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 (Jun 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
Treatments studied
Targeted therapy
Chemotherapy
Other
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)
Demographics
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.
Frequently asked questions
Is NCT06280495 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require KRAS?
Yes, KRAS wild-type is a required biomarker for enrollment.
Does this trial require NRAS?
Yes, NRAS wild-type is a required biomarker for enrollment.
Does this trial require BRAF?
Yes, BRAF wild-type is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 75 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify