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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000003831
Receipt No. R000003001
Scientific Title A phase 1 study of a combination chemotherapy, Sorafenib and intrahepatic arterial infusion of IA-call® (DDP-H), for advanced hepatocellular carcinoma.
Date of disclosure of the study information 2010/07/01
Last modified on 2012/01/10

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Basic information
Public title A phase 1 study of a combination chemotherapy, Sorafenib and intrahepatic arterial infusion of IA-call® (DDP-H), for advanced hepatocellular carcinoma.
Acronym A combination chemotherapy of Sorafenib and DDP-H for HCC (Phase 1).
Scientific Title A phase 1 study of a combination chemotherapy, Sorafenib and intrahepatic arterial infusion of IA-call® (DDP-H), for advanced hepatocellular carcinoma.
Scientific Title:Acronym A combination chemotherapy of Sorafenib and DDP-H for HCC (Phase 1).
Region
Japan

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

Objectives
Narrative objectives1 Selection of candidate predictors for therapeutic efficacy and determination of dose-limiting toxicity, maximum tolerated dose, therapeutic dose, and a type and frequency of adverse events in combination chemotherapy with intrahepatic arterial infusion of DDP-H for patients with advanced hepatocellular carcinoma.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase I

Assessment
Primary outcomes Dose-limiting toxicity, recommended dose, adverse events.
Key secondary outcomes Response rate, time to progression, overall 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 Sorafenib is administered everyday at a dose of 400mg bid one month prior to an initiation of DDP-H, which is infused to the entire liver through a hepatic artery at a rate of 3mg/min in total of 65 mg/m2. DDP-H infusion is repeated three times with an interval of 4 to 8 weeks. If dose-limiting toxicities (DLTs) are not depicted in 3 or more cases out of 5 cases, the same regimen is carried out by increasing a dose of Sorafenib to 600mg bid in everyday. If still DLTs are seen in less than 3 in 5 cases, a dose of Sorafenib is further increased to 800mg bid in everyday. If 3 or more cases has already suffered from DLTs with 400mg, Sorafenib is reduced to 400mg bid in alternative day or further 200mg sid in alternative day.
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
79 years-old >=
Gender Male and Female
Key inclusion criteria 1)Histologically and/or clinically proven hepatocellular carcinoma except for mixed type.
2)Adequate for none of surgical resection, puncture-based therapies, or transhepatic arterial chemoembolization
3)There are bidimensionally measurable targets in the liver.
4)Age between 20 and 79 years old.
5)ECOG performance status score of 0-2.
6)Sufficient functional reserve of major organs.
a)Neutrophil count : 1,500 /mm3 =<
b)Platelet count: 50,000 /mm3 =<
c)Hemoglobin: 8.0 g/dL =<
d)Total bilirubin: 3.0 mg/dL =>
e)Total amylase in serum: 324 IU/bL =>
f)Creatinine clearance: 50ml/min =< (adjusted for 1.73m2 of body surface area)
7)Child-Pugh score of equal or less than 7.
8)An internal of 4 or more weeks after latest therapy against hepatocellular carcinoma.
9)A written informed consent from a patient him/her self.
Key exclusion criteria 1)Pleural effusion and/or ascites refractory to treatments.
2)Comorbidity:
a)Hyper tension over 100mmHg of diastolic blood pressure under medication.
b)Uncontrollable heart failure, angina pectoris or arrhythmia.
c)Myocardial infarction within 6 months.
d)Brain metastasis.
e)Active infectious diseases except for hepatitis.
f)Active bleeding from GI tract.
g)Active concomitant cancer with invasive nature.
h)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 15

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takeshi Suda
Organization Niigata University Graduate School of Medical and Dental Sciences
Division name Department of Gastroenterology & Hepatology
Zip code
Address 1-754 Asahi-machi, Chuo-ku, Niigata, Niigata 951-8122, Japan
TEL 025-223-2207
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hirokazu Kawai
Organization Niigata Hepatocellular Carcinoma Therapy Study Group
Division name Excutive office
Zip code
Address 1-757 Asahi-machi, Chuo-ku, Niigata, Niigata 951-8122, Japan
TEL 025-227-2207
Homepage URL
Email kawaih@med.niigata-u.ac.jp

Sponsor
Institute Niigata Hepatocellular Carcinoma Therapy Study Group
Institute
Department

Funding Source
Organization None
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 新潟大学医歯学総合病院(新潟県)

Other administrative information
Date of disclosure of the study information
2010 Year 07 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
2009 Year 10 Month 26 Day
Date of IRB
Anticipated trial start date
2009 Year 11 Month 01 Day
Last follow-up date
2011 Year 03 Month 01 Day
Date of closure to data entry
2011 Year 04 Month 01 Day
Date trial data considered complete
2011 Year 05 Month 01 Day
Date analysis concluded
2011 Year 06 Month 01 Day

Other
Other related information

Management information
Registered date
2010 Year 06 Month 28 Day
Last modified on
2012 Year 01 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003001

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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