UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002418 |
|---|---|
| Receipt number | R000002962 |
| Scientific Title | Combination chemotherapy of sorafenib and S-1 in patients with advanced hepatocellular carcinoma: phase I trial |
| Date of disclosure of the study information | 2009/09/01 |
| Last modified on | 2013/09/02 08:57:59 |
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Basic information
Public title
Combination chemotherapy of sorafenib and S-1 in patients with advanced hepatocellular carcinoma: phase I trial
Acronym
Combination chemotherapy of sorafenib and S-1 in patients with advanced hepatocellular carcinoma: phase I trial
Scientific Title
Combination chemotherapy of sorafenib and S-1 in patients with advanced hepatocellular carcinoma: phase I trial
Scientific Title:Acronym
Combination chemotherapy of sorafenib and S-1 in patients with advanced hepatocellular carcinoma: phase I trial
Region
| Japan |
Condition
Condition
Hepatocellular carcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the safety of the combination chemotherapy of sorafenib and S-1 in patients with advanced hepatocellular carcinoma, and to determine recommended dose of sorafenib and S-1.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
Incident of dose-limiting toxicity
Key secondary outcomes
Adverse events
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
The combination chemotherapy of sorafenib and S-1
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) hepatocellular carcinoma confirmed by dynamic CT or dynamic MRI and AFP or PIVKA-II is over the institutional upper limit, or histologically confirmed hepatocellular carcinoma
2) no indication for transplantation, surgical resection, local ablation or transcatheter arterial embolization.
3) Child-Pugh A
4) >=20 years old
5) ECOG Performance Status 0 or 1
6) oral intake is possible
7) no preceded systemic chemotherapy (excluded adjuvant chemotherapy)
8) more than one measurable disease
9) Adequate baseline organ function:
neutrophil > 1,500/mm3, hemoglobin >=10.0g/dl, platelets > 75,000/mm3, serum bilirubin <=1.5 times of the institutional upper limit, aspartate aminotransferase and alanine aminotransferase <=5 times of the institutional upper limit, serum creatinine <1.5 mg/dL and creatinin clearance >=50ml/min
10) life expectancy >=12 weeks
11) written informed consent
Key exclusion criteria
1) histrogically confirmed combined type hepatocellular carcinoma or sarcomatous change
2) previous therapy for hepatocellular carcinoma within 30 days
3) preceded chemotherapy used sorafenib or 5-FU (excluded transcatheter arterial embolization or adjuvant chemotherapy)
4) inadequate for administration of sorafenib or S-1
5) active double cancer
6) active infection (excluded viral hepatitis)
7) water diarrhea
8) severe complication
9) refractory ascites of pleural effusion
10) metastases to central nervous system
11) pregnancy or lactaing females
12) inappropriate for entry onto this study in the judgment of the investigator
Target sample size
21
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shuichi Kaneko |
Organization
Kanazawa University Hospital
Division name
Department of Gastroenterology
Zip code
Address
13-1 Takara-Machi, Kanazawa, Ishikawa
TEL
076-265-2233
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tatsuya Yamashita |
Organization
Kanazawa University Hospital
Division name
Department of Gastroenterology
Zip code
Address
13-1 Takara-machi, Kanazawa, Ishikawa
TEL
076-265-2861
Homepage URL
ytatsuya@m-kanazawa.jp
Sponsor or person
Institute
Kanazawa 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
金沢大学病院（石川県）
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 09 | 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 | 08 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 08 | Month | 31 | Day |
Last modified on
| 2013 | Year | 09 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002962
