Can a cholesterol drug help immunotherapy fight colorectal cancer?
NCT ID NCT07718490
First seen Jul 22, 2026 · Last updated Jul 23, 2026 · Updated 1 time
Summary
This phase II trial is testing whether adding the immunotherapy drug adebrelimab and the cholesterol-lowering drug simvastatin to standard chemotherapy and targeted therapy can shrink tumors in people with advanced colorectal cancer that has not responded to prior treatment. The study enrolls adults aged 18 to 75 with a specific type of colorectal cancer (MSS/pMMR) that typically does not respond to immunotherapy alone. Researchers will measure how many patients experience tumor shrinkage and how long they live without the disease worsening.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- adebrelimab combined with simvastatin, bevacizumab, capecitabine, and oxaliplatin
- What this could lead to
- If successful, this combination could offer an effective first-line treatment option for the majority of colorectal cancer patients who do not respond to immunotherapy alone.
- What could go wrong
- This is a small, early-phase trial with only 43 participants, so results may not apply broadly. The drug combination also carries risks of immune-related side effects and chemotherapy toxicity.
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 43 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2025
- Expected to finish
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Mar 2028
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. Able to provide written informed consent and voluntarily participate in this study. 2. Male or female subjects aged between 18 and 75 years, inclusive. 3. Histologically or cytologically confirmed metastatic colorectal adenocarcinoma. 4. No prior systemic anti-tumor therapy; patients who have received neoadjuvant/adjuvant therapy are eligible if the time from the last chemotherapy to recurrence or progression is more than 6 months. 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 6. Expected survival of at least 3 months. 7. Presence of at least one measurable lesion at baseline assessed by the investigator according to RECIST 1.1. Measurable lesions must not have been previously treated with radiotherapy or other local therapy, unless the lesion located in a previously irradiated area has been confirmed to have progressed. 8. Adequate organ function as defined below (no blood products or hematopoietic growth factors are allowed within 14 days prior to the first dose of study treatment): * Absolute neutrophil count (ANC) ≥1.5×10\^9/L * Platelet count ≥100×10\^9/L * Hemoglobin ≥9 g/dL * Serum albumin ≥2.5 g/dL * Total bilirubin ≤1.5 × ULN; ALT and AST ≤2.5 × ULN, or ≤5 × ULN in the presence of liver metastases * Serum creatinine ≤1.5 × ULN, or creatinine clearance \>60 mL/min (calculated by Cockcroft-Gault formula) * Activated partial thromboplastin time (APTT) and international normalized ratio (INR) ≤1.5 × ULN. Subjects receiving stable-dose anticoagulation such as low molecular weight heparin or warfarin with INR within the expected therapeutic range are eligible. 9. Female subjects of childbearing potential must have a negative serum pregnancy test within 72 hours prior to the first dose of study treatment, must not be breastfeeding, and must agree to use effective contraception (e.g., intrauterine device, contraceptive pills, or condoms) during the study and for at least 6 months after the last dose of study treatment. Male subjects with partners of childbearing potential must be surgically sterile or agree to use effective contraception during the study and for 3 months after the last dose of study treatment, and must not donate sperm during the study period. Exclusion Criteria: 1. Received local radiotherapy within 4 weeks prior to the first dose of study drug, and adverse events due to radiotherapy have not recovered to baseline levels. Subjects who received palliative radiotherapy to peripheral sites (e.g., bone metastases) more than 4 weeks prior to the first dose are eligible, provided they have recovered from any acute adverse reactions. 2. Known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate, provided they have stable brain metastases and have not required steroid treatment for brain metastases for at least 28 days prior to study entry. This exception does not apply to carcinomatous meningitis, which is excluded regardless of clinical stability. 3. Major surgery, open biopsy, or severe trauma within 28 days prior to the first dose of study drug. 4. History of allergy to any anti-angiogenic agents, any component of monoclonal antibodies, capecitabine, oxaliplatin, or other platinum-based drugs. 5. Uncontrolled hypertension despite anti-hypertensive medication (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg). 6. Subjects with uncontrolled cardiovascular clinical symptoms or diseases, including but not limited to: (1) NYHA class II or higher heart failure; (2) unstable angina pectoris; (3) myocardial infarction within the past 1 year; (4) clinically significant supraventricular or ventricular arrhythmias without clinical intervention or still poorly controlled after clinical intervention. 7. Significant clinically relevant bleeding symptoms or clear bleeding tendency within 3 months prior to the first dose, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, or vasculitis. 8. Arterial/venous thromboembolic events within 6 months prior to the first dose, such as cerebrovascular accidents (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism. Superficial venous thrombosis may be included at the investigator's discretion. 9. Presence of another progressing or actively treated malignancy, except for non-melanoma skin cancer and cervical carcinoma in situ that have received curative treatment. 10. Subjects with other factors that, in the investigator's opinion, may lead to premature discontinuation of the study, such as other severe diseases (including psychiatric disorders) requiring concomitant treatment, clinically significant laboratory abnormalities, family or social factors that may affect subject safety or trial data collection.
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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
2 sites. 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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Jiangsu Province Hospital (The First Affiliated Hospital with Nanjing Medical University)
RECRUITINGNanjing, Jiangsu, 210008, China
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Nanjing First Hospital, Nanjing Medical University Affiliated Hospital
NOT_YET_RECRUITINGNanjing, Jiangsu, China
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Other studies related to the condition(s) this trial covers.
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- Can a targeted drug shrink tumors when only some cells carry the mutation?
- Can a Two-Drug immunotherapy combo outperform standard care in Late-Stage colorectal cancer?