Locally advanced laryngeal cancer
Conditions
Interventions
Test group:Cetuximab+Sintilimab+SBRT
Sponsors
Sun Yat-Sen University Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Confirmed laryngeal cancer through pathological examination, with stages cT2N1-3M0 and cT3-4aN0-3M0; 2. Have not received any systemic and/or local treatment for head and neck tumors; 3. Surgical treatment has been evaluated by researchers; 4. The patient has a desire to preserve their throat; 5. Male or female, age>=18 years old,6 months; 9. Adequate organ function, subjects must meet the following laboratory indicators: (1) Absolute neutrophil count (ANC)>=1.5x10 9/L without using granulocyte colony-stimulating factor in the past 14 days. (2) In the past 14 days without blood transfusion, platelet count>=100 × 10 9/L. (3) Hemoglobin>=9 g/dL (90 g/L) or>=5.6 mmol/L in the past 14 days without blood transfusion or use of erythropoietin; (4) Total bilirubinULN but direct bilirubin=60 ml/min; (7) Good coagulation function: 1) International normalized ratio (INR) or prothrombin time (PT) = 1.5 times ULN; Or the subject is receiving anticoagulant therapy, but the prothrombin time (PT) or partial thromboplastin time (PTT) is within the therapeutic range of the intended use of the anticoagulant; 2) Activated partial thromboplastin time (aPTT) or partial thromboplastin time (PTT)<=1.5 times ULN; Or the subject is receiving anticoagulant therapy, but the prothrombin time (PT) or activated partial thromboplastin time (PTT) is within the therapeutic range of the intended use of the anticoagulant; (8) Normal thyroid function is defined as thyroid stimulating hormone (TSH) within the normal range. If the baseline TSH exceeds the normal range, subjects with total T3 (or FT3) and FT4 within the normal range can also be enrolled; (9) The myocardial enzyme spectrum is within the normal range (simple laboratory abnormalities that are deemed clinically insignificant by the researchers are also allowed to be included); 10. Sign an informed consent form and be willing and able to comply with the visit, treatment plan, laboratory tests, and other research procedures outlined in the research plan.
Exclusion criteria
Exclusion criteria: 1.Having received the following therapies for the laryngeal cancer: surgical resection, radiotherapy, chemotherapy, targeted therapy and/or immunotherapy; 2.Having tumor recurrence or metastasis; 3.Have any active malignancy during the last two years, except for cured cancers (such as basal cell carcinoma, superficial bladder cancer, carcinoma in situ of cervix, thyroid papillary cancer or breast cancer); 4.Receiving systemic glucocorticoid treatment (excluding local glucocorticoids by nasal spray, inhalation or other means) or any other form of immunosuppressive therapy within 14 days before the first administration; 5.Poor control of diabetes (FBG>10mmol/L), > class 1 electrolyte disturbance after standard treatment, =class 3 hypoalbuminemia within 14 days before the first administration; 6.History of non-infectious pneumonia requiring glucocorticoid treatment within 1 year before the first administration, or there is currently clinical active interstitial lung disease; 7.History of HIV infection; 8.Active hepatitis B 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); 9.History of serious hypersensitivity to any other monoclonal antibody; 10.Before starting treatment, the patient has not fully recovered from the toxicity and/or complications caused by any intervention (i.e. = Level 1 or reaching the baseline, excluding fatigue or hair loss); 11.Pregnant or lactating women; 12.Participating in any other interventional trial simultaneously. 13.Severe chronic or active infections (including tuberculosis infections, etc.) that require systemic antibiotics, antibacterial or antiviral treatment have occurred within 14 days prior to the first administration of the investigational drug. 14.There are any other contraindications for the use of the investigational drugs (cetuximab or sintilimab) and radiotherapy in this project.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1-year larynx preservation rate;Disease-free survival rate at 1 and 3 years; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;Quality of life;Overall survival rate at 1 and 3 years;3-year larynx preservation rate; | — |
Countries
China
Contacts
Public ContactMing Song, Chunyan Chen
Sun Yat-Sen University Cancer Center
Outcome results
None listed