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Metastatic gastric cancer – Trials in Disease

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Clinical Trials for Metastatic Gastric Cancer

There are currently 11 ongoing clinical trials investigating new treatments for metastatic gastric cancer across Europe and other regions. These studies are testing various drug combinations, including antibody-drug conjugates, immunotherapies, and chemotherapy regimens, to improve outcomes for patients with advanced stomach cancer that has spread beyond its original location.

Clinical trial locations

Study of DS-3939a for Patients with Advanced or Metastatic Solid Tumors

This trial is testing a new treatment called DS-3939a for people with various types of advanced solid tumors, including certain forms of stomach cancer. The study is divided into two parts to evaluate both the safety and effectiveness of the medication.

Who can participate: Participants must have advanced cancer that has spread or is difficult to treat. They need to have a left ventricular ejection fraction of at least 50%, which is a measure of heart function. Their cancer must be measurable using standard criteria, and they should be able to carry out light work with some symptoms but remain relatively active. The study accepts different types of advanced cancers, including those of the lung, breast, ovary, bile duct, and pancreas.

Who cannot participate: Patients with metastatic solid tumors who do not meet the age requirements, are part of vulnerable populations, or do not meet safety and tolerability standards for DS-3939a cannot participate.

What the trial involves: DS-3939a is administered as an intravenous infusion directly into the bloodstream. The first part of the study focuses on understanding how safe the medication is and how well the body tolerates it. The second part evaluates how effective the treatment is at shrinking or controlling tumors, measuring what is known as the objective response rate. Throughout the study, participants undergo regular check-ups, laboratory tests, and imaging studies to monitor their health and the treatment’s effectiveness.

Investigational drug: DS-3939a is designed to help treat advanced solid tumors. It targets specific pathways that cancer cells use to grow and spread, although the exact mechanism is still being investigated.

Study of HLX22, Trastuzumab, and Chemotherapy for Patients with Advanced or Metastatic Stomach and Gastroesophageal Cancer

This trial compares a new treatment combination involving HLX22, trastuzumab, and chemotherapy to the standard treatment for advanced stomach and gastroesophageal junction cancer. The study aims to determine if the new combination offers better outcomes.

Who can participate: Participants must be at least 18 years old with a confirmed diagnosis of locally advanced or metastatic gastroesophageal junction and gastric cancer that is HER2-positive. They need adequate organ function and must test negative for HIV, hepatitis B, and hepatitis C. Women of childbearing potential must have a negative pregnancy test. Participants should have an ECOG performance status of 0-1, meaning they can perform daily activities with minimal restrictions.

Who cannot participate: Patients who have received certain previous treatments, have serious heart conditions, are pregnant or breastfeeding, have known allergies to the study drugs, or cannot follow study procedures are excluded.

What the trial involves: Participants are randomly assigned to receive either the new combination of HLX22, trastuzumab, and chemotherapy or the standard treatment with trastuzumab and chemotherapy, with or without pembrolizumab. All medications are administered intravenously. The study is double-blinded, meaning neither participants nor researchers know who receives which treatment. Regular assessments monitor cancer progression, overall survival, and any side effects.

Investigational drugs: HLX22 is a humanized monoclonal antibody targeting the HER2 protein on cancer cells. Trastuzumab also targets HER2, blocking signals that tell cancer cells to grow. Pembrolizumab is an immune checkpoint inhibitor that helps the immune system recognize and attack cancer cells. XELOX is a chemotherapy combination of capecitabine and oxaliplatin.

Study of M9140 for Patients with Advanced Stomach Cancer

This trial tests M9140, an antibody-drug conjugate designed to target and deliver treatment directly to cancer cells in patients with advanced stomach cancer.

Who can participate: Participants must have an ECOG performance status of 0 or 1 and proper blood, liver, and kidney function. They need at least one measurable tumor and a confirmed diagnosis of advanced or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma. Participants must have been intolerant to or experienced cancer progression after previous treatments, having received at least one but no more than two prior treatments for advanced disease.

