Radiotherapy/Apatinib for Adjuvant Treatment of HCC Patients receIved Curative reSEction With Microvascular Invasion
Last updated on July 2021Recruitment
- 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