UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034805
Receipt No. R000039694
Official scientific title of the study 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 2018/11/07

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Official scientific title of the study An Investigation of the relationship between adverse event and efficacy of treatment with lenvatinib in patients with unresectable hepatocellular carcinoma
Title of the study (Brief title) An Investigation of the relationship between adverse event and efficacy of treatment with lenvatinib in patients with unresectable hepatocellular carcinoma
Region
Japan

Condition
Condition advanced hepatocellular carcinoma
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The objective of this prospective study is to evaluate the efficacy of treatment with lenvatinib in patients with unresectable advanced HCC.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes efficacy
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 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
Key exclusion criteria 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
Target sample size 40

Research contact person
Name of lead principal investigator Noriyuki Akutsu
Organization Sapporo Medical University School of Medicine
Division name Department of Gastroenterology and Hepatology
Address Minami 1-jo Nishi 16-chome, Chuo-ku, Sapporo, Hokkaido, Japan
TEL 011-611-2111
Email akutsu@sapmed.ac.jp

Public contact
Name of contact person Noriyuki Akutsu
Organization Sapporo Medical University School of Medicine
Division name Department of Gastroenterology and Hepatology
Address Minami 1-jo Nishi 16-chome, Chuo-ku, Sapporo, Hokkaido, Japan
TEL 011-611-2111
Homepage URL
Email akutsu@sapmed.ac.jp

Sponsor
Institute Sapporo Medical University School of Medicine
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2018 Year 11 Month 07 Day

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2018 Year 04 Month 07 Day
Anticipated trial start date
2018 Year 06 Month 14 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information Prospective observational study

Management information
Registered date
2018 Year 11 Month 07 Day
Last modified on
2018 Year 11 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039694

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.