoundo Hospital
Tokyo, Tokyo, 101-0062, Japan
National Cancer Center Hospital
Tokyo, Tokyo, 104-0045, Japan
Yamaguchi University Hospital
Ube, Yamaguchi, 755-8505, Japan
Related Publications (2)
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.
PMID: 29631810DERIVEDUeshima 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.
PMID: 26734580DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Masatoshi Kudo, Professor
Kinki University Faculty of Medicine, Department of Gastroenterology and Hepatology
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
Study Record Dates
First Submitted
October 4, 2010
First Posted
October 5, 2010
Study Start
October 1, 2010
Primary Completion
September 1, 2013
Study Completion
September 1, 2013
Last Updated
June 15, 2011
Record last verified: 2010-10