NCT05835804Not yet recruitingPhase 2
Intratumoral Gemcitabine, Paclitaxel, Carboplatine and Intravenous Nivolumab for Locally Recurrence of Head and Neck Cancers
Source: ClinicalTrials.gov · Last updated 21 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 39 (estimated)
- First submitted
- 6 Apr 2023
- Start date
- Nov 2025
- Primary completion date
- Apr 2026
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Diseases
- Head and neck cancer
- NCT number
- NCT05835804
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 39
- From Nov 2025 to the primary completion date, Apr 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Locally recurrence of a histologically-proven SCCHN after failure of conventional treatments (surgery, radiotherapy, chemotherapy with platinum compounds, cetuximab)
Lab values
- Neutrophils \> 1000/mm3.
- Platelets \> 100 000/mm3.
Age
- Age \> 18ans
Other
- WHO status : 0, 1 or 2.
- 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.
- Blood créatinine \< 15 mg/L. Blood bilirubine \< 30 mg/L
- Prothrombin rate \> 70 %.
- Social insurance
- Informed consent
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Chu Amiens Picardie Coordinator of this site? Confirm its status | Amiens | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.