UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of efficacy of dose escalation strategy for treatment with sorafenib for hepatocellular carcinoma.
Title of the study (Brief title)	Evaluation of efficacy of dose escalation strategy for treatment with sorafenib for hepatocellular carcinoma.
Region	Japan

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

Objectives
Narrative objectives1	We examine the usefulness of the dose escalation strategy as a means to prevent discontinuation due to adverse events in the sorafenib treatment for patients with HCC.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Compared with the previously reported the TTS and the OS.
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 Tosilate (Nexavar)
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	90 years-old >
Gender	Male and Female
Key inclusion criteria	1. The patient's age is between 20 and 89 years old. 2. Unresectable HCC progression. 3. Child-Pugh class A or B. 4. PS 2 or less. 5. With or without treatment history of HCC. 6. Informed consent.
Key exclusion criteria	1. Brain metastases. 2. Bleeding tendency. 3. Advanced ascites. 4. Hepatic encephalopathy (II or more). 5. Jaundice (serum bilirubin value of 3.0 mg/dL or more). 6. Serum AST or ALT value of more than 200 IU/L. 7. Hemoglobin blood value of less than 8.0 g/dL. 8. Neutrophil count of less than 1000 /microL. 9. Platelet count of less than 50000 /microL. 10. Difficult to control hypertension. 11. During dialysis. 12. Patients who are pregnant, suspected to be pregnant or breastfeeding. 13. Patient with drug allergy. 14. Patient uses other anticancer drugs. 15. Patients who are considered not to be eligible by the investigators.
Target sample size	20

Research contact person
Name of lead principal investigator	Nobuyuki Toshikuni
Organization	Kanazawa Medical University
Division name	Department of Gastroenterology
Address	1-1 Daigaku, Uchinada, Kahoku, Ishikawa
TEL	076-286-2211
Email

Public contact
Name of contact person	Nobuyuki Toshikuni
Organization	Kanazawa Medical University
Division name	Department of Gastroenterology
Address	1-1 Daigaku, Uchinada, Kahoku, Ishikawa
TEL	076-286-2211
Homepage URL
Email

Sponsor
Institute	Kanazawa Medical University
Institute
Department

Funding Source
Organization	Kanazawa Medical University
Organization
Division
Category of Funding Organization	Other
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	2012 Year 10 Month 16 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 08 Month 21 Day
Anticipated trial start date	2012 Year 10 Month 16 Day
Last follow-up date
Date of closure to data entry	2016 Year 10 Month 01 Day
Date trial data considered complete
Date analysis concluded

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

Management information
Registered date	2012 Year 10 Month 16 Day
Last modified on	2017 Year 04 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010698