Lay Summary
Unfortunately, it is very common for patients with oesophageal cancer for their cancer to return at a later date. The VISTA trial aims at reducing this risk for those patients with oesophageal cancer who have received an initial course of chemotherapy and then had their main tumour removed by surgery.
VISTA will investigate a new cancer vaccine called ITOP1, which uses virus-based technology. A cancer vaccine is similar to those given for seasonal flu and is made up of dead/weakened germs to train the immune system to protect against future infection. ITOP1 aims to help the immune system ‘mop up’ any cancer cells still in the body after treatment and prevent them from developing into new cancers.
ITOP1 has not been used on patients before, and VISTA is designed to look at its safety, any side effects the vaccine may cause, and early signs of the vaccine’s potential to prevent cancer from coming back.
The current UK standard of care for newly diagnosed treatment of oesophageal cancer is based on a course of chemotherapy given before the primary tumour is removed by surgery, followed by further chemotherapy once the patient has fully recovered from surgery.
The first (prime) injection of the ITOP1 dose will be given 4 weeks after the first course of chemotherapy and before the surgery. A second (boost) dose injection would be given before the second course of chemotherapy. This ensures that it would not harm the standard of care that the patients can expect to receive. The aim of ITOP1 is that once the main tumour is removed, the body's immune response will be triggered by the vaccine and prevent the cancer from returning or spreading, which is the cause of the majority of oesophageal cancer deaths.
The trial will be conducted in two phases and a total of 60 participants will be enrolled. In Phase I, 8 patients will receive the ITOP1 vaccine, and a safety review will be conducted before moving to Phase II. In Phase II, 52 patients will be randomly assigned to receive either the ITOP1 vaccine or a placebo (sterile normal saline).
