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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01214343
Other study ID # SILIUS Phase III trial
Secondary ID
Status Recruiting
Phase Phase 3
First received October 4, 2010
Last updated June 14, 2011
Start date October 2010
Est. completion date September 2013

Study information

Verified date October 2010
Source Ministry of Health, Labour and Welfare, Japan
Contact Masatoshi Kudo, Professor
Phone +81-72-366-0221
Email m-kudo@med.kindai.ac.jp
Is FDA regulated No
Health authority Japan: Ministry of Health, Labor and Welfare
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 190
Est. completion date September 2013
Est. primary completion date September 2013
Accepts healthy volunteers No
Gender Both
Age group 20 Years and older
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
Japan Chiba University Hospital Chiba
Japan Gifu Municipal Hospital Gifu
Japan Hiroshima City Hospital Hiroshima
Japan Hiroshima University Hospital Hiroshima
Japan Ikeda Municipal Hospital Ikeda Osaka
Japan National Cancer Center Hospital East Kashiwa Chiba
Japan Kumamoto University Hospital Kumamoto
Japan Kawasaki Medical School Hospital Kurashiki Okayama
Japan Kurume University Medical Center Kurume Fukuoka
Japan Kyoto University Hospital Kyoto
Japan Kyorin University Hospital Mitaka Tokyo
Japan Center for Gastroenterological and Hepatological Diseases Miyazaki
Japan Musashino Red Cross Hospital Musashino Tokyo
Japan Juntendo University Nerima Hospital Nerima Tokyo
Japan Niigata University Medical and Dental Hospital Niigata
Japan Saiseikai Niigata Dai-ni Hospital Niigata
Japan Ogaki Municipal Hospital Ogaki Gifu
Japan National Hospital Organization Nagasaki Medical Center Ohmura Nagasaki
Japan Okayama University Hospital Okayama
Japan Osaka Red Cross Hospital Osaka
Japan Kinki University Hospital Osaka-Sayama Osaka
Japan Sapporo Medical University Sapporo Hokkaido
Japan Sapporo-Kosei General Hospital Sapporo Hokkaido
Japan Osaka University Hospital Suita Osaka
Japan Japanese Red Cross Takamatsu Hospital Takamatsu Kagawa
Japan The University of Tokushima Faculty of Medicine Tokushima
Japan Kyoundo Hospital Tokyo
Japan National Cancer Center Hospital Tokyo
Japan Mie University Hospital Tsu Mie
Japan Yamaguchi University Hospital Ube Yamaguchi

Sponsors (1)

Lead Sponsor Collaborator
Ministry of Health, Labour and Welfare, Japan

Country where clinical trial is conducted

Japan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Overall survival Overall survival is defined as the time from randomization to death due to any cause No
Secondary Time to progression TTP is defined as the time from randomization to radiological progression. No
Secondary Progression Free Survival PFS is defined as the time from randomization to radiological progression or death due to any cause No
Secondary Change of tumor marker Every 4-6 weeks No
Secondary Biomarker predicting the efficacy Pre and after treatment No
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