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Efficacy and Safety of Pracytarabine Versus Regorafenib in the Treatment of Patients With Hepatocellular Carcinoma
Sponsor: Xi'an Xintong Pharmaceutical Research Co.,Ltd.
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2025-09-01
Completion Date
2027-04-30
Last Updated
2025-12-31
Healthy Volunteers
No
Conditions
Interventions
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.
regorafenib
Regorafenib 160 mg, once daily, administered continuously for 3 weeks followed by 1 week of rest, i.e., each cycle is 4 weeks.
Locations (1)
Nanjing Tianyinshan Hospital
Nanjing, Jiangsu, China