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Trial Title:
PCSK9 Inhibitors in Combination With Advanced Treatment Strategies for the Treatment of Advanced Colorectal Cancer With pMMR/MSS
NCT ID:
NCT06391905
Condition:
Colorectal Cancer
Conditions: Official terms:
Colorectal Neoplasms
PCSK9 Inhibitors
Conditions: Keywords:
pMMR/MSS
PCSK9
chemotherapy
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Experimental: Advanced Treatment combined with PCSK9 inhibitor Control: Advanced
Treatmentcombined without PCSK9 inhibitor
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
PCSK9 inhibitor in combination with standard advanced first-line regimen group
Description:
Fluorouracil and platinum as the base chemotherapy regimen, with or without targeted
therapy, was administered subcutaneously at a fixed dose of 150 mg of PCSK9 inhibitor
every two weeks starting on day 1 of patient enrollment
Arm group label:
PCSK9 inhibitor in combination with standard advanced first-line regimen group
Intervention type:
Drug
Intervention name:
standard advanced first-line regimen group
Description:
Fluorouracil and platinum were used as the basic chemotherapy regimens, with or without
targeted therapy, and no additional injection of PCSK9 inhibitors
Arm group label:
Late standard first-line treatment regimen group
Summary:
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.
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.
Criteria for eligibility:
Criteria:
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;
11. subjects who, in the judgment of the Investigator, have any factors affecting
compliance with the protocol, including uncontrollable medical, psychological,
familial, sociological, or geographic conditions; or who are unwilling or unable to
comply with the procedures required in the study protocol;
12. history of idiopathic pulmonary fibrosis, drug-induced pneumonia, organic pneumonia
(i.e., occlusive bronchiolitis), idiopathic pneumonia, or evidence of active
pneumonia on CT scan of the chest at the time of screening; 13. receipt of any live
vaccine (e.g., vaccines against infectious diseases such as influenza vaccine,
varicella vaccine, etc.) within 4 weeks (28 days) prior to randomization
14. Pregnant or lactating female patients;
15. Hypersensitivity to fluorouracil-based or platinum-based agents or their excipients.
Gender:
All
Minimum age:
18 Years
Maximum age:
85 Years
Healthy volunteers:
No
Start date:
May 6, 2024
Completion date:
May 6, 2028
Lead sponsor:
Agency:
Guangdong Provincial People's Hospital
Agency class:
Other
Source:
Guangdong Provincial People's Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06391905
