UMIN-CTR Clinical Trial

Basic information
Public title	Short-term therapy of hepatic arterial infusion chemotherapy using DSM for patients with advanced hepatocellular carcinoma: pilot study
Acronym	Short-term HAIC using DSM for advanced HCC
Scientific Title	Short-term therapy of hepatic arterial infusion chemotherapy using DSM for patients with advanced hepatocellular carcinoma: pilot study
Scientific Title:Acronym	Short-term HAIC using DSM for advanced HCC
Region	Japan

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

Objectives
Narrative objectives1	We investigate the safety and efficacy of arterial infusion chemotherapy using DSM for advanced hepatocellular carcinoma patients.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Safety
Key secondary outcomes	Response, Survival, Progression-free survival

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	HAIC with DSM On day 1 and 7, cisplatin (50mg) is administered via the injection port. After that point, emulsion obtained by mixing DSM and contrast agent is injected until stasis and reflux are achieved. Subsequently, 5-fluorouracil (250 mg/body) injected continuously for 24hr from days 1 to 5 and days 8 to 12 using infuson pump. The antitumor effect is assessed every 4 weeks by dynamic CT. In principle, the treatment course is repeated several times unless the tumor progressed during the therapy.
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) Patients with advanced hepatocellular carcinoma 2) HCC without extrahepatic lesion 3) Patients who have no influence on previous treatment 4) Performance status(PS) 0 or 1 5) Child-Pugh A or B 6) Favorable function of major organs (bone marrow, kidney, heart), and meeting criteria as follows: (1) WBC >= 2500/mm3 (2) platelet count>= 50000/mm3 (3) hemogrobin level >= 9.0g/dl (4) total bilirubin <= 3.0mg/dl (5) serum creatinine level < 2mg/dl (6) BUN <= 25mg/dl (7) prothrombin time activity >= 50% 7) age >= 20years, male and female
Key exclusion criteria	1) Severe coexisting illness (expect for chronic hepatitis or liver cirrhosis) 2) Active double cancers 3) Past history of hypersensitivity for drugs including iodine and contrast agent 4) Patients with pregnancy, lactation or possibility of pregnancy 5) Chronic respiratory failure 6) No hypersensitivity to DSM 7) Patients who judged as inadequacy due to other reasons by the doctor
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Middle name Last name Issei Saeki
Organization	Yamaguchi University Graduate School of Medicine
Division name	Department of Gastroenterology and Hepatology
Zip code
Address	1-1-1 Minamikogushi, Ube, Yamaguchi
TEL	0836-22-2241
Email	issaeki@yamaguchi-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Issei Saeki
Organization	Yamaguchi University Graduate School of Medicine
Division name	Department of Gastroenterology and Hepatology
Zip code
Address	1-1-1 Minamikogushi, Ube, Yamaguchi
TEL	0836-22-2241
Homepage URL
Email	issaeki@yamaguchi-u.ac.jp

Sponsor
Institute	Yamaguchi 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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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	2015 Year 11 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Terminated
Date of protocol fixation	2015 Year 08 Month 26 Day
Date of IRB	2015 Year 08 Month 26 Day
Anticipated trial start date	2015 Year 11 Month 01 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2015 Year 10 Month 14 Day
Last modified on	2020 Year 10 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000022371