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NCT05835804 | NOT YET RECRUITING | Squamous Cell Carcinoma of the Head and Neck

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

University hospital center, Amiens

Brief Summary:

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.

Condition or disease

Squamous Cell Carcinoma of the Head and Neck

Paclitaxel

Carboplatin

Nivolumab

Intervention/treatment

GCP intratumoral catheter

Phase

PHASE2

Study Type : INTERVENTIONAL
Estimated Enrollment : 39 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : Intratumoral Gemcitabine, Paclitaxel, Carboplatine and Intravenous Nivolumab for Locally Recurrence of Head and Neck Cancers
Actual Study Start Date : 2025-11
Estimated Primary Completion Date : 2026-04
Estimated Study Completion Date : 2027-04

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * WHO status : 0, 1 or 2.
  • * Age \> 18ans
  • * Locally recurrence of a histologically-proven SCCHN after failure of conventional treatments (surgery, radiotherapy, chemotherapy with platinum compounds, cetuximab)
  • * Nivolumab treatment in second line encouring according to AMM but with insufficient efficacy
  • * Possible location of the tumour by clinical examination, CT-scan
  • * Metastases are admitted if there is no vital prognoses threaten and if a clinical benefit is expected by treating local recurrence.
  • * Neutrophils \> 1000/mm3.
  • * Platelets \> 100 000/mm3.
  • * Blood créatinine \< 15 mg/L. Blood bilirubine \< 30 mg/L
  • * Prothrombin rate \> 70 %.
  • * Social insurance
  • * Informed consent
Exclusion Criteria
  • * WHO status : 0, 1 or 2.
  • * Age \> 18ans
  • * Locally recurrence of a histologically-proven SCCHN after failure of conventional treatments (surgery, radiotherapy, chemotherapy with platinum compounds, cetuximab)
  • * Nivolumab treatment in second line encouring according to AMM but with insufficient efficacy
  • * Possible location of the tumour by clinical examination, CT-scan
  • * Metastases are admitted if there is no vital prognoses threaten and if a clinical benefit is expected by treating local recurrence.
  • * Neutrophils \> 1000/mm3.
  • * Platelets \> 100 000/mm3.
  • * Blood créatinine \< 15 mg/L. Blood bilirubine \< 30 mg/L
  • * Prothrombin rate \> 70 %.
  • * Social insurance
  • * Informed consent
Intratumoral Gemcitabine, Paclitaxel, Carboplatine and Intravenous Nivolumab for Locally Recurrence of Head and Neck Cancers

Location Details

NCT05835804

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Locations

Not yet recruiting

France, Picardy

Chu Amiens Picardie

Amiens, Picardy, France, 80054