UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001496 |
|---|---|
| Receipt number | R000001809 |
| Scientific Title | A phase 1 study of the combination chemotherapy of sorafenib with cisplatin transcatheter arterial infusion for advanced hepatocellular carcinoma. |
| Date of disclosure of the study information | 2008/12/02 |
| Last modified on | 2014/01/21 19:57:27 |
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Basic information
Public title
A phase 1 study of the combination chemotherapy of sorafenib with cisplatin transcatheter arterial infusion for advanced hepatocellular carcinoma.
Acronym
Sorafenib with CDDP-TAI for HCC (phase 1 study).
Scientific Title
A phase 1 study of the combination chemotherapy of sorafenib with cisplatin transcatheter arterial infusion for advanced hepatocellular carcinoma.
Scientific Title:Acronym
Sorafenib with CDDP-TAI for HCC (phase 1 study).
Region
| Japan |
Condition
Condition
advanced hepatocellular carcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of safety and dose-finding study of combination chemotherapy with sorafenib and cisplatin transcatheter arterial infusion for 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
The combination chemotherapy of sorafenib with transcatheter arterial infusion of cisplatin.
Sorafenib 400mg bid.
6 courses of transcatheter arterial infusion of cisplatin every 4-6 weeks.
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
Patients eligible for study entry have advanced HCC, for whom surgical resection, local ablation therapy, transcatheter arterial chemoembolization are not indicated. The diagnosis was made by either histologic examination or typical computed tomographic scans, angiographic findings and elevated serum AFP/PIVKA-II level. Eligibility criteria included the following factors: age 20-79 years; an Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2; bidimensionally measurable disease; adequate hematologic function (hemoglobin level >= 8.5 g/dL, neutrophil count >= 1,500 cells/mm3, and platelet count >= 70,000 cells/mm3); adequate hepatic function (serum total bilirubin level <= 2.0 mg/dL, serum albumin level >= 2.8 g/dL, and serum aspartate aminotransferase (AST)/alanine aminotransferase(ALT) levels within 5 times of normal limit, Child-Pugh grade within 7 points); adequate pancreatic function (serum total amylase/lipase levels within 2 times of normal limit); adequate renal function (serum creatinine level within normal limits and creatinine clearance >= 60 mL per minute); Previous local therapy for intrahepatic lesions before this treatment, such as hepatic resection, percutaneous local ablation, or transcatheter arterial chemoembolization, was allowed if it had not been done within the previous 4 weeks. And written informed consent.
Key exclusion criteria
The exclusion criteria were history of chemotherapy with sorafenib or cisplatin, active infection, uncontrollable hypertension, severe heart disease, refractory pleural effusion or ascites, severe mental disorder or encephalopathy, active gastroduodenal ulcer or esophageal bleeding, active concomitant malignancy, pregnant and lactating females, females of childbearing age unless using effective contraception, and other serious medical conditions.
Target sample size
21
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takuji Okusaka |
Organization
National Cancer Center Hospital
Division name
Hepatobiliary and Pancreatic Oncology Division
Zip code
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan
TEL
03-3542-2511
tokusaka@ncc.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takuji Okusaka |
Organization
National Cancer Center Hospital
Division name
Hepatobiliary and Pancreatic Oncology Division
Zip code
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan
TEL
03-3542-2511
Homepage URL
http://www.ncc.go.jp/jp/
tokusaka@ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital
Institute
Department
Personal name
Funding Source
Organization
The Ministry of Health, Labour and Welfare, Japan
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
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
| 2008 | Year | 12 | Month | 02 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://onlinelibrary.wiley.com/journal/
Number of participants that the trial has enrolled
Results
The combination of sorafenib at 800 mg/day with TAI of cisplatin at 65 mg/m2/cycle was determined to be the recommended regimen.
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
Completed
Date of protocol fixation
| 2008 | Year | 08 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
| 2014 | Year | 01 | Month | 13 | Day |
Date trial data considered complete
| 2014 | Year | 01 | Month | 13 | Day |
Date analysis concluded
| 2014 | Year | 01 | Month | 13 | Day |
Other
Other related information
Management information
Registered date
| 2008 | Year | 11 | Month | 11 | Day |
Last modified on
| 2014 | Year | 01 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001809
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