The pilot study NEO-CREATE, led by study chair Dr Amitesh Roy, aims to assess the safety of adding the immunotherapy drug avelumab to chemo-radiation using two standard chemotherapy drugs, carboplatin and paclitaxel, before surgery in patients with cancers of the oesophagus or the gastro-oesophageal junction.
“NEO-CREATE is a feasibility study with a safety lead-in investigating the role of immunotherapy in conjunction with chemotherapy and radiotherapy in the early stage of oesophagus and gastro-oesophageal junction cancers,” says Dr Roy.
According to the current standard of care, chemoradiotherapy treatment is given to patients before surgery. As well as assessing the safety, tolerability and feasibility of the treatment, researchers want to establish primary efficacy by way of looking at the effect of immunotherapy on the tumour by analysing the tumour sample after the surgery.
“The idea for AGITG to create the Endorsed Study Model was to proactively engage with the investigators conducting pilot trials, for example, and those trials which are possibly sponsored by the local institutions but not by AGITG,” says Dr Roy.