Who cannot participate: Patients with different types of cancer, those outside the specified age range, those unable to follow study procedures, pregnant or breastfeeding individuals, those with serious health conditions, current participants in other trials, recent major surgery patients, those with known allergies to the study medication, individuals with substance abuse history, or those with infections requiring treatment are excluded.

What the trial involves: M9140 is administered as an intravenous infusion once every three weeks. Throughout the study, participants undergo regular health monitoring, including check-ups and tests to assess how their body responds to the treatment and track tumor size. The study evaluates the objective response to treatment and monitors for any side effects.

Investigational drug: M9140 is an antibody-drug conjugate that combines an antibody targeting CEACAM5, a protein often found on certain cancer cells, with a drug that kills cancer cells. Once M9140 attaches to cancer cells, it delivers the drug directly to them while trying to limit damage to healthy cells.

Study of Oxaliplatin, Nivolumab, and Trifluridine/Tipiracil for Patients with Advanced Gastric, Esophageal, or Gastroesophageal Junction Cancer

This study compares different medication combinations to determine which is more effective in stopping cancer from progressing in patients with advanced adenocarcinoma of the stomach, esophagus, or gastroesophageal junction that does not have excess HER2 protein.

Who can participate: Participants must have adenocarcinoma of the stomach, esophagus, or gastroesophageal junction that is advanced, recurrent, or has spread and cannot be removed by surgery. Women of childbearing potential must have a negative pregnancy test and agree to use reliable birth control. Participants must be part of a Social Security System, have available tumor samples, not have difficulty swallowing, and have cancer that is HER2-negative with known status of related proteins and genes. They need at least one measurable cancer area not previously treated with radiation, must not have had prior chemotherapy for advanced cancer, be at least 18 years old, be able to receive FOLFOX chemotherapy, and have adequate organ function without DPD enzyme deficiency.

Who cannot participate: Patients with different cancer types, those who received certain prior treatments, those with serious health conditions, pregnant or breastfeeding individuals, those unable to follow procedures, those with medication allergies, participants in other trials, those with certain heart conditions, those with active infections, or those with drug or alcohol abuse history are excluded.

What the trial involves: Participants are randomly assigned to receive either trifluridine/tipiracil plus oxaliplatin with or without nivolumab, or the FOLFOX regimen with or without nivolumab. Treatment is administered in cycles with specific medication schedules. Regular medical check-ups, blood tests, and imaging studies monitor disease progression and side effects. Quality of life is assessed using questionnaires every two months.

Investigational drugs: Trifluridine/tipiracil interferes with cancer cell DNA, preventing growth and multiplication. Oxaliplatin damages cancer cell DNA to stop division. Nivolumab helps the immune system recognize and attack cancer cells. FOLFOX combines folinic acid, fluorouracil, and oxaliplatin.

Study of Trastuzumab Deruxtecan and Drug Combination for Patients with Advanced or Metastatic HER2-Positive Gastric or Gastroesophageal Junction Cancer

This trial explores whether combining trastuzumab deruxtecan with chemotherapy, with or without pembrolizumab, works better than the current standard treatment for HER2-positive stomach or gastroesophageal junction cancer.

Who can participate: Participants must sign consent forms and have adequate organ and bone marrow function. They need sufficient time since previous treatments and must use effective birth control if able to have children. Men must not donate sperm during the trial and for at least 4 months after, while women must not donate or retrieve eggs during the trial and for at least 7 months after, and should not breastfeed. Participants must be willing to attend scheduled visits and complete required procedures. They must be at least 18 years old with untreated, locally advanced, unresectable, or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma, confirmed by specific tests. They need tumor samples tested for PD-L1 expression, at least one measurable tumor on scans, a left ventricular ejection fraction of at least 50%, and an ECOG performance status of 0 or 1.

