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Safety and Efficacy of PD-1 ± mFOLFOX6 Neoadjuvant Therapy in Local Advanced sMPCC

StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Minor Re-verified, no change to tracked fieldsv5
  2. Notable Primary completion date: Sep 1, 2024 to Sep 1, 2027
    • Study completion date: Sep 1, 2026 to Dec 1, 2028
    v4
  3. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Sep 1, 2023 to May 1, 2022
    v3
  4. Minor Eligibility criteria expanded, about 12 words
    • Study description shortened, about 85 words
    • Study title shortened, about 4 words
    v2
  5. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06002789
Lead Sponsor Sixth Affiliated Hospital, Sun Yat-sen University
Conditions
(from sponsor)
Multiple Cancer, Colorectal Cancer
Related terms Colorectal Neoplasms
Enrollment 17 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov