Rectal cancer treatment typically involves surgery, often combined with radiation and chemotherapy. About 45,000 people are diagnosed with rectal cancer in the U.S. each year. Recent advances include organ-preserving approaches for some patients and immunotherapy for tumors with certain genetic markers.
What's actually going on in research
Trials are testing whether radiation or even surgery can be avoided in patients whose tumors respond completely to chemotherapy. Immunotherapy with checkpoint inhibitors like pembrolizumab works remarkably well for tumors with mismatch repair deficiency. Researchers are also studying new chemotherapy combinations, targeted drugs for specific mutations, and ways to predict which patients need intensive treatment.
Total neoadjuvant therapy
Giving all chemotherapy and radiation before surgery — rather than some after — appears to increase the chance that tumors disappear completely. Some patients with complete responses may be able to avoid surgery entirely through careful monitoring.
Immunotherapy for MMR-deficient tumors
About 5-10% of rectal cancers have mismatch repair deficiency, making them highly responsive to checkpoint inhibitors. Studies now show that immunotherapy alone can eliminate these tumors before surgery, potentially sparing patients from chemotherapy and radiation.
Organ preservation
Trials are defining which patients whose tumors shrink completely with treatment can safely skip surgery. This watch-and-wait approach requires close monitoring but preserves bowel function and quality of life.
What to know before you search
Eligibility typically depends on tumor stage, distance from the anal verge, prior treatments, mismatch repair status, and whether metastases are present.
What types of trials are currently open
- Neoadjuvant treatment trials — Testing chemotherapy, radiation, or immunotherapy given before surgery to shrink tumors. Some studies explore whether patients with complete responses can avoid surgery.
- Targeted therapy trials — Testing drugs aimed at specific mutations like KRAS, BRAF, or HER2 that drive some rectal cancers.
- Immunotherapy trials — Testing checkpoint inhibitors, often in tumors with mismatch repair deficiency or high mutation burden.
- Surgical trials — Comparing different surgical techniques or studying minimally invasive approaches like robotic surgery.
- Quality of life studies — Following patients to understand long-term bowel, sexual, and urinary function after treatment.
Recently added Rectal Cancer trials
Hydrogel Spacer During Definitive Radiotherapy for Cervical Cancer
This prospective, single-center study will evaluate the feasibility, spatial stability, and dosimetric effects of an absorbable hydrogel spacer placed between the cervix/vagina and rectum before definitive radiotherapy for cervical cancer. Approximately 30 participants will receive hydrogel spacer implantation before the first fraction of external beam radiotherapy (EBRT), followed by standard definitive radiotherapy including EBRT and image-guided brachytherapy (IGBT). Serial magnetic resonance imaging (MRI) and computed tomography (CT) will be used to assess spacer position, thickness, and stability throughout treatment. Radiation doses to the rectum and other organs at risk will be evaluated across the full course of radiotherapy. The primary objective is to assess the effect of the hydrogel spacer on cumulative rectal dose while maintaining adequate target coverage. Procedure-related safety and feasibility will also be evaluated.
KLF4 Epigenetic Modulation
The study investigates the epigenetic regulation of KLF4 during the progression from colorectal polyps to adenomas and carcinomas. Quantitative KLF4 methylation will be assessed in colorectal tissue samples obtained during routine colonoscopy, together with KLF4 gene expression and its correlation with methylation status in matched tissue samples. The study will also evaluate quantitative and site-specific molecular approaches for the assessment of KLF4 methylation.
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