A phase I/II study in combination of YHI-1001 and Sorafenib in patients with advanced hepatocellular carcinoma previously untreated with systemic chemotherapy
Phase 1
- Conditions
- patients with advanced hepatocellular carcinoma previously untreated with systemic chemotherapy
- Registration Number
- JPRN-jRCT2080222078
- Lead Sponsor
- Yakult Honsha Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 164
Inclusion Criteria
(1)Patients with advanced or metastatic hepatocellular carcinoma
(2)Patients with ECOG PS of 0-1
(3)Patients who can be treated with oral medications and have no gastrointestinal function disorder which is considered to affect the absorption of medications
Exclusion Criteria
(1)Patients with a history of treatment with HDAC inhibitors
(2)Pregnant women and lactating mothers
(3)Patients with brain metastases or suspected brain metastases based on the clinical symptoms
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method