Ongoing Clinical Trials for Metastatic Gastrointestinal Cancer
There are currently 3 ongoing clinical trials exploring new treatment approaches for metastatic gastrointestinal cancer. These studies are investigating different strategies, including personalized chemotherapy dosing for patients with enzyme deficiencies, advanced imaging techniques to improve surgical outcomes, and combinations of immunotherapy with chemotherapy for esophagogastric cancers.
Clinical trial locations
- France
- Italy
- Netherlands
Chemotherapy Dose Adjustment for Gastrointestinal Cancer Patients with DPD Deficiency Using Fluorouracil, Capecitabine, and Oxaliplatin
This study is being conducted in France and focuses on patients with digestive system cancers who have a deficiency in a liver enzyme called dihydropyrimidine dehydrogenase (DPD). This enzyme plays an important role in breaking down certain chemotherapy drugs, particularly fluoropyrimidines like fluorouracil and capecitabine.
Main focus: The trial aims to find the safest and most effective way to adjust chemotherapy doses for patients with DPD deficiency. The goal is to reduce the risk of severe side effects while maintaining treatment effectiveness. Researchers will compare different dosing strategies based on uracilemia levels, which are measured before treatment begins. The study will monitor patients during the first two cycles of treatment to assess side effects affecting blood cells and the digestive system.
Who can participate: Patients must be 18 years or older with gastrointestinal cancer requiring chemotherapy with fluoropyrimidines and oxaliplatin. They must have adequate organ function and an ECOG performance status of 2 or less. Women of childbearing age need a negative pregnancy test and must use reliable contraception during treatment and for 6 months afterward. Patients must not have previously received fluoropyrimidine treatment.
Who cannot participate: The study excludes patients who have already been treated with fluoropyrimidines, those without gastrointestinal cancer, and patients who do not have pre-treatment uracilemia measurements available. Patients must also be starting the specific chemotherapy combination of fluoropyrimidines and oxaliplatin to be eligible.
Investigational treatments: The study uses fluoropyrimidine-based chemotherapy, including fluorouracil (given intravenously) and capecitabine (taken orally), in combination with oxaliplatin. These drugs work by interfering with DNA synthesis in cancer cells, preventing their growth and division. The dosing is adjusted based on each patient’s DPD enzyme levels to minimize side effects.
Study on Indocyanine Green with Extracellular Vesicles for Better Tumor Visualization in Patients Undergoing Surgery for Digestive System Cancers
This innovative trial in Italy is testing a new approach to help surgeons see tumors more clearly during surgery for digestive system cancers, including colon, rectal, gastric, and pancreatic tumors.
Main focus: The study evaluates OncoGreen, a special formulation that combines indocyanine green (a fluorescent dye) with extracellular vesicles taken from the patient’s own blood. This combination is designed to make tumors glow under special lighting during surgery, helping surgeons identify tumor edges more precisely. The trial has two phases: the first focuses on safety and determining the optimal dose, while the second assesses how well OncoGreen improves tumor visualization during surgery.
Who can participate: Patients must be 18 years or older with a diagnosed solid tumor of the digestive tract that requires surgical removal. They need to have good overall health with an ECOG performance status of 0-1 and adequate organ function suitable for major cancer surgery. Patients must be eligible for a plasmapheresis procedure, which is used to collect blood components needed to prepare OncoGreen. They must test negative for HIV, hepatitis B and C, and syphilis.
Who cannot participate: The study excludes patients with cancers other than digestive system tumors, those whose tumors cannot be surgically treated, and patients unable to undergo surgery. Pregnant or breastfeeding women cannot participate, nor can those with known allergies to the study drug or severe medical conditions that could interfere with the study.
Investigational treatments: OncoGreen combines indocyanine green with autologous extracellular vesicles. The vesicles, taken from the patient’s own blood, carry the fluorescent dye directly to tumor cells. This personalized approach minimizes the risk of rejection while improving tumor visibility during surgery using fluorescence imaging technology.
Study of Retifanlimab, Capecitabine, and Oxaliplatin for First-Line Treatment in Patients with Metastatic Esophagogastric Cancer
This trial in the Netherlands is investigating a combination treatment approach for metastatic cancer of the esophagus and stomach. The study combines immunotherapy with standard chemotherapy to explore how these treatments affect the immune system’s ability to fight cancer.
Main focus: The study examines how the combination of Retifanlimab (an immune checkpoint inhibitor), capecitabine, and oxaliplatin affects immune response markers, particularly Interferon gamma and cytotoxic T cells in the tumor environment. The treatment involves an initial phase with capecitabine and oxaliplatin chemotherapy, followed by maintenance treatment with Retifanlimab. Researchers will assess overall survival, progression-free survival, response rates, side effects, and quality of life.
Who can participate: Adults over 18 with confirmed metastatic or surgically unresectable cancer of the stomach or esophagus can participate. Patients must have a condition called dMMR (mismatch repair deficiency) and their tumors must be accessible for repeated biopsies. The cancer should be HER2 negative, or if HER2 positive, patients must be unable to receive trastuzumab treatment. Participants need an ECOG performance status of 0-2 and adequate liver, kidney, and blood function. They should not have received prior chemotherapy or radiotherapy for metastatic or unresectable disease, except for certain allowed treatments.
Who cannot participate: The study excludes patients with cancers not related to the esophagus or stomach, those who have received interfering treatments, and individuals with serious health conditions making participation unsafe. Pregnant or breastfeeding women, patients with allergies to study medications, those with active infections requiring treatment, recent major surgery patients, and individuals with certain immune system disorders cannot participate.
Investigational treatments: The study uses three medications: Retifanlimab (an anti-PD-1 immunotherapy given intravenously), capecitabine (oral chemotherapy), and oxaliplatin (intravenous chemotherapy). Retifanlimab works by blocking a protein that prevents immune cells from attacking cancer, while the chemotherapy drugs interfere with cancer cell DNA to stop their growth. Retifanlimab is used as maintenance therapy after the initial chemotherapy phase.
Summary
These three clinical trials represent diverse approaches to treating metastatic gastrointestinal cancer, each conducted in a different European country. The French study addresses an important safety concern by personalizing chemotherapy doses for patients with DPD deficiency, potentially reducing severe side effects while maintaining treatment effectiveness. The Italian trial takes an innovative surgical approach using patient-derived materials to improve tumor visualization during operations. The Dutch study explores the promising combination of immunotherapy with standard chemotherapy for esophagogastric cancers.
All three trials require participants to have good overall health and adequate organ function, reflecting the demanding nature of cancer treatments. The studies focus on different aspects of cancer care: personalized dosing safety, surgical precision, and immune system enhancement. Common chemotherapy drugs like capecitabine and oxaliplatin appear in multiple trials, demonstrating their established role in treating digestive system cancers. Patients interested in participating should discuss these options with their healthcare providers to determine which trial might be most appropriate for their specific situation.
