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PCSK9 Inhibitors in Combination With Advanced Treatment Strategies for the Treatment of Advanced Colorectal Cancer With pMMR/MSS

NCT06391905•Guangdong Provincial People's Hospital

Summary

Detailed Description

The purpose of this study is to preliminarily observe the efficacy and safety of PCSK9 inhibitors in combination with standard advanced first-line regimens in the treatment of advanced colorectal cancer with pMMR/MSS. To evaluate progression-free survival (PFS) after PCSK9 inhibitor combination, overall survival (OS) after PCSK9 inhibitor combination, and to evaluate the safety and tolerability of PCSK9 inhibitor combination therapy based on NCI-CTCAE version 4.03, and to further explore efficacy predictive biomarkers based on changes in the expression of specific immune markers in blood and tissue specimens at baseline and after treatment.

Eligibility

Age

18 - 85 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age 18-75 years old, gender is not limited, and signed informed consent;
•2. Histologically confirmed colorectal adenocarcinoma with pMMR/MSS;
•3. Colorectal cancer with distant metastasis or inability to be radically surgically resected as assessed by imaging examination Patient;
•4. Immunohistochemistry or sequencing to evaluate the high expression status of PCSK9 in tumors;
•5. ECOG score 0-1;
•6. Expected survival ≥ 3 months.

Exclusion Criteria

•1. Hypocholesterolemia, hypolipidemia and its family history, previous allergic reaction to PCSK9 inhibitors History of allergic reaction to PCSK9 inhibitors;
•2. preoperative pathological diagnosis of advanced colorectal adenocarcinoma without pMMR/MSS, with the chance of radical surgical treatment;
•3. Hypolipidemia caused by combination with other long-term lipid-lowering drugs;
•4. malignancies other than colorectal cancer with negligible risk of metastasis or death (e.g., expected 5-year OS \>90%) within 5 years prior to enrollment and for which a radical outcome is expected after treatment (e.g., adequately treated carcinoma in situ of the uterine cervix, basal or squamous cell skin cancers, limited prostate cancers treated for radical purposes, ductal carcinomas in situ treated for radical purposes surgically), with the exception of (b) the following;
•5. history of autoimmune diseases, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis;
•6. major surgery within 4 weeks prior to enrollment or incomplete recovery from previous surgery;
•7. systemic immunostimulatory drug therapy (including but not limited to interferon or IL-2) within 4 weeks or 5 half-lives of the drug, whichever is shorter, prior to enrollment;
•8. pre-existing or clinically significant CNS disease at screening, such as epilepsy, seizures, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, organic brain syndromes, or psychiatric disorders;
•9. receipt of systemic corticosteroids (\>10 mg/d prednisone equivalent) or other systemic immunosuppressants, etc. within 2 weeks prior to randomization;
•10. previous allogeneic bone marrow transplantation or previous solid organ transplantation;
+4 more criteria

Key Dates

Start Date

May 6, 2024

Primary Completion Date

April 6, 2028

Completion Date

May 6, 2028

Last Updated

April 30, 2024

Enrollment

ESTIMATED participants

Conditions

Colorectal Cancer

Interventions

PCSK9 inhibitor in combination with standard advanced first-line regimen group

DRUG

standard advanced first-line regimen group

DRUG

Contacts

YONG LI, Doctor

CONTACT

13822177479 liyong@gdph.org.cn

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 30, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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PCSK9 Inhibitors in Combination With Advanced Treatment Strategies for the Treatment of Advanced Colorectal Cancer With pMMR/MSS

Inclusion Criteria

Exclusion Criteria

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