Triple therapy aims to wipe out colorectal cancer before surgery
NCT ID NCT07691632
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
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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 35 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jun 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2027
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 years and older
- 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: * 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
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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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.
Contacts and locations
Locations
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Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- A phase 2, randomized, open-label study of VVD-133214 in COmbination with pembrolizumab compared to pembrolizumab monotherapy in participants with advanced colorectal adenocarcinoma (CRC) harboring microsatellite instability (MSI) and/or deficient mismatch repair (DMMR)
- Can an antimalarial drug boost immunotherapy against colorectal cancer?
- Can Direct-to-Abdomen chemotherapy tame GI cancers that spread?
- Could a single protein unlock the secrets of colorectal cancer?
- Can a new drug combo shrink Hard-to-Treat tumors?
- Can a new immunotherapy combo shrink Hard-to-Treat tumors?