About this trial
For locally advanced gastric and gastroesophageal junction adenocarcinoma (cT3-4bNanyM0), perioperative PD-1 antibody combined with chemotherapy can downstage tumor stage, increase the R0 resection rate, and may improve the long-term survival. Combination of perioperative surufatinib, sintilimab and chemotherapy for locally advanced gastric and gastroesophageal junction adenocarcinoma could be a novel therapeutic strategy to increase response rate and therapeutic efficacy. Surufatinib, as the oral drug in this study is a small molecule kinase inhibitor that mainly acts on vascular growth factor receptor (VEGFR1, 2,3), fibroblast growth factor receptor 1(FGFR1) and colony stimulating factor 1 receptor (CSF1R). It is a proprietary product developed by Hutchison Whampoa Pharmaceutical (Shanghai, China) Co., LTD. Surufatinib has been approved for neuroendocrine tumor. This study is a monocenter, single-arm phase 2 clinical trial to evaluate tolerability, safety and efficacy of perioperative surufatinib in combination with sintilimab and chemotherapy in locally advanced gastric and gastroesophageal junction adenocarcinoma.
Eligibility criteria
Qualifiers
signed informed consent
patients age 18-75 years;
Histologically CT/MRI confirmed cT3-4bNanyM0 gastric or GEJ adenocarcinoma;
ECOG 0-1, no surgery contraindications;
Disqualifiers
signs of distant metastases
Prior chemotherapy, radiotherapy, surgery for gastric cancer;
Significant cardiovascular disease
major surgical procedure within 4 weeks prior to initiation of study treatment
Trial design
Treatments tested in this trial
- Surufatinib
- Sintilimab
- Oxaliplatin
- S1