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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000004215 |
Receipt No. | R000005065 |
Scientific Title | Safety and Efficacy Study of Sorafenib in Japanese Child-Pugh A and B Patients with Advanced Hepatocellular Carcinoma |
Date of disclosure of the study information | 2010/10/01 |
Last modified on | 2016/07/27 |
Basic information | ||
Public title | Safety and Efficacy Study of Sorafenib in Japanese Child-Pugh A and B Patients with Advanced Hepatocellular Carcinoma | |
Acronym | Safety and Efficacy Study of Sorafenib in Japanese patients with Advanced Hepatocellular Carcinoma | |
Scientific Title | Safety and Efficacy Study of Sorafenib in Japanese Child-Pugh A and B Patients with Advanced Hepatocellular Carcinoma | |
Scientific Title:Acronym | Safety and Efficacy Study of Sorafenib in Japanese patients with Advanced Hepatocellular Carcinoma | |
Region |
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Condition | ||
Condition | Advanced Hepatcellular Carcinoma | |
Classification by specialty |
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Classification by malignancy | Malignancy | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | To evaluate the efficacy and safety of Sorafenib for Japanese Child-Pugh A and B patients with advanced hepatocellular carcinoma. |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | Exploratory |
Trial characteristics_2 | |
Developmental phase | Phase II |
Assessment | |
Primary outcomes | Time to Progression (TTP) |
Key secondary outcomes |
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 |
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Interventions/Control_1 | Sorafenib 400mg twice daily | |
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 |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | 1)Age >= 20 years
2)Patients who have been diagnosed with hepatocellular carcinoma by histologycally or typical diagnostic images 3)No indication for surgical resection, local thrapy(Percutaneous ethanol injection, radiofrequency ablation, microwave coagulation therapy, transcatheter arterial chemoembolization, radiation therapy) 4)Child-Pugh A or B 5)Performance status (ECOG scale): 0,1 or 2 6)Life expectancy of at least 12 weeks 7)At least 1 target lesion measurable 8)Adequate organ function |
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Key exclusion criteria | 1)Second primary malignancy
2)Severe cardiac complication 3)Active infection 4)HIV infection 5)Encephalopacy 6)Gastro-esophazeal varices requiring preventive treatment 7)Uncontrolled massive ascitis |
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Target sample size | 100 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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Organization | Chiba University Hospital | ||||||
Division name | Department of Gastroenterology | ||||||
Zip code | |||||||
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TEL | |||||||
Homepage URL | |||||||
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 | |
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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 |
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Related information | |
URL releasing protocol | |
Publication of results | Published |
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 | Completed | ||||||
Date of protocol fixation |
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Date of IRB | |||||||
Anticipated trial start date |
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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 |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005065 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |