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

Launched by CENTRE HOSPITALIER UNIVERSITAIRE, AMIENS · Apr 26, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with locally recurrent squamous cell carcinoma of the head and neck (SCCHN) who have not responded well to previous treatments like surgery, radiation, and chemotherapy. The researchers want to see if combining a specific type of chemotherapy (using drugs called gemcitabine, paclitaxel, and carboplatin) with an immunotherapy drug (nivolumab) can help these patients. This combination may help the body’s immune system better attack the cancer while also reducing the risk of the cancer becoming resistant to treatment.

To participate in this trial, patients must be at least 18 years old and have a confirmed diagnosis of recurrent SCCHN after other treatments have failed. They should also be in relatively good health, with specific blood counts and organ function within certain limits. Participants will receive the new treatment and will be monitored closely for any effects. Importantly, the trial is not yet recruiting, but it aims to provide new hope for patients facing limited treatment options.

Gender

ALL

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