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Gastric cancer – Trials in Disease

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Clinical Trials for Gastric Cancer: Treatment Options and Research Studies

Currently, 40 clinical trials are investigating new treatments for gastric cancer, also known as stomach cancer. These studies are evaluating innovative medications, combination therapies, and treatment approaches across multiple countries in Europe. The trials focus on different stages of the disease, from early resectable cancer to advanced metastatic forms, and include both newly diagnosed patients and those who have received previous treatments.

Clinical trial locations

Study of AZD9574 and Temozolomide for Patients with Advanced Solid Tumors, Including Breast, Ovarian, Pancreatic, and Prostate Cancers

This trial is testing a new medication called AZD9574, both alone and in combination with other anti-cancer treatments. The study focuses on various types of advanced cancers including certain brain tumors, breast cancer, ovarian cancer, prostate cancer, and pancreatic cancer. Participants must be at least 18 years old with cancer that is worsening and have received confirmation of advanced cancer suitable for the treatment.

Inclusion criteria: Patients must provide signed consent, have good performance status, adequate organ function, and confirmed advanced cancer. Women who can have children must use effective birth control and have negative pregnancy tests.

Exclusion criteria: Patients without the specific cancer types being studied or the required genetic mutations cannot participate. Those with brain metastases from breast cancer or other health conditions that make participation unsafe are also excluded.

Focus: The study will evaluate the safety and tolerability of AZD9574 when used alone and with other treatments. It will monitor how the body processes the drug and assess its effectiveness through regular health checks, blood tests, and imaging scans.

Investigational drug: AZD9574 is an experimental medication being tested for treating advanced solid tumors. It is administered as a film-coated tablet taken orally and may be combined with other anti-cancer agents to target specific biomarkers.

Study of BOLD-100 with FOLFOX chemotherapy (fluorouracil, folinic acid, and oxaliplatin) in patients with advanced gastrointestinal tumors, colorectal, gastric, or pancreatic cancer

This study evaluates combining an investigational drug called BOLD-100 with standard FOLFOX chemotherapy in patients with advanced gastrointestinal tumors. The study is conducted in two parts: first determining the safest dose, then testing effectiveness in more patients.

Inclusion criteria: Participants must be at least 18 years old with adequate organ function, normal blood cell counts, proper liver and kidney function, and measurable tumors. Previous treatment side effects must be resolved or mild, and patients must be able to take oral medications.

Exclusion criteria: Those excluded include patients under 18, those with allergies to FOLFOX medications, active infections, pregnant or breastfeeding women, severe kidney or liver problems, and those with blood disorders affecting blood cell counts.

Focus: The trial combines BOLD-100 with FOLFOX chemotherapy to study safety and effectiveness. Treatment includes intravenous medications and regular monitoring through check-ups, blood tests, and heart activity monitoring.

Investigational drugs: BOLD-100 is an investigational medication being studied with standard FOLFOX chemotherapy (fluorouracil, leucovorin, and oxaliplatin), which works by stopping or slowing cancer cell growth.

Study of Disitamab Vedotin and Tucatinib for Patients with Advanced Breast Cancer or Gastric Cancer

This clinical trial tests Disitamab Vedotin alone or combined with Tucatinib for treating advanced gastric cancer and gastroesophageal junction adenocarcinoma. The medications target HER2 protein, which affects cancer cell growth.

Inclusion criteria: Participants must be at least 18 years old with confirmed diagnosis of locally-advanced or metastatic gastric or breast cancer that cannot be surgically removed. They must have specific HER2 status and have experienced disease progression after standard treatments.

Exclusion criteria: Patients with different cancer types, pregnant or breastfeeding women, those with severe health conditions, or unable to follow study procedures are excluded.

Focus: The treatment involves intravenous infusion of Disitamab Vedotin and oral Tucatinib tablets. Regular monitoring assesses safety, effectiveness, and tumor response. The study aims to determine the maximum tolerated dose and antitumor activity.

Investigational drugs: Disitamab Vedotin targets HER2 protein on cancer cells to inhibit their growth. Tucatinib works alongside it to enhance treatment effectiveness in advanced breast and gastric cancers.

