To evaluate the efficacy and safety of Chemotherapy With XELOX (Oxaliplatin + Capecitabine) and Bevacizumab in Combination With Adebrelimab in First-line Treatment of Microsatellite Stable (MSS) Initially Unresectable Metastatic Colorectal Cancer.
At present, the survival benefit of MSS mCRC patients is limited, and the general survival time is only about 3-4 months. Up to now, the standard treatment plan is FOLFOX combined with bevacizumab. AtezoTRIBE study shows that compared with FOLFOXIRI+ bevacizumab, the standard treatment plan is better than the standard treatment plan. The combination of PD-L1 monomone attillizumab extended mPFS from 11.4 months to 12.9 months, showing certain efficacy, and the combination of Attillizumab did not increase adverse reactions. Based on the above, this study aims to explore the efficacy and safety of chemotherapy with XELOX (oxaliplatin + capecitabine) regimen and bevacizumab combined with adbelizumab in first-line treatment of microsatellite stable (MSS) type of initial unresectable metastatic colorectal cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
36
This product is administered by intravenously guttae. The recommended dose of subcutaneous injection is 1200mg, administered every 3 Weeks (Q3W).
130 mg/m2, ivgtt, d1, Q3W
1000mg/m2, po, bid, d1-14, Q3W Maintenance therapy: 1250mg/m2, po, bid, d1-14, Q3W
7.5mg/kg,ivgtt, d1, Q3W
The Fourth Affiliated Hospital Zhejiang University School of Medicine
Jinhua, Zhejiang, China
RECRUITINGProgression-free survival
Progression-free survival (PFS) denotes the chances of staying free of disease progression for a group of individuals suffering from a cancer after a particular treatment.
Time frame: Up to 2 years
Organ retention rate
The proportion of patients who achieved pre-specified tumor volume reduction and maintained the minimum time limit was the sum of complete and partial responses.
Time frame: Up to 2 years
Overall survival
The proportion of participants who remain survival at 2 years
Time frame: Up to 2 years
Disease Control Rate
The percentage of patients with advanced cancer whose therapeutic intervention has led to a complete response, partial response, or stable disease.
Time frame: Up to 2 years
Surgical conversion rate
The rate of conversion to surgery.
Time frame: Up to 2 years
TRAEs
Number of participants with treatment-related adverse events as assessed by NCI-CTCAE v5.0
Time frame: Up to 2 years
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