Metastatic colorectal cancer with microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR) molecular phenotypes could significantly benefit from immune checkpoint inhibitor therapy, ushering in the MSI era of immunotherapy for colorectal cancer. However, MSI-H/dMMR is present in only 15%-20% of stage II/III and 5% of stage IV colorectal cancer patients, while the vast majority of patients exhibit microsatellite stability (MSS) or proficient mismatch repair (pMMR) types, which are insensitive to immunotherapy. Therefore, how to enhance the efficacy of immunotherapy in the pMMR/MSS population through combination therapy has become a hotspot and challenge in colorectal cancer research.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
43
Adebrelimab\[1200mg i.v, q3w\], Capecitabine \[1000mg/m² po, bid, d1-d14, q3w\], Oxaliplatin \[130mg/m² i.v, d1, q3w\], Bevacizumab \[7.5mg/kg i.v, d1, q3w\], Simvastatin \[80mg po qd\] regimen treatment, 6-8 weeks, then enter the maintenance phase, with oxaliplatin discontinued during the maintenance phase
Jiangsu Province Hospital (The First Affiliated Hospital with Nanjing Medical University)
Nanjing, Jiangsu, China
RECRUITINGNanjing First Hospital, Nanjing Medical University Affiliated Hospital
Nanjing, Jiangsu, China
NOT_YET_RECRUITINGInvestigator-assessed Objective Response Rate(ORR)
ORR is the proportion of participants with investigator-assessed complete or partial response per \[RECIST 1.1\] criteria, with response confirmed on subsequent imaging.
Time frame: 2 years.
Overall Survival(OS)
OS is the time from treatment initiation to death from any cause. Patients alive at study end will be censored at their last known contact date.
Time frame: up to 5 years after treatment discontinuation
Progression Free Survival(PFS)
PFS is the time from treatment initiation to disease progression or death (whichever comes first), assessed per \[RECIST 1.1\] criteria. Patients without events at study end will be censored at their last assessment date.
Time frame: From treatment initiation until documented disease progression, death, or up to 1 years of follow-up, with survival follow-up conducted every 3 months (±14 days) via telephone after treatment discontinuation.
Disease Control Rate(DCR)
DCR is the proportion of participants with investigator-assessed CR, PR, or SD per \[RECIST 1.1\] criteria, with response confirmed on subsequent imaging.
Time frame: Imaging examinations will be performed every 6 weeks for the first 12 months after initial treatment, then every 12 weeks thereafter through study completion (maximum follow-up of 1 years).
Safety (Adverse Events, Vital Signs, Laboratory Parameters, and Quality of Life Assessed Using NCI-CTCAE v5.0)
Time frame: From ICF through 100 days after the last dose of study treatment
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