NCT05770882

Chidamide + Regorafenib in Hepatocellular Carcinoma (HCC)

A Phase Ib/II, Two-part, Non-randomized, Open-label Study to Evaluate the Safety, Tolerability, Efficacy, and Pharmacokinetics of Chidamide in Combination With Regorafenib in Patients With Hepatocellular Carcinoma

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Great Novel Therapeutics Biotech & Medicals Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is an open-label, multicenter, phase Ib/II study, which includes a Part I (phase Ib) and a Cohort Expansion part (Part II; phase II). Part I of the study is designed to assess the safety, tolerability, PK profiles, efficacy, and PD biomarkers of the study medications in patients with HCC. Part II of the study is designed to assess the efficacy, safety, and PD biomarkers.

Conditions

• Hepatocellular Carcinoma (HCC)

Interventions

Type	Name	Description
DRUG	Chidamide	Subjects will receive a single dose of chidamide. 5mg tablet. One dose every three days.
DRUG	Regorafenib	Subjects will receive a single dose of Regorafenib. 40mg tablet. One dose daily.

Timeline

• Start date: 2023-04-25
• Primary completion: 2025-01-17
• Completion: 2025-01-17
• First posted: 2023-03-16
• Last updated: 2025-03-11

Locations

5 sites across 1 country: Taiwan