Intratumoral Gemcitabine, Paclitaxel, Carboplatine and Intravenous Nivolumab for Locally Recurrence of Head and Neck Cancers
- Conditions
- PaclitaxelCarboplatinNivolumabSquamous Cell Carcinoma of the Head and Neck
- Interventions
- Drug: GCP intratumoral catheter
- Registration Number
- NCT05835804
- Lead Sponsor
- Centre Hospitalier Universitaire, Amiens
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 39
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Intratumoral chemotherapy GCP intratumoral catheter -
- Primary Outcome Measures
Name Time Method local response rate according to RECIST criteria 3 years RECIST is a standard way to measure the response of a tumor to treatment. The criteria to determine whether a tumor disappears, shrinks, are complete response (CR), partial response (PR), stable disease (SD) and progressive disease (PD).
Evaluation of target lesions
* Complete Response (CR): Disappearance of all target lesions
* Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD
* Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions
* Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started Evaluation of non-target lesions
* Complete Response (CR): Disappearance of all non-target lesions and no
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
CHU Amiens Picardie
🇫🇷Amiens, Picardie, France