Improving early treatment response in rectal cancer with radiation plus immune therapy
Official title: Early response to radiotherapy and immunotherapy in rectal cancer: an integrated molecular, cellular, and spatial approach
Funded at Ut Southwestern Medical Center · NIH-11134641 · Data updated 2026-11-12
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 start | August 1, 2023 |
| Project end | July 31, 2028 |
| Funding year | 2025 |
| Award (this year) | $658,048 |
| NIH project number | 5R01CA283953-03 |
| Project ID | NIH-11134641 on NIH RePORTER |
Who could benefit from this research
✓Could help
Adults with locally advanced rectal cancer who are candidates for neoadjuvant short-course radiation and chemotherapy are the ideal participants.
✕Less likely to help
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.
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.
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 gone: 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
-
Ut Southwestern Medical Center
Dallas, United States Active
Researchers
- Principal investigator: Aguilera, Todd a — Ut Southwestern Medical Center
- Study coordinator: Aguilera, Todd a
Related research
Other NIH-funded projects on the same topics.
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Early response to radiotherapy and immunotherapy in rectal cancer
A new approach combines short-course radiation, chemotherapy, and an immune therapy antibody to try to shrink rectal cancers before surgery or avoid surgery altogether.
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Investigating new treatment combinations for rectal cancer using radiation and immunotherapy
This study is looking for ways to help people with locally advanced rectal cancer by testing a new treatment that combines radiation, chemotherapy, and an innovative immune-boosting drug called αCD40, with the hope of improving outcomes and possibly avoiding surgery.
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Role of Twice-Daily Thoracic Radiotherapy in Limited-Stage SCLC in the Immunotherapy Era
This project looks at whether giving twice-daily radiotherapy for limited-stage small cell lung cancer still helps patients today who are also getting immunotherapy.
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A study aims to tailor radiotherapy choices for rectal cancer patients by using multiple biological and imaging signals to guide treatment decisions.
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Creating a digital model for rectal cancer to improve radiotherapy
This study is looking for patients with rectal cancer to help create a digital model that can personalize and improve radiotherapy treatments by examining how their immune system responds to radiation therapy.
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This study is looking at how focusing on a protein called ATM can make cancer treatments like radiation and immunotherapy work better by boosting the immune system's ability to fight tumors, which could lead to improved results for patients.
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.