1070 - Induction-Concurrent Chemoradiotherapy with or without Camrelizumab for Postoperative Residual High-Grade Gliomas: An Open, Randomized, Phase II Clinical Study

Purpose/Objective(s):

The aim of this study was to explore whether camrelizumab-induced chemotherapy with concurrent chemoradiotherapy and adjuvant therapy improves overall survival, the recent efficacy and the incidence of adverse events in patients with residual high-grade gliomas after surgery.

Materials/Methods:

All patients were pathologically and molecularly pathologically confirmed patients with grades WHO III and IV gliomas, imaging-confirmed residual post-surgical lesions =1 cm, and patients who had not been treated with radiotherapy or chemotherapy.After enrollment, patients were randomly assigned(1:1) to the experimental group or the standard therapy group, Treatment regimen:?the standard therapy group:Received temozolomide combined with simultaneous chemoradiotherapy and temozolomide adjuvant chemotherapyand. ?the experimental group:Received induction chemotherapy with camrelizumab (200 mg) starting 2 weeks after surgery, and the standard therapy with 200 mg of camrelizumab intravenously once every 3 weeks for 8 cycles (comprising two induction, two concurrent to radiotherapy, and six adjuvant cycles);The primary endpoint was the two-year overall survival rate, and the secondary endpoints included short-term efficacy and adverse reactions. The overall survival rate at 2 years after the end of treatment was calculated by using the Kaplan-Meier method,and the adverse effects were evaluated by using the CTCAE 5.0, Whether there is a difference in recent efficacy between the standard therapy group and the experimental group.

Results:

A total of 49 patients were enrolled in the study, 24 in the camrelizumab group and 25 in the standard therapy group, and the median age of the two groups was 46.08±16.46 and 46.6±13.52 years, respectively, and both groups were predominantly grade IV (glioblastoma). Preliminary results showed that in this study, the ORR of the camrelizumab group was significantly higher compared to the standard therapy group (42% vs. 12%, p=0.023 ), and the 2-year overall survival rate of the experimental group had a tendency to increase compared to that of the control group (58.3% vs. 46.8%), and the difference was not statistically significant (p=0.139).The incidence of leukopenia in the experimental group was 37.5%, significantly lower than the 72% observed in the control group, with a statistically significant difference (p=0.015). While the experimental group showed decreasing trends in thrombocytopenia, neutropenia, and anemia compared to the control group, these differences did not reach statistical significance (p > 0.05).

Conclusion:

The findings from a prospective randomized clinical trial suggest that patients with postoperative residual high-grade gliomas, camrelizumab induction chemotherapy combined with the standard treatment regimen showed a trend toward improving 2-year overall survival (OS) and significantly increased the objective response rate (ORR). The adverse reactions in patients were mild and well-tolerated.