Head and Neck Cancer
Conditions
Keywords
postoperative radiotherapy, induction immunotherapy and chemotherapy
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.
Detailed description
Induction chemotherapy combined with immunotherapy has shown promising efficacy in the treatment of patients with locally advanced head and neck cancers. However, how to choose a proper postoperative treatment remains unknown. Eligibility patients were assigned to two arms, each divided into three groups: observation, immunotherapy maintenance, and radiotherapy (50 Gy dose) plus immunotherapy maintenance group for low-risk arm; radiotherapy (50 Gy or 60Gy dose) plus immunotherapy maintenance groups, concurrent chemotherapy plus immunotherapy maintenance group for a high-risk arm. Disease-free survival, overall survival, and treatment-related toxicity would be calculated to evaluate the efficacy of treatments.
Interventions
COMBINATION_PRODUCTanti-PD-1 or PD-L1 antibody
immunotherapy maintenance with anti-PD-1 or PD-L1 antibody every three weeks for 13 cycles after radiotherapy
RADIATIONpostoperative radiaotherapy
postoperative radiotherapy (60Gy or 50Gy)
Sponsors
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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 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; 5. 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; 6. Severe comorbidities including myocardial infarction, arrhythmia, cerebral vascular disease, ulceration disease, mental disease and uncontrolled diabetes
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease-free survival | 2 years | defined as the time from random assignment to documented local or regional relapse, distant metastasis, or death from any cause, whichever occurred first after 2 years of treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | 2 years | defined as the time from random assignment to death from any cause or censored at the date of last follow-up. |
| Local-Regional failure survival | 2 years | defined as the time from random assignment to documented local or regional relapse, whichever occurred first after 2 years of treatment. |
| Toxicity Adverse events | 2 years | Analysis of acute and late adverse events (AEs) are evaluated. Numbers of patients of treatment-related adverse events (acute toxicity) and late radiation toxicities were assessed by NCI-CTCAE v5.0. |
Countries
China
Contacts
Primary ContactYi Xu
Outcome results
None listed