Who cannot participate: Patients with other cancer types, recent cancer treatments, serious heart problems, uncontrolled high blood pressure, active infections requiring treatment, those who are pregnant or breastfeeding, those with medication allergies, those with severe allergic reaction history, those with drug or alcohol abuse history, or those unable to follow procedures are excluded.

What the trial involves: Participants are randomly assigned to receive either trastuzumab deruxtecan with chemotherapy and pembrolizumab, or the standard treatment. Medications are given intravenously or orally as tablets. Treatment continues in cycles with regular monitoring through check-ups, blood tests, and imaging scans. Quality of life questionnaires are completed during and after treatment.

Investigational drugs: Trastuzumab deruxtecan combines a HER2-targeting antibody with chemotherapy. Pembrolizumab helps the immune system recognize and attack cancer cells. Trastuzumab blocks HER2 protein signals that promote cancer cell growth.

Study of zolbetuximab, pembrolizumab and chemotherapy in adults with HER2-negative, Claudin 18.

This study tests whether adding zolbetuximab to pembrolizumab and chemotherapy works better than chemotherapy and pembrolizumab alone as a first treatment for stomach cancer or gastroesophageal junction adenocarcinoma that cannot be surgically removed or has spread.

Who can participate: Participants must be at least 18 years old with tumors testing positive for PD-L1 and confirmed gastric or gastroesophageal adenocarcinoma that is advanced or has spread. They need measurable disease by imaging scans, good physical function with an ECOG score of 0 or 1, life expectancy of at least 12 weeks, ability to receive mFOLFOX6 or CAPOX chemotherapy and pembrolizumab, and tumors that are HER2-negative and CLDN18.2-positive.

Who cannot participate: Those with known allergies to study medications, previous chemotherapy for advanced cancer, active autoimmune disease requiring systemic treatment, untreated or unstable brain metastases, other cancers within the last 5 years, significant heart conditions, active hepatitis B or C, active tuberculosis, pregnant or breastfeeding women, inability to swallow oral medications, major surgery within 4 weeks, participation in another trial within 4 weeks, any condition making participation unsafe, or inability to provide informed consent are excluded.

What the trial involves: Participants receive either zolbetuximab or placebo along with pembrolizumab and chemotherapy through intravenous infusions, with some chemotherapy taken as tablets. Chemotherapy options include CAPOX or mFOLFOX6. Regular assessments include physical examinations, blood tests, heart monitoring, and evaluation of treatment response and side effects.

Investigational drugs: Zolbetuximab targets Claudin 18.2 protein found on some stomach cancer cells, helping the immune system recognize and attack them. Pembrolizumab blocks the PD-L1 protein that cancer cells use to hide from the immune system. CAPOX combines capecitabine and oxaliplatin, while mFOLFOX6 includes fluorouracil, leucovorin, and oxaliplatin.

Study on Dostarlimab Immunotherapy for Patients with Localized Gastric Cancer with Deficient Mismatch Repair or High Microsatellite Instability

This trial tests dostarlimab, an immunotherapy drug, in patients with localized stomach cancer that has specific genetic characteristics called deficient mismatch repair or microsatellite instability high.

Who can participate: Participants must provide signed informed consent and have adequate liver function with liver-related blood tests within specific limits. Blood clotting tests must be within normal limits unless on blood-thinning medication deemed safe by doctors. A CT scan must show no cancer spread or non-surgical disease. Female participants must not be pregnant or breastfeeding, while male participants must agree to certain conditions during the study and for 4 months after. Tumor tissue samples from upper gastrointestinal endoscopy must be provided with images. Participants must attend scheduled visits, follow the treatment plan, and undergo necessary tests. They must be registered in a National Health Care System, have an ECOG performance status of 0-1, and be between 18 and 75 years old. Patients over 75 can participate if they meet additional conditions. They need specific stomach cancer confirmed by tests without spread to other body parts, no spread to the abdominal lining unless further tests rule it out, no previous treatment for localized stomach cancer, tumors with dMMR/MSI-H genetic characteristics, adequate blood cell counts, and adequate kidney function.

