Unique ID issued by UMIN | UMIN000002401 |
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Receipt number | R000002928 |
Scientific Title | A randomized controlled trial of sorafenib versus 5-FU arterial infusion and interferon therapy (FAIT) for advanced hepatocellular carcinoma |
Date of disclosure of the study information | 2009/09/01 |
Last modified on | 2022/08/10 10:38:27 |
A randomized controlled trial of sorafenib versus 5-FU arterial infusion and interferon therapy (FAIT) for advanced hepatocellular carcinoma
A randomized controlled trial of sorafenib versus 5-FU arterial infusion and interferon therapy (FAIT) for advanced hepatocellular carcinoma
A randomized controlled trial of sorafenib versus 5-FU arterial infusion and interferon therapy (FAIT) for advanced hepatocellular carcinoma
A randomized controlled trial of sorafenib versus 5-FU arterial infusion and interferon therapy (FAIT) for advanced hepatocellular carcinoma
Japan |
hepatocellular carcinoma
Hepato-biliary-pancreatic medicine |
Malignancy
NO
To evaluate the efficacy and safety of 5-FU arterial infusion and interferon thearpy (FAIT) in comparison with sorafenib in patients with advanced hepatocellular carcinoma which is not eligible for or refractory to surgical or locoregional therapies, or transcatheter hepatic arterial chemoembolization.
Efficacy
Overall survival
Response rate, progression-free survival, response in tumor markers, incidence and severity of adverse events
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
2
Treatment
Medicine |
Experimental arm
5-FU arterial infusion and interferon therapy (FAIT)
Reference arm
Sorafenib
20 | years-old | <= |
80 | years-old | > |
Male and Female
1) Patients with hepatocellular carcinoma which was diagnosed pathologically or by typical radiological findings on enhanced CT or MRI within 4 weeks before registration.
2) Patients with hepatocellular carcinoma which is not eligible for surgical and percutaneous locoregional therapies and is refractory to other conventional therapies such as transcatheter hepatic arterial chemoembolization, with and without portal vein tumor thrombus.
3) Patients with no extrahepatic metastases. In paticular, metastases to the brain should be ruled out on CT or MRI in suspected patients.
4) Patients who has not received any treatment for hepatocellular carcinoma in the last 4 weeks before registration.
5) Patients aged 20-79 years.
6) Patients with Eastern Cooperative Oncology Group Performans Status of 0 or 1.
7) Patients with adequate hematological, hepatic and renal function, as indicated by
Hemoglobin concentration of 8.0g/dl or more
White blood cell count between 3000 and 12000 /mm3
Platelet count of 40000/mm3 or more
Child-Pugh classification A
Serum creatinine concentration of 1.5 mg/dl or less
8) Patients without severe cardiac, pulmonary or psychiatric comorbidities.
9) Patients without any other malignant disease, or with malignancy at least 5 years after curative treatment.
10) Patients agreeing to use adequate contraception methods during the trial.
11) Women who are not pregnant or lactating, and not expecting future pregnancy.
12) Patients who are judged adequate to participate by the atending physician.
See inclusion criteria.
140
1st name | |
Middle name | |
Last name | Shuntaro Obi |
Kyoundo Hospital
Department of Hepatology
1-8 kanda-surugadai, Chiyoda-Ku, Tokyo
1st name | |
Middle name | |
Last name | Yuji Kondo |
University of Tokyo Hospital
Department of Gastroenterology
ykon-tky@umin.ac.jp
Department of Hepatology, Kyoundo Hospital
Sasaki fundation
Non profit foundation
NO
2009 | Year | 09 | Month | 01 | Day |
Unpublished
Terminated
2009 | Year | 08 | Month | 27 | Day |
2009 | Year | 08 | Month | 01 | Day |
2009 | Year | 09 | Month | 01 | Day |
2012 | Year | 08 | Month | 01 | Day |
2009 | Year | 08 | Month | 29 | Day |
2022 | Year | 08 | Month | 10 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002928
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