Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Apatinib
  • Hepatectomy
  • Hepatocellular Carcinoma
  • Radiotherapy
Type
Interventional
Phase
Phase 2
Design
Allocation: RandomizedIntervention Model: Factorial AssignmentIntervention Model Description: 2X2 factorial designMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 75 years
Gender
Both males and females

Description

RAISE trial will recruit 160 patients, and they will be randomized (1:1:1:1) to four groups (radiotherapy group, apatinib group, radiotherapy+apatinib group and control group). Patients in radiotherapy group will receive Intensity Modulated Radiation Therapy (IMRT) at a dose of 50Gy/25fraction after...

RAISE trial will recruit 160 patients, and they will be randomized (1:1:1:1) to four groups (radiotherapy group, apatinib group, radiotherapy+apatinib group and control group). Patients in radiotherapy group will receive Intensity Modulated Radiation Therapy (IMRT) at a dose of 50Gy/25fraction after randomization. Patients in apatinib group will receive oral apatinib at an initial dose of 500mg/qd until recurrence, patient withdrawal or unacceptable toxic effects. Patients in radiotherapy+apatinib group will receive Intensity Modulated Radiation Therapy (IMRT) at a dose of 50Gy/25fraction after randomization and after radiotherapy they will receive oral apatinib at an initial dose of 500mg/qd until recurrence, patient withdrawal or unacceptable toxic effects. Patients on the control arm will be actively monitored after randomization.

Tracking Information

NCT #
NCT03732105
Collaborators
Not Provided
Investigators
Study Chair: Ming Kuang, PhD First Affiliated Hospital, Sun Yat-Sen University