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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2010 by Ministry of Health, Labour and Welfare, Japan.
Recruitment status was:  Recruiting
Sponsor:
Information provided by:
Ministry of Health, Labour and Welfare, Japan
ClinicalTrials.gov Identifier:
NCT01214343
First received: October 4, 2010
Last updated: June 14, 2011
Last verified: October 2010
  Purpose
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.

Condition Intervention Phase
Advanced Hepatocellular Carcinoma
Carcinoma
Carcinoma, Hepatocellular
Liver Neoplasms
Neoplasms
Drug: Sorafenib with Low-dose FP
Drug: Sorafenib
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Ministry of Health, Labour and Welfare, Japan:

Primary Outcome Measures:
  • Overall survival [ Time Frame: Overall survival is defined as the time from randomization to death due to any cause ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to progression [ Time Frame: TTP is defined as the time from randomization to radiological progression. ] [ Designated as safety issue: No ]
  • Progression Free Survival [ Time Frame: PFS is defined as the time from randomization to radiological progression or death due to any cause ] [ Designated as safety issue: No ]
  • Change of tumor marker [ Time Frame: Every 4-6 weeks ] [ Designated as safety issue: No ]
  • Biomarker predicting the efficacy [ Time Frame: Pre and after treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 190
Study Start Date: October 2010
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sorafenib with Low-dose FP Drug: 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.
Other Names:
  • Nexavar
  • Low-dose FP
Active Comparator: Sorafenib Drug: 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 Name: Nexavar

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 20 Years and older.
  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:

  1. 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
  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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01214343

Locations
Japan
National Cancer Center Hospital East
Kashiwa, Chiba, Japan, 277-8577
Kurume University Medical Center
Kurume, Fukuoka, Japan, 839-0863
Ogaki Municipal Hospital
Ogaki, Gifu, Japan, 503-8502
Sapporo Medical University
Sapporo, Hokkaido, Japan, 060-8556
Sapporo-Kosei General Hospital
Sapporo, Hokkaido, Japan, 060-8556
Japanese Red Cross Takamatsu Hospital
Takamatsu, Kagawa, Japan, 760-0017
Mie University Hospital
Tsu, Mie, Japan, 514-8507
National Hospital Organization Nagasaki Medical Center
Ohmura, Nagasaki, Japan, 856-8562
Kawasaki Medical School Hospital
Kurashiki, Okayama, Japan, 701-0192
Ikeda Municipal Hospital
Ikeda, Osaka, Japan, 563-8510
Kinki University Hospital
Osaka-Sayama, Osaka, Japan, 589-8511
Osaka University Hospital
Suita, Osaka, Japan, 565-0871
Kyorin University Hospital
Mitaka, Tokyo, Japan, 181-8611
Musashino Red Cross Hospital
Musashino, Tokyo, Japan, 180-8610
Juntendo University Nerima Hospital
Nerima, Tokyo, Japan, 177-0033
Yamaguchi University Hospital
Ube, Yamaguchi, Japan, 755-8505
Chiba University Hospital
Chiba, Japan, 260-8677
Gifu Municipal Hospital
Gifu, Japan, 500-8513
Hiroshima City Hospital
Hiroshima, Japan, 730-8518
Hiroshima University Hospital
Hiroshima, Japan, 734-8551
Kumamoto University Hospital
Kumamoto, Japan, 860-8556
Kyoto University Hospital
Kyoto, Japan, 606-8507
Center for Gastroenterological and Hepatological Diseases
Miyazaki, Japan, 880-0003
Saiseikai Niigata Dai-ni Hospital
Niigata, Japan, 950-1104
Niigata University Medical and Dental Hospital
Niigata, Japan, 951-8520
Okayama University Hospital
Okayama, Japan, 700-8558
Osaka Red Cross Hospital
Osaka, Japan, 543-8555
The University of Tokushima Faculty of Medicine
Tokushima, Japan, 770-8503
Kyoundo Hospital
Tokyo, Japan, 101-0062
National Cancer Center Hospital
Tokyo, Japan, 104-0045
Sponsors and Collaborators
Ministry of Health, Labour and Welfare, Japan
Investigators
Study Chair: Masatoshi Kudo, Professor Kinki University Faculty of Medicine, Department of Gastroenterology and Hepatology
  More Information

Responsible Party: Kinki University Faculty of Medicine, Department of Gastroenterology and Hepatology
ClinicalTrials.gov Identifier: NCT01214343     History of Changes
Other Study ID Numbers: SILIUS Phase III trial 
Study First Received: October 4, 2010
Last Updated: June 14, 2011
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Ministry of Health, Labour and Welfare, Japan:
sorafenib
Hepatic intraarterial infusion chemotherapy
HAIC
Low dose FP
cisplatin
fluorouracil

Additional relevant MeSH terms:
Carcinoma
Neoplasms
Carcinoma, Hepatocellular
Liver Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Adenocarcinoma
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Sorafenib
Cisplatin
Fluorouracil
Niacinamide
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Antimetabolites
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on December 02, 2016