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Recruiting Phase 1, Phase 2 NCT07010120

A Clinical Trial of Neoadjuvant Targeted Therapy, Immunotherapy, and Lysogenic HSV-Based Virotherapy in Resectable Head and Neck Squamous Cell Carcinoma

Trial Parameters

Condition HNSCC
Sponsor West China Hospital
Study Type INTERVENTIONAL
Phase Phase 1, Phase 2
Enrollment 29
Sex ALL
Min Age 18 Years
Max Age 70 Years
Start Date 2025-06-10
Completion 2027-05-31
Interventions
TislelizumabAfatinibLysogenic HSV virus.

Brief Summary

Evaluation of the safety and tolerability of immune-targeted therapy combined with neoadjuvant therapy with lysogenic HSV virus for patients with surgically resectable squamous carcinoma of the head and neck.

Eligibility Criteria

Inclusion Criteria: Age ≥18 and ≤70 years old, regardless of gender; Patients with head and neck squamous carcinoma who are pathologically confirmed and fulfill the following conditions: Patients with locally advanced head and neck squamous carcinoma (excluding nasopharyngeal, salivary gland and thyroid malignant tumors) who are initially diagnosed and have no distant metastasis; Non oropharyngeal HNSCC carcinoma and HPV-negative oropharyngeal carcinoma, stages III, IVA and IVB; HPV-positive oropharyngeal cancers, stages II and III; HPV status of oropharyngeal cancer will be determined by p16 immunohistochemistry. Treatable by surgical resection as evaluated by head and neck surgery; Definite lymph node metastasis and lymph node stage is not N0 or Nx. An Eastern Cooperative Oncology Group (ECOG) physical status score of 0 to 1; Have adequate organ and bone marrow function as defined below: Subjects voluntarily enrolled in the study, signed an informed consent form, and were able to com

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