Chidamide + Regorafenib in Hepatocellular Carcinoma (HCC)
NCT05770882 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 7
Last updated 2025-03-11
Summary
This open-label, phase Ib/II, multicenter study evaluated the safety, tolerability, efficacy, and PK of chidamide in combination with regorafenib in patients with HCC. Chidamide, a histone deacetylase inhibitor, functions as a tumor inhibitor. Regorafenib, a receptor tyrosine kinase inhibitor, was approved as second-line systemic treatment for HCC patients.
Conditions
- Hepatocellular Carcinoma (HCC)
Interventions
- DRUG
-
Chidamide
Subjects will receive a single dose of chidamide. 5mg tablet. One dose every three days.
- DRUG
-
Subjects will receive a single dose of Regorafenib. 40mg tablet. One dose daily.
Sponsors & Collaborators
-
Great Novel Therapeutics Biotech & Medicals Corporation
lead INDUSTRY
Principal Investigators
-
Chia-Nan Chen, Ph.D. · Great Novel Therapeutics Biotech & Medicals Corporation
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-04-25
- Primary Completion
- 2025-01-17
- Completion
- 2025-01-17
Countries
- Taiwan
Study Locations
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