UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005697 |
|---|---|
| Receipt number | 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 11:24:20 |
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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
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
ogasawaras@graduate.chiba-u.jp
Sponsor or person
Institute
Chiba 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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006740
