Locally advanced oral squamous cell carcinoma
Conditions
Interventions
Experimental arm:Neoadjuvant sintilimab combined with TP regimen followed by radical surgery and risk-stratified adjuvant therapy (low-risk: sintilimab monotherapy
high-risk: radiotherapy or concurrent chemoradiotherapy followed by sequential sintilimab).
Sponsors
Sun Yat-sen Memorial Hospital,Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age >=18 years and =1.5 × 10?/L, without administration of granulocyte colony-stimulating factor within 14 days prior to testing; (2) Platelet count >=100 × 10?/L, without blood transfusion within 14 days prior to testing; (3) Hemoglobin >90 g/L, without blood transfusion or erythropoietin use within 14 days prior to testing; (4) Total bilirubin <=1.5 × the upper limit of normal (ULN); for patients with Gilbert’s syndrome or isolated indirect hyperbilirubinemia of non-hepatic origin, total bilirubin <=3 × ULN is permitted; (5) Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <=2.5 × ULN (patients with liver involvement may have ALT or AST <=5 × ULN); (6) Creatinine clearance =60 mL/min as calculated by the Cockcroft–Gault formula, and serum creatinine <=1.5 × ULN; (7) Adequate coagulation function, defined as international normalized ratio (INR) and prothrombin time <=1.5 × ULN; (8) Normal thyroid function, defined as thyroid-stimulating hormone (TSH) within the normal range; if baseline TSH is outside the normal range, patients with normal total T3 (or free T3) and free T4 levels may still be eligible; (9) Cardiac enzyme levels within the normal range (isolated laboratory abnormalities deemed clinically insignificant by the investigator are allowed); 9. For women of childbearing potential, a negative urine or serum pregnancy test must be obtained within 3 days prior to the first administration of study treatment (Cycle 1, Day 1). If a urine pregnancy test result is indeterminate, a serum pregnancy test is required. Women not of childbearing potential are defined as those who are postmenopausal for at least one year, or who have undergone surgical sterilization or hysterectomy; 10. For participants with reproductive potential, all subjects (regardless of sex) must agree to use highly effective contraception methods with a failure rate of less than 1% per year throughout the entire treatment period, for 120 days after the last dose of study drug, and for 180 days after the last dose of chemotherapy.
Exclusion criteria
Exclusion criteria: 1. Prior treatment with agents targeting PD-1, PD-L1, PD-L2, or CTLA-4, or any other antibodies or drugs specifically targeting T-cell co-stimulatory or immune checkpoint pathways. 2. Participation in another interventional clinical trial, or use of an investigational drug or experimental device within 4 weeks prior to the first dose of study treatment. 3. Prior radiotherapy to the head and neck region. 4. Use of traditional Chinese medicines with indications for OSCC or immunomodulatory agents (e.g., thymosin, interferon, interleukins) within 2 weeks prior to the first dose of study treatment; local medications used for the control of pleural effusion are permitted. 5.History of active autoimmune disease requiring systemic treatment (e.g., corticosteroids or immunosuppressive agents) within 2 years prior to the first dose of study treatment, with the following exceptions: (1) Hypothyroidism managed with thyroid hormone replacement therapy; (2) Diabetes mellitus controlled with insulin; (3) Adrenal or pituitary insufficiency managed with physiological doses of corticosteroids. 6. Use of immunosuppressive agents, defined as: (1) Prohibition of systemic corticosteroid therapy within 1 week prior to the first dose of study treatment; (2) Prohibition of other immunosuppressive agents; (3) Exceptions include intranasal, inhaled, or topical corticosteroids; (4) Physiological doses of corticosteroids are permitted (e.g., prednisone or equivalent <=10 mg/day). 7. Prior systemic antitumor drug therapy, except for patients who previously received systemic chemotherapy and have completed a treatment-free interval of at least 12 months before initiation of neoadjuvant study treatment. 8. History of allogeneic solid organ transplantation or allogeneic hematopoietic stem cell transplantation, with the exception of corneal transplantation. 9. Known hypersensitivity or allergy to any active ingredient or excipient of the study drugs, including sintilimab, carboplatin, cisplatin, or nab-paclitaxel. 10. Failure to recover to baseline or <= Grade 1 toxicity (according to CTCAE) from any prior intervention-related complications or toxicities prior to study enrollment, with the exception of fatigue and alopecia. 11. Known human immunodeficiency virus (HIV) infection, defined as positive HIV-1/2 antibody test. 12. Untreated active hepatitis B virus (HBV) infection, defined as HBsAg positivity with HBV DNA levels exceeding the upper limit of normal at the study center laboratory. Note: Patients meeting the following criteria may be eligible: (1) HBV DNA <1,000 copies/mL (200 IU/mL) with active antiviral therapy during the study period to prevent viral reactivation; (2) Patients who are anti-HBc positive, HBsAg negative, anti-HBs negative, and HBV DNA negative do not require prophylactic antiviral therapy but must be closely monitored for viral reactivation. 13. Active hepatitis C virus (HCV) infection, defined as positive anti-HCV antibody with detectable HCV RNA above the lower limit of detection. 14. Receipt of a live attenuated vaccine within 30 days prior to the first dose of study treatment; inactivated vaccines (e.g., injectable inactivated influenza vaccine) are permitted. Intranasal vaccines are considered live attenuated and are not allowed. 15. Pregnant or breastfeeding women. 16. Presence of severe or uncontrolled systemic diseases, including but not limited to the following conditions: (1) Cardiac disorders: severe arrhythmias (e.g., complete left
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2-year event-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival;pathological complete response;Treatment-related adverse events;Major pathological response;Radiologic assessments; | — |
Countries
China
Contacts
Public ContactJingsong Li
Sun Yat-sen Memorial Hospital,Sun Yat-sen University
Outcome results
None listed