OncoMatch/Clinical Trials/NCT06002789
Safety and Efficacy of PD-1 ± mFOLFOX6 Neoadjuvant Therapy in Local Advanced sMPCC
Is NCT06002789 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including MSI-H/MSS (dMMR/pMMR) mixed sMPCC: combination of mFOLFOX6+PD-1 monoclonal antibody neoadjuvant therapy and All-MSI-H (dMMR) sMPCC: single-drug PD-1 monoclonal antibody neoadjuvant therapy for multiple cancer.
Treatment: MSI-H/MSS (dMMR/pMMR) mixed sMPCC: combination of mFOLFOX6+PD-1 monoclonal antibody neoadjuvant therapy · All-MSI-H (dMMR) sMPCC: single-drug PD-1 monoclonal antibody neoadjuvant therapy — At present, radical resection ± preoperative neoadjuvant chemotherapy for colorectal cancer is still the standard comprehensive treatment. In recent years, immunotherapy of PD-1 monoclonal antibody has a significant effect in the second-line/first-line treatment of dMMR/MSI-H advanced colorectal cancer and the neoadjuvant treatment of early colorectal cancer. Synchronous multiple primary colorectal cancer (sMPCC) is a relatively rare type of colorectal cancer (CRC) that refers to the simultaneous occurrence of 2 or more independent primary malignancies in the colon or rectum. The recent large-scale, single-center retrospective study of the investigator showed that compared with single primary colorectal cancer (SPCRC)patients, the incidence of dMMR/MSI-H was significantly higher in sMPCC patients. Besides, a certain proportion of sMPCC patients could both have MSI and MSS tumors at the same time. There is no standard regimen for this patients so far. This study intends to treat the MSI-H/MSS (dMMR/pMMR) mixed sMPCC patients with combination of mFOLFOX6+PD-1 monoclonal antibody neoadjuvant therapy, and treat the all-MSI-H (dMMR) sMPCC patients with single-drug PD-1 monoclonal antibody neoadjuvant therapy. Given the current gaps in the guideline, the investigator intends to take the lead in carrying out this open, multi-center, prospective clinical phase II study. This study might provide a clinical evidence for individual treatment of sMPCC patients, in preserving the functions and organs to the greatest extent.
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Biomarker criteria
Required: MSH1 loss
Required: MSH2 loss
Required: MSH6 loss
Required: PMS2 loss
Disease stage
Excluded: Stage OUTSIDE PELVIC DISTANT METASTASIS
Clinical staging T3-4NxM0, with or without positive MRF, with or without positive EMVI; distant metastasis were excluded by chest and abdominal enhanced CT and pelvic enhanced MRI; outside pelvic distant metastasis evidences [excluded]
Prior therapy
Cannot have received: colorectal surgery
No colorectal surgery history
Cannot have received: chemotherapy
No chemotherapy or radiotherapy history
Cannot have received: radiation therapy
No chemotherapy or radiotherapy history; Pelvic or abdominal radiotherapy history [excluded]
Cannot have received: biopharmaceutical treatment (such as monoclonal antibody)
No biopharmaceutical treatment history(such as monoclonal antibody)
Cannot have received: immunotherapy (anti PD-1 antibody, anti PD-L1 antibody, anti PD-L2 antibody, anti CTLA-4)
immunotherapy(such as anti PD-1antibody, anti PD-L1 antibody, anti PD-L2 antibody or anti CTLA-4)
Cannot have received: other research drug treatment
other research drug treatment
Lab requirements
Cardiac function
No arrhythmia needing anti-arrhythmia treatment (except β-blocking agent or Digoxin), no symptomatic coronary heart disease or myocardial ischemia (myocardial infarction within 6 months) or CHF > NYHA grade II
Arrhythmia need anti-arrhythmia treatment(except β-blocking agent or Digoxin), symptomatic coronary heart disease or myocardial ischemia(myocardial infarction within 6 months) or congestive heart-failure (CHF) > NYHA grade II [excluded]
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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