A randomized, open, Phase II comparison of the safety and efficacy of a reduced and re-escalated dose of sorafenib versus a reduced and maintained dose of sorafenib in patients with advanced hepatocellular carcinoma.
Not Applicable
- Conditions
- Hepatocellular carcinoma
- Registration Number
- JPRN-UMIN000014566
- Lead Sponsor
- Chiba university hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 114
Inclusion Criteria
Not provided
Exclusion Criteria
1) History of a primary tumor diagnosed in the past 3 years 2) Presence of active bacterial infections, HIV/AIDS, or other diseases that would preclude study participation 3) Presence of uncontrolled or significant cardiovascular disease 4) Regular phenytoin or warfarin use 5) Presence of mental incapacity or psychiatric illness.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time to progression after randomization
- Secondary Outcome Measures
Name Time Method Overall Survival Overall survival after randomization; OS after randomization Time to progression Drug concentration of sorafenib Safety