Phase II Multi-centered Study of Perioperative Ivonescimab Versus Pembrolizumab Combined with Standard of Care (SOC) in Patients with Resectable, Locally Advanced Head and Neck Squamous Cell Carcinoma
Phase II Multicentered Study of Perioperative Ivonescimab Versus Pembrolizumab Combined with Standard of Care (SOC) in Patients with Resectable, Locally Advanced Head and Neck Squamous Cell Carcinoma
Sponsor: Fudan University + Fujian Cancer Hospital
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Major pathological response
Time frame: 4 months
Secondary Endpoints
Event-free survival rate
Overall survival rate
pCR rate
Eligibility Criteria
Inclusion Criteria: 1. ) Patients who signed the informed consent and were willing to complete the study according to the protocol. 2. ) Age ≥18. 3. ) Patients diagnosed with head and neck squamous cell carcinoma by histology, including those with primary lesions in the oropharynx, oral cavity, larynx, or hypopharynx, or those with head and neck squamous cell carcinoma of unknown primary lesion after comprehensive examination and multidisciplinary discussion. 4. ) Locally advanced head and neck squamous cell carcinoma that can be surgically resected ( AJCC staging 8th edition: stage III-IVB), excluding T4b. 5. ) There was at least one measurable lesion before treatment, which met the requirement of " measurable lesion " in RECIST 1.1 standard. 6. ) Expected survival period: \>3 months. 7. ) ECOG score 0-1. 8. ) Good organ function: Meet the following requirements: 1. Absolute neutrophil count ( ANC ) ≥ 1.5 ×10 9 / L ; 2. Platelet count ≥ 100 × 10 9 / L ; 3. Hemoglobin ≥ 9 g/…
Read full criteria on CT.gov →✦ Analyst Commentary
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