Who cannot participate: Patients who had surgery to remove the tumor, experienced disease progression, have positive biopsies showing cancer cells, or do not show improvement in endoscopy results are excluded.

What the trial involves: Participants undergo initial assessments including liver and kidney function tests, blood tests, imaging studies, and tumor biopsies to confirm eligibility. Treatment with dostarlimab begins via intravenous infusion at 500 mg, with dosage and frequency determined by the study protocol. Regular follow-up visits monitor treatment response and side effects through physical examinations, blood tests, imaging studies, and possibly additional biopsies. At one year, the response is evaluated to determine if there is a clinical complete response.

Investigational drug: Dostarlimab is an immunotherapy medication designed to help the immune system recognize and attack cancer cells. It blocks a protein called PD-1 on immune cells, enhancing the body’s ability to fight cancer.

Study on Pre-operative Capecitabine, Oxaliplatin, Docetaxel, and Atezolizumab for Patients with Resectable Gastric or Gastro-esophageal Junction Cancer

This trial studies the safety and feasibility of using capecitabine, oxaliplatin, docetaxel, and atezolizumab before surgery to remove stomach or gastroesophageal junction cancer.

Who can participate: Participants must sign an informed consent form, be willing to undergo esophagogastroscopy and provide tissue samples, and have negative pregnancy tests if female and of childbearing potential. They must use reliable birth control during the study and for specified periods after the last dose. Participants need confirmed gastric or gastroesophageal junction adenocarcinoma that can be surgically removed, an ECOG performance status of 0 or 1, and be 18 years or older. They must have no signs of distant cancer spread and adequate blood and organ function. CT scans of chest and abdomen within 4 weeks before joining are required, with PET scans and EUS required for tumors at the gastroesophageal junction. For diffuse type stomach cancer, diagnostic laparoscopy must ensure no cancer spread to the abdominal lining.

Who cannot participate: Patients without gastric adenocarcinoma or gastroesophageal junction cancer, those without histological examination confirmation, those with non-resectable cancer, those outside the specified age range, or those in vulnerable populations are excluded.

What the trial involves: Treatment begins with oxaliplatin and docetaxel given intravenously, and capecitabine taken orally. Atezolizumab is then administered intravenously to enhance immune response. During the combination treatment phase, all medications are used together. After treatment, evaluations using imaging tests determine if surgery is needed. Regular follow-up appointments monitor recovery and check for cancer recurrence.

Investigational drugs: Capecitabine interferes with cancer cell growth. Oxaliplatin helps kill cancer cells. Docetaxel prevents cancer cells from dividing and growing. Atezolizumab helps the immune system recognize and attack cancer cells.

Study on the Safety of Trifluridine/Tipiracil for Patients with Dihydropyrimidine Dehydrogenase Deficiency and Metastatic Colorectal or Gastroesophageal Cancer

This trial evaluates the safety of trifluridine/tipiracil in patients with metastatic colorectal or gastroesophageal cancer who have dihydropyrimidine dehydrogenase deficiency, which affects how their body processes certain chemotherapy drugs.

Who can participate: Participants must sign written consent before any trial procedures. Women of childbearing potential must have negative pregnancy tests within 7 days before starting treatment and agree to use effective birth control during the study and for up to 7 months after. Participants must be willing to attend scheduled visits, follow the treatment plan, and complete laboratory tests. They must be part of the Social Security System, have adenocarcinoma of the colon, rectum, or gastroesophageal area confirmed by tests showing proficient mismatch repair or microsatellite stable, have metastatic cancer that cannot be removed by surgery, have at least one measurable tumor, not have had previous treatment for metastatic disease, have known DPD deficiency defined by specific plasma uracil levels, be at least 18 years old, have an ECOG performance status of 0 or 1, and have adequate bone marrow, kidney, and liver function.

