New combo therapy aims to wipe out rectal cancer before surgery
NCT ID NCT07381400
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
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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 128 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Feb 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2031
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. 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
Only the study team decides who joins. These are the ways to reach them.
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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.
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Other studies related to the condition(s) this trial covers.
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