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New combo therapy aims to wipe out rectal cancer before surgery

NCT ID NCT07381400

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether adding an immunotherapy drug (serplulimab) to standard chemotherapy before surgery can improve outcomes for people with a common type of locally advanced rectal cancer (MSS/pMMR). About 128 participants will be randomly assigned to receive either chemo alone or chemo plus immunotherapy for six cycles before surgery. The main goal is to see if the combination leads to a higher rate of complete cancer disappearance (pathological complete response).

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
mFOLFOX6 chemotherapy and serplulimab (an immunotherapy drug)
What this could lead to
If successful, this combination could increase the chance of eliminating all cancer before surgery, potentially reducing the need for more aggressive treatments.
What could go wrong
This is an early phase 2 trial with only 128 participants, so results may not apply to everyone. Immunotherapy can cause immune-related side effects, and the added benefit over chemotherapy alone is uncertain.

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 128 people

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

Expected to start

Feb 2026

An estimate. Start dates often move.

Expected to finish

Dec 2031

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. Rectal cancer patients with MRI showing the lower edge of the tumor within 15 cm of the anal verge, cT3-4 N any or cT any N1/2; 2. Pathologically confirmed adenocarcinoma, with pMMR (MLH1, MSH2, MSH6, and PMS2) positivity for all four proteins, or gene testing indicating microsatellite stability; 3. No complete bowel obstruction, or proximal colostomy relieving bowel obstruction; 4. Aged 18 to 75 years, regardless of gender; 5. ECOG performance status: 0-1; 6. Expected survival time ≥2 years; 7. No previous chemotherapy, radiotherapy, targeted therapy, or immunotherapy; 8. Laboratory test results meeting the following criteria during screening:Hematology: Neutrophil count ≥1.5×10⁹/L, platelet count ≥75×10⁹/L, hemoglobin ≥80 g/L; Liver function: AST and ALT ≤2.5× upper limit of normal (ULN); total bilirubin ≤1.5×ULN; Kidney function: Serum creatinine ≤1.5×ULN; Coagulation function: APTT ≤1.5×ULN, INR ≤1.5, PT ≤1.5×ULN; Urine protein: Urine protein ≤1+ (if ≥2+, 24-hour urine protein test required, and if result \<1g, inclusion is allowed); Cardiac left ventricular ejection fraction ≥50%; 9. Female participants must not be breastfeeding, and pregnancy test results must be negative; 10. Voluntary signing of the informed consent form, with the ability to understand and comply with the study requirements. Exclusion Criteria: 1. Local invasion of surrounding organs by rectal tumor: Imaging tests suggest the tumor directly invades adjacent organs or structures, i.e., tumors with clinical stage cT4 below the peritoneal reflection or cT4b above the peritoneal reflection; 2. Patients with distant metastasis; 3. Previous treatment with any chemotherapy, radiotherapy, targeted therapy, or immunotherapy; 4. Active autoimmune diseases requiring systemic treatment (e.g., corticosteroids or immunosuppressants) within the past 2 years prior to enrollment; 5. History of HIV infection, or active chronic hepatitis B or C (high viral DNA load); 6. Currently receiving tuberculosis treatment or having received tuberculosis treatment in the past year prior to screening for active tuberculosis; 7. Known or suspected allergy to the study drugs or any drug related to the study; 8. Severe cardiovascular or cerebrovascular diseases; 9. Severe active infection or uncontrollable infection requiring systemic treatment, or unexplained fever \>38.5°C within 14 days before the first dose; 10. Systemic corticosteroid treatment or other immunosuppressants within 14 days before the first dose, or immunostimulants within 4 weeks prior to the first dose; 11. Clear history of neurological or psychiatric disorders, including epilepsy or dementia; 12. Subjects who, for any other reason, may not be able to complete the study, or the investigator deems them unsuitable for inclusion; 13. 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

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  1. The official record

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