200
Participants
Start Date
January 1, 2025
Primary Completion Date
January 1, 2027
Study Completion Date
January 1, 2027
Dual antibody A
Starting 2-6 weeks after surgery, synchronous TMZ radiotherapy and chemotherapy will be performed. After completing synchronous radiotherapy and chemotherapy for 28 days, TMZ combined with PD-1/VEGF dual antibody will be used as adjuvant therapy. PD-1/VEGF dual antibody 20mg/kg intravenous infusion once, with a cycle of 21 days.
Dual antibody B
Starting 2-6 weeks after surgery, synchronous TMZ radiotherapy and chemotherapy will be performed. After completing synchronous radiotherapy and chemotherapy for 28 days, TMZ combined with PD-1/CTLA-4 dual antibody will be used as adjuvant therapy. PD-1/CTLA-4 dual antibody 6mg/kg intravenous infusion once, with a cycle of 14 days.
Modified Stupp
Starting 2-6 weeks after surgery, synchronous TMZ radiotherapy and chemotherapy will be performed. For partially resected lesions or short-term recurrence and progression lesions after surgery, high-dose PGTV 66Gy/30Gy will be given locally. PTV1 in high-risk areas around the tumor bed will be 60Gy/30F, and in low-risk areas will be 54Gy/30F. After completing synchronous radiotherapy and chemotherapy for 28 days, 6 cycles of adjuvant TMZ chemotherapy will be started.
Stupp protocol
Synchronized TMZ radiotherapy and chemotherapy will begin 2-6 weeks after surgery, and 6 cycles of adjuvant TMZ chemotherapy will begin 28 days after completing the synchronized radiotherapy and chemotherapy. Radiotherapy regimen: PTV1 60Gy/30F in high-risk areas around the tumor bed, 54Gy/30F in low-risk areas. TMZ synchronous chemotherapy regimen: 75mg/m2 po qd. TMZ adjuvant chemotherapy regimen: The first cycle is 150mg/m2 po qd on d1-5,28 days; Cycle 2-6: Cycle 1: 200mg/m2 po qd for d1-5,28 days.
RECRUITING
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China, Hangzhou
Second Affiliated Hospital, School of Medicine, Zhejiang University
OTHER