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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000005697
Receipt No. R000006740
Scientific Title Phase I/II Study of Capecitabine in Combination with Peginterferon Alfa-2a for Patients with Advanced Hepatocellular Carcinoma
Date of disclosure of the study information 2011/06/01
Last modified on 2013/08/10

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Basic information
Public title Phase I/II Study of Capecitabine in Combination with Peginterferon Alfa-2a for Patients with Advanced Hepatocellular Carcinoma
Acronym Phase I/II Study of Capecitabine in Combination with Peginterferon Alfa-2a for Patients with Advanced Hepatocellular Carcinoma
Scientific Title Phase I/II Study of Capecitabine in Combination with Peginterferon Alfa-2a for Patients with Advanced Hepatocellular Carcinoma
Scientific Title:Acronym Phase I/II Study of Capecitabine in Combination with Peginterferon Alfa-2a for Patients with Advanced Hepatocellular Carcinoma
Region
Japan

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

Objectives
Narrative objectives1 To evaluate the safety and efficacy of Capecitabine in Combination with Peginterferon Alfa-2a for Patients with Advanced Hepatocellular Carcinoma.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Time to Progression (TTP)
Key secondary outcomes Overall Survival (OS)
Progression Free Survival (PFS)
Response Rate (RR)
Safety

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Capecitabine, Peginterferon Alfa-2a
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) 20 years-old (Gender does not matter).
2) Acquisition of written informed consent.
3) Have been diagnosed with hepatocellular carcinoma.
4) Surgical resection or local therapy is unlikely to lead to complete necrosis.
5) Not suitable for treatment with sorafenib.
6) ECOG performance status of 0-2.
7) Child-Pugh A.
8) Expected survival more than 12 weeks
9) Among patients who fulfill the inclusion criteria.
Key exclusion criteria 1) Patients with a history of malignancy.
2) Corresponding to the sever heart disease.
3) Active clinically-serious infections.
4) History of HIV infection.
5) Hemodialysis.
6) Clinical or radiological evidence of CNS metastases.
7) Uncontrollable massive ascites, pleural effusion.
8) Clinically-significant gastrointestinal bleeding within 4 weeks prior to study entry.
9) Severe allergy for fluoropyrimidines.
10) HBV-DNA positive and not being treated with nucleotide analogues.
11) Anticoagulant therapy with warfarin potassium.
12) During treatment with Tegafur gimeracil oteracil potassium, or within 7 days after discontinuation.
13) Use Sho-saiko-to.
14) Use oral phenytoin.
15) Severe thyroid disease.
Target sample size 42

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Osamu Yokosuka
Organization Chiba University Hospital
Division name Department of Gastroenterology
Zip code
Address 1-8-1 Inohana, Chuou-ku, Chiba
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Sadahisa Ogasawara
Organization Chiba University Hospital
Division name Department of Gastroenterology
Zip code
Address
TEL
Homepage URL
Email ogasawaras@graduate.chiba-u.jp

Sponsor
Institute Chiba University Hospital
Institute
Department

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
2011 Year 06 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 No longer recruiting
Date of protocol fixation
2011 Year 05 Month 06 Day
Date of IRB
Anticipated trial start date
2011 Year 05 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 06 Month 01 Day
Last modified on
2013 Year 08 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006740

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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