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NCT07381075PHASE2NOT_YET_RECRUITING

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

Endpoints are classified and published by ProgramSignal analysts.

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Key Facts

Study type
INTERVENTIONAL
Conditions
Head and Neck Squamous Cell Carcinoma
Interventions
Becotatug Vedotin, Becotatug Vedotin Combined with Penpulimab, Becotatug Vedotin Combined with Ivonescimab
Enrollment
120 participants
Primary completion
Oct 2028
Study completion
Jun 2029
First posted
Feb 2026
Last updated
Feb 2026

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

Read full criteria on CT.gov →

✦ Analyst Commentary

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

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Source

Open on ClinicalTrials.gov