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

Recruiting now · Phase 2

Conditions studied: Head and Neck Cancer

In brief

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.

Key facts

Study ID

NCT05777824

Run by

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

People needed

84

Starts

2023-01-01

Expected to finish

2027-12-30

Last updated by the study team

2023-10-11

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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;

You may not qualify if…

• 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

Where it is running

• National Cancer Center /National Clinical Research Center for Cancer/Cancer Hospital, CAMS & PUMC — Beijin, Beijing Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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