Ongoing Clinical Trials for Small Intestine Carcinoma
There are currently 2 ongoing clinical trials exploring new treatment approaches for small intestine carcinoma. These trials are investigating combination therapies including immunotherapy and chemotherapy regimens, conducted in the Netherlands and France.
Clinical trial locations
- France
- Netherlands
Study on the Effectiveness of Botensilimab and Balstilimab for Patients with Various dMMR and pMMR Tumors
This trial is being conducted in the Netherlands and focuses on testing a combination of two immunotherapy drugs called Botensilimab and Balstilimab. Both medications are monoclonal antibodies designed to help the body’s immune system recognize and attack cancer cells more effectively.
Main inclusion criteria: Participants must be at least 18 years old with non-metastatic cancer that has not spread to other parts of the body. They should be eligible for a study biopsy and have a WHO performance status of 0 or 1, meaning they are fully active or have some symptoms but can still do light work. Blood tests must show adequate levels of white blood cells, platelets, hemoglobin, and normal liver and kidney function within 7 days before starting the study. Women of childbearing potential must use reliable birth control during the study and for 20 weeks after the last dose, with a negative pregnancy test required. Men who are sexually active with women of childbearing potential must also use reliable birth control for 28 weeks after the last dose.
Main exclusion criteria: Patients with severe allergic reactions to similar drugs, those who are currently pregnant or breastfeeding, patients with active infections requiring treatment, or those with other serious health conditions that could interfere with the study are excluded. Additionally, patients who have received another investigational drug recently, had major surgery recently, have a history of certain types of cancer not included in the study, or have known immune system disorders cannot participate.
Study focus: The main goal is to evaluate how well these two drugs work together in treating various types of tumors. Researchers will observe the response of tumors to this treatment, particularly looking for a major pathologic response where 10% or less viable tumor remains after treatment. Both medications are administered through intravenous infusion directly into a vein. The trial will also assess the safety and feasibility of using these drugs before surgery.
Investigational drugs: Botensilimab (also known as AGEN1181) and Balstilimab (AGEN2034) are both immune checkpoint inhibitors that enhance the body’s natural defenses against cancer by blocking proteins that help cancer cells evade the immune system.
Study on FOLFOX and Docetaxel for Patients with Advanced or Metastatic Stomach and Esophagus Cancer
This clinical trial is taking place in France and explores chemotherapy treatment options for patients with oesophago-gastric adenocarcinoma, which affects the stomach and the area where the esophagus meets the stomach. The study also includes patients with duodenal and small bowel cancer.
Main inclusion criteria: Patients must have adenocarcinoma in the stomach or where the stomach meets the esophagus, confirmed by tissue examination. The cancer must be HER2 negative, which means specific protein tests (IHC not 3+ or 2+ with positive FISH) show low levels of HER2 protein. The disease must be either metastatic or unresectable and locally advanced, with at least one measurable area of cancer according to RECIST v1.1 guidelines. Patients must be eligible for first-line chemotherapy with FOLFOX, with or without docetaxel, have a WHO performance status of 0-1, and be at least 18 years old. No major surgery should have occurred within 4 weeks before joining the study.
Main exclusion criteria: The trial excludes patients with other serious health conditions that could interfere with the study, pregnant or breastfeeding women, those who recently participated in another clinical trial, patients with allergies to the study medications, those unable to follow study procedures, patients with certain types of cancer other than the one being studied, severe liver or kidney problems, uncontrolled infections, certain heart conditions, or those unable to provide informed consent.
Study focus: The primary goal is to determine if these treatments can help patients live longer without their cancer getting worse. Participants will receive either the standard FOLFOX treatment (which includes fluorouracil, calcium levofolinate, and oxaliplatin) or the TFOX treatment (FOLFOX plus anhydrous docetaxel). The study will monitor and compare the effects of these treatments over a period of up to 24 months, with progression-free survival evaluated 12 months after the last patient is enrolled.
Investigational drugs: FOLFOX is a combination chemotherapy regimen that includes fluorouracil, calcium levofolinate, and oxaliplatin, all administered intravenously. Docetaxel is a taxane-type chemotherapy medication that works by interfering with cell division, specifically by stabilizing microtubules and preventing their disassembly, which is crucial for stopping cancer cells from growing and dividing.
Summary
Currently, there are 2 ongoing clinical trials offering treatment options for patients with small intestine carcinoma and related gastrointestinal cancers. These trials are geographically diverse, with one located in the Netherlands and one in France, providing access to investigational treatments in different European countries.
The trials represent two distinct therapeutic approaches. The Netherlands-based study focuses on immunotherapy using a combination of immune checkpoint inhibitors (Botensilimab and Balstilimab), which help the immune system fight cancer more effectively. This approach is particularly suitable for patients with non-metastatic disease who are candidates for treatment before surgery.
The France-based trial explores chemotherapy options, specifically comparing the standard FOLFOX regimen with an enhanced version that includes Docetaxel. This study targets patients with locally advanced or metastatic disease who require first-line chemotherapy treatment.
Both trials have specific eligibility requirements regarding performance status, previous treatments, and various health parameters. Patients interested in participating should discuss these options with their healthcare providers to determine which trial, if any, might be appropriate for their individual situation.