UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	An Investigation of the Safety of Continued Treatment with Sorafenib in Patients with Unresectable Hepatocellular Carcinoma after the First Disease Progression
Title of the study (Brief title)	An Investigation of the Safety of Continued Treatment with Sorafenib in Patients with Unresectable Hepatocellular Carcinoma after the First Disease Progression
Region	Japan

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

Objectives
Narrative objectives1	The objective of this study is to evaluate the safety and efficacy of continued treatment with sorafenib in patients with unresectable advanced HCC after documentation of PD according to the modified RECIST criteria.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Safety after documentation of the first PD
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Sorafenib 400mg twice daily
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 measurable with contrast-enhanced computed tomography (CT) or contrast- enhanced magnetic resonance imaging (MRI) 4)No carryover of effects or adverse effects of prior treatment (A washout period of at least 2 weeks will be established before the start of the clinical study for patients who have undergone hepatic resection, percutaneous local treatment, TAE, hepatic arterial infusion, and radiation therapy.) 5)Child-Pugh class A 6)Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 7)Adequate functional reserve of major organs 8)Over 20 years old 9)Capable of complying with requirements with respect to visit days, medication, and laboratory tests 10)The patient provides written informed consent before the start of the clinical study
Key exclusion criteria	1)History of use of sorafenib or another molecular-targeted drug 2)History of systemic chemotherapy 3)Clinically significant ascites (i.e., refractory ascites requiring drainage) 4)History of liver transplantation 5)Esophageal varices with the potential to bleed 6)Any of the following diseases within 12 months before enrollment in the clinical study: myocardial infarction, unstable angina, cardiac failure, and cerebrovascular disorder 7)Concurrent or prior hepatic encephalopathy 8)Brain tumor 9)Currently on dialysis 10)Gastrointestinal hemorrhage during the previous month 11)Active double cancer 12)Currently treated with a CYP3A4 inducer (e.g., rifampicin) 13)Serious coexisting disease (NCI CTCAE grade 2 or higher arrhythmia and poorly controlled hypertension) 14)History of hypersensitivity to any component of the study drug 15)Orally taking an herbal medicine approved for the treatment of cancer (e.g., sho-saiko-to) 16)Human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS) -related disease 17)Pregnant or nursing 18)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	Yasuo Hamamoto
Organization	Keio university school of medicine
Division name	division of gastroenterology department of internal medicine
Address	35 Shinanomachi, Shinjuku-ku, Tokyo
TEL	03-3353-1211
Email	yhamamoto@z2.keio.jp

Public contact
Name of contact person	Noriyuki Akutsu
Organization	Sapporo Medical University Hospital
Division name	First Department of Internal Medicine
Address	Minami 1, Nishi 16-291, Chuo-ku, Sapporo, Hokkaido, Japan
TEL	011-611-2111
Homepage URL
Email	akutsu@sapmed.ac.jp

Sponsor
Institute	Sapporo Medical University Hospital
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	2011 Year 06 Month 21 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 06 Month 01 Day
Anticipated trial start date	2011 Year 06 Month 13 Day
Last follow-up date	2014 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2011 Year 06 Month 21 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=R000006874