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Neoadjuvant Chemotherapy and PD-1 Inhibitor for Locally Advanced Rectal Cancer(CONTROL-01)

StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Dec 1, 2024 to Jun 1, 2025
    • Study sites: 0 to 1
    • Study title revised
    v2
  2. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
To evaluate the safety and preliminary efficacy of preoperative chemotherapy and PD-1 inhibitor Tislelizumab for Rectal Cancer patients.Go through laboratory and medical tests to verify eligibility to enter the study, receive the experimental combination of drugs CAPOX (Oxaliplatin and Capecitabine) for 3 cycles prior to surgery and undergo laboratory tests and study procedures on specified days during the study period, complete end of study evaluations and tests, and participate in post-study follow up every three months for three years.
Trial Details
NCT Number NCT06647680
Lead Sponsor The Affiliated Hospital of Qingdao University
Conditions
(from sponsor)
Rectal Cancer Patients
Related terms Pathologic Complete Response, Rectal Neoplasms
Enrollment 35 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov