UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000002418
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email

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
Email ytatsuya@m-kanazawa.jp

Sponsor
Institute Kanazawa 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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002962

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.