NCT06478927

Backline Treatment of Advanced Hepatocellular Carcinoma With Palbociclib

A Single-Arm, Prospective, Open Clinical Study of Palbociclib for Backline Treatment of Advanced Hepatocellular Carcinoma

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (estimated)
• Sponsor: Henan Cancer Hospital · Other Government
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Currently, it has been demonstrated that CDK4 is highly expressed in hepatocellular carcinoma patients and is significantly associated with poor prognosis in hepatocellular carcinoma patients. Palbociclib is the world's first marketed inhibitor of the cell cycle protein-dependent kinase CDK4/6, which is capable of blocking cell cycle progression and inhibiting tumor cell proliferation. However, current evidence for the use of CDK4/6 inhibitors in patients with advanced hepatocellular carcinoma cells remains lacking. This study used palbociclib backline treatment for patients with advanced hepatocellular carcinoma, aiming to further validate the potential role of CDK4/6 inhibitors in the treatment of patients with advanced hepatocellular carcinoma.

Detailed description

This study was a single arm, prospective, open clinical study. Twenty-two patients with advanced hepatocellular carcinoma were enrolled in this study and were simultaneously treated and observed with palbociclib. The efficacy and safety of palbociclib in patients with advanced hepatocellular carcinoma were evaluated by PFS, ORR, DCR, OS, and AE.

Conditions

• Hepatocellular Carcinoma

Interventions

Type	Name	Description
DRUG	Palbociclib capsules	Palbociclib capsules, oral, 125 mg/dose, qd, take 3 weeks and then stop for 1 week, 28d for one treatment cycle until disease progression or intolerable toxicity.

Timeline

• Start date: 2024-01-15
• Primary completion: 2026-01-15
• Completion: 2027-01-15
• First posted: 2024-06-27
• Last updated: 2024-06-27

Locations

1 site across 1 country: China