Who cannot participate: Patients without metastatic adenocarcinoma of the colon, rectum, or certain parts of the stomach and esophagus, those without known DPD deficiency, those not undergoing first treatment for cancer, those outside the specified age range, those not part of the specified trial group, or those in vulnerable populations are excluded.

What the trial involves: Trifluridine/tipiracil is taken orally in tablet form, with dosage and frequency determined by healthcare providers. After two months, evaluations assess disease control rate and monitor for toxicities. Treatment continues with regular monitoring for adverse events and side effects. Quality of life is assessed using questionnaires at the start and every two months. At treatment completion, final evaluations measure overall efficacy, progression-free survival, overall survival, and objective response rate.

Investigational drug: Trifluridine/tipiracil is being tested as an alternative chemotherapy option for patients with DPD deficiency. Trifluridine works by incorporating into DNA and interfering with its function, while tipiracil helps maintain trifluridine’s activity by inhibiting its breakdown.

Study of intraperitoneal paclitaxel combined with systemic therapy versus systemic therapy alone for patients with gastric cancer and peritoneal metastases

This study compares combining intraperitoneal paclitaxel (given directly into the abdominal cavity) with standard therapy versus standard therapy alone for patients with stomach cancer that has spread to the abdominal lining.

Who can participate: Participants must have confirmed gastric or gastroesophageal junction cancer proven by tissue examination, be at least 18 years old, have cancer spread to the peritoneum confirmed by tissue or fluid examination, have had laparoscopy within 4 weeks before joining, have life expectancy of at least 3 months, good physical function with ECOG score of 0-1, adequate blood test results showing sufficient white blood cells, hemoglobin, and platelets, adequate liver and kidney function, and use highly effective birth control if able to have children. Women must not be pregnant or breastfeeding.

Who cannot participate: Those under 18 or over 75 years old, those with previous chemotherapy for stomach cancer, history of other cancers in the past 5 years, pregnant or breastfeeding women, serious heart conditions, severe liver or kidney problems, active serious infections, peripheral neuropathy grade 2 or higher, inability to take oral medications, major surgery within 4 weeks, participation in other trials within 30 days, mental conditions preventing understanding of requirements, known allergic reactions to study medications, or serious medical conditions interfering with participation are excluded.

What the trial involves: Participants are randomly assigned to receive either intraperitoneal paclitaxel plus standard therapy or standard therapy alone. Medications are given through different methods: intravenously for pembrolizumab, paclitaxel, oxaliplatin, nivolumab, docetaxel, fluorouracil, and trastuzumab; intraperitoneally for paclitaxel in one group; and orally for capecitabine. Regular medical examinations, blood tests, assessment of side effects, quality of life questionnaires, and imaging scans monitor health status and treatment response.

Investigational drug: Paclitaxel is a chemotherapy medication administered both intravenously and intraperitoneally. It stops cancer cells from dividing and growing by targeting cellular structures involved in cell division.

Study on Irinotecan, Fluorouracil, Oxaliplatin, and Calcium Folinate for Patients with Resectable Stomach and Gastroesophageal Junction Cancer

This trial tests the FOLFOXIRI medication combination for treating resectable stomach and gastroesophageal junction adenocarcinoma before and after surgery.

Who can participate: Participants must have gastric or gastroesophageal junction adenocarcinoma that can be surgically removed, be able to follow study rules and procedures, have surgeon confirmation of surgical eligibility, have cancer at a specific stage described as cT2-4a or cN+, cM0, be 18 years or older, have a WHO performance status of 1 or less, have ruled out peritoneal carcinomatosis if suspected using laparoscopy, have blood test results within normal limits including adequate hemoglobin, absolute neutrophil count, platelets, bilirubin, ALAT, and creatinine, use highly effective birth control methods during the study and for 6 months after, and sign informed consent.

