Not yet recruitingPHASE2INTERVENTIONAL

Neoadjuvant Systemic and Peritoneal Chemotherapy for Advanced Gastric Cancer

This study is investigating a new treatment approach for advanced stomach cancer, specifically for patients where cancer cells have been found in the fluid surrounding their abdominal organs or have formed very small growths on the abdominal lining. It combines regular chemotherapy given into the bloodstream with a specialised treatment called PIPAC, which delivers chemotherapy directly into the abdomen as a spray. The aim is to see if this combined treatment is safe and more effective at clearing cancer cells from the abdomen, potentially allowing more patients to have surgery. Researchers hope to improve survival for this particular group of stomach cancer patients by directly targeting the cancer where it has spread.

At a glance

Status

Not yet recruiting

Phase

PHASE2

Sponsor

Imperial College London

Enrolment target

Start

01 Nov 2023

Estimated completion

01 Jul 2030

Gastric Cancer Peritoneal Metastases Chemotherapy Effect

What is this study about?

This research study is about finding better ways to treat stomach cancer, especially when it has started to spread to the lining of the tummy area (known as the peritoneum). While stomach cancer itself is challenging, its spread to this lining often makes it even harder to treat effectively using standard methods.

Currently, there's a real need to improve the chances of survival for patients with this specific type of advanced stomach cancer. This study explores a new method that combines regular chemotherapy, which travels through your bloodstream, with a special procedure called PIPAC. PIPAC delivers chemotherapy drugs directly into the abdomen as a fine mist during a keyhole surgery. This direct delivery aims to tackle cancer cells in the abdomen more effectively, hopefully clearing them enough so that more patients can then go on to have surgery to remove the main tumour.

The idea behind this study is that by directly targeting the cancer cells where they have spread, we might be able to shrink them or even make them disappear from the abdominal lining. This could open up the possibility of life-changing surgery for patients who might not otherwise be able to have it, ultimately aiming to improve their long-term outcomes and quality of life. The study wants to confirm that this combined approach is safe and effective for a carefully chosen group of patients.

Key takeaways

Investigates combining standard chemotherapy with direct abdominal chemotherapy (PIPAC) for advanced stomach cancer.
Aims to treat stomach cancer that has spread slightly to the lining of the abdomen.
Hopes to make more patients eligible for surgery following treatment.
The study focuses on confirming the safety and effectiveness of this new combined approach.
Patient wellbeing and careful selection are key parts of the study design.

Who may be eligible?

To be considered for this study, you would need to have been diagnosed with stomach cancer. It's important that tests show cancer cells in the fluid around your abdominal organs, or only very small amounts of cancer spread on the lining of your abdomen. The cancer must not have spread to other distant organs like your lungs or liver, and your lymph nodes (glands) shouldn't show widespread cancer beyond what could normally be removed in standard surgery. You also shouldn't have had any chemotherapy for this cancer yet.

There are also some general health requirements. You would need to be well enough to undergo treatment, usually meaning you are able to carry out most of your normal daily activities. Your body mass index (BMI) should be within a certain range, and you shouldn't have severe swallowing difficulties or other uncontrolled serious health conditions that might make the treatment too risky.

Some reasons you wouldn't be able to join include if the cancer has spread extensively on the abdominal lining, has formed large amounts of fluid in your abdomen (ascites), or if it has features that make you eligible for immunotherapy. Certain blood levels, being pregnant or breastfeeding, or having unmanageable health issues would also mean you couldn't take part.

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.

Have you been diagnosed with stomach cancer?
Do tests show cancer cells in your abdominal fluid or only very small growths on the abdominal lining?
Has the cancer not spread to other distant organs like the liver or lungs?
Are you generally well enough to undergo cancer treatment?
Have you not received any chemotherapy for this cancer yet?
Are you not pregnant or breastfeeding?

Answer every question to see your result.

What does participation involve?

If you join this study, you will receive a combination of standard chemotherapy given through a vein and a special treatment called PIPAC. Your doctors will follow local guidelines for the specific chemotherapy drugs, and the PIPAC procedure will involve specific doses of Doxorubicin and Cisplatin delivered into your abdomen.

You will have three cycles of chemotherapy given into your bloodstream, and these will be alternated with three PIPAC procedures. Each treatment cycle will occur every six weeks. Following these treatments, you will undergo further tests to see how the cancer has responded. If the treatment has been successful in clearing the cancer cells from your abdomen, you may then be considered for surgery to remove the main stomach tumour. The total duration of this treatment phase would be around 18 weeks, followed by assessment.

Potential risks and benefits

Participating in this study might offer the potential benefit of a more effective treatment for your specific type of advanced stomach cancer, potentially clearing cancer cells from your abdomen and making surgery possible where it might not have been before. However, as with all medical treatments, there are potential risks and side effects associated with both chemotherapy and the PIPAC procedure. Your medical team will discuss these in detail. You are free 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.

Imperial College London, Hammersmith Hospital Campus
Verified postcode
London, United Kingdom

Common questions

What is PIPAC?

PIPAC (Pressurized IntraPeritoneal Aerosol Chemotherapy) is a procedure where chemotherapy drugs are sprayed directly into your abdomen as a mist during a keyhole surgery. This aims to get the drugs straight to the cancer cells on the lining of your belly.

Why is this study important for stomach cancer?

This study aims to find a better way to treat stomach cancer that has spread to the abdominal lining, which is currently very difficult to treat. It hopes to improve patients' chances of having surgery and living longer.

Will I still receive standard chemotherapy?

Yes, you will receive standard chemotherapy into your bloodstream alongside the PIPAC treatment directly into your abdomen. This study combines both approaches.

What happens after the treatment in the study?

After completing the combined chemotherapy and PIPAC treatments, you will have tests to see how the cancer has responded. If successful, you may then be considered for surgery to remove the main stomach tumour.

Can I choose to leave the study at any point?

Yes, you have the right to withdraw from the study at any time, for any reason, and this decision will not affect your future medical care.

How to find out more

Piers R Boshier, FRCS, PhD

prb03@ic.ac.uk 020 7594 8197 Official trial record

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