OncoMatch/Clinical Trials/NCT06280495
Neoadjuvant Serplulimab & Bevacizumab With FOLFOX vs. FOLFOX Alone in RAS/BRAF WT, pMMR/MSS CRC Patients
Is NCT06280495 recruiting? Yes, currently enrolling (May 2026). This Phase 2/3 trial studies multiple treatments including Oxaliplatin and Fluorouracil for colorectal cancer.
Treatment: Oxaliplatin · Fluorouracil · Serplulimab · Bevacizumab — The primary objective of this study is to assess whether the addition of Serplulimab (a PD-1 inhibitor) and Bevacizumab (an anti-angiogenesis agent) to the standard FOLFOX chemotherapy can enhance the immune microenvironment in the liver, increase T lymphocyte infiltration, and consequently improve the postoperative prognosis for patients with surgically resectable colorectal cancer liver metastases (RAS/BRAF wild-type, pMMR/MSS) compared to FOLFOX alone.
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Biomarker criteria
Required: KRAS wild-type
Genetic testing and/or immunohistochemistry confirmation of RAS, BRAF wild-type, and pMMR/MSS
Required: NRAS wild-type
Genetic testing and/or immunohistochemistry confirmation of RAS, BRAF wild-type, and pMMR/MSS
Required: BRAF wild-type
Genetic testing and/or immunohistochemistry confirmation of RAS, BRAF wild-type, and pMMR/MSS
Required: MLH1 proficient mismatch repair (pMMR)
Genetic testing and/or immunohistochemistry confirmation of RAS, BRAF wild-type, and pMMR/MSS
Required: MSH2 proficient mismatch repair (pMMR)
Genetic testing and/or immunohistochemistry confirmation of RAS, BRAF wild-type, and pMMR/MSS
Required: MSH6 proficient mismatch repair (pMMR)
Genetic testing and/or immunohistochemistry confirmation of RAS, BRAF wild-type, and pMMR/MSS
Required: PMS2 proficient mismatch repair (pMMR)
Genetic testing and/or immunohistochemistry confirmation of RAS, BRAF wild-type, and pMMR/MSS
Required: MSI1 microsatellite stable (MSS)
Genetic testing and/or immunohistochemistry confirmation of RAS, BRAF wild-type, and pMMR/MSS
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: surgical resection — primary colorectal tumor
Primary colorectal tumor has been or can be radically resected
Cannot have received: chemotherapy
Exception: except for surgical resection of primary lesions
No prior anti-tumor therapy for liver metastases, except for surgical resection of primary lesions
Cannot have received: targeted therapy
No prior anti-tumor therapy for liver metastases, except for surgical resection of primary lesions
Cannot have received: immunotherapy
No prior anti-tumor therapy for liver metastases, except for surgical resection of primary lesions
Cannot have received: intervention
No prior anti-tumor therapy for liver metastases, except for surgical resection of primary lesions
Cannot have received: oxaliplatin-containing adjuvant chemotherapy (oxaliplatin)
Exception: if received within the past one year
Received oxaliplatin-containing adjuvant chemotherapy regimen within the past one year
Lab requirements
Blood counts
platelets >90×10^9/L; white blood cells >3×10^9/L; neutrophils >1.5×10^9/L
Kidney function
Serum creatinine below the upper limit of normal (ULN), or calculated creatinine clearance rate >50ml/min (using Cockcroft-Gault formula)
Liver function
Serum bilirubin ≤1.5 times the upper limit of normal (ULN), transaminases ≤5 times ULN, alkaline phosphatase ≤2.5 ULN, no ascites, normal coagulation function, albumin ≥35g/L; Liver function classified as Child-Pugh grade A
Normal hematological function (platelets >90×10^9/L; white blood cells >3×10^9/L; neutrophils >1.5×10^9/L); Serum bilirubin ≤1.5 times the upper limit of normal (ULN), transaminases ≤5 times ULN, alkaline phosphatase ≤2.5 ULN, no ascites, normal coagulation function, albumin ≥35g/L; Liver function classified as Child-Pugh grade A; Serum creatinine below the upper limit of normal (ULN), or calculated creatinine clearance rate >50ml/min (using Cockcroft-Gault formula)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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