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Neoadjuvant Chemoradiotherapy Combined With PD-1 Inhibitor and Thymalfasin for pMMR/MSS Locally Advanced Mid-low Rectal Cancer

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Notable Primary endpoint revisedv3 Show 8 more changesShow less
    • Trial status: Not Yet Recruiting to Active, Not Recruiting
    • Primary completion date changed from estimate of Jul 1, 2024 to Dec 1, 2024
    • Start date changed from estimate of Dec 1, 2023 to Jan 3, 2024
    • Eligibility criteria shortened, about 137 words
    • Secondary endpoints: 11 to 7
    • Study description shortened, about 7 words
    • Site contacts updated at 2 of 2 sites
    • Publications: 4 to 5
  2. Notable Start date: Oct 9, 2023 to Dec 1, 2023
    • Secondary endpoints: details revised at 3 of 11 entries
    v2
  3. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This is an open, prospective, multi-center, single-arm phase II clinical study assessing the efficacy and safety of neoadjuvant chemoradiotherapy combined with PD-1 inhibitor and thymalfasin in patients with pMMR/MSS locally advanced middle and low rectal cancer.
Trial Details
NCT Number NCT06056804
Lead Sponsor Beijing Friendship Hospital
Collaborators: Peking Union Medical College Hospital
Conditions
(from sponsor)
Locally Advanced Rectal Cancer
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov