Perioperative Surufatinib Plus Sintilimab Combined With Chemotherapy in Gastric/Gastroesophageal Junction Adenocarcinoma

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorFudan University

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

Treatment groups

20 Participants
are divided into 1 treatment group

Sponsors and collaborators