Oral squamous cell carcinoma
Conditions
Interventions
The treatment of adebelimab combined with albumin-paclitaxel and cisplatin :Advanlimab 1200 mg, administered by intravenous infusion, with each infusion lasting 30 min (not less than 20 min and not mo
Sponsors
Hunan Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age: 18–75 years old, gender not limited; 2. A confirmed histological or cytological diagnosis of locally advanced oral squamous cell carcinoma (T1–2N+/T3–4 any N, according to the AJCC 8th Edition staging); 3. Patients with locally advanced stages who are suitable for surgery; 4. At least one measurable lesion (RECIST v1.1 standard); 5. The ECOG performance status score is 0 or 1; 6. Patients who have not received systematic treatment; 7. It has adequate organ and bone marrow functions, as defined below: hemoglobin >= 9.0 g/dL; Absolute neutrophil count >= 1.5 × 10^9/L; Platelet count >= 100×10^9/L; INR= 3.0 g/dL; Serum creatinine 60 mL/min or creatinine clearance > 60 mL/min calculated according to the Cockcroft-Gault formula (using actual weight): Male: Creatinine clearance = (weight × (140–age))/(72 × serum creatinine); Female: Creatinine clearance rate = (body weight × (140–age))/(72 × serum creatinine) × 0.85, where CL = mL/min; Serum creatinine = mg/dL; 8. If one has hepatitis B virus (HBV) infection, such as positive HBsAg, HBV-DNA testing is required, and HBV-DNA must be = 2000 IU/mL, they received at least one week of antiviral treatment before enrollment (only nucleoside drugs such as entecavir, tenofovir fumarate disoproxil, and tenofovir alafenamide fumarate tablets were allowed), and the viral copy number decreased by more than 10 times (1 lg) compared to before treatment. For HBV-infected individuals, antiviral treatment must be received throughout the study period. Subjects positive for hepatitis C virus (HCV)–RNA must receive antiviral treatment in accordance with the treatment guidelines; 9. Expected survival period >= 12 weeks; 10. Voluntarily participate in this study and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Pregnant or lactating women, or those who are fertile but refuse to take contraceptive measures; 2. For patients with two consecutive episodes of 2+ - 3+ in urine protein or 4+ in proteinuria, an additional 24-hour urine protein quantification test is required, with a 24-hour urine protein quantification >1g. 3. There has been a history of other malignant tumors in the past five years; 4. Allergic to any of the test drugs and their excipients, with a history of severe allergies or contraindications to the test drugs; 5. Those with uncontrolled, symptomatic brain metastases or a history of uncontrollable mental illness, or severe intellectual or cognitive dysfunction; 6. Pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia and severe impairment of lung function; 7. Subjects with active, known or suspected autoimmune diseases, hypothyroidism that only requires hormone replacement therapy, and skin diseases (such as vitiligo, psoriasis or alopecia) that do not require systemic treatment can be selected. 8. Congestive heart failure, uncontrollable arrhythmia, myocardial infarction within 6 months, unstable angina pectoris, stroke or transient ischemic attack; 9. Severe active infections that require intravenous antibiotic treatment occurred during the enrollment period; 10. Have received or are about to receive a live vaccine within 30 days prior to the administration of Adebelimab; 11. Known history of HIV infection; 12. Patients who cannot comply with the trial protocol or cooperate with follow-up; 13. Those who the researchers consider unsuitable to participate in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete response rate (pCR);Overall survival(OS);Surgical safety/radiotherapy safety/drug treatment safety ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate (ORR);Major pathological response rate (MPR);Disease-free survival(DFS); | — |
Countries
China
Contacts
Public ContactLiu Feng
Hunan Cancer Hospital
Outcome results
None listed