HERES trial: Trastuzumab and standard treatment with chemo- and immunotherapy as first line treatment for HER2 positive esophageal squamous cell carcinoma patients
This clinical trial is testing a new combination of treatments for people diagnosed with cancer of the oesophagus (the food pipe). Standard care usually involves chemotherapy along with an immunotherapy drug called pembrolizumab. In this trial, researchers want to see if adding a targeted medicine named trastuzumab (Trazimera) works even better. Trastuzumab targets a specific protein on some cancer cells called HER2. If cancer has high levels of HER2, it is called 'HER2 positive'. Researchers hope that combining this targeted drug with standard medicines will help shrink tumours and stop them from growing. The study aims to find out how well the treatment works and whether it is safe, so doctors can decide if it should be tested in larger groups of patients in the future.
At a glance
What is this study about?
Cancer of the oesophagus affects the food pipe, which carries food and liquid from your throat down into your stomach. For people who need treatment to control this cancer, doctors often use a mix of standard chemotherapy drugs and immunotherapy. Immunotherapy works by helping your body's own natural immune system recognise and attack cancer cells. While these medicines can help, doctors are always looking for better ways to improve how well they work.
Some oesophageal cancers have high levels of a protein called HER2 on the surface of their cells. This protein can cause cancer cells to grow and spread more quickly. Trastuzumab is a medicine that specifically tracks down and blocks the HER2 protein, which can help slow down or stop cancer growth. While trastuzumab is already used for other cancers, such as breast cancer and stomach cancer, researchers want to learn if it helps in oesophageal squamous cell cancer too.
In this Phase II trial, doctors are giving trastuzumab alongside standard chemotherapy and immunotherapy to a small group of patients. By closely tracking how many tumours shrink, the research team hopes to learn whether this treatment combination is safe, effective, and worth studying in larger trials. This could help shape future first-line treatments for people with this type of cancer.
Key takeaways
- Tests a new combination of targeted therapy, immunotherapy, and chemotherapy.
- Aimed at adults with HER2-positive cancer of the food pipe (oesophagus).
- Designed for people receiving their first line of treatment for advanced cancer.
- Requires regular hospital visits for drips, blood tests, and scans.
- Participation is entirely voluntary and you can stop at any time.
Who may be eligible?
This trial is open to adults aged 18 and older who have been diagnosed with a specific type of oesophageal cancer called squamous cell carcinoma. To take part, your cancer must be tested to confirm that it has higher than normal amounts of the HER2 protein (HER2 positive).
The trial is designed for people who are starting their first round of treatment for advanced cancer, meaning you have not yet received chemotherapy or immunotherapy for this stage of the illness. Both men and women can participate, provided they are well enough to carry out daily activities and undergo standard cancer treatments.
You may not be able to take part if you have already had certain cancer treatments, if your cancer is not HER2 positive, or if you have other serious medical conditions affecting your heart, liver, or kidneys. Your hospital cancer team will run tests to confirm whether this study is safe and suitable for 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.
- I am 18 years of age or older.
- I have been diagnosed with oesophageal squamous cell carcinoma.
- My cancer has tested positive for the HER2 protein.
- I am looking for my first treatment plan for this stage of cancer.
- I am well enough to attend regular hospital appointments for treatment and tests.
What does participation involve?
Taking part in this study involves receiving a combination of medicines through a drip into a vein (an infusion) or as tablets to swallow at home. You will receive chemotherapy (using medicines such as oxaliplatin, fluorouracil, or capecitabine), an immunotherapy drug called pembrolizumab, and the targeted drug trastuzumab. Treatments are given in regular cycles, usually every two to three weeks, meaning you will need to visit the hospital clinic frequently.
During your visits, your healthcare team will check your blood, monitor your heart health, and ask how you are feeling. You will also have regular body scans, such as CT scans, every few cycles to measure whether the cancer is shrinking or staying stable. The treatment continues as long as it is helping you and any side effects remain manageable, and the team will follow up with you regularly to see how you are doing over time.
Potential risks and benefits
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Common questions
What does HER2 positive mean?
HER2 is a protein found on the surface of cells. If your cancer is 'HER2 positive', it means the cells make too much of this protein, which can cause the cancer to grow. Special tests on your tumour sample can check for this.
Is this a completely new drug?
No. Trastuzumab is already widely used and approved for other HER2-positive cancers, like breast and stomach cancer. This trial is testing whether it is also effective for this specific type of food pipe cancer.
Will I have to pay for the trial treatments?
No, clinical trial medicines and any extra tests needed for the study are provided free of charge through the trial.
What happens if the treatment causes bad side effects?
Your safety comes first. The doctors can lower your doses, pause treatment, or stop the study medicine completely if side effects become too difficult or risky.
Can I leave the study if I change my mind?
Yes. You have the right to withdraw from the trial at any stage, for any reason, and your standard cancer care will continue as normal.
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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