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Active not recruitingPHASE2INTERVENTIONAL

Clinical Trial Evaluating FOLFIRI + Durvalumab vs FOLFIRI + Durvalumab and Tremelimumab in Second-line Treatment of Patients With Advanced Gastric or Gastro-oesophageal Junction Adenocarcinoma

This study investigates new treatment options for advanced stomach or food pipe cancers that have not responded to initial chemotherapy. It combines a standard chemotherapy called FOLFIRI with one or two newer drugs: Durvalumab and Tremelimumab. These newer drugs are types of immunotherapy, which work by helping your body's immune system fight cancer. The researchers want to find out how effective these combinations are at controlling the cancer and improving patients' survival. This is a Phase 2 study, meaning it's still in the earlier stages of testing these new combinations in a group of people to check their safety and how well they work.

At a glance

Status
Active not recruiting
Phase
PHASE2
Sponsor
Federation Francophone de Cancerologie Digestive
Enrolment target
107
Start
17 Jul 2019
Estimated completion
27 Nov 2024

What is this study about?

When people have advanced stomach or where the food pipe joins the stomach cancer, sometimes the cancer doesn't respond to the first round of chemotherapy, or it comes back. Doctors are always looking for new and better ways to treat these cancers. This study explores using a standard chemotherapy combination, FOLFIRI, along with newer types of medicines called immunotherapies. Immunotherapies, like Durvalumab and Tremelimumab, help your body's own immune system recognise and fight the cancer cells. This is different from traditional chemotherapy which directly attacks cancer cells.

The study has two main groups of patients. One group will receive FOLFIRI chemotherapy with Durvalumab. The other group will receive FOLFIRI chemotherapy with both Durvalumab and Tremelimumab. By comparing these two approaches, researchers hope to learn if adding Tremelimumab to the FOLFIRI-Durvalumab combination offers additional benefits. The main goal is to see how many patients are alive and their cancer hasn't progressed after 4 months of treatment.

This kind of research is really important because advanced stomach cancer can be difficult to treat. Finding more effective treatments can help improve patients' health and quality of life. This particular study is a 'Phase 2' study, which means it's one of the earlier steps in testing new treatments to make sure they are safe and show promise before being tested in much larger groups of people.

Key takeaways

  • This study evaluates new drug combinations for advanced stomach or food pipe cancer.
  • It combines standard FOLFIRI chemotherapy with immunotherapy drugs (Durvalumab, Tremelimumab).
  • The aim is to find out how well these new combinations work and their safety.
  • It's for patients whose cancer has progressed after previous chemotherapy.
  • This is a Phase 2 study, an earlier stage of testing new treatments.

Who may be eligible?

To join this study, people generally need to be 18 years or older and have a confirmed diagnosis of advanced stomach cancer or cancer where the food pipe joins the stomach that cannot be removed by surgery. Critically, your cancer must have come back or worsened after previous platinum-based chemotherapy treatments.

You also need to be well enough to take part, meaning you can mostly look after yourself. Your body's organs, such as your liver, kidneys, and blood, need to be working within certain healthy ranges. The researchers will also need to review a sample of your tumour tissue to understand specific features of your cancer.

There are also reasons why someone might not be able to join. For example, if you are currently in another clinical study, if you've recently had other cancer treatments (within the last two weeks before this study starts), or if you have certain other serious health conditions, you might not be eligible. The study team will discuss all these details 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.

  1. Are you 18 years or older?
  2. Do you have advanced stomach or food pipe cancer?
  3. Has your cancer progressed after earlier platinum-based chemotherapy?
  4. Are you generally well enough to participate in a study?
  5. Are your routine blood tests (like blood count, liver, and kidney function) within healthy limits?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first go through a screening process to check if you meet all the requirements. This involves various tests and checks similar to what you might have for regular cancer care. Once you're in the study, you would receive either one of the two treatment combinations (FOLFIRI with Durvalumab, or FOLFIRI with Durvalumab and Tremelimumab).

The treatments would be given in cycles, typically involving visits to the clinic for infusions. You would have regular check-ups, blood tests, and scans (like CT scans) to monitor your health, how you're responding to the treatment, and to look for any side effects. The exact number of visits and tests would be explained by the study team, but generally, studies like this involve frequent hospital visits during the treatment phase and then follow-up appointments after treatment if it ends. The total duration of your participation would depend on how your body responds to the treatment.

Potential risks and benefits

Participating in this study might offer you access to new treatments before they are widely available, which could potentially help control your cancer. However, there's no guarantee the treatment will work for you, and it's possible you might not benefit. All medicines have potential side effects, and the drugs in this study, including chemotherapy and immunotherapies, can cause various side effects, some of which could be serious. The study team will explain all known risks. Remember, taking part in a clinical trial is always voluntary, and you are free to withdraw at any time without giving a reason, and your medical care will not be affected.

Locations (35)

  • Ch - Centre Hospitalier
    Verified postcode
    Abbeville, France
  • Ch - Hôpital Claude Bernard
    Verified postcode
    Albi, France
  • Chu - Hôpital Sud
    Verified postcode
    Amiens, France
  • Privé - Clinique de L'Europe
    Verified postcode
    Amiens, France
  • Chu - Hôpital Hôtel Dieu
    Verified postcode
    Angers, France
  • Privé - Hôpital Privé D'Antony
    Verified postcode
    Antony, France
  • Ch - Hôpital Victor Dupouy
    Verified postcode
    Argenteuil, France
  • Ch - Hôpital Henri Duffaut
    Verified postcode
    Avignon, France
  • Privé - Clinique Sainte Catherine
    Verified postcode
    Avignon, France
  • Ch - Hôpital Côte Basque
    Verified postcode
    Bayonne, France
  • Privé - Clinique Capio Belharra
    Verified postcode
    Bayonne, France
  • Chu - Hôpital Jean Minjoz
    Verified postcode
    Besançon, France

Common questions

What is FOLFIRI chemotherapy?

FOLFIRI is a standard combination of chemotherapy drugs that are given together to treat certain cancers. It includes drugs like 5-FU and irinotecan.

What are Durvalumab and Tremelimumab?

These are types of immunotherapy drugs that work by helping your body's immune system recognise and fight cancer cells.

What does 'advanced' stomach cancer mean?

It means the cancer has spread from where it started or cannot be fully removed by surgery.

Will I know which treatment I'm getting?

Because this is a comparative study, you would be assigned to one of two groups. The study team will explain if you will know which specific combination you receive.

How long will I be on the study treatment?

The length of treatment varies depending on how your cancer responds and how well you tolerate the treatment. The study team will discuss the likely duration with you.

How to find out more

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

Discussion

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