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Intratumoral Gemcitabine, Paclitaxel, Carboplatine and Intravenous Nivolumab for Locally Recurrence of Head and Neck Cancers

Study acronym: NIVOCHIMLOC
StatusNot Yet Recruiting
PhasePhase 2
Started
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Record status
This record was last updated March 21, 2025 (before its estimated April 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Notable Primary completion date: Apr 2025 to Apr 2026
    • Start date: Nov 1, 2024 to Nov 2025
    • Study completion date: Apr 2026 to Apr 2027
    v4
  2. Notable Start date: Jun 1, 2023 to Nov 1, 2024v3
  3. Minor Interventions: intratumoral catheter (Drug) to GCP intratumoral catheter (Drug)v2
  4. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Patients with locally recurrent squamous-cell carcinoma of the head and neck (SCCHN) after Chemotherapy and immunotherapy have a very poor prognosis and limited therapeutic options. Intratumoral chemotherapy (ITC) with cisplatin and epinephrine in order to increase the local cisplatin retention lead to a 50 % response rate in several studies but was given up due to the poor local tolerance with frequent necrosis of the peritumoral tissues. Gemcitabine, carboplatin and paclitaxel (GCP) are used in advanced SCCHN. These chemotherapies seem to be interesting options for intratumoral infusion: their different effect could lead to avoid chemotherapy resistance with a good tolerance profile, without tissue necrosis profile. The other major option for recurrent SCCHN is immunotherapy by Nivolumab, an anti PD-1 with a 13% mediane response rate. Nevertheless, the failure of this treatment stay unclear, but immunosuppressive action of the tumour is suspected. The presence of tumoral antigen could lead to better response to immunotherapy; association of chemotherapy and immunotherapy seems a promosing association to avoid treatment resistance as cytotoxic release tumoral antigen; it could also be associated to an abscopal effect. The aim of the study is to evaluate the efficacy of ITC using GCP in LOCAL recurrent SCCHN treated by nivolumab.
Trial Details
NCT Number NCT05835804
Lead Sponsor Centre Hospitalier Universitaire, Amiens
Conditions
(from sponsor)
Squamous Cell Carcinoma of the Head and Neck, Paclitaxel, Carboplatin, Nivolumab
Related terms Squamous Cell Carcinoma of Head and Neck
Enrollment 39 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov