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 @ 12:39 PM
Ignite Modification Date:
2025-12-24 @ 12:39 PM
NCT ID:
NCT06793761
Eligibility Criteria:
Inclusion Criteria:
* Patients with histologically and/or cytologically diagnosed squamous cell carcinoma of the larynx and hypopharynx
* Patients with recurrence of primary lesions or second primary lesions after definitive treatment
* At least 6 months from the end of the last platinum-containing treatment
* Cisplatin-tolerant
* Age ≥ 18 years
* ECOG 0-1
* Measurable disease as defined by RECIST v1.1
* Normal organ function
* Female and male participants of reproductive potential must agree to use appropriate contraception throughout the study and for 180 days after the last study treatment
* Male participants must not donate sperm throughout the study and for 180 days after the last study treatment
Exclusion Criteria:
* T stage after relapse (rT) is T4b
* Presence of distant metastasis
* Received live vaccines within 30 days before enrollment
* Diagnosed with immunodeficiency or received systemic steroids or any other form of immunosuppressive therapy within 7 days before enrollment
* Have radiologically detectable (even if asymptomatic and/or previously treated) central nervous system metastases and/or carcinomatous meningitis;
* Have undergone surgery before starting the study or have not recovered adequately from toxicity or complications caused by the intervention;
* Have had allogeneic tissue/solid organ transplantation;
* Have severe hypersensitivity reactions (≥ grade 3) to PD-1 inhibitors and chemotherapy or any of its adjuvants, radiotherapy;
* Have active autoimmune disease and require systemic treatment in the past 2 years;
* Have a history of (non-infectious) pneumonia requiring steroid treatment;
* Have a history of human immunodeficiency virus (HIV) infection;
* Any medical history, treatment, or laboratory abnormality that could confound the study results, interfere with the participant's participation throughout the study, or be detrimental to the participant's best interests;
* A known history of psychiatric or substance abuse disorder
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06793761
Study Brief:
Protocol Section:
NCT06793761