Head and neck squamous cell carcinoma
Conditions
Interventions
Trial Group:Adebrelimab 1200mg, intravenous infusion, on Cycle Day 1 for 3 cycles
Fruquintinib (as fumarate) 10mg per day, orally, from Cycle Day 1 to 14 for 2 cycles. Surgery performed 1-4 weeks after completion of neoadjuvant therapy. Best supportive care may be provided postoper
Sponsors
Shandong Second Provincial General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age 18 to 75 years, both males and females; 2. Patients with histologically or cytologically confirmed head and neck squamous cell carcinoma (HNSCC); 3. No prior systemic treatment for HNSCC; 4. Staged as stage III-IVB according to the AJCC TNM staging system; 5. ECOG performance status: 0~1; 6. Expected survival time >=12 weeks; 7. Good major organ function, and laboratory test data meet the following criteria: (1) Blood routine: absolute neutrophil count >=1.5×10^9/L (or greater than the lower limit of normal for the center's laboratory), platelet count >=100×10^9/L, hemoglobin >=90g/L; (2) Liver function: serum total bilirubin =60 ml/min/1.73 m^2 (calculated using the Cockcroft-Gault formula); 8. Female subjects with childbearing potential, and male subjects whose partners are women with childbearing potential, must use a medically accepted contraceptive method (such as an intrauterine device, oral contraceptives, or condoms) during the study treatment period, and for at least 6 months after the last dose of adeprelimab and at least 6 months after the last dose of chemotherapy; 9. Voluntary participation in this study, signed informed consent form, good compliance, and cooperation with follow-up.
Exclusion criteria
Exclusion criteria: 1. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage; 2. History of allergy to any component of adeprelimab; 3. Received any of the following treatments: (1) Received any other investigational drug within 4 weeks prior to first use of the investigational drug or no less than 5 half-lives after the last research treatment; (2) Enrolled in another clinical study simultaneously, unless it is an observational (non-interventional) clinical study or follow-up of an interventional clinical study; (3) Received anti-tumor treatment (including radiotherapy, chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biological therapy, or tumor embolization) within 2 weeks prior to first use of the investigational drug; (4) Receiving corticosteroids within 2 weeks prior to first use of the investigational drug (daily >10 mg prednisone equivalent dose). Routine chemotherapy pretreatment with hormones is allowed without dosage adjustment. Other special cases require communication with the investigator. In the absence of active autoimmune disease, inhaled or topical steroids and adrenal corticosteroids with dosages >10mg/day prednisone efficacy doses are allowed for substitution; (5) Patients who have received anti-tumor vaccines or have received live vaccines within 4 weeks prior to first administration of the investigational drug; (6) Major surgery or severe trauma within 4 weeks prior to first use of the investigational drug; (7) Patients who have previously received taxane drug treatment; 4. Toxicity from previous anti-tumor treatment has not recovered to Grade 2) occurred within 4 weeks prior to first use of the investigational drug, such as severe pneumonia requiring hospitalization, bacteremia, infectious comorbidities, etc.; Baseline chest imaging suggests active pulmonary inflammation, signs and symptoms of infection within 2 weeks prior to first use of the investigational drug, or requiring oral or intravenous antibiotic treatment, except for prophylactic antibiotic use; 9. History of interstitial lung disease (excluding radiation pneumonitis or non-infectiou
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathologic complete response (pCR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate (ORR);R0 resection rate;Median event-free survival (mEFS);Overall survival (OS);Disease-free survival (DFS);Quality of life score (EORTC QLQ-C30); | — |
Countries
China
Contacts
Public ContactLü Zhenghua, Wei Yumei
Shandong Second Provincial General Hospital
Outcome results
None listed