Ongoing, recruitingPhase II and Phase III (Integrated)Interventional

Nivolumab during active surveillance after neoadjuvant chemoradiation for esophageal cancer: SANO-3 study

This research, called the SANO-3 study, is investigating whether a medicine called nivolumab can help patients with oesophageal cancer after they've had chemotherapy, radiotherapy, and potentially surgery. The main goal is to see if nivolumab can prevent the cancer from returning, either in the original area or spreading to other parts of the body. This is measured by how long patients live without their cancer coming back. Researchers will also be looking at how many patients develop side effects and how severe these might be. The study is open to adults aged 18 and over, both men and women, who have been diagnosed with oesophageal cancer and have completed their initial treatment.

At a glance

Status

Ongoing, recruiting

Phase

Phase II and Phase III (Integrated)

Sponsor

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

Enrolment target

Start

30 Sep 2024

oesophageal cancer

What is this study about?

This study is called SANO-3 and it's looking into oesophageal (gullet) cancer. Oesophageal cancer is cancer that starts in the pipe that food passes through from your mouth to your stomach.

The study wants to find out if a medicine called nivolumab can help people who have already had treatment for their oesophageal cancer. This previous treatment usually involves chemotherapy (strong medicines to kill cancer cells), radiotherapy (using high-energy rays), and sometimes surgery to remove the cancer. After these treatments, some people may be under 'active surveillance', which means doctors carefully watch them for any signs that the cancer might be returning.

Nivolumab is being given to see if it can stop the cancer from coming back, either in the same area or in other parts of the body. The main thing the researchers are looking at is how long patients stay free from the cancer returning. They will also be very carefully monitoring any side effects that people might experience from the treatment.

Key takeaways

The study tests nivolumab to stop oesophageal cancer return.
It's for patients who've completed initial chemotherapy/radiotherapy.
Main goal: see how long patients live without cancer coming back.
Researchers will closely monitor for side effects.
Open to adults aged 18 and over, both men and women.

Who may be eligible?

To be able to take part in this study, you need to be an adult, at least 18 years old. Both men and women are welcome to participate.

Your doctor will also need to confirm that you have been diagnosed with oesophageal cancer and have already completed your initial treatment for it. This includes having had chemotherapy and/or radiotherapy.

There will be other detailed medical checks to make sure the study is a safe and suitable option for you. Your medical team will go through all the specific requirements with you.

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 old or older?
Have you been diagnosed with oesophageal cancer?
Have you already finished your initial chemotherapy and/or radiotherapy for your cancer?
Are you able to attend regular appointments for treatment and check-ups?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be given the study drug, nivolumab, as an infusion (drip) into your vein. Doctors will regularly check how you are doing, looking for any signs of the cancer returning and carefully monitoring for side effects. You will have regular appointments and tests, which might include scans and blood tests. This will help the study team keep a close eye on your health and how the treatment is working. We don't have the exact total duration or frequency of visits here, but all details would be explained clearly before you agree to join.

Potential risks and benefits

Taking part in any study has potential benefits and risks. A potential benefit of taking part in this study is that nivolumab might help prevent your oesophageal cancer from returning. However, it's also possible that the treatment may not work for everyone, and it won't be known if it helps until the study is complete. All medicines can have side effects, and nivolumab might cause some. These will be carefully monitored, and your study team will give you more detailed information about potential side effects. Remember, you can decide to stop participating at any time.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Netherlands

Common questions

What is oesophageal cancer?

Oesophageal cancer is cancer that starts in your gullet, which is the tube that carries food from your mouth to your stomach.

What is nivolumab?

Nivolumab is a medicine that helps your body's immune system fight cancer cells. It's given as a drip into your vein.

What does 'active surveillance' mean?

Active surveillance means doctors are carefully watching your health and doing regular checks to see if there are any signs of your cancer returning after treatment.

Why is this study being done?

This study aims to find out if nivolumab can help stop oesophageal cancer from coming back in patients who have already had chemotherapy and/or radiotherapy.

Will I get the actual study drug or a dummy drug?

The information provided doesn't specify if there's a dummy drug (placebo) arm. This is a crucial question to ask the study team if you're considering participation.