Low-dose apatinib combined with camrelizumab and the SOX regimen in the neoadjuvant treatment of locally advanced gastric/gastroesophageal junction adenocarcinoma (SPACE-neo): a protocol for an open-label, single-arm, clinical trial

Abstract

Background: Neoadjuvant chemotherapy with S-1 plus oxaliplatin (SOX regimen) has shown promising results in pathological response rate and survival rate in patients with locally advanced resectable gastric cancer (LAGC). We previously carried out the SPACE study to assess efficacy and safety of low-dose apatinib combined with camrelizumab and the SOX regimen as a first-line treatment of advanced gastric/ gastroesophageal junction adenocarcinoma (AGC/GEJC). The preliminary results demonstrated a high objective response rate. However, the SPACE study was conducted in patients with AGC, but the efficacy of LAGC patients is not yet known. The SPACE-neo study is designed to investigate whether this combination could improve outcomes in patients with locally advanced gastric/gastroesophageal junction cancer (LAGC/ GEJC) as neoadjuvant therapy.Methods: SPACE-neo is a prospective, open-label, single-arm study conducted in China at the First Affiliated Hospital of Nanjing Medical University (Jiangsu Province Hospital). Thirty-two patients with human epidermal growth factor receptor 2 (HER2)-negative or HER2-unknown LAGC/GEJC confirmed by histopathology or cytology will be recruited. Included patients shall be clinically staged as M0 and either T3 to T4 or N+ assessed by ultrasound endoscopy and thoracoabdominal-enhanced computed tomography or magnetic resonance imaging. The patients will receive three cycles of this combined regimen as a neoadjuvant treatment. Each patient will receive screening visits within 2 weeks before the first cycle and planned visits before every cycle of treatment. Key monitoring data include imaging data, pathological findings, and adverse events associated with neoadjuvant and surgical treatment. The primary endpoints are major pathological response (MPR) and safety. MPR is the proportion of patients whose residual tumor cells

Camrelizumab and apatinib combined with chemotherapy in perioperative effective therapy for advanced gastric carcinoma with peritoneal metastasis: a case report

“…Several studies have demonstrated that apatinib could shorten the onset time and potentiate the anti-tumor effects of camrelizumab across various types of solid tumors, including advanced hepatocellular carcinoma, cervical cancer, lung cancer, and osteosarcoma ( 18 , 24 - 27 ). Peng et al investigated the effects of camrelizumab in combination with CAPOX followed by camrelizumab plus apatinib therapy on advanced GC patients and revealed encouraging anti-tumor activity and manageable toxicity ( 28 ), Pan et al also evaluated the efficacy and safety of apatinib in combination with camrelizumab and the SOX regimen as a first-line treatment for advanced gastric/gastro-oesophageal junction adenocarcinoma and the results showed a high objective response rate (ORR) ( 29 ). Therefore, camrelizumab in combination with apatinib has strong clinical data to support the treatment of GC.…”