Postoperative Management for HNSCC Based on Pathological Response of Induction Chemotherapy and Immunotherapy (HN)
Head and Neck Cancer
About this trial
This is an interventional treatment trial for Head and Neck Cancer focused on measuring postoperative radiotherapy, induction immunotherapy and chemotherapy
Eligibility Criteria
Inclusion Criteria: The subjects are not limited by gender, age from 18 to 75 years old; Histopathologically confirmed squamous cell carcinoma of the head and neck cancer; Locally advanced squamous cell carcinoma diagnosed as T3-4 or N+ stage according to AJCC 8th edition staging; ECOG score 0-1; without distant metastasis; received induction chemotherapy plus immunotherapy, followed by surgery The expected survival is expected to be no less than 6 months. No contraindications to chemotherapy, immunotherapy, and radiotherapy; Exclusion Criteria: Past malignancies history (except for stage I non-melanoma skin cancer or cervical carcinoma in situ) Received any systemic anti-tumor therapy for target lesions before induction chemotherapy and immunotherapy; Previously experienced head and neck radiation therapy; Subjects who have used corticosteroids (>10 mg/day prednisone or other equivalent hormones) or other immunosuppressive agents for systemic treatment within 1 month before enrollment. In the absence of active autoimmune disease, inhaled or topical corticosteroids and adrenal hormone replacement therapy at therapeutic doses of prednisone ≤10 mg/day are permitted; Patients with pleural effusion, pericardial effusion or ascites that need to be drained with clinical symptoms, or who have received serous cavity effusion drainage for the purpose of treatment within 2 weeks before enrollment; Severe comorbidities including myocardial infarction, arrhythmia, cerebral vascular disease, ulceration disease, mental disease and uncontrolled diabetes
Sites / Locations
- National Cancer Center /National Clinical Research Center for Cancer/Cancer Hospital, CAMS & PUMCRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
No Intervention
Experimental
Experimental
Experimental
Experimental
Experimental
low-risk and PCR
low-risk and MPR
low-risk and IPR
high-risk and PCR
high-risk and MPR
high-risk and IPR
Observation
immunotherapy maintenance
postoperative radiotherapy (50 Gy) and immunotherapy maintenance
postoperative radiotherapy (50 Gy) and immunotherapy maintenance
postoperative radiotherapy (60 Gy) and immunotherapy maintenance
postoperative concurrent chemoradiotherapy (60 Gy) and immunotherapy maintenance