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

NCT06391905 | Not Yet Recruiting Phase 2

• 1 other identifier: lron-Man 02
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Colorectal Cancer

Keywords

pMMR/MSS; PCSK9; chemotherapy

Outcome Measures

Primary Outcomes (1)

• Objective response rateObjective response rate (ORR)

  Objective response rate (ORR) after PCSK9 inhibitor in combination with standard advanced first-line regimen in patients with advanced colorectal cancer with pMMR/MSS

  5years

Secondary Outcomes (2)

• Progression-free survival (PFS)

  5years

• Overall survival (OS)

  5years

Other Outcomes (1)

• Safety evaluation index

  During the study

Study Arms (2)

Late standard first-line treatment regimen group

OTHER

Fluorouracil and platinum were used as the basic chemotherapy regimens, with or without targeted therapy, and no additional injection of PCSK9 inhibitors

Drug: standard advanced first-line regimen group

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

EXPERIMENTAL

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

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

Interventions

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

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

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

standard advanced first-line regimen group DRUG

Fluorouracil and platinum were used as the basic chemotherapy regimens, with or without targeted therapy, and no additional injection of PCSK9 inhibitors

Late standard first-line treatment regimen group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Hypocholesterolemia, hypolipidemia and its family history, previous allergic reaction to PCSK9 inhibitors History of allergic reaction to PCSK9 inhibitors;
• preoperative pathological diagnosis of advanced colorectal adenocarcinoma without pMMR/MSS, with the chance of radical surgical treatment;
• Hypolipidemia caused by combination with other long-term lipid-lowering drugs;
• 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;
• history of autoimmune diseases, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis;
• major surgery within 4 weeks prior to enrollment or incomplete recovery from previous surgery;
• 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;
• 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;
• receipt of systemic corticosteroids (\>10 mg/d prednisone equivalent) or other systemic immunosuppressants, etc. within 2 weeks prior to randomization;
• previous allogeneic bone marrow transplantation or previous solid organ transplantation;
• 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;
• 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
• \. Pregnant or lactating female patients;
• \. Hypersensitivity to fluorouracil-based or platinum-based agents or their excipients.

Sponsors & Collaborators

• Guangdong Provincial People's Hospital: lead

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Central Study Contacts

YONG LI, Doctor

CONTACT

13822177479; liyong@gdph.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician of Gastrointestinal Surgery

Model Details: Experimental: Advanced Treatment combined with PCSK9 inhibitor Control: Advanced Treatmentcombined without PCSK9 inhibitor

Study Record Dates

• First Submitted: April 23, 2024
• First Posted: April 30, 2024
• Study Start: May 6, 2024
• Primary Completion (Estimated): April 6, 2028
• Study Completion (Estimated): May 6, 2028
• Last Updated: April 30, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share