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Immunotherapy combo aims to wipe out High-Risk rectal cancer before surgery
NCT ID NCT07214142
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study is testing whether adding an immunotherapy drug (PD-1 inhibitor) to standard chemoradiation can better shrink or eliminate tumors in people with locally advanced rectal cancer that has a high chance of coming back. About 30 participants will receive the combination treatment before surgery. The main goal is to see how many patients have no cancer cells left in their tissue after treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- PD-1 inhibitor (immunotherapy drug) combined with chemotherapy and radiation
- What this could lead to
- If successful, this combination could increase the chance of eliminating all tumor cells before surgery, potentially reducing recurrence risk for high-risk rectal cancer patients.
- What could go wrong
- This is a small, early-phase (Phase 2) single-arm study with only 30 participants, so results may not apply broadly. Immunotherapy can cause immune-related side effects, and the added benefit over standard treatment is not yet proven.
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 30 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2025
An estimate. Start dates often move.
- 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 75 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. Pathologically confirmed rectal adenocarcinoma; 2. Mid-low rectal cancer, with the lower edge of the tumor located within 12 cm from the anal verge; 3. Magnetic resonance imaging (MRI) suggests locally advanced rectal cancer (T3 or T4 and M0), accompanied by at least one of the following risk factors: cT4, N2, lymphovascular invasion, involvement of the mesorectal fascia, or enlarged lateral lymph nodes (short-axis diameter \> 8 mm); patients with potentially resectable disease; 4. Polymerase chain reaction (PCR) testing indicates microsatellite stability (MSS) type; 5. No prior antitumor therapy, such as chemotherapy, radiotherapy, immunotherapy, or targeted therapy; 6. Age between 18 and 75 years; 7. ECOG Performance Status (PS) score of 0-1; 8. Laboratory test results: WBC ≥ 3.5 × 10\^9/L, Hb ≥ 100 g/L, PLT ≥ 100 × 10\^9/L; normal liver and kidney function; 9. Absence of severe comorbidities, and ability to tolerate surgical treatment; 10. The patient or their immediate family member voluntarily agrees to participate in this study and provides written informed consent. Exclusion Criteria: 1. Recurrent rectal cancer; 2. Synchronous colorectal cancer; 3. Pregnant or lactating patients; 4. History of other malignant tumors; 5. Previous antitumor therapy, including chemotherapy or radiotherapy; 6. Dysfunction of vital organs such as cardiac or pulmonary insufficiency; 7. History of autoimmune diseases or immunodeficiency disorders; 8. Use of immunosuppressive drugs within the past year; 9. Distant metastasis to organs such as the abdominal cavity, pelvis, liver, or lungs; 10. Active bleeding; 11. Tumor involvement of adjacent structures such as the prostate or sacral organs, making the tumor unresectable; 12. Allergy to chemotherapeutic agents, immune checkpoint inhibitors, or cetuximab; 13. Psychiatric disorders or lack of capacity for civil conduct, unable to provide informed consent.
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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 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.
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