RecruitingPhase I/IIInterventional

A clinical trial assessing the safety, tolerability and anti-tumour activity of the ITOP1 vaccination in patients with surgically resectable oesophageal adenocarcinoma

This study is looking at a new treatment called ITOP1, a type of 'vaccine' for oesophageal cancer. Unfortunately, this cancer often comes back after initial treatment. The ITOP1 vaccine aims to help your body's immune system 'mop up' any remaining cancer cells after chemotherapy and surgery, hopefully stopping the cancer from returning. This is the first time ITOP1 will be given to people. Researchers want to find out if it's safe, what side effects it might cause, and if there are early signs that it helps reduce the risk of cancer coming back. The study involves giving two doses of the vaccine at specific times during standard cancer treatment, without changing existing care. It's hoped this could improve how we treat oesophageal cancer in the future.

At a glance

Status

Recruiting

Phase

Phase I/II

Sponsor

University of Oxford

Enrolment target

Start

11 Nov 2025

Estimated completion

31 Oct 2026

Surgically resectable oesophageal adenocarcinoma deemed suitable for surgery and neoadjuvant/adjuvant chemotherapy

What is this study about?

When someone has oesophageal cancer, even after surgery and chemotherapy, there's a risk that the cancer might come back later. This trial, called VISTA, is looking for new ways to lower that risk for people who have had chemotherapy and surgery to remove their main tumour. It's investigating a new treatment called ITOP1, which works like a vaccine.

Think of a flu vaccine – it teaches your body's immune system to recognise and fight off the flu virus. In a similar way, the ITOP1 'cancer vaccine' uses a special technology to train your immune system. The goal is for your immune system to find and destroy any tiny cancer cells that might still be left in your body after treatment. This could stop these cells from growing into new cancers.

Because ITOP1 is a new treatment, this study is divided into two main parts (called phases). In the first phase, a small group of people will receive ITOP1 so doctors can carefully check if it's safe and what side effects it might cause. If it's found to be safe, more people will join the second phase. They will either receive ITOP1 or a saltwater solution (called saline), and doctors will compare the results to see if ITOP1 shows promise in preventing the cancer from returning.

Key takeaways

The VISTA trial is studying a new 'vaccine', ITOP1, for oesophageal cancer.
It aims to prevent cancer from returning after surgery and chemotherapy.
This is the first time ITOP1 is being tested in humans; safety is the main focus.
Participants will receive ITOP1 alongside their usual cancer treatment.
Your participation could help improve future treatments for oesophageal cancer.
The study has involved patients in its design to make it easier for people.

Who may be eligible?

This study is for adults aged 18 and over who have been diagnosed with a specific type of oesophageal or gastro-oesophageal junction cancer. It's important that your cancer can be removed by surgery and that your medical team believes surgery would be a good option for you with the aim of curing the cancer.

You also need to be well enough to receive treatment, which doctors measure using a scale that checks your daily activity levels. Your blood test results for your organs (like your liver and kidneys) and blood cells also need to be within healthy ranges.

There are also some reasons why you might not be able to join. For example, if you've recently taken part in another clinical trial with a new medicine or if you have certain medical conditions that might interfere with the study treatment.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years or older?
Do you have a specific type of oesophageal or gastro-oesophageal junction cancer?
Has your medical team decided that surgery is a good option for your cancer, aiming for a cure?
Are you well enough to undergo cancer treatments, as assessed by your doctor?
Are your routine blood test results for organs and blood cells generally healthy?
Have you not received any experimental treatments in another clinical study within the last four weeks?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive two injections of the ITOP1 vaccine during your standard treatment for oesophageal cancer. The first injection would be given about four weeks after your initial chemotherapy, before your surgery. The second injection would be given before your second round of chemotherapy, after you've recovered from surgery. This timing is chosen carefully so it doesn't interfere with your usual care.

Throughout the study, you would attend regular appointments at the hospital. These appointments will involve check-ups to see how you're feeling, blood tests, and possibly some extra scans like CT scans. These additional tests are needed to monitor how your body is reacting to the vaccine and to check for any signs of the cancer returning. The study is expected to run from December 2024 until October 2028, and you would be followed up for a period of time to see the long-term effects of the treatment.

Potential risks and benefits

It's important to understand that because ITOP1 is new, we don't know for sure if it will directly benefit you. However, by taking part, you would be helping doctors learn more about oesophageal cancer and potentially contribute to developing better treatments for future patients. Like all medical treatments, there are potential risks. As ITOP1 has not been given to people before, side effects are not fully known, but researchers will monitor you very closely. There's a small risk of discomfort, bruising, or bleeding from blood samples and a very small additional radiation risk from extra CT scans. The study team has taken many steps to reduce these risks, and they will explain everything clearly. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (4)

Churchill Hospital
Approximate
Oxford, England
St James's University Hospital
Approximate
Leeds, England
Southampton General Hospital
Approximate
Southampton, England
The Christie
Approximate
Manchester, England

Common questions

What is ITOP1?

ITOP1 is a new 'cancer vaccine' being tested to see if it can help stop oesophageal cancer from returning after standard treatment.

Will I still receive my normal cancer treatment?

Yes, you will still receive your standard chemotherapy and surgery as planned. The vaccine is given alongside these treatments.

What phase is this trial?

This is a Phase I/II trial. Phase I checks safety in a small group, and Phase II then looks at safety and early signs of effectiveness in more people.

What are the main risks?

The main risks are that ITOP1 hasn't been tried in humans before, so side effects are uncertain. There are also risks from blood tests and extra scans, which the team will monitor closely.

Who is running this study?

The study is being run from the University of Oxford and funded by Infinitopes.

How to find out more

OCTO VISTA Trial Team

OCTO-VISTA@oncology.ox.ac.uk - Official trial record

Always speak to your GP or specialist before deciding to take part in a study.