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 |
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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
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
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
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
