Clinical trial NCT05835804: Intratumoral Gemcitabine, Paclitaxel, Carboplatine and Intravenous Nivolumab for Locally Recurrence of Head and Neck Cancers
Official title: Intratumoral Gemcitabine, Paclitaxel, Carboplatine and Intravenous Nivolumab for Locally Recurrence of Head and Neck Cancers
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Squamous Cell Carcinoma of the Head and Neck
Paclitaxel
Carboplatin
Nivolumab
Keywords: Squamous Cell Carcinoma of the Head and Neck
local reccurence of malignant tumor
intrumoral chemotherapy
gemcitabin
paclitaxel
carboplatin
nivolumab
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2023-04-28
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: local response rate according to RECIST criteria
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens Picardie
state: Picardie
Study officials:
References: