Clinical Trials for Gastrointestinal Carcinoma
Currently, there are 5 ongoing clinical trials investigating new treatments for gastrointestinal carcinoma. These studies are testing various medications and treatment approaches, including targeted therapies, immunotherapies, and chemotherapy combinations. Trials are being conducted across multiple European countries, offering patients with advanced or metastatic disease opportunities to access experimental treatments that may improve outcomes and quality of life.
Clinical trial locations
- Denmark
- Finland
- France
- Study on the Effectiveness and Safety of BAY 2927088 for Patients with Advanced Solid Tumors with HER2 Mutations
- Study on the Effects of Methylprednisolone and Sodium Chloride in Patients Undergoing Surgery for Digestive Cancer
- Study on the Safety and Effectiveness of Domvanalimab, Zimberelimab, and Quemliclustat in Adults with Advanced Upper Gastrointestinal Cancer
- Italy
- Netherlands
- Spain
Study on the Effectiveness and Safety of BAY 2927088 for Patients with Advanced Solid Tumors with HER2 Mutations
This trial is testing BAY 2927088, an oral medication taken as a tablet, for patients with advanced solid tumors that have a specific genetic change called a HER2 mutation. The medication works as a reversible tyrosine kinase inhibitor, blocking proteins that help cancer cells grow.
Inclusion criteria: Participants must be at least 18 years old and have an advanced solid tumor that cannot be removed by surgery, including colorectal, biliary tract, bladder, cervical, or endometrial cancers (but not lung cancer). Patients must have a confirmed HER2-activating mutation and at least one tumor area that can be measured. They should have already tried standard treatments or have no other satisfactory treatment options available.
Exclusion criteria: Patients without a HER2 mutation, those not meeting the age requirements, pregnant or breastfeeding women, and those with certain medical conditions that could interfere with the study cannot participate. People who have recently participated in another clinical trial or have allergies to the study medication are also excluded.
Study focus: The trial aims to evaluate how well BAY 2927088 reduces tumor size or stops tumor growth, and to assess its safety profile. Researchers will monitor participants for up to 36 months, tracking tumor response, side effects, quality of life, and how long the treatment keeps the disease under control. Regular check-ups will include imaging tests and safety assessments to understand the medication’s effectiveness and potential risks.
Study on the Impact of Cisplatin and Drug Combination on Speech and Cognition in Cancer Patients
This Finnish trial examines how cancer treatments affect patients’ ability to understand speech in noisy environments, as well as their thinking abilities and quality of life. The study involves patients receiving treatments intended to cure their cancer.
Inclusion criteria: Participants must be between 18 and 75 years old, have a cancer diagnosis being treated with curative intent using cisplatin, oxaliplatin, cisplatin-based chemoradiation, or radiation therapy for head and neck cancers. They must have age-appropriate normal hearing, be native Finnish speakers, and provide written informed consent.
Exclusion criteria: People without a cancer diagnosis, those outside the specified age range, and vulnerable populations who may need special protection cannot participate.
Study focus: The trial assesses short-term effects of cancer treatments on speech perception in noise, hearing function, and cognitive abilities. The investigational drugs include cisplatin, oxaliplatin, gemcitabine, capecitabine, mesna, ifosfamide, etoposide, and bleomycin, administered either intravenously or orally. Participants undergo baseline assessments followed by regular monitoring for approximately 3-4 months after treatment completion. The study will continue until 2031 and aims to provide insights that could improve future treatment plans and support services.
Study on Capecitabine and Oxaliplatin for Patients with Advanced or Metastatic Gastrointestinal Cancer with CES1 Variant
This Dutch trial investigates how the body processes capecitabine and oxaliplatin in patients with advanced or metastatic disease, particularly in individuals with a specific genetic variation called CES1 1165–33 C>A. This genetic difference may influence how the body breaks down the medication, potentially affecting effectiveness and side effects.
Inclusion criteria: Participants must be at least 18 years old and planned to start treatment with capecitabine and oxaliplatin as part of standard care. They must be considered fit for this treatment by their doctor and able to understand study requirements, read, and sign the consent form.
Exclusion criteria: Patients with locally advanced or metastatic gastrointestinal carcinoma where the cancer has spread beyond the initial digestive system location cannot participate. Those outside the specified age range and vulnerable populations are also excluded.
