A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of Atezolizumab with or without Tiragolumab (Anti-Tigit Antibody) in Patients with Unresectable Esophageal Squamous Cell Carcinoma whose Cancers have not Progressed following Definitive Concurrent Chemoradiotherapy
This Phase III clinical trial is testing whether immunotherapy drugs can help people with oesophageal squamous cell carcinoma (a type of gullet cancer) that cannot be operated on. Participants must have recently finished standard chemoradiotherapy without their cancer worsening. Immunotherapy works by helping your body's immune system recognize and fight cancer cells. In this trial, researchers are comparing standard care to either one immunotherapy drug (atezolizumab) or a combination of two immunotherapy drugs (atezolizumab and tiragolumab). To make the comparison fair, some participants may receive dummy treatments (placebos). The main goal is to find out if these new drug combinations can delay cancer growth, improve overall survival, and protect quality of life better than standard monitoring alone.
At a glance
What is this study about?
The oesophagus, or gullet, is the tube that carries food from your mouth down to your stomach. When cancer develops in the lining of the gullet, it can be difficult to treat, especially if doctors are unable to remove it safely with surgery. The usual treatment for this is chemoradiotherapy, which is chemotherapy combined with radiotherapy. While this can shrink or control the tumour, doctors are actively looking for ways to stop the cancer from growing back.
This trial investigates a type of cancer treatment called immunotherapy. Instead of attacking cancer cells directly like chemotherapy, immunotherapy trains your own immune system to spot and destroy cancer cells. This study tests two specific immunotherapy drugs: atezolizumab (Tecentriq) and tiragolumab. Researchers want to see whether giving these drugs after chemoradiotherapy works better than receiving a dummy treatment (placebo).
Taking part in this study helps researchers understand whether adding one or both of these immunotherapy medicines can keep people free from cancer for longer, help them live longer overall, and maintain their day-to-day quality of life. The results could help shape future NHS treatments for people facing this type of cancer.
Key takeaways
- A study testing two immunotherapy drugs for gullet cancer that cannot be removed by surgery.
- Open to adults whose cancer has not worsened following chemoradiotherapy.
- Aims to find out if immunotherapy can delay cancer recurrence and improve survival.
- Given as a regular drip at the hospital alongside health monitoring and scans.
- Participation is completely voluntary, and you can withdraw at any time.
Who may be eligible?
This trial is open to adults aged 18 and older who have been diagnosed with oesophageal squamous cell carcinoma (cancer of the gullet) that cannot be treated with surgery.
To take part, your cancer must not have grown or spread after completing standard chemoradiotherapy (a combination of chemotherapy and radiotherapy). Your doctor will run scans to confirm that your cancer is currently stable or shrinking.
People who have had their tumour completely removed with surgery, or whose cancer has continued to grow despite chemoradiotherapy, will not be able to join. You will also need to be reasonably active and well enough to attend regular hospital appointments.
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.
- I am aged 18 or over.
- I have been diagnosed with oesophageal squamous cell carcinoma.
- My cancer cannot be removed with surgery.
- I have recently completed chemoradiotherapy (chemo plus radiation).
- My most recent scans show my cancer has not grown or spread.
What does participation involve?
If you take part, you will be placed into a treatment group by chance (randomised). You might receive both active immunotherapy drugs, one active drug with a dummy drip (placebo), or two dummy drips. Neither you nor your doctor will know which group you are in, which ensures the test remains fair. All treatments are given directly into a vein through a drip (intravenous infusion) at the hospital.
You will visit the clinic every few weeks for treatment and checks. During these visits, doctors will run blood tests, perform physical exams, and occasionally carry out CT or MRI scans to monitor the cancer. You will also fill out short questionnaires about how you feel and whether you have any swallowing difficulties. Treatment usually continues for up to a year or as long as the cancer does not worsen and side effects remain manageable.
Potential risks and benefits
Locations (9)
- —UnverifiedBelgium
- —UnverifiedSpain
- —UnverifiedAustria
- —UnverifiedGreece
- —UnverifiedPoland
- —UnverifiedPortugal
- —UnverifiedItaly
- —UnverifiedFrance
- —UnverifiedGermany
Common questions
What is a placebo and why is it used?
A placebo is a harmless dummy treatment, like salt water in a drip, with no active medicine. It is used so researchers can clearly tell if the new drugs are genuinely effective compared to receiving no additional treatment.
Can I choose which treatment group I join?
No. A computer assigns you to a group by chance. This process is called randomisation and is essential to ensure the study results are completely unbiased.
Will I have to pay for the trial drugs?
No. In the UK, all trial medications, extra scans, and study-related tests are provided free of charge.
How long will I be in the study?
You will usually receive treatment for up to a year, provided your cancer remains stable and side effects are manageable. The study team will then monitor your health for several years afterwards.
What happens if I feel unwell during the trial?
You will be given contact details for the study team. You can reach out at any time, and your doctors can pause or stop the treatment to protect your health if needed.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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