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

This trial tests a new treatment called DS-3939a given through intravenous infusion for advanced solid tumors including gastric cancer. The study evaluates safety, tolerability, and effectiveness of this experimental medication.

Inclusion criteria: Participants must be at least 18 years old with measurable disease and good performance status. They need a left ventricular ejection fraction of at least 50% and adequate organ function. For different study parts, patients must have confirmed diagnosis of specific cancers.

Exclusion criteria: Patients without the specific cancer types being studied or outside the specified age range cannot participate. Vulnerable populations are also excluded.

Focus: The medication DS-3939a is administered intravenously in cycles. Regular monitoring includes physical exams, blood tests, electrocardiograms, and imaging studies to assess treatment response and safety.

Investigational drug: DS-3939a is an investigational medication delivered directly into the bloodstream, being tested to assess safety and effectiveness in shrinking or controlling tumors in patients with advanced solid tumors.

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

This study compares a new combination treatment of HLX22 with trastuzumab and chemotherapy against standard treatment for HER2-positive gastric or gastroesophageal junction cancer that has spread or advanced.

Inclusion criteria: Participants must be at least 18 years old with confirmed diagnosis of HER2-positive gastric or gastroesophageal junction cancer. They need adequate organ function, good performance status, and must provide tumor samples for testing.

Exclusion criteria: Patients with other cancer types, those who received certain previous treatments, pregnant or breastfeeding women, those with serious heart conditions, active infections, or unable to follow study procedures are excluded.

Focus: Treatment involves intravenous infusion of HLX22, trastuzumab, and chemotherapy drugs (XELOX regimen). Regular monitoring includes blood tests, imaging scans, and assessments for side effects and effectiveness.

Investigational drugs: HLX22 is a humanized antibody that targets HER2 protein on cancer cells. Trastuzumab blocks HER2 signals that tell cancer cells to grow. XELOX combines capecitabine and oxaliplatin chemotherapy drugs to kill cancer cells.

Study of hyperthermic intraperitoneal chemotherapy with oxaliplatin, fluorouracil, and calcium levofolinate in patients with advanced gastric cancer after surgery

This study compares survival rates between surgery with Hyperthermic Intraperitoneal Chemotherapy (HIPEC) versus surgery alone for advanced stomach cancer. HIPEC involves circulating heated chemotherapy drugs directly in the abdominal cavity.

Inclusion criteria: Participants must be between 18 and 75 years old with confirmed gastric adenocarcinoma suitable for surgical removal. They need good physical condition, adequate blood and organ function, and must use effective birth control if capable of reproduction.

Exclusion criteria: Those excluded include patients outside the age range, with distant metastases, previous cancer treatments, severe heart/lung/liver/kidney disease, pregnancy or breastfeeding, active infections, or obesity with BMI greater than 35.

Focus: Patients undergo D2 resection surgery. Group A receives HIPEC with heated chemotherapy (calcium levofolinate, fluorouracil, oxaliplatin) administered during and 6-8 weeks after surgery. Regular monitoring tracks recovery, complications, and cancer recurrence.

Investigational drugs: HIPEC combines heat with chemotherapy drugs delivered directly into the abdominal cavity after surgery. This targeted treatment helps eliminate remaining cancer cells more effectively than traditional methods.

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

This trial studies treatment combining zolbetuximab, pembrolizumab and chemotherapy for gastric and gastroesophageal junction cancers in patients whose tumors are HER2-negative but positive for CLDN18.2 and PD-L1 proteins.

Inclusion criteria: Participants must be at least 18 years old with confirmed advanced or metastatic gastric or gastroesophageal junction cancer that cannot be surgically removed. Tumors must test positive for PD-L1 and CLDN18.2 proteins and negative for HER2. Patients need good physical function and adequate organ function.

Exclusion criteria: Those excluded include patients with known allergies to study medications, active autoimmune disease, untreated brain metastases, history of other cancers within 5 years, significant heart conditions, active infections, pregnancy or breastfeeding, or inability to swallow oral medications.

Focus: Treatment includes intravenous zolbetuximab or placebo plus pembrolizumab and chemotherapy (CAPOX or mFOLFOX6). Regular monitoring includes assessments of cancer response, side effects, blood tests, heart monitoring, and quality of life evaluations.

