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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | TP regimen Adbelimab Surgery or radiotherapy should be performed 1-4 weeks after the completion of neoadjuvant therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adebrelimab | Drug | 1200mg, intravenous infusion, D1, Every three weeks, there are two cycles in total. |
|
| Measure | Description | Time Frame |
|---|---|---|
| ORR | Objective response rate (ORR) | From enrollment to first efficacy evaluation (around 6-8 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| pCR | pathological complete response,pCR | Evaluate based on pathological results, with an evaluation period from enrollment to 2 weeks after surgery |
| R0 resection rate | R0 is the ratio of no residual material under the microscope after resection. |
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Inclusion Criteria:
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:
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/exclusion criteria;
5. Active autoimmune diseases, history of autoimmune diseases (such as interstitial pneumonia, colitis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to the above diseases or syndromes); Excluding childhood asthma/allergies with vitiligo or those who have already recovered, patients who do not require any intervention in adulthood; Autoimmune mediated hypothyroidism treated with stable doses of thyroid replacement hormone; Type I diabetes with a stable dose of insulin;
6. Have a history of immune deficiency, including HIV test positive, or have other acquired or congenital immune deficiency diseases, or have a history of organ transplantation and allogeneic bone marrow transplantation, or active hepatitis (hepatitis B reference: HBV DNA test value exceeds 500 IU/ml or 2500 copies/mL);
7. The subject has uncontrolled cardiovascular clinical symptoms or diseases, including but not limited to: (1) NYHA class II or above heart failure; (2) Unstable angina pectoris; (3) Have experienced myocardial infarction within one year; (4) Clinically significant supraventricular or ventricular arrhythmias that have not been clinically intervened or are still poorly controlled after clinical intervention;
8.Within 4 weeks prior to the first use of the investigational drug, there has been a severe infection (CTCAE 5.0>grade 2), such as severe pneumonia requiring hospitalization, bacteremia, infection complications, etc; Baseline chest imaging examination suggests the presence of active pulmonary inflammation, symptoms and signs of infection within 2 weeks prior to the first use of the study drug, or the need for oral or intravenous administration Or intravenous use of antibiotics for treatment, except for prophylactic use of antibiotics;
9. History of interstitial lung disease (excluding history of radiation pneumonia and non infectious pneumonia that have not been treated with steroids);
10. Patients with active pulmonary tuberculosis infection found through medical history or CT examination, or patients with a history of active pulmonary tuberculosis infection within the past year before enrollment, or patients with a history of active pulmonary tuberculosis infection more than one year ago but without formal treatment;
11. Diagnosed with any other malignant tumor within 5 years prior to the first use of the investigational drug, except for malignant tumors with low-risk metastasis and mortality risk (5-year survival rate>90%), such as basal cell or squamous cell carcinoma or cervical carcinoma in situ that have been adequately treated;
12. Pregnant or lactating women;
13. According to the researcher's assessment, there may be other factors that could force the subject to terminate the study midway, such as suffering from other serious illnesses (including mental illnesses) that require concurrent treatment, severe abnormal laboratory test values, family or social factors that may affect the subject's safety or the collection of trial data.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiuping Ding, Dr. | Contact | +86 18654539599 | drdxp85@126.com |
| Name | Affiliation | Role |
|---|---|---|
| wanjun chen, physician | Shandong Cancer Hospital and Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Hospital of Shandong First Medical University | Recruiting | Jinan | Shandong | 250117 | China |
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| TP regimen | Drug | 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. |
|
| Surgery or radiotherapy | Procedure | Surgery or radiotherapy should be performed 1-4 weeks after the completion of neoadjuvant therapy. |
|
| Evaluate based on pathological results, with an evaluation period from enrollment to 2 weeks after surgery |
| EFS | Event-Free Survival(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) |
| Adverse event incidence rate | Adverse events that occurred during the research process | Follow up from enrollment until 90 days after the last treatment |
| ID | Term |
|---|---|
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| C111043 | TP protocol |
| D013514 | Surgical Procedures, Operative |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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