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.
Able to provide written informed consent and voluntarily participate in this study.
Male or female subjects aged between 18 and 75 years, inclusive.
Histologically or cytologically confirmed metastatic colorectal adenocarcinoma.
No prior systemic anti-tumor therapy; patients who have received neoadjuvant/adjuvant therapy are eligible if the time from the last chemotherapy to recurrence or progression is more than 6 months.
Received local radiotherapy within 4 weeks prior to the first dose of study drug, and adverse events due to radiotherapy have not recovered to baseline levels. Subjects who received palliative radiotherapy to peripheral sites (e.g., bone metastases) more than 4 weeks prior to the first dose are eligible, provided they have recovered from any acute adverse reactions.
Known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate, provided they have stable brain metastases and have not required steroid treatment for brain metastases for at least 28 days prior to study entry. This exception does not apply to carcinomatous meningitis, which is excluded regardless of clinical stability.
Major surgery, open biopsy, or severe trauma within 28 days prior to the first dose of study drug.
History of allergy to any anti-angiogenic agents, any component of monoclonal antibodies, capecitabine, oxaliplatin, or other platinum-based drugs.
Single group
Adebrelimab
DrugAdebrelimab\[1200mg i.v, q3w\], 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
Investigator-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.
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.
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.
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.
Safety (Adverse Events, Vital Signs, Laboratory Parameters, and Quality of Life Assessed Using NCI-CTCAE v5.0)
Click on the lead sponsor to view all of their trials.
The First Affiliated Hospital with Nanjing Medical University
Lead sponsor
Jiangsu HengRui Medicine Co., Ltd.
Collaborator
