Improving early treatment response in rectal cancer with radiation plus immune therapy
Early response to radiotherapy and immunotherapy in rectal cancer: an integrated molecular, cellular, and spatial approach
People with locally advanced rectal cancer will get short-course radiation and chemotherapy, and some will also receive the immune-activating drug sotigalimab to help the tumor shrink and lower the chance it spreads.
Quick facts
| Grant type | R01 grant |
|---|---|
| Study type | NIH-funded research |
| Funding institution | Ut Southwestern Medical Center NIH-funded |
| Lab location | 1 site (Dallas, United States) |
| Project ID | NIH-11134641 on NIH RePORTER |
What this research studies
If you join, you'll be randomized to receive short-course radiation followed by chemotherapy either with or without the immune-activating antibody sotigalimab. Doctors will collect tumor biopsies, blood samples, and imaging to track how the tumor and immune cells change over time using molecular, cellular, and spatial methods. This phase II trial aims to increase complete responses so more people might avoid surgery and reduce metastatic spread. Treatments and sample collection will take place at UT Southwestern with scheduled follow-up visits.
Who could benefit from this research
Good fit: Adults with locally advanced rectal cancer who are candidates for neoadjuvant short-course radiation and chemotherapy are the ideal participants.
Not a fit: People with very early-stage rectal cancer not needing neoadjuvant therapy, those medically ineligible for immunotherapy, or with contraindicating autoimmune conditions may not benefit from this trial.
Why it matters
Potential benefit: If successful, adding sotigalimab could increase complete tumor responses and allow more patients to avoid surgery while lowering the risk of cancer spread.
How similar studies have performed: Preclinical data show CD40 agonists can boost radiation effects and sotigalimab showed promise in early-phase trials, but benefit in common colorectal cancers remains limited and is still being tested.
Where this research is happening
Dallas, United States
- Ut Southwestern Medical Center — Dallas, United States (Active)
Researchers
- Principal investigator: Aguilera, Todd a — Ut Southwestern Medical Center
- Study coordinator: Aguilera, Todd a
About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page below.