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RecruitingPhase 1NCT06741982

A Clinical Study on Neoadjuvant Treatment of Resectable Head and Neck Squamous Carcinoma With Immune-targeted Therapy and Lysogenic HSV Virus

◆ AI Clinical Summary

This study tests a new combination treatment given before surgery for head and neck cancer. The treatment combines immune-boosting therapy with a modified virus designed to fight cancer cells.

Key Objective:This trial is testing whether combining immune therapy with a lysogenic HSV virus can safely shrink head and neck cancers before surgery.

Who to Consider:Patients with surgically resectable squamous cell carcinoma of the head and neck who are willing to receive experimental treatment before surgery should consider this trial.

Trial Parameters

ConditionHNSCC
SponsorWest China Hospital
Study TypeINTERVENTIONAL
PhasePhase 1
Enrollment21
SexALL
Min Age18 Years
Max Age70 Years
Start Date2024-12-15
Completion2026-12-15
Interventions
Lysogenic HSV virus.TislelizumabAfatinib

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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: 1. Age ≥18 and ≤70 years old, regardless of gender; 2. Patients with head and neck squamous carcinoma who are pathologically confirmed and fulfill the following conditions: 1. 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. 2. Treatable by surgical resection as evaluated by head and neck surgery; 3. Definite lymph node metastasis and lymph node stage is not N0 or Nx. 3. An Eastern Cooperative Oncology Group (ECOG) physical status score of 0 to 1; 4. Have adequate organ and bone marrow function as defined below: 5. Subjects voluntarily enrolled in the study, signed an informed cons

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