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

NCT ID: NCT05835804

Last Updated: 2025-03-21

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-30
• Study Completion Date: 2027-04-30

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intratumoral chemotherapy

Group Type: EXPERIMENTAL

GCP intratumoral catheter

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU Amiens Picardie

Amiens, Picardie, France

Countries

France

Central Contacts

Aline HOUESSINON, MD

Role: CONTACT

houessinon.aline@chu-amiens.fr

03 22 45 54 99

Facility Contacts

Aline HOUESSINON, MD

Role: primary

houessinon.aline@chu-amiens.fr

03 22 45 54 99

Other Identifiers

PI2020_843_0003

Identifier Type: -

Identifier Source: org_study_id