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RecruitingPHASE3INTERVENTIONAL

Trifluridine/Tipiracil + Fruquintinib Versus Trifluridine/Tipiracil Alone for Metastatic Oeso-gastric Adenocarcinoma

This important study is for people with advanced cancer of the stomach or where the food pipe joins the stomach (oesophago-gastric junction). Despite recent progress in cancer treatments, these cancers can be very serious. This trial is investigating whether a new combination of two drugs, trifluridine/tipiracil and fruquintinib, can help people live longer and improve their quality of life. Trifluridine/tipiracil is already used as a treatment, and fruquintinib is a newer drug that works by cutting off the blood supply to the tumour. Researchers want to see if adding fruquintinib to the existing treatment can provide better results for patients as part of a third-line treatment option.

At a glance

Status
Recruiting
Phase
PHASE3
Sponsor
Federation Francophone de Cancerologie Digestive
Enrolment target
324
Start
15 Dec 2025
Estimated completion
30 Nov 2030

What is this study about?

This study is about finding better ways to treat advanced cancer that starts in the stomach or where the food pipe joins the stomach. These types of cancers, called adenocarcinomas, can be very challenging to treat, especially when they have spread to other parts of the body (metastasized).

Currently, initial treatments often involve chemotherapy, and more recently, immunotherapy drugs have shown promise by helping the body's own immune system fight the cancer. There are also targeted therapies like zolbetuximab, which attack specific proteins on cancer cells. However, when these treatments stop working, doctors need other options. Second-line treatments often involve drugs like paclitaxel and ramucirumab, which can extend life, but usually only for a few months. For patients needing a third option, a drug called trifluridine/tipiracil (sometimes called TAS-102) can offer a bit more time, but its benefits can be limited.

This is where this new study, called FRUQUITAS, comes in. Researchers believe that if they combine trifluridine/tipiracil with another drug called fruquintinib, they might see better results. Fruquintinib is an exciting drug that works by stopping new blood vessels from forming in tumours, effectively starving them of the blood and nutrients they need to grow. This type of drug is known as an anti-angiogenic drug. Fruquintinib has already shown good results in other cancers, like bowel cancer. This trial will compare giving both trifluridine/tipiracil and fruquintinib together to giving trifluridine/tipiracil by itself, to see if the combination can help patients with advanced stomach or oesophago-gastric cancer live longer and with a better quality of life.

Key takeaways

  • This study is testing two drugs together for advanced stomach or oesophagus cancer.
  • It aims to see if combining trifluridine/tipiracil with fruquintinib works better than one drug alone.
  • Fruquintinib works by cutting off the blood supply to tumours.
  • This trial is for patients whose cancer has grown despite some previous treatments.
  • It could offer a new option for patients in a later stage of their treatment journey.

Who may be eligible?

To join this study, you would generally need to be at least 18 years old and have a confirmed diagnosis of advanced stomach or oesophago-gastric adenocarcinoma that has spread to other parts of your body. You should have already received and tried two or three previous types of treatment for your advanced cancer and your cancer should have grown despite these treatments. This includes common chemotherapy drugs like platinum salts, fluoropyrimidine, and irinotecan or taxane, and potentially other treatments like anti-HER2 drugs, immunotherapy, ramucirumab, or anti-claudin 18.2 drugs.

Your general health needs to be good enough to take part. This will be checked using a standard scale (WHO performance status 0-1), which means you are able to carry out most daily activities without much trouble. Your blood tests, including your blood count and how well your liver and kidneys are working, also need to be within a healthy range. If you are able to have children, both you and your partner would need to agree to use effective contraception during the study and for six months after your last dose of medication.

The research team will also need access to a sample of your tumour tissue, either from a surgery or a biopsy, to help them with the study. You also need to be willing to take part in additional biological studies, which will involve providing more samples. If you meet these main points, the study doctor will discuss all the detailed requirements with you to see if you are a good fit for this research.

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.

  1. I am at least 18 years old.
  2. I have advanced stomach or oesophago-gastric cancer.
  3. I have already had two or three lines of treatment for my advanced cancer and it has grown despite these.
  4. My general health is good enough to take part (my doctor will check this).
  5. I am willing for the study team to use a tissue sample from my tumour.
  6. If I can have children, I am willing to use effective birth control during and after the study.
Answer every question to see your result.

What does participation involve?

If you join this study, you'll be assigned by chance (like flipping a coin) to one of two groups. One group will receive trifluridine/tipiracil plus fruquintinib, and the other group will receive trifluridine/tipiracil alone. Both medicines are given as tablets. You would have regular hospital visits, likely every few weeks, for check-ups, blood tests, and scans to see how the treatment is working. The study team will explain how and when to take your medicines. You will be closely monitored for any side effects. Treatment will continue for as long as it is helping you and you are tolerating it well. After you stop treatment, you will still have follow-up visits or calls to track your health and long-term effects. The total duration of your participation in the study will depend on how you respond to the treatment.

Potential risks and benefits

Taking part in a clinical trial might offer potential benefits, such as access to new treatments that are not yet widely available. There is a chance that the combination of drugs could be more effective than standard treatment in controlling your cancer and extending your life. However, new treatments also come with potential risks, including side effects that are not yet fully known or understood. These could range from mild to serious. The research team will monitor you closely for any side effects and support you throughout the study. Remember, your participation is completely voluntary, and you can withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (64)

  • Centre Hospitalier
    Verified postcode
    Aurillac, France· Not yet recruiting
  • Institut Sainte Catherine
    Verified postcode
    Avignon, France· Not yet recruiting
  • Centre Hospitalier
    Verified postcode
    Bayeux, France· Not yet recruiting
  • Bayonne- Clinique Belharra
    Verified postcode
    Bayonne, France· Not yet recruiting
  • Centre Hospitalier Côte Basque
    Verified postcode
    Bayonne, France· Not yet recruiting
  • ICONE
    Verified postcode
    Bezannes, France· Not yet recruiting
  • BORDEAUX-Institut Bergonié
    Verified postcode
    Bordeaux, France· Not yet recruiting
  • Clinique Tivoli
    Verified postcode
    Bordeaux, France· Not yet recruiting
  • C.H.U. de Brest
    Verified postcode
    Brest, France· Not yet recruiting
  • Cac - François Baclesse
    Verified postcode
    Caen, France· Not yet recruiting
  • CHU Côte de Nacre
    Verified postcode
    Caen, France· Not yet recruiting
  • Ch - Jean Rougier
    Verified postcode
    Cahors, France· Not yet recruiting

Common questions

What is 'advanced' cancer?

Advanced cancer means the cancer has spread from where it started to other parts of your body. This is also called metastatic cancer.

What do the drugs fringuatinib and trifluridine/tipiracil do?

Trifluridine/tipiracil is a chemotherapy drug that damages cancer cells. Fruquintinib works by cutting off the blood supply to the cancer cells, which stops them from growing.

Who is funding this study?

The study details don't mention the specific funder, but it's an international trial run by research groups (ENGIC and PRODIGE).

Will I know which treatment I'm getting?

Because you'll be assigned by chance to one of two groups, you might not know which specific treatment combination you are receiving, as this helps make the study results more reliable.

How long will I be on the treatment?

You will stay on the treatment for as long as it is helping to control your cancer and you are feeling well enough to continue, or until a certain point in the study design.

How to find out more

Project manager

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

Interested in taking part?

Register your interest

Share your details and the research team for "Trifluridine/Tipiracil + Fruquintinib Versus Trifluridine/Ti…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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