CTIM-13. NEOADJUVANT TREATMENT OF RECURRENT HIGH-GRADE GLIOMAS WITH CAMRELIZUMAB IN COMBINATION WITH APATINIB: A PROSPECTIVE PHASE II CLINICAL STUDY

Abstract BACKGROUND High-grade gliomas exhibit recurrent and resistant to treatments, and require urgent therapeutic innovation. This phase II trial presents preliminary results of neoadjuvant camrelizumab (PD-1 inhibitor) combined with apatinib (VEGFR2 TKI) for recurrent high-grade gliomas. METHODS This single-center, single-arm, phase II trial (NCT04588987) enrolled patients (age >18, KPS ≥60) with recurrent high-grade gliomas suitable for re-resection after prior STUPP therapy. Patients received i.v. camrelizumab 200mg (D1) and oral apatinib 250mg (D1-D7). Surgery was performed 1 week post-drug discontinuation. Adjuvant treatment with i.v. camrelizumab 200 mg every two weeks (from 2 weeks ± 5 days post-surgery) in combination with continuous oral apatinib 250 mg/d (from 4 weeks post-surgery) was administered until death/unacceptable toxicity. Primary endpoint: overall survival (OS). Secondary endpoints: 1-year OS rate, 6-/12-month PFS rates, time to progression (TTP), KPS, and adverse events (AEs). Result: From October 2020 to December 2024, 28 patients were enrolled (median age 42 years [range 23-62]; 22 glioblastoma, 4 anaplastic astrocytoma, 1 anaplastic oligodendroglioma, 1 gliosarcoma). The 24 patients completed adjuvant therapy with follow-up, and 4 patients continue on adjuvant therapy. As of May 28, 2025, median OS for all patients was 13.700 months (95% CI: 8.711-18.689), with 1-year OS rate 54.8%. Median PFS was 5.070 months (95% CI: 2.568-7.572), with 6-month PFS rate 47.6%. The 22 patients with recurrent glioblastoma (rGBM) showed the median OS of 15.370 months (95% CI: 4.493-26.247), and the 1-year OS rate was 61.5%. The median PFS was 8.330 months (95% CI: 2.941-13.719), with the 6-month PFS rate of 56.4% in the rGBM subgroup. Historical neoadjuvant anti-PD1 monotherapy for rGBM yielded OS 13.7 months and PFS 3.3 months (Nat Med, 2019). CONCLUSIONS Camrelizumab in combination with apatinib neoadjuvant therapy showed excellent efficacy in recurrent high-grade gliomas, and was significantly superior to PD1 inhibitor monotherapy neoadjuvant treatment in rGBM patients.