Can a lighter radiation punch still knock out rectal cancer?
NCT ID NCT07646639
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a lower dose of short-course radiotherapy, combined with chemotherapy and two immune-boosting drugs, works as well as the standard radiation dose for locally advanced rectal cancer. About 122 adults will be randomly assigned to one of two radiation doses, followed by the same drug cocktail. The goal is to see if the gentler approach can still achieve complete tumor disappearance, potentially allowing more patients to avoid major surgery.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Sintilimab (anti-PD-1 antibody), Interleukin-2, CAPOX chemotherapy, and short-course radiotherapy
- What this could lead to
- If successful, this could point toward a less toxic radiotherapy regimen that still effectively shrinks tumors, potentially allowing more patients to avoid surgery and preserve their rectum.
- What could go wrong
- This is an early phase II trial with only 122 participants, so results may not apply broadly. Combining multiple drugs also raises the risk of side effects, and the low-dose radiotherapy might prove less effective than the standard dose.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 122 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2026
- Expected to finish
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Dec 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Male and female patients aged 18 to 70 years. 2. Histologically confirmed rectal adenocarcinoma with the distal margin of the tumor located within 12 cm of the anal verge. 3. MRI-based clinical stage T3-T4 or any T with lymph node-positive (N+) disease. 4. Adequate hematologic, hepatic, and renal function defined as: absolute neutrophil count \>=1.5 x 10\^9/L; platelet count \>=75 x 10\^9/L; serum total bilirubin \<=1.5 x upper normal limit (UNL); aspartate aminotransferase \<=2.5 x UNL; alanine aminotransferase \<=2.5 x UNL; serum creatinine \<=1.5 x UNL. 5. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. Exclusion Criteria: 1. Metastatic disease (Stage IV). 2. Recurrent rectal cancer. 3. Concurrent active bleeding, perforation, or other complicated conditions requiring emergency surgery. 4. Prior systemic anticancer therapy for rectal cancer. 5. Presence of another non-colorectal neoplastic disease at the same time. 6. Patients with any active autoimmune disease or a history of autoimmune disease requiring steroids or immunomodulatory therapy. 7. Patients with interstitial lung disease, non-infectious pneumonitis, or uncontrolled systemic diseases (e.g., diabetes mellitus, hypertension, pulmonary fibrosis, and acute pneumonitis). 8. Any unresolved grade \>=2 toxicity (according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0) resulting from previous treatment, except for anemia, alopecia, and skin hyperpigmentation. 9. Prior treatment with anti-programmed death-1 (PD-1)/PD-L1 antibody or anti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody. 10. Pregnant or breastfeeding women. 11. Known or tested positive for human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS). 12. Known or suspected history of allergy to any of the relevant drugs used in the study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Jiangsu Province Hospital
RECRUITINGNanjing, Jiangsu, 210000, China
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