Who cannot participate: Patients with different cancer types, previous interfering treatments, other serious health conditions, inability to follow procedures or attend visits, pregnant or breastfeeding women, participants in other trials simultaneously, medication allergies, substance abuse history, certain infections, or inability to give informed consent are excluded.

What the trial involves: Treatment begins with fluorouracil, oxaliplatin, calcium folinate, and irinotecan hydrochloride trihydrate administered intravenously. This is part of a perioperative phase involving medication before and after surgery. Surgery is performed based on initial treatment response, with effectiveness evaluated within 30 days. After surgery, treatment continues with the same medication combination. Regular follow-up appointments at 12, 18, 24, 30, 36, 48, and 60 months monitor health and treatment effectiveness.

Investigational drugs: Irinotecan interferes with cancer cell growth. FOLFOXIRI is a combination chemotherapy regimen including irinotecan, fluorouracil, oxaliplatin, and calcium folinate, used around the time of surgery to shrink tumors and improve surgical outcomes.

Summary

The 11 ongoing clinical trials for metastatic gastric cancer are distributed across multiple European countries, with notable concentration in Western and Southern Europe. France, Italy, and Spain show particularly strong representation, each hosting multiple trials. Germany, the Netherlands, and Portugal also serve as significant locations for this research. Several trials are conducted across multiple countries simultaneously, reflecting international collaboration in gastric cancer research.

The trials test diverse therapeutic approaches, including antibody-drug conjugates like M9140 and trastuzumab deruxtecan, immunotherapies such as pembrolizumab, nivolumab, dostarlimab, and atezolizumab, and various chemotherapy combinations. Many studies focus on HER2-positive tumors, while others target HER2-negative cancers with specific genetic markers like Claudin 18.2 or deficient mismatch repair. Several trials evaluate combination therapies, comparing new treatment regimens against standard care to determine optimal approaches for different patient populations.

The trials generally require participants to have good organ function, adequate performance status, and specific cancer characteristics determined by genetic testing. Most studies exclude patients who are pregnant, breastfeeding, have serious heart conditions, or have received certain previous treatments. Treatment typically involves intravenous administration of medications, with some oral components, and regular monitoring through imaging studies, blood tests, and physical examinations. The research spans multiple years, with some trials extending through 2030, reflecting the long-term nature of cancer treatment evaluation.

Ongoing Clinical Trials on Metastatic gastric cancer

  • A study to test the safety and effectiveness of ONA-255 in patients with advanced cancer including breast cancer and gastric cancer

    Recruiting

    1 1
    Investigated diseases:
    Spain

  • Study of intraperitoneal paclitaxel combined with systemic therapy versus systemic therapy alone for patients with gastric cancer and peritoneal metastases

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Italy The Netherlands Norway Sweden

  • Evaluating intraperitoneal irinotecan with systemic therapy in patients with gastric peritoneal metastases

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    The Netherlands

  • Study of Trastuzumab Deruxtecan and Drug Combination for Patients with Advanced or Metastatic HER2-Positive Gastric or Gastroesophageal Junction Cancer

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Austria Belgium Czechia France Germany Italy +6

  • Study of HLX22, Trastuzumab, and Chemotherapy for Patients with Advanced or Metastatic Stomach and Gastroesophageal Cancer

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Germany Greece Italy Poland Portugal Romania +1

  • Study on Dostarlimab Immunotherapy for Patients with Localized Gastric Cancer with Deficient Mismatch Repair or High Microsatellite Instability

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    France Italy

  • Study of DS-3939a for Patients with Advanced or Metastatic Solid Tumors

    Recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Belgium France Spain

  • Study of zolbetuximab, pembrolizumab and chemotherapy in adults with HER2-negative, Claudin 18.

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Czechia France Germany Italy Lithuania +5

  • Study of M9140 for Patients with Advanced Stomach Cancer

    Not recruiting

    1 1
    Investigated diseases:
    Austria France Germany Italy Spain

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