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Can a lighter radiation punch still knock out rectal cancer?

NCT ID NCT07646639

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 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

Phase 2

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

Participants

About 122 people

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

Started

May 2026

Expected to finish

Dec 2030

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 70 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. 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.

  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

  • Jiangsu Province Hospital

    RECRUITING

    Nanjing, Jiangsu, 210000, China

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