Clinical trial locations
- Belgium
- Czechia
- Denmark
- Estonia
- France
- Germany
- Hungary
- Ireland
- Italy
- Latvia
- Lithuania
- Netherlands
- Poland
- Portugal
- Romania
- Spain
Study of zolbetuximab, pembrolizumab and chemotherapy in adults with HER2-negative, Claudin 18.
This trial studies whether adding zolbetuximab to pembrolizumab and chemotherapy works better than chemotherapy and pembrolizumab alone as a first treatment for HER2-negative gastric and gastroesophageal junction cancer that tests positive for CLDN18.2 and PD-L1 proteins.
Inclusion criteria: Participants must be at least 18 years old and have confirmed gastric or gastroesophageal junction adenocarcinoma that cannot be surgically removed or has spread to other parts of the body. The cancer must test positive for PD-L1 and CLDN18.2 proteins and be HER2-negative. They must be able to receive treatment with chemotherapy and pembrolizumab, have good physical function status (ECOG 0 or 1), and a life expectancy of at least 12 weeks.
Exclusion criteria: Patients with known allergies to study medications, previous chemotherapy for advanced cancer, active autoimmune disease requiring treatment, untreated or unstable brain metastases, other cancers within the last 5 years (except certain successfully treated cancers), significant heart conditions, active hepatitis or tuberculosis infections, who are pregnant or breastfeeding, unable to swallow oral medications, major surgery within 4 weeks, participation in another trial within 4 weeks, or conditions that would make participation unsafe cannot participate.
Focus: Participants receive either zolbetuximab or placebo along with pembrolizumab and chemotherapy (either CAPOX or mFOLFOX6). All medications are given through intravenous infusion, with some chemotherapy taken as tablets. The study tracks how long participants live, whether cancer grows or spreads, and monitors side effects.
Investigational drugs: Zolbetuximab targets Claudin 18.2 protein on cancer cell surfaces, helping the immune system recognize and attack cancer cells. Pembrolizumab blocks PD-L1 protein to help the immune system detect and fight cancer cells. CAPOX and mFOLFOX6 are chemotherapy combinations that work together to kill cancer cells or stop them from growing.
Study on [18F]FAPI-74 for Better Cancer Imaging in Patients with Esophagogastric and Pancreatic Cancer
This trial tests whether a new imaging method using [18F]FAPI-74 PET/CT can detect oesophagogastric adenocarcinoma and pancreatic ductal adenocarcinoma better than current standard methods in newly diagnosed, treatment-naive patients.
Inclusion criteria: Participants must be 18 years or older and provide voluntary written informed consent. They must have a new diagnosis of oesophagogastric adenocarcinoma or pancreatic ductal adenocarcinoma confirmed by histology or cytology, with cancer classified as cT1-4N0-3M0 for OGA or cT1-4N0-2M0-1 for PDAC. They must have had or be scheduled for an [18F]FDG PET/CT scan within 4 weeks, or for PDAC patients, conventional CT or MRI of the upper abdomen within 4 weeks.
Exclusion criteria: Patients who have already received cancer treatment, have other serious health conditions, are pregnant or breastfeeding, are unable to give informed consent, have allergies to substances used in the study, or are participating in another clinical trial cannot participate.
Focus: Participants undergo PET/CT scanning using the [18F]AlF-FAPI-74 imaging agent, which is injected intravenously. The scan aims to detect cancer-associated fibroblasts and provide better information about cancer presence and extent compared to conventional imaging methods.
Investigational drug: [18F]AlF-FAPI-74 is a radiopharmaceutical imaging agent that targets fibroblast activation protein, which is often overexpressed in cancer-associated fibroblasts, allowing for enhanced imaging of tumors in PET/CT scans.
Study on the Effects of Rilvegostomig and Drug Combination for Patients with Advanced Gastric or Gastroesophageal Junction Cancer
This trial explores new drug combinations including rilvegostomig with chemotherapy for patients with locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma.
Inclusion criteria: Participants must be 18 years or older, weigh more than 35 kg, have locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma, not have received previous treatment for this cancer, have measurable disease according to RECIST 1.1, ECOG PS of 0 or 1, life expectancy of at least 12 weeks, and adequate organ and bone marrow function.
Exclusion criteria: Patients with other types of cancer, previous treatments that might interfere with study results, other serious health conditions, who are pregnant or breastfeeding, unable to follow study procedures, participated in another trial recently, have allergies to study medication, have a history of substance abuse, an active infection, or a mental health condition cannot participate.
Focus: Participants are randomly assigned to receive either FOLFOX or TFOX chemotherapy regimens. FOLFOX includes fluorouracil, calcium levofolinate, and oxaliplatin. TFOX adds anhydrous docetaxel to FOLFOX. All medications are administered intravenously in cycles. The study evaluates objective response rate and progression-free survival at 6 months.
Investigational drugs: The novel agent being tested in combination with chemotherapy aims to improve treatment outcomes by potentially shrinking tumors or stopping their growth. Chemotherapy uses drugs to kill cancer cells or stop them from growing.
Study of Tremelimumab and Durvalumab for Patients with Resectable Stomach or Gastroesophageal Junction Cancer with Microsatellite Instability
This trial investigates the combination of durvalumab and tremelimumab immunotherapy medications for patients with resectable gastric or gastroesophageal junction cancer characterized by microsatellite instability and without Epstein-Barr virus infection.
Inclusion criteria: Participants must provide written informed consent, be at least 18 years old, have ECOG Performance Status of 0-1, weigh more than 30 kg, have resectable gastric or gastroesophageal junction cancer without distant metastases confirmed by imaging, life expectancy of at least 12 weeks, MSI-high status confirmed and EBV-negative, adequate bone marrow and organ function, and be able to access treatment and follow-up at the participating center.
Exclusion criteria: Patients with cancer that has spread to other organs, cancer that cannot be surgically removed, cancer that does not show microsatellite instability, or cancer with EBV infection cannot participate.
Focus: Participants receive durvalumab and tremelimumab through intravenous infusion before surgery or as definitive treatment. The study monitors cancer response to immunotherapy, tracking whether cancer disappears completely, how long participants live without cancer recurrence, and overall survival rates.
Investigational drugs: Tremelimumab blocks a protein that prevents the immune system from attacking cancer cells, allowing better targeting and destruction of cancer cells. Durvalumab blocks a different protein (PD-L1) on cancer cells, enhancing the body's natural defenses to fight cancer.
Study on the Effectiveness of Bemarituzumab and FLOT Chemotherapy for Patients with Resectable Gastric and Gastroesophageal Junction Cancer
This trial evaluates the combination of bemarituzumab with FLOT chemotherapy (fluorouracil, levoleucovorin, oxaliplatin, and docetaxel) given before and after surgery for patients with gastric and gastroesophageal junction adenocarcinoma whose cancer cells show FGFR2b overexpression.
Inclusion criteria: Participants must sign informed consent, be willing to attend visits and follow treatment schedule, have confirmed gastric or gastroesophageal junction adenocarcinoma, provide tumor tissue for FGFR2b analysis showing positive overexpression status, have ECOG performance status 0 or 1, cancer classified as cT2-T4a or N+ without distant spread, adequate blood and organ function including specific levels of liver enzymes, albumin, bone marrow function, kidney function, and blood clotting function, be at least 18 years old, and agree to use contraception if of childbearing potential.
Exclusion criteria: Patients with other types of cancer, previous treatment with similar drugs, certain other health conditions, who are pregnant or breastfeeding, unable to follow study procedures, have allergies to study drugs, participated in another trial recently cannot participate.
Focus: Participants receive bemarituzumab combined with FLOT chemotherapy through intravenous infusion over six months. Treatment is given before surgery to shrink tumors and after surgery to eliminate remaining cancer cells. The study monitors treatment response, side effects, and overall patient health.
Investigational drug: Bemarituzumab is a monoclonal antibody that targets and blocks the FGFR2b protein on cancer cells, helping to slow down or stop cancer cell growth when combined with FLOT chemotherapy.
Summary
These 22 ongoing clinical trials represent a diverse range of treatment approaches for adenocarcinoma gastric across Europe. Several key observations emerge from this overview:
Geographic distribution: Trials are concentrated in Western and Southern Europe, with France, Italy, Spain, Germany, Belgium, and Poland hosting the most studies. This distribution reflects both the clinical research infrastructure in these countries and the disease burden.
Treatment approaches: The trials explore three main therapeutic strategies. Immunotherapy combinations, particularly involving pembrolizumab, appear in multiple trials, often combined with chemotherapy. Several studies focus on antibody-drug conjugates including trastuzumab deruxtecan, ifinatamab deruxtecan, and JK06. Targeted therapies like zolbetuximab targeting Claudin 18.2 protein feature prominently in several trials.
Patient populations: Most trials target advanced, metastatic, or unresectable disease, though some studies focus on resectable cancer with neoadjuvant or perioperative treatment approaches. Many trials specify biomarker requirements such as HER2 status, PD-L1 expression, Claudin 18.2 positivity, or microsatellite instability.
Treatment settings: The majority of trials investigate first-line treatment options, though several focus on patients who have progressed after previous therapies. Some studies explore novel combinations of existing treatments or compare experimental regimens to standard care.
The variety of approaches being tested reflects the complexity of gastric adenocarcinoma and the need for personalized treatment strategies based on tumor characteristics and patient factors. These trials collectively aim to improve outcomes for patients with this challenging disease.