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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
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
Fluorouracil and platinum were used as the basic chemotherapy regimens, with or without targeted therapy, and no additional injection of PCSK9 inhibitors
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
Time frame: 5years
Progression-free survival (PFS)
Progression-free survival (PFS) after PCSK9 inhibitor combination therapy
Time frame: 5years
Overall survival (OS)
Overall survival (OS) after PCSK9 inhibitor combination therapy
Time frame: 5years
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