Squamous Cell Carcinoma of Head and Neck
Conditions
Keywords
PD-L1, Local late stage
Brief summary
This single-arm exploratory study plans to enroll 69 locally advanced head and neck squamous cell carcinoma (LA-HNSCC) patients. Participants will receive Adebrelimab (PD-L1 antibody) plus TP regimen (docetaxel/cisplatin) as neoadjuvant therapy for 1-4 weeks, followed by surgery and subsequent follow-up phase.
Interventions
PROCEDURESurgery or radiotherapy
Surgery or radiotherapy should be performed 1-4 weeks after the completion of neoadjuvant therapy.
DRUGAdebrelimab
1200mg, intravenous infusion, D1， Every three weeks, there are two cycles in total.
DRUGTP regimen
TP regimen: Docetaxel 75 mg/m2, intravenous infusion, D1， Cisplatin 75 mg/m2, intravenous infusion, D1， Every three weeks, there are two cycles in total.
Sponsors
Xiuping Ding
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* 1\. Patients with head and neck squamous cell carcinoma diagnosed by histology or cytology; * 2\. Have not received systematic treatment for head and neck squamous cell carcinoma in the past; * 3\. According to the AJCC TNM staging system, it is divided into stages III-IVB; * 4\. ECOG score: 0-1 point; * 5\. Expected survival period ≥ 12 weeks; * 6\. The main organ functions well and the laboratory test data meets the following standards: (1) Blood routine: absolute neutrophil count ≥ 1.5 × 109/L (or greater than the lower limit of normal laboratory values in the research center), platelet count ≥ 100 × 109/L, hemoglobin ≥ 90g/L; (2) Liver function: serum total bilirubin ≤ 1.5 times the upper limit of the standard value (ULN), AST and ALT ≤ 2.5 times ULN. If the patient has liver metastasis, this standard is ≤ 5 times ULN; (3) Renal function: CrCl ≥ 60 ml/min/1.73 m2 (calculated according to the Cockcroft Gault formula); * 7\. Female subjects with fertility, as well as male subjects with partners who are fertility women, are required to use a medically approved contraceptive measure (such as intrauterine device, contraceptive pill, or condom) during the study treatment period, at least 6 months after the last use of adebelimab, and at least 6 months after the last use of chemotherapy; * 8\. Voluntarily join this study, sign the informed consent form, have good compliance, and cooperate with follow-up.
Exclusion criteria
* 1\. There is uncontrollable pleural effusion, pericardial effusion, or peritoneal effusion that requires repeated drainage; * 2\. Have a history of allergies to any components of Adabelimab in the past; * 3\. Have received any of the following treatments: 1. Received any other investigational drug within 4 weeks prior to the first use of the investigational drug or had a half-life of no more than 5 from the last investigational drug; 2. Simultaneously enrolled in another clinical study, unless it is an observational (non interventional) clinical study or an interventional clinical study follow-up; 3. Received anti-tumor therapy (including radiotherapy, chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, or tumor embolization) within 2 weeks prior to the first use of the investigational drug; 4. Subjects who need to receive corticosteroids (equivalent to\>10mg prednisone per day) within 2 weeks prior to the first use of the study drug. Allow the use of hormones for routine chemotherapy pretreatment without the need for dose adjustment. Other special circumstances require communication with the researcher. In the absence of active autoimmune diseases, inhalation or local use of steroids and corticosteroids with a dosage greater than 10mg/day of prednisone efficacy dose are allowed as substitutes for adrenal cortex hormones; 5. Individuals who have received anti-tumor vaccines or have received live vaccines within 4 weeks prior to the first administration of the study drug; 6. Having undergone major surgery or suffered severe trauma within 4 weeks prior to the first use of the investigational drug; 7. Patients who have received previous treatment with paclitaxel drugs; * 4\. The toxicity of previous anti-tumor treatments has not recovered to ≤ CTCAE 5.0 Grade 1 (excluding hair loss) or the level specified in the inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ORR | From enrollment to first efficacy evaluation (around 6-8 weeks) | Objective response rate (ORR) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| pCR | Evaluate based on pathological results, with an evaluation period from enrollment to 2 weeks after surgery | pathological complete response，pCR |
| R0 resection rate | Evaluate based on pathological results, with an evaluation period from enrollment to 2 weeks after surgery | R0 is the ratio of no residual material under the microscope after resection. |
| EFS | The time from enrollment to the first occurrence of endpoint events such as disease progression and death(maximum follow-up time of 2 years) | Event-Free Survival（EFS） |
| Adverse event incidence rate | Follow up from enrollment until 90 days after the last treatment | Adverse events that occurred during the research process |
Countries
China
Contacts
Primary ContactXiuping Ding, Dr.
Outcome results
None listed