Ongoing Clinical Trials for Colon Cancer Stage IV
There is currently 1 ongoing clinical trial for Stage IV colon cancer. This trial is investigating a combination of immune checkpoint inhibitors with high-dose Vitamin C as a treatment approach before surgery. The trial is being conducted in Italy and focuses on patients with mismatch repair proficient colorectal cancer.
Clinical trial locations
- Italy
Study on High-Dose Vitamin C with Ipilimumab and Nivolumab for Patients with Colorectal Cancer
This clinical trial is investigating a combination treatment approach for patients with a specific type of advanced colon cancer called mismatch repair proficient colorectal cancer. The treatment combines three components given before surgery: two medications that help the immune system fight cancer (Ipilimumab and Nivolumab) and high-dose Vitamin C. All three components are delivered directly into the bloodstream through intravenous infusion.
Main focus and goal: The primary purpose of this study is to evaluate how well this combination therapy works when given before surgery to remove the cancer. Researchers want to understand if using Ipilimumab, Nivolumab, and high-dose Vitamin C together can improve how well the cancer responds to treatment before surgical intervention. The study will help determine potential benefits and identify any side effects of this treatment combination.
Who can participate: To be eligible for this trial, you must:
- Be at least 18 years old
- Have a confirmed diagnosis of colon cancer that is suitable for surgical removal, including cases where cancer has spread to the liver but can still be operated on
- Have an ECOG performance status of less than 2, meaning you are able to perform most daily activities with relatively good function
- Be willing to use effective birth control during the trial if you or your partner can have children
- Be able to follow all study procedures and attend all required visits throughout the study duration
- Women of childbearing potential must have a negative pregnancy test within one week before starting treatment
Who cannot participate: You are not eligible for this trial if you:
- Have any other type of cancer besides colon cancer
- Have a specific genetic characteristic called pMMR/MSS
- Are part of a vulnerable population requiring special protection or care
- Have psychological, family, social, or geographical issues that would make it difficult to follow the study requirements
Investigational drugs:
Ipilimumab is an immune checkpoint inhibitor that helps your immune system recognize and attack cancer cells more effectively. It works by blocking a protein called CTLA-4, which normally keeps immune cells in check. By blocking this protein, Ipilimumab allows your immune system to better target and destroy cancer cells.
Nivolumab is another immune checkpoint inhibitor that works similarly but targets a different protein called PD-1 on immune cells. When used together with Ipilimumab, it aims to enhance the overall immune response against the cancer, potentially making the treatment more effective.
High-dose Vitamin C is being used in much larger amounts than you would typically get from food or regular supplements. In this trial, it is being studied for its potential to boost the effectiveness of the immune checkpoint inhibitors in fighting cancer cells before surgery. The exact way it works in this context is still being investigated, but it may help create an environment where immune cells can function more effectively.
What to expect during the trial:
The trial involves several phases. After an initial visit where you provide consent and undergo baseline testing, you will begin the treatment phase where you receive all three medications through intravenous infusion. Throughout the trial, you will have regular monitoring visits to assess your health and how the treatment is affecting the cancer. If you remain eligible, you will then undergo surgery to remove the primary cancer and any liver metastases if present. The study team will closely monitor you for any side effects and evaluate how well the treatment is working.
Summary
Currently, there is only one ongoing clinical trial specifically for Stage IV colon cancer, which is being conducted in Italy. This trial represents an innovative approach combining immune checkpoint therapy with high-dose Vitamin C as a neoadjuvant treatment, meaning it is given before surgery. The focus on mismatch repair proficient colorectal cancer addresses a specific subtype of the disease. The trial uses two established immune checkpoint inhibitors, Ipilimumab and Nivolumab, which are already used in cancer treatment, but explores their combination with high-dose Vitamin C to potentially enhance their effectiveness. This research aims to develop new treatment strategies that may improve outcomes for patients with advanced colon cancer who are candidates for surgical intervention.
