Colorectal cancer is the third most common cancer in the United States, with about 150,000 new diagnoses each year. Treatment typically combines surgery, chemotherapy, radiation, and increasingly, immunotherapy or targeted drugs based on the tumor's genetic profile. Five-year survival varies widely by stage, from over 90% for localized disease to around 15% for metastatic.
What's actually going on in research
Trials are testing immunotherapy combinations for tumors with mismatch repair deficiencies, targeted drugs against specific mutations like KRAS G12C and HER2, antibody-drug conjugates that deliver chemotherapy directly to cancer cells, and new approaches to liver-only metastases. Researchers are also studying circulating tumor DNA tests to detect recurrence earlier and guide treatment decisions.
Immunotherapy expansion
Pembrolizumab and similar drugs work well for tumors with mismatch repair defects, about 5% of colorectal cancers. Trials now test whether combining immunotherapy with other drugs can help the remaining 95%.
KRAS-targeted drugs
KRAS mutations drive about 40% of colorectal cancers and were long considered untreatable. New drugs target specific KRAS variants, particularly G12C, with more variants under study.
Circulating tumor DNA
Blood tests that detect cancer DNA fragments may catch recurrence months before scans show anything. Trials are testing whether acting on these early signals improves outcomes.
What to know before you search
Eligibility typically depends on cancer stage, prior treatments, tumor biomarker status (MSI, KRAS, BRAF, HER2), and whether cancer is limited to one organ or widespread.
What types of trials are currently open
- Adjuvant trials — Testing treatments after surgery to prevent cancer from returning, often comparing shorter chemotherapy courses or adding immunotherapy for certain tumor types.
- Metastatic treatment trials — Testing new drug combinations, targeted therapies, or immunotherapy approaches for cancer that has spread beyond the colon or rectum.
- Biomarker-driven trials — Matching people to treatments based on their tumor's mutations, such as KRAS, BRAF, HER2, or mismatch repair status.
- Liver metastases trials — Testing specialized approaches for cancer that has spread only to the liver, including surgery, ablation, and regional chemotherapy.
- Prevention trials — Testing drugs or lifestyle changes to prevent polyps or cancer in people at high risk due to family history or inherited syndromes.
Recently added Colorectal Cancer trials
Methylation Profile Test (Methylscape) in Body Fluids for Multi-Cancer Detection and Monitoring in Colombia
DNA methylation changes occur early and broadly during carcinogenesis. Methylscape is a rapid assay that detects global DNA methylation patterns in body fluids (blood, urine, and saliva) and may detect a cancer signal and predict the cancer signal origin (CSO) from a single fluid sample, using the differential interaction between methylated and unmethylated DNA and gold nanoparticles. This prospective observational study evaluates the diagnostic performance (sensitivity and specificity) of the Methylscape test in Colombian patients with various biopsy-confirmed solid tumors compared with age- and sex-matched cancer-free (healthy) volunteers. The study is conducted in three parts: Phase 1 validates the assay in 250 patients with cancer; Sub-study 2a compares 1,500 patients with cancer against 1,500 matched cancer-free volunteers; and Sub-study 2b uses serial blood and urine sampling in 300 patients with early-stage disease to assess detection of disease relapse during follow-up, in parallel with standard imaging. The study also estimates positive and negative predictive values (PPV/NPV) and projects the budget impact and cost-effectiveness of Methylscape as a multi-cancer early detection (MCED) tool in an upper-middle-income Latin American setting.
AI-Based Stool Image Analysis for Colorectal Neoplasia Risk Assessment
This prospective observational substudy evaluates the association between artificial intelligence-derived features from stool images analyzed using the FAEX Health digital platform and fecal immunochemical test results in adults undergoing colorectal cancer screening or diagnostic evaluation. Participants will capture stool images using a mobile application. The primary analysis will compare AI-derived image outputs with quantitative FIT values and FIT positivity. Secondary exploratory analyses will assess associations with colonoscopy and histopathological findings when these results are available. The platform will be used exclusively for research and will not provide diagnoses, replace clinical evaluation, or influence medical decisions.
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