Recruiting

Study of intraperitoneal chemotherapy (PIPAC) with cisplatin and doxorubicin combined with minimally invasive surgery in patients with high-risk gastric cancer

Verified siteRegistered drug

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on patients with gastric adenocarcinoma, a type of stomach cancer. The research examines a treatment approach that combines surgery with a specialized method called Pressurised Intraperitoneal Aerosol Chemotherapy (PIPAC). This technique delivers chemotherapy drugs directly into the abdominal cavity in the form of a spray after minimally invasive stomach surgery.

The treatment involves two chemotherapy medications: doxorubicin and cisplatin, which are administered through the PIPAC method. The procedure is performed immediately after stomach surgery and repeated once more after 6-8 weeks. The purpose of this study is to determine if this combined approach can help prevent the cancer from spreading to the lining of the abdominal cavity in high-risk stomach cancer patients.

During the study, patients will undergo minimally invasive surgery to remove part of their stomach, followed by the PIPAC treatment. The treatment process will be monitored through regular check-ups and imaging tests. Patients will be followed for at least 12 months after their surgery to assess their recovery and the effectiveness of the treatment.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial surgery
You will undergo minimally invasive D2 gastrectomy (surgical removal of part or all of the stomach using small incisions)
The surgery will be performed using either robotic or laparoscopic techniques
Step 2
First PIPAC treatment
PIPAC (Pressurised Intraperitoneal Aerosol Chemotherapy) will be administered immediately after the surgery
The treatment involves delivering two medications as an aerosol directly into the abdominal cavity:
- Doxorubicin through intraperitoneal route
- Cisplatin through intraperitoneal route
Step 3
Recovery and monitoring
Your hospital stay duration will be monitored
Medical staff will check for any complications during the first 30 days after surgery
Your quality of life will be assessed using specific questionnaires
Step 4
Second PIPAC treatment
A second PIPAC treatment will be administered 6-8 weeks after the surgery
The same medications will be used as in the first treatment
Step 5
Follow-up period
You will be monitored for at least 12 months after surgery
Follow-up will include PET-CT/CT scans and diagnostic procedures to check for signs of disease
Your health status will be tracked through medical records for up to five years after surgery

Who can join the trial?

11 criteria

Age between 18 and 80 years
Diagnosed with stomach cancer (gastric adenocarcinoma) or cancer at the junction between stomach and esophagus (Siewert type III)
Must be able to provide written informed consent and follow study requirements
check
Women who can become pregnant must:
- Have a negative pregnancy test when joining the study
- Use effective birth control during the study and for 3 months after
- check
  Cancer must be either:
  - Advanced stage (T3-T4a) of any type, or
  - Earlier stage (T2) if poorly developed or showing specific cell patterns
  - No spread of cancer beyond the original site (M0 stage)
  - Good physical condition (ECOG 0-1, meaning able to perform all or most daily activities)
  - Planning to undergo minimally invasive stomach surgery (robotic or laparoscopic D2 gastrectomy)
  - If cancer cells were found in stomach fluid samples, they must become negative after initial chemotherapy

Who cannot join the trial?

15 criteria

Age below 18 or above 65 years
Presence of distant metastases (cancer spread to organs far from the stomach)
Previous stomach surgery
History of other cancers in the past 5 years, except for successfully treated skin cancer
Serious heart conditions that would make surgery risky
Severe liver disease (conditions affecting liver function)
Severe kidney disease (conditions affecting kidney function)
Pregnancy or breastfeeding
Active infection that requires treatment
Unable to understand and sign informed consent
Mental health conditions that could interfere with following study procedures
Known allergies to the study medications
Participation in other clinical trials within the last 30 days
Immunodeficiency (weakened immune system)
Unable to undergo surgery due to medical conditions

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Centre Hospitalier Universitaire De Lille
Lille, France
Verified
Karolinska University Hospital
Solna, Sweden
Verified
Odense University Hospital
Odense, Denmark

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

RecruitingNot yet recruiting

Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC)
is a targeted treatment method where chemotherapy drugs are delivered directly into the abdominal cavity in the form of a pressurized spray. This technique allows the medication to reach areas that may contain cancer cells more effectively than traditional chemotherapy. The treatment is administered during surgery and then repeated several weeks later. It is specifically designed to prevent and treat the spread of cancer cells in the peritoneal cavity (the space within the abdomen).
Minimally Invasive D2 Gastrectomy
is a surgical procedure where part or all of the stomach is removed through small incisions in the abdomen, along with surrounding lymph nodes (D2 lymphadenectomy). This surgical approach aims to remove the gastric cancer while causing less trauma to the body compared to traditional open surgery.

What is already known about the treatment

PIPAC (Pressurized Intraperitoneal Aerosol Chemotherapy) – An innovative treatment method that delivers chemotherapy drugs in the form of a pressurized aerosol directly into the peritoneal cavity during minimally invasive surgery. This technique is specifically designed for treating gastric adenocarcinoma and other abdominal cancers, with the medication being administered through specialized equipment during laparoscopic procedures. PIPAC works by creating a fine mist of chemotherapy drugs that distributes evenly throughout the peritoneal cavity, allowing for better penetration into cancerous tissues while minimizing systemic side effects. This treatment belongs to the class of targeted local chemotherapy delivery systems and represents a modern approach to treating high-risk gastric cancer patients, typically administered immediately after gastrectomy and again 6-8 weeks later.

Investigated diseases

Gastric adenocarcinoma - A type of cancer that develops from the glandular cells in the stomach lining. It begins when stomach cells become abnormal and grow uncontrollably, forming a tumor in the inner lining (mucosa) of the stomach. The disease typically develops slowly over many years and may spread through the stomach wall to nearby organs and lymph nodes. As the cancer progresses, it can affect normal stomach function and may spread to other parts of the digestive system. The condition can develop in any part of the stomach, though most commonly occurs in the lower portion.