UMIN-CTR Clinical Trial

Basic information
Public title	A phase I,II trial of hepatic arterial infusion chemotherapy with cisplatin and 5-fluorouracil for unresectable advanced hepatocellular carcinoma
Acronym	A phase I,II trial of HAIC with CDDP+5-FU for advanced HCC
Scientific Title	A phase I,II trial of hepatic arterial infusion chemotherapy with cisplatin and 5-fluorouracil for unresectable advanced hepatocellular carcinoma
Scientific Title:Acronym	A phase I,II trial of HAIC with CDDP+5-FU for advanced HCC
Region	Japan

Condition
Condition	hepatocellular carcinoma
Classification by specialty	Hepato-biliary-pancreatic medicine Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Safety, efficacy
Basic objectives2	Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase I,II

Assessment
Primary outcomes	safety
Key secondary outcomes	efficacy

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	hepatic arterial infusion chemotherapy. 5-FU 300mg/m2, day 1 to 5, 5 to 19. CDDP 45mg/m2, 55mg/m2 or 65mg/m2, day2. 1 course = 28 days. continue till PD.
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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients were considered eligible for this study based on following criteria: advanced unresectable hepatocellular carcinoma; clinical stage III or IVA; no prior chemotherapy or radiation therapy within one month; an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1; age; 18 years; adequate baseline bone marrow function (hemoglobin level>9g/dl, neutrophil count>1,500/mm3 and platelet count >70,000/mm3) ; adequate hepatic function (total bilirubin level;2.0 mg/dl, aspartate aminotransferase and alanine aminotransferase levels five times the upper limit of normal); adequate renal function (serum creatinine level1.5 mg/dl); adequate respiratory and cardiac function; no metastatic lesion except for liver; and life expectancy at least three months. Written informed consent was obtained from all patients.
Key exclusion criteria	complete obstruction of either celiac artery, common hepatic artery or splenic artery
Target sample size	28

Research contact person
Name of lead principal investigator	1st name Middle name Last name Koji Miyanishi
Organization	Sapporo Medical University School of Medicine
Division name	Dept. of Medical Oncology
Zip code
Address	South1, West16, Chuo-ku, Sapporo
TEL	011-611-2111
Email	miyako@sapmed.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Koji Miyanishi
Organization	Sapporo Medical University School of Medicine
Division name	Dept. of Oncology and hematology
Zip code
Address	South1, West16, Chuo-ku, Sapporo
TEL	0119611-2111
Homepage URL
Email	miyako@sapmed.ac.jp

Sponsor
Institute	Sapporo Medical University School of Medicine
Institute
Department

Funding Source
Organization	Sapporo Medical University School of Medicine
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	2014 Year 04 Month 16 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	Completed
Date of protocol fixation	2008 Year 05 Month 20 Day
Date of IRB	2008 Year 06 Month 24 Day
Anticipated trial start date	2008 Year 06 Month 24 Day
Last follow-up date	2018 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	2014 Year 04 Month 16 Day
Last modified on	2020 Year 10 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016015