Investigational drugs: Zolbetuximab targets Claudin 18.2 protein to help the immune system attack cancer cells. Pembrolizumab blocks PD-L1 to help the immune system fight cancer. CAPOX and mFOLFOX6 are chemotherapy combinations that kill cancer cells.

Study on [18F]-AlF-FAPI-74 for Staging Advanced Stomach Cancer in Patients Using PET/CT and Laparoscopy

This study evaluates whether a new imaging method using [18F]AlF-FAPI-74 PET/CT can improve staging of advanced gastric cancer without requiring invasive procedures like laparoscopy.

Inclusion criteria: Participants must be at least 18 years old with confirmed diagnosis of advanced gastric cancer and surgically resectable tumor. The cancer must be accessible for biopsies and determined suitable for surgery by a medical team.

Exclusion criteria: Patients with other cancer types, pregnant or breastfeeding women, severe heart problems, kidney or liver disease, recent major surgery, current participation in another trial, or any condition making participation unsafe are excluded.

Focus: Participants undergo non-invasive [18F]AlF-FAPI-74 PET/CT scan after receiving an intravenous injection. Results are discussed in multidisciplinary team meetings to determine treatment plans. Additional procedures like biopsies may be recommended based on scan results.

Investigational drug: [18F]AlF-FAPI-74 is an imaging agent used in PET/CT scans to provide detailed pictures of cancer spread, helping doctors decide if further procedures like surgery are necessary.

Study on [68Ga]Ga-FAPI-46 and Iodixanol for Better Imaging in Patients with Pancreatic and Gastroesophageal Cancer

This trial tests whether total body PET/CT with [68Ga]Ga-FAPI-46 tracer provides better imaging than standard methods for diagnosing and planning treatment in pancreatic and gastroesophageal cancers.

Inclusion criteria: Participants must be at least 18 years old and able to read and understand Danish. For Group A: suspected pancreatic cancer with no signs of distant spread and suitable for curative surgery. For Group B: confirmed diagnosis of carcinoma from lower esophagus, gastroesophageal junction, or stomach, and considered operable.

Exclusion criteria: Patients without pancreatic or gastroesophageal cancer, outside the specified age range, or part of vulnerable populations cannot participate.

Focus: Participants receive [68Ga]Ga-FAPI-46 tracer through intravenous injection followed by PET/CT scan within 30 minutes. A follow-up scan may be done at 60 minutes. Results are evaluated to determine sensitivity and impact on patient management.

Investigational drug: [68Ga]Ga-FAPI-46 is a tracer used in PET/CT scans to help visualize cancer more clearly, working by targeting fibroblast activation protein often overexpressed in cancerous tissues.

Study on AZD0901 and Drug Combination for Patients with Advanced Gastric, Gastroesophageal, and Pancreatic Cancers Expressing Claudin 18.2

This trial tests AZD0901 alone and combined with chemotherapy medications (irinotecan, folinic acid, gemcitabine, fluorouracil) for advanced gastric, gastroesophageal junction, and pancreatic cancers expressing Claudin 18.2 protein.

Inclusion criteria: Participants must be at least 18 years old with confirmed adenocarcinoma and positive CLDN18.2 protein test. For Sub study 1: gastric or gastroesophageal cancer with up to two previous treatments. For Sub study 2: metastatic or advanced pancreatic cancer with no previous treatments. Patients need measurable disease, good performance status, life expectancy of at least 12 weeks, adequate organ function, and weigh more than 35 kg.

Exclusion criteria: Patients with different cancer types, tumors not expressing CLDN18.2, outside specified age range, or unable to safely tolerate treatment are excluded.

Focus: Treatment involves intravenous infusion of AZD0901 alone or combined with other cancer medications. Regular monitoring includes assessments of safety, effectiveness, and tumor response through imaging studies.

Investigational drug: AZD0901 targets Claudin 18.2 protein to help treat advanced cancers by disrupting cancer cell growth and survival. It is classified as an investigational anti-cancer agent.

Study on the Effectiveness and Safety of AZD0901 Compared to Standard Treatments for Adults with Advanced Gastric or Gastroesophageal Junction Cancer Expressing Claudin 18.2

This study compares AZD0901 with standard treatments (docetaxel, irinotecan, paclitaxel, trifluridine, tipiracil, or ramucirumab) for advanced gastric or gastroesophageal junction cancer expressing Claudin 18.2 protein.

