UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004691
Receipt number R000005583
Scientific Title A phase 2 study of combination chemotherapy for hepatocellular carcinoma using Miripla (SM11355) and IA-call (DDP-H)
Date of disclosure of the study information 2011/09/18
Last modified on 2017/04/01 16:24:16

* 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

A phase 2 study of combination chemotherapy for hepatocellular carcinoma
using Miripla (SM11355) and IA-call (DDP-H)

Acronym

Combination chemotherapy of SM11355 and DDP-H for HCC

Scientific Title

A phase 2 study of combination chemotherapy for hepatocellular carcinoma
using Miripla (SM11355) and IA-call (DDP-H)

Scientific Title:Acronym

Combination chemotherapy of SM11355 and DDP-H for HCC

Region

Japan


Condition

Condition

Hepatocellular carcinoma

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Malignancy

Genomic information

YES


Objectives

Narrative objectives1

This study aims to select candidate predictors for therapeutic efficacy of and to clarify the usefulness of combinatorial usage of SM11355 with intrahepatic arterial infusion of DDP-H in local managements of hepatocellular carcinoma.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Phase II


Assessment

Primary outcomes

Tiem to progression

Key secondary outcomes

overall survival


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

NO

Institution consideration

Institution is considered as a block.

Blocking

YES

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

SM11355

Interventions/Control_2

SM11355 after intrahepatic infusion of DDP-H

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) Histologically and/or clinically proven hepatocellular carcinoma except for mixed type.
2) Local managements are difficult by surgical resection, puncture-based therapies, radiation therapy or transcatheter arterial chemoembolization.
3) No indication or consent for liver transplantation.
4) Indication for lipiodolization using SM11355 and intrahepatic arterial infusion of DDP-H.
5) No additional treatments will be performed targeting the lesions for SM11355.
6) In the area where SM11355 is going to be infused, there are target lesions larger than 10mm, which can be measured using CT and/or MRI.
7) Age over 20 years old.
8) ECOG performance status score of 0-2.
9) Sufficient functional reserve of major organs as indicated below.
>Neutrophil count :1,500/mm3 =<
>Platelet count :50,000/mm3 =<
>Hemoglobin : 8.0 g/dL =<
>Albumin : 3.0 g/dL =<
>Total bilirubin : 3.0 mg/dL =>
>Total amylase in serum : 324 IU/bL =>
>Creatinine clearance : 50ml/min =< (adjusted for 1.73m2 of body surface area)
10) Child-Pugh score of equal or less than 8.
11) An interval of 4 or more weeks after any latest therapy against hepatocellular carcinoma.
12) A written informed consent from a patient himself/herself.

Key exclusion criteria

1) Pleural effusion and/or ascites refractory to treatments.
2) Comorbidity:
>Active infectious diseases except for hepatitis.
>Active bleeding from GI tract.
>Active concomitant cancer with invasive nature.
>Severe mental disorder or hepatic encephalopathy.
3) A history of severe allergic reaction against iodine contrast medium and/or platinum agents.
4) A pregnant or lactating female or female of childbearing age unless using effective contraception.
5) Ongoing interferon therapy.
6) Difficulties of oral intake.
7) Other serious conditions judged to be inadequate by a responsible doctor.

Target sample size

200


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takeshi Suda

Organization

Uonuma Institute of Community Medicine, Niigata Medical and Dental Hospital

Division name

Department of Gastroenterology & Hepatology

Zip code


Address

4132 Urasa, Minami-Uonuma, Niigata 949-7302, Japan

TEL

025(777)3200

Email

tspitt@med.niigata-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Takeshi Suda

Organization

Uonuma Institute of Community Medicine, Niigata Medical and Dental Hospital

Division name

Department of Gastroenterology & Hepatology

Zip code


Address

4132 Urasa, Minami-Uonuma, Niigata 949-7302, Japan

TEL

025(777)3200

Homepage URL


Email

tspitt@med.niigata-u.ac.jp


Sponsor or person

Institute

Niigata Hepatocellular Carcinoma Therapy Study Group

Institute

Department

Personal name



Funding Source

Organization

No

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan


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

1) Department of Gastroenterology and Hepatology, Uonuma Institute of Community Medicine, Niigata Medical and Dental Hospital
2) Division of Gastroenterology and Hepatology, Graduate School of Medical and Dental Sciences, Niigata University
3) Department of Gastroenterology and Hepatology, Niigata City General Hospital


Other administrative information

Date of disclosure of the study information

2011 Year 09 Month 18 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

2010 Year 12 Month 20 Day

Date of IRB


Anticipated trial start date

2011 Year 01 Month 01 Day

Last follow-up date

2015 Year 12 Month 11 Day

Date of closure to data entry

2016 Year 06 Month 01 Day

Date trial data considered complete

2016 Year 08 Month 01 Day

Date analysis concluded

2016 Year 11 Month 01 Day


Other

Other related information



Management information

Registered date

2010 Year 12 Month 09 Day

Last modified on

2017 Year 04 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005583


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name