Unique ID issued by UMIN | UMIN000034805 |
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Receipt number | R000039694 |
Scientific Title | An Investigation of the relationship between adverse event and efficacy of treatment with lenvatinib in patients with unresectable hepatocellular carcinoma |
Date of disclosure of the study information | 2018/11/07 |
Last modified on | 2022/11/14 08:24:30 |
An Investigation of the relationship between adverse event and efficacy of treatment with lenvatinib in patients with unresectable hepatocellular carcinoma
An Investigation of the relationship between adverse event and efficacy of treatment with lenvatinib in patients with unresectable hepatocellular carcinoma
An Investigation of the relationship between adverse event and efficacy of treatment with lenvatinib in patients with unresectable hepatocellular carcinoma
An Investigation of the relationship between adverse event and efficacy of treatment with lenvatinib in patients with unresectable hepatocellular carcinoma
Japan |
advanced hepatocellular carcinoma
Hepato-biliary-pancreatic medicine |
Malignancy
NO
The objective of this prospective study is to evaluate the efficacy of treatment with lenvatinib in patients with unresectable advanced HCC.
Safety,Efficacy
efficacy
Observational
20 | years-old | <= |
Not applicable |
Male and Female
1)Histologically or clinically (imaging and tumor markers) diagnosed hepatocellular carcinoma
2)Not eligible for local treatment (e.g., surgery, RFA, TAE, and ethanol injection)
3)Lesions evaluable with contrast-enhanced computed tomography (CT) or contrast- enhanced magnetic resonance imaging (MRI)
4)No carryover of effects or adverse effects of prior treatmen
5)Child-Pugh Score 5-8
6)Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
7)Adequate functional reserve of major organs
8)Patients with systolic blood pressure of 140 mmHg or less and diastolic blood pressure of 90 mmHg or less
9)Over 20 years old
10) Capable of complying with requirements with respect to visit days, medication, and laboratory tests
11)The patient provides written informed consent before the start of the clinical study
1)Clinically significant ascites (i.e., refractory ascites requiring drainage)
2)History of liver transplantation
3)Esophageal varices with the potential to bleed
4)Concurrent or prior hepatic encephalopathy
5)Brain tumor
6)Currently on dialysis
7)Active double cancer
8)Orally taking an herbal medicine approved for the treatment of cancer (e.g., sho-saiko-to)
9)Human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS) -related disease
10)Pregnant or nursing
11)Otherwise found by the investigator or subinvestigator to be ineligible as a subject
40
1st name | Noriyuki |
Middle name | |
Last name | Akutsu |
Sapporo Medical University School of Medicine
Department of Gastroenterology and Hepatology
0608543
Minami 1-jo Nishi 16-chome, Chuo-ku, Sapporo, Hokkaido, Japan
011-611-2111
akutsu@sapmed.ac.jp
1st name | Noriyuki |
Middle name | |
Last name | Akutsu |
Sapporo Medical University School of Medicine
Department of Gastroenterology and Hepatology
0608543
Minami 1-jo Nishi 16-chome, Chuo-ku, Sapporo, Hokkaido, Japan
011-611-2111
akutsu@sapmed.ac.jp
Sapporo Medical University School of Medicine
none
Self funding
IRB of Sapporo medical university
S1 W17, Chuo-ku, Sapporo, 060-8556, Japan
011-611-2111
ji-rskk@sapmed.ac.jp
NO
2018 | Year | 11 | Month | 07 | Day |
Unpublished
Completed
2018 | Year | 04 | Month | 07 | Day |
2018 | Year | 06 | Month | 14 | Day |
2018 | Year | 06 | Month | 14 | Day |
2022 | Year | 10 | Month | 30 | Day |
Prospective observational study
2018 | Year | 11 | Month | 07 | Day |
2022 | Year | 11 | Month | 14 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039694
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