UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000019344
Receipt number R000022371
Scientific Title Short-term therapy of hepatic arterial infusion chemotherapy using DSM for patients with advanced hepatocellular carcinoma: pilot study
Date of disclosure of the study information 2015/11/01
Last modified on 2020/10/18 09:23:48

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 or person

Institute

Yamaguchi University Hospital

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022371


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name