Head and Neck Squamous Cell Carcinoma
Conditions
Interventions
Trial group:Induction period (2 cycles) : Adbelimab 1200mg, 40-60 minutes, no longer than 2 hours, q3w
Chemotherapy: Albumin paclitaxel 260mg/m2 d1, iv, cisplatin 60-75mg/m2 d1, iv, q3w
Treatment period: Surgery + postoperative concurrent chemoradiotherapy or concurrent chemoradiotherapy: radiotherapy 70Gy/35f, chemotherapy: cisplatin 80-100mg/m2 d1, 22, 43
Maintenance period: Researchers determine the treatment plan based on the patient's condition by referring to the guidelines.
Sponsors
Fourth Hospital of Hebei Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-75 years old, both men and women; 2. Histopathology or cytologically confirmed head and neck squamous cell carcinoma (including but not limited to oropharyngeal, hypopharyngeal, laryngeal, and oral cavity cancer, etc.); 3. Clinical stage classified as locally advanced: stage III-IVB; 4. Have not received any systemic anti-tumor treatment; 5. At least one measurable lesion (According to RECIST 1.1); 6. ECOG: 0~1; 7. Expected survival period = 6 months; 8. Major organ function has to meet the following criteria: (1) Blood routine examination: 1) HB = 90 g/L; 2) ANC = 1.5 × 10^9 / L; 3) PLT = 100 × 10^9 / L; (2) Biochemical examination: 1) ALB = 30 g/L; 2) ALT and AST < 2.5 × ULN; 3) TBIL = 1.5 × ULN; 4) Cr = 1.5 × ULN; 9. Left ventricular ejection fraction (LVEF) = 50%; 10. Females of childbearing potential must have a negative pregnancy test (serum or urine) within 14 days prior to enrollment and voluntarily agree to use appropriate contraceptive methods during the study period and for 8 weeks after the last dose of the study drug. For males, they should be surgically sterile or agree to use appropriate contraceptive methods during the study period and for 8 weeks after the last dose of the study drug. 11. Participants were willing to join in this study, and written informed consent, good adherence, cooperate with the follow-up.
Exclusion criteria
Exclusion criteria: 1. Presence of other malignant tumors within the past 5 years, except for locally curable cancers such as basal or squamous cell skin cancer, superficial bladder cancer, low-risk prostate cancer, breast cancer, or cervical cancer. 2. Presence of significant vital organ (e.g., liver, kidney, heart) diseases or dysfunctions, such as known poorly controlled diabetes, poorly controlled hypertension, liver failure, unstable angina, history of myocardial infarction within 6 months, congestive heart failure, history of cerebrovascular accident within 6 months, or history of severe neurological or psychiatric diseases. 3. Presence of active, clinically serious infection (CTCAE Grade 3 or higher). 4. Severe coagulation disorders or bleeding tendencies. 5. History of organ transplantation, or other acquired or congenital immune system diseases. 6. Pregnant or breastfeeding women, or women planning to become pregnant. 7. Current or recent (within 28 days prior to enrollment) receipt of other investigational drugs or participation in other clinical trials. 8. The researchers think inappropriate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2-year Event-Free-Survival Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR);2-year Overall Survival (OS) Rate ;Adverse Events ; | — |
Countries
China
Contacts
Public ContactZhao Yan, Wang Yuxiang
Fourth Hospital of Hebei Medical University
Outcome results
None listed