Ongoing, recruitingHuman Pharmacology (Phase I)- First administration to humansInterventional

INTERACT stomach

The INTERACT stomach study is an early-stage research trial for people who have stomach cancer that has spread. Specifically, it's for cancer that has spread to the peritoneum, which is the lining of your tummy area. This is a very early study, called a Phase 1 trial, meaning it's the first time this particular treatment is being given to humans. The main goal is to check if the new treatment is safe and to understand how it behaves in the body, such as how it's absorbed, processed, and removed. Researchers will also look for any side effects. This study is an important step in trying to find new ways to treat this type of cancer.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

Enrolment target

Start

06 Aug 2024

Stomach Cancer with metastasis in the peritoneum

What is this study about?

The INTERACT stomach study is a clinical trial focusing on individuals diagnosed with stomach cancer that has spread to a specific area called the peritoneum. The peritoneum is a membrane that lines the inside of your abdomen and covers your abdominal organs. When cancer spreads to this area, it's often more challenging to treat.

This trial is in its very first stage, known as a Phase 1 study. This means that the new treatment being investigated has not been given to people before. The main purpose at this early stage is not to cure the cancer, but to carefully check the safety of the new treatment. Researchers want to understand if it's well-tolerated and to find the right dose. They will also look at how the body handles the treatment, including how it's absorbed, distributed, and eventually leaves your system.

By carefully studying these early findings, researchers can decide if the treatment shows enough promise to be tested in larger groups of people in future studies. This is a crucial step in developing new medicines and improving care for patients with stomach cancer that has spread.

Key takeaways

This is an early-stage (Phase 1) study for stomach cancer that has spread to the abdomen lining.
The main goal is to test the safety and proper dose of a new treatment in people.
It's open to adults aged 18 and older, both men and women.
Participation involves regular hospital visits for monitoring and receiving treatment.
You have the right to stop participating at any time.
This study helps develop new ways to treat stomach cancer in the future.

Who may be eligible?

To join the INTERACT stomach study, you need to be at least 18 years old. There is no upper age limit, meaning people of all adult ages can be considered. Both men and women are welcome to take part.

The study is specifically for people who have been diagnosed with stomach cancer that has spread to the peritoneum. This means that the cancer has moved from the stomach to the lining of the abdomen. The research team will review your medical records to confirm that you meet all the necessary health criteria for participating in a study of this kind.

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 old or older.
I have been diagnosed with stomach cancer.
My stomach cancer has spread to the lining of my abdomen (peritoneum).
I am prepared to attend regular hospital visits for treatment and check-ups.

Answer every question to see your result.

What does participation involve?

Taking part in this early-stage study would involve regular visits to the hospital or clinic. These visits are important for the medical team to closely monitor your health and how you are responding to the treatment. During these visits, there will be various assessments, which might include blood tests, physical examinations, and possibly scans, to check on your well-being and the effects of the treatment.

You would receive the study medication as directed by the research team. The exact number of visits, the types of assessments, and the duration of treatments will be explained in detail by the study doctor. After completing the treatment phase, there will likely be a follow-up period, which could involve further check-ups to see how you are doing over time. The total length of your participation will be discussed with you.

Potential risks and benefits

Participating in a clinical trial like INTERACT stomach might offer some potential benefits, such as access to a new treatment that isn't widely available yet. You would also be contributing to medical research, which could help future patients with similar conditions. However, because this is a new treatment, there are also potential risks. You might experience side effects that are currently unknown, or the treatment might not be effective for your cancer. Your comfort and safety are a priority, and you would have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

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 does 'stomach cancer with metastasis in the peritoneum' mean?

It means the stomach cancer has spread from where it started to the lining of the tummy area (abdomen).

What is a 'Phase 1' study?

This is the very first time a new treatment is tried in humans. The main goal is to check its safety and how it works in the body.

Will this study cure my cancer?

The main aim of a Phase 1 study is to check the treatment's safety and how it works, not primarily to cure. Finding a cure often takes many stages of research.

Can I stop participating in the study if I want to?

Yes, you have the right to leave the study at any time, for any reason. Your decision will not affect your future medical care.

Who can join this study?

Adults aged 18 and over, both men and women, who have stomach cancer that has spread to the peritoneum.