Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2025-12-24 @ 7:58 PM
NCT ID:
NCT05835804
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05835804
Study Brief:
Protocol Section:
NCT05835804