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

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

39

Participants

Timeline

Start Date

November 30, 2025

Primary Completion Date

April 30, 2026

Study Completion Date

April 30, 2027

Conditions
Squamous Cell Carcinoma of the Head and NeckPaclitaxelCarboplatinNivolumab
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 will be started 1 to 7 days before the first intratumoral infusion and every 15 days, until progression or 2 until years in case of partial response, complete response or stabilization. Evaluation of tumour size will be done by CT-scan, or MRI 2every 2 months and PET-FDG every 3 months.

Trial Locations (1)

80054

CHU Amiens Picardie, Amiens

All Listed Sponsors
lead

Centre Hospitalier Universitaire, Amiens

OTHER

NCT05835804 - Intratumoral Gemcitabine, Paclitaxel, Carboplatine and Intravenous Nivolumab for Locally Recurrence of Head and Neck Cancers | Biotech Hunter | Biotech Hunter