Inclusion criteria: Participants must be at least 18 years old with confirmed adenocarcinoma that cannot be surgically removed or has spread. Cancer must show positive CLDN 18.2 expression confirmed by central lab and have worsened after at least one previous treatment including fluoropyrimidine and platinum drugs. Patients need measurable cancer, good performance status, life expectancy of at least 12 weeks, adequate organ function, weigh at least 35 kg, and meet birth control requirements.

Exclusion criteria: Patients with different cancer types, those not expressing Claudin18.2, outside age range, unable to follow procedures, or part of vulnerable populations are excluded.

Focus: Participants receive either AZD0901 or standard treatment chosen by investigator through intravenous infusion. Regular monitoring assesses cancer progression, survival, side effects, and quality of life.

Investigational drug: AZD0901 targets Claudin 18.2 protein to improve progression-free survival and overall survival in patients who have received previous treatments for advanced gastric or gastroesophageal junction cancer.

Summary

The 40 ongoing clinical trials for gastric cancer represent a diverse range of treatment approaches across multiple European countries. A significant concentration of trials is taking place in France, Germany, Italy, and Spain, reflecting these countries’ strong research infrastructure for oncology studies.

Several notable trends emerge from these trials. Many studies focus on immunotherapy combinations, particularly involving checkpoint inhibitors like pembrolizumab, nivolumab, and tislelizumab. Multiple trials are investigating targeted therapies based on specific biomarkers, especially HER2 status and CLDN18.2 expression. Advanced imaging techniques using novel tracers like 68Ga-FAPI-46 and [18F]AlF-FAPI-74 are being evaluated to improve disease staging and treatment planning.

The trials span different disease stages, from resectable cancer requiring perioperative treatment to advanced metastatic disease. Some studies explore innovative approaches like HIPEC (heated intraperitoneal chemotherapy) combined with surgery for high-risk patients. Several trials compare new combination therapies with established standard treatments to determine whether novel approaches offer survival benefits.

Most trials require patients to have good performance status and adequate organ function. Common exclusion criteria include pregnancy, severe heart conditions, active infections, and recent participation in other clinical trials. The studies generally include both newly diagnosed patients and those who have progressed after previous treatments, offering hope for patients at different stages of their treatment journey.

Ongoing Clinical Trials on Gastric cancer

  • A Study of Zanidatamab for Patients with Previously Treated HER2-Expressing Solid Tumors

    Recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Spain

  • A study comparing injection under the skin versus infusion into the vein of tislelizumab with chemotherapy for patients with advanced gastric or gastroesophageal junction cancer

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Austria Czechia France Italy Poland Spain

  • A study of irinotecan and a drug combination for patients with gastric cancer or gastroesophageal junction cancer undergoing surgery.

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    The Netherlands

  • A study of pumitamig and a drug combination versus nivolumab and a drug combination for patients with untreated advanced or metastatic stomach or esophageal cancer

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    France Germany Italy Poland Romania Spain

  • A study to evaluate the use of FAPI-46 (68Ga) imaging to detect peritoneal cancer spread in patients with colorectal, gastric, ovarian, or pancreatic cancer

    Recruiting

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

  • A Study of CLDN6 CAR-T Cell Therapy With or Without CLDN6 RNA-LPX Vaccine in Patients With CLDN6-Positive Advanced Solid Tumors That Returned or Did Not Respond to Treatment

    Recruiting

    1 1
    Investigated diseases:
    Germany The Netherlands Sweden

  • Study of AZD4360 safety and effectiveness in adults with advanced solid tumors including gastric, gastroesophageal junction, biliary tract cancer and pancreatic cancer

    Recruiting

    1 1
    Investigated diseases:
    Germany

  • Study on [18F]-AlF-FAPI-74 for Staging Advanced Stomach Cancer in Patients Using PET/CT and Laparoscopy

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    The Netherlands

  • 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 the Effectiveness and Safety of BAY 2927088 for Patients with Advanced Solid Tumors with HER2 Mutations

    Recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Denmark France Italy Spain

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