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Triple threat: immunotherapy, chemo, and radiation take on rectal cancer

NCT ID NCT07622771

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 84 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2026

Expected to finish

Dec 2032

An estimate. End dates often move.

Lead sponsor

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

18 to 75 years

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Sun Yat-sen University Cancer Center, 651 Dongfeng East Road, Guangzhou 510060, P. R. China

    RECRUITING

    Guangzhou, Guangdong, 510000, China

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