Triple threat: immunotherapy, chemo, and radiation take on rectal cancer
NCT ID NCT07622771
First seen Jun 27, 2026 · Last updated Sep 18, 2026 · Updated 2 times
Summary
This phase 2 trial is testing whether adding an immunotherapy drug (adebrelimab) to a chemotherapy combo (NALIRIFOX) and radiation can improve outcomes for people with a certain type of locally advanced rectal cancer (pMMR/MSS). About 84 participants will be randomly assigned to receive either short-course or long-course radiation along with the drugs. The main goal is to see how many patients have no cancer left after treatment, either from surgery or from a watch-and-wait approach.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Adebrelimab (an immunotherapy drug) plus NALIRIFOX (a combination of chemotherapy drugs: oxaliplatin, liposomal irinotecan, leucovorin, and fluorouracil) plus radiotherapy
- What this could lead to
- If this works, it could offer a more effective way to shrink rectal tumors before surgery, potentially allowing some patients to avoid surgery altogether.
- What could go wrong
- This is an early phase 2 trial with only 84 people, so results are not definitive. The combination of drugs and radiation may cause significant side effects, and it may not work better than standard treatment.
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 84 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 2032
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. Patients or their family members agree to participate in the study and sign the informed consent form; 2. Age 18-75 years, male or female; 3. Locally advanced rectal adenocarcinoma confirmed by histopathology; 4. Clinical stage cT3-4bN0M0 or cTxN+M0, with or without MRF positive, with or without EMVI positive, expected to R0 resection; 5. without intestinal obstruction; 6. ECOG PS 0-1; 7. expect survival up to 2 years; 8. White blood cell count \> 3.5×109/L;Platelet count ≥ 100×109/L;Hemoglobin ≥ 80 g/L; 9. ALT ≤ 1.5×ULN, AST ≤ 1.5×ULN ; 10. Serum creatinine ≤ 100μmol/l, Exclusion Criteria: 1. With inguinal lymph node metastasis or lateral lymph node metastasis (lymph node diameter ≥7 mm, or lymph node morphology and MRI features consistent with typical metastatic lymph nodes); 2. Arrhythmia requiring antiarrhythmic treatment (except beta-blockers or digoxin), symptomatic coronary artery disease or myocardial ischemia (myocardial infarction within the last 6 months), or congestive heart failure exceeding NYHA Class II; 3. Severe hypertension poorly controlled with medication; 4. History of HIV infection, or active hepatitis B (HBV DNA ≥ 2000 IU/mL or 10⁴ copies/mL), or hepatitis C (positive hepatitis C antibody with HCV-RNA above the lower limit of detection of the assay); 5. Active pulmonary tuberculosis (TB), currently receiving anti-tuberculosis treatment, or having received anti-tuberculosis treatment within 1 year prior to screening; 6. Other active clinically severe infections (NCI-CTCAE Version 5.0); 7. Preoperative evidence of distant metastasis outside the pelvis; 8. Cachexia or organ function decompensation. 9. History of pelvic or abdominal radiotherapy; 10. Multiple primary colorectal cancers; 11. Patients with seizures requiring treatment (e.g., corticosteroids or antiepileptic therapy); 12. History of other malignancies within 5 years, except cured cervical carcinoma in situ or basal cell carcinoma of the skin; 13. Drug abuse, or medical, psychological, or social conditions that may interfere with the patient's participation in the study or affect the evaluation of study results; 14. Active autoimmune disease or history of autoimmune disease (including but not limited to: interstitial pneumonia, uveitis, enterocolitis, hepatitis, hypophysitis, nephritis, hyperthyroidism, and hypothyroidism); 15. Receipt of any anti-infective vaccine (e.g., influenza vaccine, varicella vaccine, etc.) within 4 weeks prior to enrollment; 16. Comorbidities requiring long-term treatment with immunosuppressive agents, or requiring systemic or local administration of corticosteroids at immunosuppressive doses (dose \>10 mg/day of prednisone or other glucocorticoids with equivalent efficacy); 17. Known or suspected hypersensitivity to the investigational drug, or to any medication administered in relation to this study; 18. Any unstable condition that may jeopardize patient safety or compliance; 19. Pregnant or lactating women, or women of childbearing potential not using adequate contraception; 20. Refusal to sign the informed consent form.
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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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Sun Yat-sen University Cancer Center, 651 Dongfeng East Road, Guangzhou 510060, P. R. China
RECRUITINGGuangzhou, Guangdong, 510000, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can drug cocktail spare rectal cancer patients from surgery?
- Can two immunotherapy drugs help rectal cancer patients skip pelvic radiation?
- MRI and microbes: a new way to predict rectal cancer outcomes?
- Can a new drug shield rectal cancer patients from Radiation's worst side effects?
- Could a Tumor's genes reveal who can skip chemo?