Colorectal CancerPhase 2NCT06391905
PCSK9 Inhibitors in Combination With Advanced Treatment Strategies for the Treatment of Advanced Colorectal Cancer With pMMR/MSS
A Phase 2 study testing PCSK9 inhibitor in combination with standard advanced first-line regimen group and standard advanced first-line regimen group in people with Colorectal Cancer, run by Guangdong Provincial People's Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- PCSK9 inhibitor in combination with standard advanced first-line regimen group and standard advanced first-line regimen group
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 6 May 2024to 6 May 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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
- 14. Pregnant or lactating female patients;
- 15. Hypersensitivity to fluorouracil-based or platinum-based agents or their excipients.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the 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.
- Conditions
- Colorectal Cancer
- Being tested
- PCSK9 inhibitor in combination with standard advanced first-line regimen group, standard advanced first-line regimen group
- Keywords
- pMMR/MSS, PCSK9, chemotherapy
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCSK9 inhibitor in combination with standard advanced first-line regimen groupDrug
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
standard advanced first-line regimen groupDrug
Fluorouracil and platinum were used as the basic chemotherapy regimens, with or without targeted therapy, and no additional injection of PCSK9 inhibitors
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: PCSK9 inhibitor in combination with standard advanced first-line regimen group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 5years
Secondary outcomes (2)
Progression-free survival (PFS)
Progression-free survival (PFS) after PCSK9 inhibitor combination therapy
Measured: 5years
Overall survival (OS)
Overall survival (OS) after PCSK9 inhibitor combination therapy
Measured: 5years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2024
- Study start6 May 2024 (estimated)
- Primary completion6 Apr 2028 (estimated)
- Study completion6 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Guangdong Provincial People's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Experimental: Advanced Treatment combined with PCSK9 inhibitor Control: Advanced Treatmentcombined without PCSK9 inhibitor
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yong Li, MD, Guangdong Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06391905
- Sponsor's protocol ID
- lron-Man 02
- Status last verified
- Apr 2024
- First submitted
- 23 Apr 2024
- Last updated
- 30 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PCSK9 Inhibitors in Combination With Advanced Treatment Strategies for the Treatment of Advanced Colorectal Cancer With pMMR/MSS
- ClinicalTrials.gov ID
- NCT06391905
- Acronym / sponsor ID
- lron-Man 02
- Conditions
- Colorectal Cancer
- Keywords
- pMMR/MSS, PCSK9, chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Guangdong Provincial People's HospitalUniversity, hospital or other
- Study start
- 6 May 2024 (estimated)
- Primary completion
- 6 Apr 2028 (estimated)
- Study completion
- 6 May 2028 (estimated)
- First posted
- 30 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Experimental: Advanced Treatment combined with PCSK9 inhibitor Control: Advanced Treatmentcombined without PCSK9 inhibitor
| Arm | Type | Receives |
|---|---|---|
| Late standard first-line treatment regimen group | Other | Drug: standard advanced first-line regimen groupFluorouracil and platinum were used as the basic chemotherapy regimens, with or without targeted therapy, and no additional injection of PCSK9 inhibitors |
| PCSK9 inhibitor in combination with standard advanced first-line regimen group | Experimental | Drug: PCSK9 inhibitor in combination with standard advanced first-line regimen groupFluorouracil 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 |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (14 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PCSK9 inhibitor in combination with standard advanced first-line regimen groupFluorouracil 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 |
| standard advanced first-line regimen groupFluorouracil and platinum were used as the basic chemotherapy regimens, with or without targeted therapy, and no additional injection of PCSK9 inhibitors | Drug | Late standard first-line treatment regimen group |
Primary outcome
Objective response rateObjective response rate (ORR)
Time frame: 5years
Objective response rate (ORR) after PCSK9 inhibitor in combination with standard advanced first-line regimen in patients with advanced colorectal cancer with pMMR/MSS
2 secondary outcomes
Progression-free survival (PFS)
Time frame: 5years
Overall survival (OS)
Time frame: 5years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PCSK9 inhibitor in combination with standard advanced first-line regimen group and standard advanced first-line regimen group in people with Colorectal Cancer, run by Guangdong Provincial People's Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact YONG LI, Doctor (13822177479, liyong@gdph.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rateObjective response rate (ORR) (time frame: 5years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2024.