HPV positive oropharyngeal squamous carcinoma
Conditions
Interventions
Intervention group:Albumin-bound Paclitaxel, 260mg/m2 + Cisplatin, 60mg/m2 + Sintilimab, 200mg, Q3W, iv drip, 2 cycles
Sponsors
Sun Yat-Sen University Cancer Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Sign the written informed consent before implementing any test related process; 2. Sex unlimited, age = 18; 3. Histologically or cytologically determined, the investigator assessed that oropharyngeal squamous cell carcinoma without any treatment was locally advanced (T2 with a maximum diameter of>3.0 cm, and all T3 and T4), and the specific anatomical sites included tonsil, soft palate, root of tongue, and posterior wall of oropharynx; 4. Use p16 immunohistochemical test as an alternative indicator to determine whether HPV+(use medium or strong positive (tumor cells) = 70% as the diagnostic standard or use HPV DNA or RNA test; 5. According to the evaluation standard of solid tumor curative effect (RECIST 1.1), there is at least one imaging measurable lesion; 6. Have not received any systematic treatment for the current disease in the past. 7. ECOG score 0-1; 8. Expected survival time > 6 months; 9. Sufficient organ function, subject shall meet the following laboratory indicators: 1) Absolute neutrophil count (ANC) = 1.5x109/L without granulocyte colony stimulating factor in recent 14 days 2) Platelets = 100 in the last 14 days without blood transfusion × 109/L 3) Hemoglobin = 9 g/dL (90 g/L) or = 5.6 mmol/L without blood transfusion or use of erythropoietin in the last 14 days 4) Total bilirubin = 1.5 × Upper limit of normal value (ULN); Or total bilirubin>ULN but direct bilirubin = ULN 5) Aspartate aminotransferase (AST), alanine aminotransferase (ALT) = 2.5 × ULN, or subjects with liver metastasis = 5 × ULN 6) Blood creatinine = 1.5 × ULN and creatinine clearance (calculated by Cockcroft Gault formula) = 60 ml/min 7) Good coagulation function: International normalized ratio (INR) or prothrombin time (PT) = 1.5 times ULN; Or the subject is receiving anticoagulation treatment, but the prothrombin time (PT) or partial thromboplastin time (PTT) is within the treatment range of the intended use of anticoagulant; Activated partial thromboplastin time (aPTT) or partial thromboplastin time (PTT) = 1.5 times ULN; Or the subject is receiving anticoagulation treatment, but prothrombin time (PT) or activated partial thromboplastin time (PTT) is within the treatment range of the intended use of anticoagulant 8) Normal thyroid function is defined as thyroid stimulating hormone (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 can also be included in the group 9) Myocardial zymogram is within the normal range (if the researchers comprehensively judge that the simple laboratory abnormality has no clinical significance, it can also be included in the group); 10. Female subjects of childbearing age should receive urine or serum pregnancy test within 3 days before receiving the first study drug administration (the first day of the first cycle) and the result is negative. If the urine pregnancy test result cannot be confirmed as negative, a blood pregnancy test is required. Women of non childbearing age are defined as those who have had at least one year after menopause, or who have undergone surgical sterilization or hysterectomy; 11. If there is a risk of pregnancy, all subjects (male or female) should use contraceptives with an annual failure rate of less than 1% during the whole treatment period until 120 days after the last study drug administration (or 180 days after the last chemotherapy drug administration).
Exclusion criteria
Exclusion criteria: 1. Currently participating in the intervention clinical research treatment, or receiving other research drugs or using research instruments within 4 weeks before the first administration; 2. Have received the following therapies in the past: anti PD-1, anti PD-L1 or anti PD-L2 drugs or drugs targeting another kind of stimulation or synergistic inhibition of T cell receptors (such as CTLA-4, OX-40, CD137); 3. Within 2 weeks before the first administration, he has received systematic systemic treatment with Chinese patent medicine or immunomodulatory drugs (including thymosin, interferon and interleukin) with anti-tumor indications; 4. Active autoimmune diseases requiring systemic treatment (such as the use of disease relieving drugs, glucocorticoids or immunosuppressants) occurred within 2 years before the first administration. Alternative therapy (such as thyroxine, insulin or physiological glucocorticoid for adrenal or pituitary insufficiency) is not considered as systemic therapy; 5. The study was receiving systemic glucocorticoid treatment (excluding local glucocorticoids by nasal spray, inhalation or other means) or any other form of immunosuppressive therapy within 7 days before the first administration; Note: It is allowed to use glucocorticoid with physiological dose (prednisone = 10 mg/day or equivalent); 6. Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation; 7. People who are known to be allergic to the active ingredients or excipients of the study drug cindilimab, as well as the chemotherapy drugs of this study, such as cisplatin, carboplatin, paclitaxel and docetaxel; 8. 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); 9. Known history of human immunodeficiency virus (HIV) infection (i.e. HIV 1/2 antibody positive); 10. 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); 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 11. Subjects with active HCV infection (HCV antibody positive and HCV RNA level higher than the lower limit of detection); 12. Inoculate live vaccine within 30 days before the first administration (the first cycle, the first day); Note: It is allowed to receive inactivated virus vaccine for injection against seasonal influenza within 30 days before the first administration; However, live attenuated influenza vaccine administered intranasal is not allowed. 13. Pregnant or lactating women; 14. There are any serious or uncontrollable systemic diseases, such as: 1) There are significant and uncontrollable abnormalities in rhythm, conduction or morphology of resting ECG, such as complete left bundle branch block, heart block above degree II, ventricular arrhythmia or atrial fibrillation; 2) Unstable angina
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major pathological response;Safety; | — |
Secondary
| Measure | Time frame |
|---|---|
| Complete pathological response;Objective response rate;Disease control rate;Disease-free survival;Overall survival; | — |
Countries
China
Contacts
Public ContactMing Song
Sun Yat-Sen University Cancer Center
Outcome results
None listed