CapeOX Combined With Bevacizumab Plus Anti-PD1 Antibody as Neoadjuvant Therapy for Locally Recurrent Colorectal Cancer
This prospective, single-arm study aims to investigate the efficacy and safety of CapeOX combined with Bevacizumab plus Anti-PD1 Antibody as neoadjuvant therapy for locally recurrent colorectal cancer
• Primary colorectal cancer underwent radical surgery, histologically confirmed as adenocarcinoma and achieved R0 resection, and postoperative adjuvant chemotherapy with Xelox or other first-line standard regimens.
• Based on the imaging and histological examination results, the patient was clinically assessed and diagnosed with locally recurrent colorectal adenocarcinoma.
• The patients did not receive any treatment, including chemotherapy, targeted therapy, immunotherapy, or radiotherapy, within the past month.
• Measurable disease according to the Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria.
• Eastern Cooperative Oncology Group (ECOG) 0-1.
• Absence of distant metastasis confirmed by CT, MRI or PET/CT.
• Adequate hematologic and organ function, defined by protocol-specified laboratory test results, obtained within 7 days before first dose. Absolute neutrophil count ≥1500/mm3, platelet ≥100,000/mm3, Hb ≥10g/dl, serum creatinine ≤1.5 times ULN, creatinine clearance rate ≥50mL/min, ALT and AST ≤2.5 times ULN, INR or aPTT ≤1.5 times ULN (INR ≤2 times ULN and aPTT in normal range for patients who are on prophylactic anticoagulant therapy within 14 days before study treatment), total bilirubin level ≤2 times ULN (within 7 days before study treatment).
• Women of childbearing age should confirm that serum pregnancy test is negative and agree to use effective contraceptive methods during study treatment and the following 60 days.
• Life expectancy\> 3 months
• Signed and written informed consent