Head and Neck Squamous Carcinom
Conditions
Interventions
Cohort A (Finotonlimab in combination with carboplatin and taxanes):None
Cohort B (Finotonlimab in combination with carboplatin and taxanes):None
Cohort C (Finotonlimab in combination with Cetuximab):None
Sponsors
Shanghai East Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: 1: Voluntarily participate in the study and sign the Informed Consent Form (ICF) 2: Age >= 18 years at the time of ICF signing, regardless of gender 3: Histologically or cytologically confirmed recurrent or metastatic HNSCC (not eligible for local curative therapies such as surgery or radiotherapy) with primary tumors located in the oral cavity, oropharynx, hypopharynx, larynx, nasal cavity, or paranasal sinuses, and no prior systemic therapy for recurrent/metastatic disease 4: At least one measurable tumor lesion according to RECIST (Response Evaluation Criteria in Solid Tumors) version 1.1 5: ECOG (Eastern Cooperative Oncology Group) performance status score of 0-2, with no clinically significant deterioration within the past two weeks 6: Adequate organ function and deemed suitable for Finotonlimab combination therapy by the investigator
Exclusion criteria
Exclusion criteria: 1: (Cohorts A and B) Prior multimodal therapy containing PD-1/PD-L1 inhibitors and/or platinum-based agents for locally advanced disease, with recurrence/progression or treatment intolerance within 6 months after the last dose of PD-1/PD-L1 inhibitors and/or platinum-based agents; (Cohort C) Prior multimodal therapy containing PD-1/PD-L1 inhibitors and/or EGFR-targeted monoclonal antibodies for locally advanced disease, with recurrence/progression or treatment intolerance within 6 months after the last dose of PD-1/PD-L1 inhibitors and/or EGFR-targeted monoclonal antibodies 2: Known hypersensitivity to the active pharmaceutical ingredients or excipients of the investigational drugs, or contraindications specified in the respective cohort’s drug labeling 3: Presence of primary immunodeficiency or active autoimmune disease 4: History of >= Grade 3 immune-related adverse events (irAEs) or >= Grade 2 immune-mediated myocarditis during prior immunotherapy 5: Pregnancy or lactation 6: Any other condition deemed inappropriate for participation in this clinical study by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate, ORR;Patients quality of life; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease Control Rate,DCR;Duration of Response,DoR;Progression-Free Survival, PFS;Overall Survival,OS; | — |
Countries
China
Contacts
Public ContactGuo Ye
Shanghai East Hospital
Outcome results
None listed