Neoadjuvant treatment of recurrent high-grade gliomas with camrelizumab in combination with apatinib: A prospective phase II clinical study.

Abstract

2061 Background: High-grade gliomas exhibit extremely 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). Results: 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 27 patients completed adjuvant therapy with follow-up, and 1 patients continue on adjuvant therapy. As of January 14, 2026, median OS for all patients was 11.100 months (95% CI: 8.818 -13.382), with 1-year OS rate 46.4%. Median PFS was 4.870 months (95% CI: 4.351 – 5.389), with 6-month PFS rate 39.3%. The 22 patients with recurrent glioblastoma (rGBM) showed the median OS of 11.670 months (95% CI: 8.303 -15.037), and the 1-year OS rate was 50.0%. The median PFS was 5.070 months (95% CI: 4.381 -5.759), with the 6-month PFS rate of 40.9% in the rGBM subgroup. Historical neoadjuvant anti-PD1 monotherapy for rGBM yielded OS 13.9 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 superior to PD1 inhibitor monotherapy neoadjuvant treatment in rGBM patients. Clinical trial information: NCT04588987 .