OncoMatch/Clinical Trials/NCT06791512
mFOLFOX6 + Bevacizumab + PD-1 Monoclonal Antibody Vs. mFOLFOX6 in Locally Advanced pMMR/MSS CRC
Is NCT06791512 recruiting? Yes, currently enrolling (Jun 2026). This Phase 3 trial studies multiple treatments including mFOLFOX6 + Bevacizumab + PD-1 monoclonal antibody and mFOLFOX6 for colorectal cancer (crc).
Treatment: mFOLFOX6 + Bevacizumab + PD-1 monoclonal antibody · mFOLFOX6 — Neoadjuvant immunotherapy has shown promising therapeutic effects in mismatch repair-deficient or microsatellite instability-high (dMMR/MSI-H) colorectal cancer (CRC). However, for patients with mismatch repair-proficient or microsatellite stable (pMMR/MSS) CRC, the efficacy of PD-1 monoclonal antibody remains limited. Enhancing the efficacy of immunotherapy in pMMR/MSS CRC has become a key area of exploration. Additionally, for locally advanced (cT4NxM0) CRC patients, achieving R0 resection poses a significant challenge. Failure to achieve R0 resection often results in recurrence, severely impacting patient survival outcomes. Our previous phase II clinical study (BASKET Ⅱ) demonstrated that the neoadjuvant regimen of mFOLFOX6 combined with Bevacizumab and PD-1 monoclonal antibody significantly enhanced the immunotherapy sensitivity of locally advanced pMMR/MSS CRC, leading to improved pathological complete response (pCR) rates and higher R0 resection rates. This prospective, multicenter, randomized phase III trial aims to evaluate whether the neoadjuvant regimen of mFOLFOX6 + Bevacizumab + PD-1 monoclonal antibody can further improve pCR rate, enhance survival outcomes, and maintain an acceptable safety profile compared to mFOLFOX6 alone in pMMR/MSS locally advanced CRC patients.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Other
Cancer type
Colorectal Cancer
Biomarker criteria
Required: MSH1 protein expression (positive)
Tumor biopsy immunohistochemical (IHC) identified pMMR, including all of the MSH1,MSH2,MSH6 and PMS2 protein expression and diagnosed as proficient mismatch repair(pMMR)
Required: MSH2 protein expression (positive)
Tumor biopsy immunohistochemical (IHC) identified pMMR, including all of the MSH1,MSH2,MSH6 and PMS2 protein expression and diagnosed as proficient mismatch repair(pMMR)
Required: MSH6 protein expression (positive)
Tumor biopsy immunohistochemical (IHC) identified pMMR, including all of the MSH1,MSH2,MSH6 and PMS2 protein expression and diagnosed as proficient mismatch repair(pMMR)
Required: PMS2 protein expression (positive)
Tumor biopsy immunohistochemical (IHC) identified pMMR, including all of the MSH1,MSH2,MSH6 and PMS2 protein expression and diagnosed as proficient mismatch repair(pMMR)
Disease stage
Required: Stage CT4NXM0
Demographics
Prior therapy
Cannot have received: chemotherapy
No prior chemotherapy
Cannot have received: radiotherapy
No prior radiotherapy
Cannot have received: biopharmaceutical treatments (e.g., monoclonal antibody)
No history of biopharmaceutical treatments (e.g., monoclonal antibody )
Cannot have received: immunotherapy (e.g., anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibodies)
No history of immunotherapy (e.g., anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibodies)
Cannot have received: investigational drugs
No history of treatment with investigational drugs
Cannot have received: colorectal surgery
No history of colorectal surgery
Cannot have received: pelvic or abdominal radiotherapy
History of pelvic or abdominal radiotherapy
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT06791512 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 MSH1?
Yes, MSH1 protein expression is a required biomarker for enrollment.
Does this trial require MSH2?
Yes, MSH2 protein expression is a required biomarker for enrollment.
Does this trial require MSH6?
Yes, MSH6 protein expression is a required biomarker for enrollment.
What disease stage is eligible?
Stage CT4NXM0 is required.
Is there an age limit?
Yes. Patients must be 80 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