Study focus: The trial examines the relationship between the genetic variation and medication processing, measuring blood and urine levels of treatment-related substances. Researchers are particularly interested in understanding hand-foot syndrome, a side effect causing redness, swelling, and pain in hands and feet. Capecitabine is taken orally, while oxaliplatin is given through intravenous infusion. The study continues until December 2026 and aims to tailor treatments to improve outcomes and reduce side effects.
Study on the Effects of Methylprednisolone and Sodium Chloride in Patients Undergoing Surgery for Digestive Cancer
This French trial evaluates whether a pre-surgery dose of corticosteroids can reduce the risk of major complications after surgery. The study compares patients receiving methylprednisolone injections to those receiving a placebo.
Inclusion criteria: Participants must be at least 18 years old, scheduled for planned surgery for any type of digestive cancer (excluding purely liver surgery) with curative intent, have provided written informed consent, and be affiliated with national health insurance.
Exclusion criteria: Patients not scheduled for digestive cancer surgery, those outside the specified age range, and vulnerable populations cannot participate.
Study focus: The trial assesses whether corticosteroids reduce major complications within 30 days after surgery. The medications being tested are Methylprednisolone Viatris and Solumedrol, given as intravenous injections. Participants are randomly assigned to receive either the treatment or placebo before surgery. The study also monitors overall survival, disease-free survival, infection rates, surgical wound healing at 30 days, and safety factors such as high blood sugar and electrolyte imbalances. The trial continues until November 2026.
Study on the Safety and Effectiveness of Domvanalimab, Zimberelimab, and Quemliclustat in Adults with Advanced Upper Gastrointestinal Cancer
This French trial explores the safety and effectiveness of immunotherapy combinations for patients with advanced cancers of the stomach, gastroesophageal junction, and esophagus.
Inclusion criteria: Participants must have confirmed locally advanced, unresectable, or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma. They should have a life expectancy of at least 3 months, an ECOG Performance Score of 0-1 (meaning they are fully or nearly fully active), at least one measurable tumor lesion according to standard criteria, adequate organ and bone marrow function, and be able to provide a previous tumor sample for PD-L1 testing. The study is open to adults of any gender.
Exclusion criteria: Patients with other cancer types, serious heart problems, uncontrolled high blood pressure, active infections including HIV or hepatitis, those who are pregnant or breastfeeding, organ transplant recipients, participants in other clinical trials, people with known allergies to study drugs, autoimmune disease history, recent drug or alcohol abuse, or recent cancer treatments are excluded.
Study focus: The trial tests combinations of domvanalimab, zimberelimab, and quemliclustat, along with chemotherapy drugs including calcium folinate, oxaliplatin, and fluorouracil. These medications are given as intravenous infusions. Domvanalimab and zimberelimab work by helping the immune system recognize and attack cancer cells, while quemliclustat interferes with cancer cell growth pathways. Participants receive treatment for up to 24 months with regular monitoring including physical examinations, blood tests, and imaging studies to track treatment response and manage side effects.
Summary
The five ongoing clinical trials for gastrointestinal carcinoma reflect a diverse approach to improving treatment outcomes. France hosts the most trials with three studies, followed by one trial each in the Netherlands and Finland, while one multinational trial spans Denmark, Italy, France, and Spain. This concentration of research activity in France suggests strong institutional support for cancer research in the region.
The trials explore different treatment strategies ranging from targeted therapies and immunotherapies to supportive care interventions. Two studies focus on advanced or metastatic disease using novel targeted therapies and immunotherapy combinations, while others examine how standard chemotherapies can be optimized through genetic testing or how supportive medications like corticosteroids might reduce surgical complications. One unique study addresses quality of life concerns by examining how cancer treatments affect speech perception and cognitive function.
Most trials target patients with advanced disease who have limited treatment options, although one study focuses on the surgical setting. The variety of investigational drugs includes BAY 2927088 for HER2-mutated tumors, immunotherapies like domvanalimab and zimberelimab, standard chemotherapies like capecitabine and oxaliplatin, and supportive medications such as corticosteroids. This range demonstrates the multifaceted approach researchers are taking to improve outcomes for patients at different stages of disease and treatment.
