Triple therapy aims to wipe out colorectal cancer before surgery

NCT ID NCT07691632

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 09, 2026 · Last updated Jul 10, 2026 · Updated 1 time

Summary

This phase 2 trial tests whether giving a combination of an immunotherapy drug (serplulimab), an epigenetic drug (decitabine), and chemotherapy (CAPOX) before surgery can improve outcomes for people with locally advanced colorectal cancer. The study enrolls 35 adults with previously untreated stage cT3/cT4N+M0 colorectal adenocarcinoma. Participants receive four cycles of the drug combination, then undergo surgery. The main goal is to see how many patients have no cancer cells left in their surgical specimen (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
Serplulimab, Decitabine, Oxaliplatin, Capecitabine
What this could lead to
If successful, this combination could become a new pre-surgery treatment option that increases the chance of eliminating all cancer cells before surgery for patients with locally advanced colorectal cancer.
What could go wrong
This is a small, early-phase study (35 people) with no control group, so results may not apply broadly. The drug combination may cause significant side effects, and the added benefit over standard 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 35 people

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

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Dec 2027

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 years and older

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: * Voluntarily signs written informed consent before screening. * Male or female, aged 18 years or older. * Has at least one measurable lesion according to RECIST version 1.1. * ECOG performance status score of 0 to 1. * Histologically or pathologically confirmed colorectal adenocarcinoma with no prior antitumor treatment, staged as cT3/cT4N+M0 locally advanced colorectal cancer according to the AJCC/UICC 8th edition based on contrast-enhanced CT or MRI, with colonoscopy and/or diagnostic laparoscopy if clinically indicated. * Planned to undergo surgery after neoadjuvant therapy according to clinical staging. * Expected survival of more than 3 months. * Adequate major organ function, meeting all of the following criteria: * Hematology: neutrophil count ≥1.5 × 10\^9/L, platelet count ≥100 × 10\^9/L, hemoglobin ≥90 g/L, and white blood cell count ≥3.5 × 10\^9/L, without blood transfusion, granulocyte colony-stimulating factor, or other hematopoietic growth factors within 14 days before screening. * Hepatic function: ALT and AST ≤2.5 × upper limit of normal, and total bilirubin ≤1.5 × upper limit of normal, or ≤3 × upper limit of normal for patients with Gilbert syndrome. * Renal function: serum creatinine ≤1.5 × upper limit of normal or creatinine clearance ≥60 mL/min. * Coagulation function: activated partial thromboplastin time, international normalized ratio, and prothrombin time ≤1.5 × upper limit of normal. Exclusion Criteria: * Prior treatment with any antitumor therapy, including chemotherapy, radiotherapy, hormonal therapy, or molecular targeted therapy. * Prior immunotherapy with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti-CTLA-4 antibody, or any other antibody or drug targeting T-cell co-stimulation or immune checkpoint pathways. * History of another malignancy within 5 years or concurrent malignancy, except cured carcinoma in situ of the cervix, non-melanoma skin cancer, or other malignancy treated with curative intent with no evidence of disease for at least 5 years. * Pre-existing peripheral neuropathy of grade 2 or higher according to NCI-CTCAE version 5.0. * Known active central nervous system metastasis and/or carcinomatous meningitis. * History of severe hypersensitivity reaction to any component of a product or formulation similar to the study PD-1 antibody, or known severe hypersensitivity reaction to other monoclonal antibodies, oxaliplatin, capecitabine, or related compounds, defined as NCI-CTCAE version 5.0 grade 3 or higher. * Known history of hereditary bleeding disorder or coagulation disorder associated with bleeding risk. * Major surgery within 4 weeks before enrollment. * Has not recovered from complications of prior surgery to grade 1 or lower according to CTCAE version 5.0, except alopecia and fatigue. * Requires immunosuppressive medication within 2 weeks before enrollment or during the study, except intranasal, inhaled, topical, or local steroid injections; systemic corticosteroids at physiological doses equivalent to prednisone ≤10 mg/day; or short-term use of steroids for prevention or treatment of non-autoimmune allergic conditions for no more than 7 days. * Active autoimmune disease or history of autoimmune disease with potential recurrence. * Known history of interstitial lung disease or non-infectious pneumonitis. * Known history of active tuberculosis. * History of human immunodeficiency virus infection, other acquired or congenital immunodeficiency disease, organ transplantation, or stem cell transplantation. * Positive hepatitis B surface antigen with HBV DNA ≥10\^4 copies/mL or ≥2000 IU/mL at screening, or active hepatitis C defined as positive HCV antibody with HCV RNA above the lower limit of detection. * Active or uncontrolled infection requiring systemic treatment within 2 weeks before enrollment. * Receipt of a live viral vaccine within 4 weeks before enrollment. * Intestinal obstruction, inflammatory bowel disease, extensive intestinal resection with chronic diarrhea, Crohn's disease, ulcerative colitis, or chronic diarrhea. * Breastfeeding, or planning pregnancy during treatment and within 6 months after completion of treatment. * Unwillingness to use effective contraception during treatment and within 6 months after completion of treatment, including male participants capable of fathering a child, female participants, and their male partners. * Any other condition that, in the investigator's judgment, may affect protocol compliance or assessment of study endpoints and makes the participant unsuitable for this 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

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  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.

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  3. A doctor treating you

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Contacts and locations

Locations

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin, Tianjin Municipality, China

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