UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of Sorafenib and intermittent hepatic arterial infusion chemotherapy using Cisplatin for advanced hepatocellular carcinoma with portal vein tumor thrombus : a phase 1 study
Title of the study (Brief title)	The effect of Sorafenib and intermittent HAIC using CDDP for advanced HCC with PVTT : P-1 study
Region	Japan

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

Objectives
Narrative objectives1	We evaluate the safety and efficacy of this therapy for advanced HCC
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase I

Assessment
Primary outcomes	Dose limiting toxicity, Recommended dose
Key secondary outcomes	Adverse event rate, Response rate

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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 (oral intake) for 28 days CDDP:20mg/m2 HAIC (day1,8,15)
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	85 years-old >=
Gender	Male and Female
Key inclusion criteria	1.Patients diagnosed with HCC 2.Above vp3 3.Child-Pugh A or B 4.ASA PS 0-1 5.WBC>3000/ul, Neutro>1500/ul, Hb>10.0g/dl, Platelet>75000/ul, T-Bil below 1.5 times higher than normal range, AST/ALT below 5 times higher than normal range, Creatinine below 1.5 times higher than normal range. 6.Beyond surgical indication 7.Patients that agree this study on document of informed concent
Key exclusion criteria	1.Presence of metastasis 2.Presence of hepatic encephalopathy 3.Patients with active bacterial infection 4.Patients having blood vessel abnormality that difficult to insert hepatic arterial infusion port 5.Patients having severe disease 6.Patients losing of control over bowel movements 7.Patients with double cance 8.During pregnancy or breast-feeding woman 9.Contraindication of sorafenib or cisplatin
Target sample size	18

Research contact person
Name of lead principal investigator	Morihiko Ishizaki
Organization	Kansai Medical University Hirakata Hospital
Division name	Department of surgery
Address	2-3-1 Shinmachi, Hirakata Osaka 573-1191 JAPAN
TEL	072-804-0101
Email

Public contact
Name of contact person	Morihiko Ishizaki
Organization	Kansai Medical University Hirakata Hospital
Division name	Department of surgery
Address	Kansai Medical University Hirakata Hospital
TEL	072-804-0101
Homepage URL
Email	ishizakm@hirakata.kmu.ac.jp

Sponsor
Institute	Kansai Medical University Hirakata Hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	none
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	2010 Year 09 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 03 Month 12 Day
Anticipated trial start date	2010 Year 09 Month 01 Day
Last follow-up date	2011 Year 12 Month 01 Day
Date of closure to data entry	2011 Year 12 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	2010 Year 08 Month 26 Day
Last modified on	2016 Year 06 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004941