A Phase II Clinical Trial of Anti-EGFR Antibody-drug Conjugate (ADC) Combined With or Without Immune Checkpoint Inhibitors in the Neoadjuvant Treatment of Resectable Locally Advanced Head and Neck Squamous Cell Carcinoma
A Randomized, Non-comparative, Multicenter Phase II Clinical Trial of Becotatug Vedotin Combined With or Without Immune Checkpoint Inhibitors (Penpulimab/Ivonescimab) in the Neoadjuvant Treatment of Resectable Locally Advanced Head and Neck Squamous Cell Carcinoma
Sponsor: West China Hospital
No open prediction endpoints
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Primary Endpoints (CT.gov)
pCR
Time frame: After surgery (approximately 9-10 weeks after start of study treatment)
Secondary Endpoints
MPR
Eligibility Criteria
Inclusion Criteria: 1. Age: 18 - 70 years old, gender not restricted; 2. Histopathologically diagnosed as squamous cell carcinoma of the head and neck (including oral cancer, laryngeal cancer, hypopharyngeal cancer, and oropharyngeal cancer, etc.); 3. Patients with resectable locally advanced head and neck squamous cell carcinoma (LA-HNSCC); 4. Eastern Cooperative Oncology Group (ECOG) score of 0 or 1; 5. Have not received any treatment for head and neck squamous cell carcinoma before, including drug treatment, radiotherapy, surgical treatment, etc.; 6. No distant metastasis; 7. The patient has the intention for radical treatment; 8. Good hematopoietic function (total white blood cell count ≥ 3.0×109 /L, absolute lymphocyte count ≥ 0.8×109/L, absolute neutrophil count ≥ 1.5×109/L, platelet count ≥ 100×109 /L, hemoglobin ≥ 90g/L) and no blood transfusion or biological response modifiers (such as granulocyte growth factors, erythropoietin growth factors, etc.) treatment within 14 days b…
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