Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT05731726 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Serplulimab Combined With CAPEOX + Celecoxib as Neoadjuvant Treatment for Locally Advanced Rectal Cancer

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date: Dec 20, 2025 to Dec 30, 2026 Completion date: Dec 30, 2025 to Dec 30, 2026 · Interventions: Capecitabine (Drug), Celecoxib (Drug), Oxaliplatin (Drug), Serplilumab (Drug) to Capecitabine (Drug), Celecoxib (Drug), Oxaliplatin (Drug), Serplulimab (Drug) · Site contact updated · 1 morev5 Show 4 more changesShow less
    • Completion date: Dec 30, 2025 to Dec 30, 2026
    • Interventions: Capecitabine (Drug), Celecoxib (Drug), Oxaliplatin (Drug), Serplilumab (Drug) to Capecitabine (Drug), Celecoxib (Drug), Oxaliplatin (Drug), Serplulimab (Drug)
    • Site contact updated
    • Eligibility criteria expanded, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  2. Primary completion date: Feb 20, 2024 to Dec 20, 2025 Completion date: Feb 20, 2025 to Dec 30, 2025 · Eligibility criteria expanded, about 36 words · Secondary endpoints: 6 to 7 · 1 morev4 Show 4 more changesShow less
    • Completion date: Feb 20, 2025 to Dec 30, 2025
    • Eligibility criteria expanded, about 36 words
    • Secondary endpoints: 6 to 7
    • Site contact updated

    See this version in full on ClinicalTrials.gov ↗

  3. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Start date changed from estimate of Feb 20, 2023 to Feb 22, 2023 · Secondary endpoints: 4 to 6v3 Show 3 more changesShow less
    • Study sites: 0 to 1
    • Start date changed from estimate of Feb 20, 2023 to Feb 22, 2023
    • Secondary endpoints: 4 to 6

    See this version in full on ClinicalTrials.gov ↗

  4. Secondary endpoints revised (4) Eligibility criteria shortened, about 1 wordv2 Show 1 more changeShow less
    • Eligibility criteria shortened, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Colorectal cancer of Mismatch Repair-proficient (pMMR)/ Microsatellite Stability (MSS) accounts for approximately 85% of all colorectal cancer patients, which might be insensitive to immunotherapy. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy, such as CAPEOX regimen, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Celecoxib, a COX-2 inhibitor, can improve the immune microenvironment and have a potential to synergy with immunotherapy. Chemotherapy can improve the immunogenicity of cancer cells that might enhance the efficacy of immunotherapy. The aim of this study is to explore whether chemotherapy and cyclooxygenase (COX) inhibitors combined with anti-PD-1 monoclonal antibody (mAb) could improve efficacy for resectable colorectal cancer patient with the pMMR/MSS phenotype.
Trial Details
NCT Number NCT05731726
Lead Sponsor Zhejiang University
Conditions pMMR, MSS, MSI-L, Locally Advanced Rectal Carcinoma
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov