Ongoing Clinical Trials for Rectosigmoid Cancer
There is currently 1 ongoing clinical trial for rectosigmoid cancer, focusing on immunotherapy treatment given before surgery to improve outcomes in early-stage disease. The trial is being conducted in the Netherlands and aims to test new combinations of immune checkpoint inhibitors that help the body’s immune system fight cancer cells more effectively.
Clinical trial locations
Study on Pre-Surgery Immunotherapy with Relatlimab, Anti-IL-8 mAb, and Ipilimumab for Early-Stage Colon Cancer Patients
This clinical trial is exploring new immunotherapy treatments for early-stage rectosigmoid cancer, a type of cancer that begins in the glandular cells at the junction between the colon and rectum. The trial focuses on giving these treatments before surgery to see if they can shrink tumors and improve surgical outcomes.
Main focus and goal: The study aims to determine whether combinations of immunotherapy drugs given before surgery are safe and effective for patients with early-stage cancer. Researchers want to understand how well these treatments work in reducing tumor size and improving the chances of successful surgery. The trial will also examine how the immune system responds to treatment and track any changes in the tumor itself.
Investigational drugs: The trial tests several medications including Relatlimab, anti-IL-8 mAb (BMS-986253), Ipilimumab (Yervoy), and Nivolumab (Opdivo). These are immune checkpoint inhibitors, which are drugs that help the immune system recognize and attack cancer cells by blocking proteins that normally prevent this immune response. Most of these medications are given directly into the bloodstream through a vein. Additionally, patients receive Celecoxib (Celebrex), which is taken orally as a capsule.
Main inclusion criteria: To participate in this trial, you must be at least 18 years old and have non-metastatic adenocarcinoma of the colon or rectosigmoid, meaning the cancer has not spread to other parts of the body. The cancer must be at a specific stage (greater than cT3 and/or N+). You need to have a CT scan within 28 days before joining and undergo a colonoscopy to obtain tissue samples for the study. You must be in good general health, able to perform light work at minimum, and have acceptable levels of blood cell counts, liver function, and kidney function based on tests done within 7 days before registration. Both men and women of childbearing potential must agree to use reliable birth control methods during the study and for several months after the last dose. You must also sign an informed consent form showing you understand and agree to participate.
Main exclusion criteria: The trial has relatively few exclusion criteria. Patients whose cancer is classified as rectal rather than rectosigmoid cannot participate. Those who fall outside the specified age range or belong to clinical trial groups not included in this particular study are also excluded.
What to expect: After joining the study, you will undergo an initial assessment including a review of your medical history and physical examination. During the treatment phase, you will receive the immunotherapy medications over a period of time before your planned surgery, which should occur within 6 to 8 weeks. Throughout the trial, you will be closely monitored through regular check-ups and tests to track both safety and effectiveness. The trial was estimated to conclude by December 3, 2024, with final assessments to determine overall outcomes and any long-term effects.
Summary
Currently, there is one active clinical trial for rectosigmoid cancer, taking place in the Netherlands. This trial represents an important investigation into using immunotherapy before surgery for early-stage disease. The focus on immune checkpoint inhibitors reflects a growing interest in harnessing the body’s own immune system to fight cancer more effectively. The study uses multiple immunotherapy drugs in combination, exploring whether this approach can improve outcomes compared to traditional treatment methods. Patients interested in participating should note the specific requirements regarding cancer stage, overall health status, and the need for tissue samples through colonoscopy.