Unique ID issued by UMIN | UMIN000007199 |
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Receipt number | R000008479 |
Scientific Title | Phase II study of sorafenib with S-1 for advanced hepatocellular carcinoma. |
Date of disclosure of the study information | 2012/02/01 |
Last modified on | 2014/05/30 09:45:55 |
Phase II study of sorafenib with S-1 for advanced hepatocellular carcinoma.
Phase II study of sorafenib with S-1 for advanced hepatocellular carcinoma.
Phase II study of sorafenib with S-1 for advanced hepatocellular carcinoma.
Phase II study of sorafenib with S-1 for advanced hepatocellular carcinoma.
Japan |
Hepatocellular carcinoma
Hepato-biliary-pancreatic medicine |
Malignancy
NO
To evaluate the safety and effectiveness of S-1+Sorafenib in patients with advanced hepatocellular carcinoma
Safety,Efficacy
Phase II
Time to progression
Overall survival
Response rate
Disease control rate
Incidence of adversed effect
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
S-1 80%dose 2weeks on, 1week off
Sorafenib 800mg/day everyday
20 | years-old | <= |
Not applicable |
Male and Female
1)Patients who have been diagnosed with hepatocellular carcinoma by histologically or typical diagnostic images
2)No indication for surgical resection, local thrapy(Percutaneous ethanol injection, radiofrequency ablation, microwave coagulation therapy, transcatheter arterial chemoembolization, radiation therapy)
3)Systemic chemotherapy naive
4)At least 1 target lesion measurable
5)Performance status (ECOG scale): 0,1
6)Age >= 20 years
7)Adequate bone marrow, liver, renal and cardiac function as assessed by the following
(a)Neutrophil >= 1500/mm3
(b)Hemoglobin >= 9.0 g/dl
(c)Platelets >= 50000/mm3
(d)Total bilirubin < 3.0mg/dl
(e)Liver transaminases <= 10 x Upper limit of Normal(ULN)
(f)ALB >= 2.8 g/dl
(g)Cre <= ULN
(h)PT >= 40%
8)Child-pugh A
9)Patients can take food and drugs oral
10)Life expectancy of at least 12 weeks
11)Written informed consent
1)Previous therapy for hepatocellular carcinoma within 30days before study entry
2)Major surgery within 30 days before study entry or surgery within 15 days before study entry
3)Portal vein tumor thrombus in the main trunk
4)Uncontrollable hypertension
5)Pleural effusion, ascitis and pericardial fluid requiring drainage or affecting the respiratory and circulating dynamics
6)get an albumin preparation or a blood transfusion within 30 days before study entry
7)Hepatoencepharopathy. Brain lesions with clinical symptoms
8)Central nerve system tumor(including brain metastasis)
9)Bone metastasis with clinical symptoms
10)Active infection(except HBV and HCV infection)
11)Evidence of serious gastrointestinal bleeding within 30days before study entry
12)Gastro-esophageal varices requiring preventive treatment
13)Pregnant or lactating woman.Not consent to use contraceptive method during the study treatment
14)Second primary malignancy (except in situ carcinoma or prior malignancy treated more than 5 years ago without recurrence)
15)Severe hypersensitivity of TS-1 or sorafenib
16)Severe complication
17)Any patients judged by the investigator to be unfit to participate in the study
25
1st name | |
Middle name | |
Last name | Osamu Yokosuka |
Chiba University
Department of medicine and clinical oncology
1-8-1 Inohana, Chuo-ku, Chiba, Japan
1st name | |
Middle name | |
Last name | Yoshihiko Ooka |
Chiba University
Department of medicine and clinical oncology
1-8-1 Inohana, Chuo-ku, Chiba, Japan
043-226-2083
Department of Medicine and Clinical Oncology, Graduate School of Medicine, Chiba University
Health Labour Sciences Research Grant
NO
2012 | Year | 02 | Month | 01 | Day |
Published
Completed
2011 | Year | 07 | Month | 01 | Day |
2011 | Year | 07 | Month | 01 | Day |
2013 | Year | 09 | Month | 01 | Day |
2013 | Year | 09 | Month | 15 | Day |
2013 | Year | 10 | Month | 01 | Day |
2013 | Year | 10 | Month | 01 | Day |
2012 | Year | 02 | Month | 01 | Day |
2014 | Year | 05 | Month | 30 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008479
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