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Recruiting Phase 2 NCT05777824

NCT05777824 Postoperative Management for HNSCC Based on Pathological Response of Induction Chemotherapy and Immunotherapy

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Clinical Trial Summary
NCT ID NCT05777824
Status Recruiting
Phase Phase 2
Sponsor Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Condition Head and Neck Cancer
Study Type INTERVENTIONAL
Enrollment 84 participants
Start Date 2023-01-01
Primary Completion 2025-12-30

Trial Parameters

Condition Head and Neck Cancer
Sponsor Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 84
Sex ALL
Min Age 18 Years
Max Age 75 Years
Start Date 2023-01-01
Completion 2025-12-30
Interventions
anti-PD-1 or PD-L1 antibodypostoperative radiaotherapy

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Brief Summary

To develop postoperative stratification treatment for patients who have received induction chemotherapy and immunotherapy in locally advanced head and neck cancers. Risk stratification is based on clinical characteristics and pathological responses. In order to achieve no inferior survival rate and a lower treatment-related toxicity rate than the standard treatment.

Eligibility Criteria

Inclusion Criteria: 1. The subjects are not limited by gender, age from 18 to 75 years old; 2. Histopathologically confirmed squamous cell carcinoma of the head and neck cancer; 3. Locally advanced squamous cell carcinoma diagnosed as T3-4 or N+ stage according to AJCC 8th edition staging; 4. ECOG score 0-1; 5. without distant metastasis; 6. received induction chemotherapy plus immunotherapy, followed by surgery 7. The expected survival is expected to be no less than 6 months. 8. No contraindications to chemotherapy, immunotherapy, and radiotherapy; Exclusion Criteria: 1. Past malignancies history (except for stage I non-melanoma skin cancer or cervical carcinoma in situ) 2. Received any systemic anti-tumor therapy for target lesions before induction chemotherapy and immunotherapy; 3. Previously experienced head and neck radiation therapy; 4. Subjects who have used corticosteroids (\>10 mg/day prednisone or other equivalent hormones) or other immunosuppressive agents for systemic treat

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