Head and neck squamous carcinoma
Conditions
Interventions
Intervention group:Toripalimab, 240mg Q3W, 8 cycles
Sponsors
Sun Yat-sen University Cancer Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Pathologically diagnosed head and neck squamous carcinoma, with a clinical stage of III-IVB (II-III for HPV positive oropharyngeal squamous carcinoma). 2. Male or female, 18-75 years old. 3. ECOG score 0 or 1. 4. Have received at least one cycle of neoadjuvant chemoimmunotherapy.The immunotherapy regimen is anti-PD-1 or anti-PD-L1 drug, including but not limited to Pembrolizumab, Nivolumab, Toripalimab, Camrelizumab, Tislelizumab, and Sintilimab. The chemotherapy regimen is a platinum-based doublet-agent regimen. 5. Have received radical operation after the planed neoadjuvant chemoimmunotherapy. 6. The postoperative pathological evaluation showed a complete pathological response, including the primary lesion and the regional lymph nodes. 7. No residual tumor or new lesion observed by radiological evaluation at 1 month after the surgery. 8. Expected survival time > 6 months. 9. Sufficient organ function, subject shall meet the following laboratory indicators: 1. Absolute neutrophil count (ANC) >= 1.5 x 10^9/L without using granulocyte colony stimulating factor in recent 14 days; 2. Platelets >= 100 x 10^9/L in the last 14 days without blood transfusion; 3. Hemoglobin >= 9 g/dL (90 g/L) without blood transfusion or use of erythropoietin in the last 14 days; 4. Total bilirubin ULN but direct bilirubin ULN; 5. Aspartate aminotransferase (AST), alanine aminotransferase (ALT) = 60 ml/min; 7. Normal thyroid function is defined as thyroid shormone (TSH) within normal range. If the baseline TSH is beyond the normal range, the subjects whose total T3 (or FT3) and FT4 are within the normal range included in the group 8) Myocardial zymogram is within the normal range (if the researchers comprehensively judge that the simple laboratory abnormality has no significance, it can also be included in the group). 10. Written consent.
Exclusion criteria
Exclusion criteria: 1. IVc stage patients with head and neck squamous carcinoma before the treatment (or IV stage for HPV positive oropharyngeal squamous carcinoma). 2. Level 4 immune-related adverse events (NCI-CTCAE 5.0) or any other circumstance that needs discontinue immunotherapy permanently during the neoadjuvant chemoimmunotherapy or whithin 30 days after the last medication. 3. Have any active malignant disease with 2 years before the treatment,except for the cured malignant tumor. 4. Receiving systemic glucocorticoid treatment or any other form of immunosuppressive therapy within 14 days before the first administration; Note: It is allowed to use glucocorticoid with physiological dose (prednisone grade 1, or >= grade 3 hypoalbuminemia, despite receiving standard drug treatment. 6. Have the following disease history: interstitial lung disease, non-infective pneumonia, pulmonary fibrosis, acute lung disease, etc. 7. Severe chronic or active infection requiring systemic antibiotic, antibacterial or antiviral treatment occurred within 14 days before the first administration. 8. History of HIV infection. 9. Active hepatitis B infection without treatment (defined as HBsAg positive and HBV-DNA copy number detected is greater than the upper limit of normal value in the laboratory of the research center); Note: hepatitis B patients who meet the following criteria can also be included in the group: 1) Before the first administration, if the HBV viral load is less than 1000 copies/ml (200 IU/ml), the subjects should receive anti HBV treatment during the whole study drug treatment to avoid virus reactivation 2) For subjects with anti HBc (+), HBsAg (-), anti HBs (-) and HBV viral load (-), preventive anti HBV treatment is not required, but virus reactivation needs to be closely monitored. 10. History of severe hypersensitivity to any other monoclonal antibodies. 11. The toxicity (caused by previous anti-tumor therapy) has not recovered to the baseline or stable status, unless it is not considered to be a potential risk of safety. 12. Pregnant or lactating women. 13. Currently participating in other intervention clinical research treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;QLQ-H&N35 score of quality of life;Disease specific survival; | — |
Countries
China
Contacts
Public ContactShuwei Chen
Sun Yat-sen University Cancer Center
Outcome results
None listed