NCT07300488

Efficacy and Safety of Pracytarabine Versus Regorafenib in the Treatment of Patients With Hepatocellular Carcinoma

Randomized, Controlled, Open-Label, Multicenter Phase Ⅱ/Ⅲ Seamless Adaptive Design Registration Clinical Trial of Pracytarabine Versus Regorafenib for Advanced Hepatocellular Carcinoma After Failure of Targeted Drugs and Immune Checkpoint Inhibitors or Dual Immune Checkpoint Inhibitors Therapy

• Status: Active Not Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Xi'an Xintong Pharmaceutical Research Co.,Ltd. · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 2/3 study evaluating the efficacy and safety of Pracytarabine versus regorafenib in patients with advanced hepatocellular carcinoma (HCC) who have experienced treatment failure with standard systemic therapies involving targeted drugs and immune checkpoint inhibitors, or dual immune checkpoint inhibitors.

Conditions

• HCC

Interventions

Type	Name	Description
DRUG	Pracytarabine	Pracytarabine 1200 mg/m²/d, administered as a continuous intravenous infusion for 7 days (Days 1 to 7), followed by a 21-day treatment-free observation period; each treatment cycle is 4 weeks.
DRUG	regorafenib	Regorafenib 160 mg, once daily, administered continuously for 3 weeks followed by 1 week of rest, i.e., each cycle is 4 weeks.

Timeline

• Start date: 2025-09-01
• Primary completion: 2027-02-28
• Completion: 2027-04-30
• First posted: 2025-12-23
• Last updated: 2025-12-31

Locations

1 site across 1 country: China