Neoadjuvant Anti-PD-1 Immunotherapy With Chemotherapy in Resectable Locally Advanced Oral Squamous Cell Carcinoma

Study acronym: NEOPCOSCC
StatusUnknown
PhasePhase 3
Started

Record status This record was last updated April 2, 2024 (before its estimated July 1, 2026 completion). Its status may not reflect the trial's current state.

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Record History

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  1. Changed Registry marked status Unknown (sponsor has not verified the record since Apr 2024); last known: Recruiting
  2. Eligibility criteria revisedv6
  3. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 1 to 3
    • Start date changed from estimate of Nov 20, 2023 to Nov 21, 2023
    v5
  4. Start date: Aug 1, 2023 to Nov 20, 2023v4
  5. Start date: May 1, 2023 to Aug 1, 2023v3
  6. Study description expanded, about 1 wordv2
  7. Study First Submitted
  • 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.
The purpose of this study is to investigate the survival benefit of neoadjuvant anti-PD-1 immunotherapy plus TP chemotherapy compared with TP chemotherapy or up-front surgery in resectable locally advanced oral squamous cell carcinoma.
Trial Details
NCT Number NCT05798793
Lead Sponsor Hospital of Stomatology, Wuhan University
Collaborators: Jiangsu HengRui Medicine Co., Ltd.
Conditions
(from sponsor)		 Oral Squamous Cell Carcinoma
Related terms Squamous Cell Carcinoma of Head and Neck
Enrollment 309 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov