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Not yet recruiting NCT05835804

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

Phase II Interventional Squamous Cell Carcinoma of the Head and Neck Paclitaxel Carboplatin Nivolumab

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: GCP intratumoral catheter.
Who it may be relevant to
Registry conditions: Squamous Cell Carcinoma of the Head and Neck, Paclitaxel, Carboplatin, Nivolumab. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Interventions

  • Drug GCP intratumoral catheter
    After local anaesthesia, intratumoral catheter will be place (one or several depending tumour criteria).The catheter placement could be guided by radiological imaging. Gemcitabine (200mg/l), carboplatin (100mg/l) and paclitaxel (20mg/l) will be each diluted in each in 160ml of NaCl0.9%. GCP will be administered successively for 8hours, at 20ml/h with a total duration of 24hours. The ITC will be done every 28 days for 6 times maximum in case of good response and tolerance. Nivolumab 240 mg IV wil

Primary outcome measures

  • local response rate according to RECIST criteria [Time frame: 3 years]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

France · 1 center
  • CHU Amiens Picardie — Amiens

Identifiers

NCT: NCT05835804 · PI2020_843_0003

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