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Immunotherapy combo aims to wipe out High-Risk rectal cancer before surgery

NCT ID NCT07214142

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 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

Phase 2

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

Participants

About 30 people

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

Expected to start

Oct 2025

An estimate. Start dates often move.

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 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. 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

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  1. 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 ↗

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