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Study of ivonescimab with chemotherapy combination for first and second-line treatment in patients with advanced or metastatic gastric and gastroesophageal cancer

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What is this study about?

This clinical trial focuses on patients with advanced or metastatic gastric cancer and esophagogastric junction cancer. The study evaluates a new treatment approach combining ivonescimab (also known as AK112/SMT112) with standard chemotherapy medications. The chemotherapy drugs used in this study include fluorouracil, irinotecan, paclitaxel, oxaliplatin, calcium levofolinate, and folinic acid.

The purpose of this research is to determine how well ivonescimab works when combined with chemotherapy in treating patients with advanced stomach and esophageal junction cancers. The study includes patients whose cancers may have specific biological markers (HER2, PD-L1, or Claudin18.2). These markers are proteins found on cancer cells that can affect how the cancer responds to treatment.

During the study, participants will receive ivonescimab through an intravenous infusion along with their chemotherapy treatment. The treatment will continue as long as patients show benefit from it and do not experience unacceptable side effects. Regular medical examinations and scans will be performed to monitor how the cancer responds to the treatment combination.

1 Initial medical assessment

Your medical condition will be confirmed through examination of gastric cancer or esophagogastric junction cancer

Various tests will be performed to check your liver function, blood count, and kidney function

A pregnancy test will be required for women who can become pregnant

2 Treatment assignment

You will receive a combination of medications through intravenous injection

The treatment includes ivonescimab combined with standard chemotherapy drugs

The chemotherapy medications include: fluorouracil, irinotecan, calcium levofolinate, folinic acid, paclitaxel, and oxaliplatin

3 Regular monitoring

Your response to treatment will be assessed through regular tumor measurements

Your overall health status will be monitored using the ECOG performance status scale

Quality of life assessments will be conducted using specific questionnaires

Any side effects or adverse reactions will be recorded and monitored

4 Ongoing evaluations

Regular scans will be performed to measure your tumor response

Blood tests will continue throughout the treatment period

Your general health and any symptoms will be assessed at each visit

5 Study completion

The study will continue until 2028

Treatment will continue until your disease progresses or you experience unacceptable side effects

Follow-up visits will be scheduled to monitor your long-term health status

Who Can Join the Study?

  • You must be 18 years or older
  • You must be diagnosed with gastric cancer or cancer of the area where the esophagus meets the stomach that has spread to other parts of the body (stage IV) or cannot be removed by surgery
  • You must have at least one tumor that can be measured using imaging tests
  • You must be able to perform daily activities with minimal assistance (ECOG score of 0 or 1)
  • Your blood tests must show:
    – Adequate white blood cell counts (neutrophils ≥1.5 × 10⁹/L)
    – Adequate platelet counts (≥100 × 10⁹/L)
    – Adequate hemoglobin levels (≥9 g/dL)
  • Your liver function tests must be within acceptable ranges
  • Your kidney function must be adequate (kidney filtration rate ≥50 mL/min)
  • Your blood clotting tests must be within normal ranges if you are not taking blood thinners
  • If you are of childbearing age, you must:
    – Have a negative pregnancy test before starting the study
    – Agree to use effective birth control during the study and for 120 days after
    – Not donate eggs during this period
  • If you are a male participant, you must:
    – Use effective birth control if your partner can become pregnant
    – Not donate sperm during the study and for 120 days after
  • You must be willing to follow all study requirements, including scheduled visits and tests
  • You must be affiliated with the Social Security System or equivalent
  • You must sign an informed consent form before any study procedures begin

Who Cannot Join the Study?

  • Prior treatment with anti-PD-1/PD-L1 therapy (a type of immunotherapy that helps your immune system fight cancer cells)
  • Active brain metastases (cancer that has spread to the brain) that are not stable or require steroids
  • History of autoimmune diseases (conditions where your immune system attacks healthy cells in your body)
  • Active or chronic infections, including hepatitis B, hepatitis C, or HIV
  • Significant heart conditions or uncontrolled high blood pressure
  • Major surgery within 28 days before starting the study treatment
  • Previous treatment with other experimental drugs within 4 weeks before starting this study
  • Active bleeding or high risk of bleeding
  • Pregnant or breastfeeding women
  • Known allergies to the study medications or their components
  • Any other serious medical condition that could interfere with study participation
  • Unable to swallow oral medications
  • Mental conditions that could affect the ability to follow study procedures

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Institut Gustave Roussy Villejuif France
Centr Georges Francois Leclerc Dijon France
Institut De Cancerologie De Lorraine Vandoeuvre Les Nancy France
Centre Hospitalier Regional Et Universitaire De Brest Brest France
Oncopole Claudius Regaud Toulouse France

Other Sites

Site Name City Country Status
Centre Hospitalier Universitaire De Poitiers Poitiers France
Institut Godinot Reims France
Institut de Cancérologie de l’Ouest Saint-Herblain France
Centre Regional Lutte Contre Le Cancer STRASBOURG, Alsace France
Centre Francois Baclesse Caen France
Centre De Lutte Contre Le Cancer Eugene Marquis Rennes France
Ctndht Lovw Bllacr Lyon France
Iewgmqnd Poyneuxmwhpzsna Cbdnjl Crzizj Marseille France
Cbrypb Oqjlf Lykvwyr Lille France
Igbyjrqw Cftew Paris France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Recruiting
01.09.2025

Trial locations

Investigated drugs:

Ivonescimab is a medication being studied for treating advanced gastric (stomach) and gastroesophageal cancer. It works by targeting specific proteins in cancer cells and helping the immune system fight the cancer. This medication is designed to be used in combination with chemotherapy treatments.

Chemotherapy (various standard cancer-fighting medications) is used in combination with ivonescimab to treat cancer. These medications work by killing rapidly dividing cells, including cancer cells, throughout the body.

Investigated diseases:

Gastric Cancer – A disease that begins in the cells of the stomach lining and can spread to other parts of the body. The cancer typically develops slowly over many years, starting with pre-cancerous changes in the inner lining of the stomach. It can grow through the stomach’s wall and extend to nearby organs or lymph nodes. When advanced, the cancer cells can travel through the bloodstream or lymphatic system to distant organs.

Esophagogastric Junction Cancer – A cancer that forms in the area where the esophagus (food pipe) meets the stomach. This type of cancer develops in the cells at this junction point and can grow into either the esophagus or stomach. The cancer begins in the innermost layer of the tissue and can gradually grow outward through the other layers. As it advances, it can spread to nearby lymph nodes and other organs.

Metastatic Cancer – A condition where cancer cells have spread from their original location to other parts of the body through the bloodstream or lymphatic system. These cells can form new tumors in different organs, creating secondary cancer sites. The new tumors are the same type of cancer as the original tumor.

Locally Advanced Cancer – A cancer that has grown outside the organ where it started but has not spread to distant parts of the body. The tumor has become large or grown into nearby tissues or lymph nodes, making it difficult or impossible to remove surgically. It remains concentrated in one general area of the body.

Trial ID:
2025-520694-39-00
Protocol code:
UC-GIG-2411
NCT ID:
NCT06846346
Trial Phase:
Therapeutic exploratory (Phase II)

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