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NCT06814067PHASE2NOT_YET_RECRUITING

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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Key Facts

Study type
INTERVENTIONAL
Conditions
Head and Neck Squamous Cell Carcinoma, Head and Neck Squamous Cell Carcinoma HNSCC
Interventions
Pembrolizumab, Ivonescimab, Surgery, Adjuvant radiotherapy
Enrollment
80 participants
Primary completion
Feb 2029
Study completion
Mar 2030
First posted
Feb 2025
Last updated
Feb 2025

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/

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✦ Analyst Commentary

Expert commentary on why this trial matters and what to watch for.

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Source

Open on ClinicalTrials.gov