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

Centre Hospitalier Universitaire, Amiens

Status and phase: Not yet enrolling; Phase 2

Conditions: Squamous Cell Carcinoma of the Head and Neck; Paclitaxel; Nivolumab; Carboplatin

Treatments: Drug: GCP intratumoral catheter

Study type: Interventional

Funder types: Other

Identifiers

NCT05835804

PI2020_843_0003

Details and patient eligibility

About

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.

Enrollment: 39 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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39 participants in 1 patient group

Intratumoral chemotherapy

Experimental group

Treatment:

Drug: GCP intratumoral catheter