Tips-13 a phase ii study of neoadjuvant camrelizumab and apatinib in patients with recurrent high-grade gliomas

Abstract BACKGROUND A single arm clinical trial (NCT04588987) about combination therapy of programmed cell death protein 1 blockades camrelizumab with antiangiogenic agent apatinib has been initiated to investigate their effectiveness for patients with recurrent high-grade Gliomas (HGG). METHODS Patients with recurrent HGG will receive single-dose intravenous injection of camrelizumab (200 mg) and daily oral administration of apatinib (250 mg/day for 7 days) 14 days before surgery for recurrent tumor. Sequential therapy will begin 2 weeks after surgery with the biweekly injection of camrelizumab and 4 weeks after surgery with the daily administration of apatinib. RESULTS Up to date (March 9, 2023), 18 patients are enrolled (13 for recurrent glioblastomas and 5 for anaplastic astrocytoma), with a medial follow-up time is 19 months. The median cycles of postoperative combination therapies were 4.5 cycles (95%CI: 3.87-5.12 ), with median progression-free survival of 4.0 months (95%CI: 2.78-5.28 ). One patient (1/18, 5.5%) discontinue the combination treatment because the patient often underwent the extended periods of hospitalization because of unacceptable liver dysfunction, and the other patient (1/18, 5.5%) withdraw the from the trail after receiving the surgery. All enrolled patients appeared one or more treatment-related adverse effects. The most common adverse effects were constipation(58%), hypertension (52%), leukocytopenia (52%), and nausea (47%). CONCLUSION the short-term results indicated that the combination therapy might be beneficial for patients with recurrent HGG and improve the patients’ overall survivals. We will present our detailed progress and results on the conference.