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The goal of this [type of study:clinical trial] is to [learn about] in [Clinical IVB stage oral squamous cell carcinoma patients]. The main question it aims to answer are:
• [Observing the effectiveness and safety of the combination of Adebrelimab and TP regimen in neoadjuvant therapy for clinical IVB stage oral squamous cell carcinoma patients] Participants will [Received treatment with Adebrelimab combined with TP regimen, followed by surgery after 2 cycles of neoadjuvant therapy. After surgery, radiotherapy and chemotherapy combined with immunotherapy were chosen based on the patient's condition, with a total follow-up of two years.].
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group | Experimental | TP: docetaxel 75 mg/m2, cisplatin 75 mg/m2 Adebrelimab: 20mg/kg, intravenous infusion, D1 Every three weeks, a total of two cycles. Surgery will be performed 1-3 weeks after the completion of neoadjuvant therapy. After surgery, radiotherapy and chemotherapy combined with immunotherapy were chosen based on the patient's condition, and a total of two years of follow-up were conducted. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adebrelimab | Drug | Adebrelimab:20mg/kg, ivdrip, D1,Q3W |
|
| Measure | Description | Time Frame |
|---|---|---|
| Effective mitigation rate(EMR) | Pathological complete remission(PCR)+Major pathological relief(MPR) | From enrollment to the end of surgery,assessed up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| DFS | Disease free survival | From enrollment to the first appearance of disease progression or date of death from any cause,whichever came first, assessed up to 36 months |
| R0 resection rate | :R0 is the ratio of no residue under the microscope after resection |
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Inclusion Criteria:
Exclusion Criteria:
There are uncontrollable pleural effusion, pericardial effusion, or abdominal effusion that require repeated drainage;
Have a history of allergies to any components of adelbizumab in the past;
Have received any of the following treatments:
The toxicity of previous anti-tumor treatments has not recovered to ≤ CTCAE 5.0 level 1 (excluding hair loss) or the level specified by the inclusion/exclusion criteria;
A history of active autoimmune diseases and 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 patients with vitiligo or childhood asthma/allergies who have already recovered and 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;
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);
The subjects have uncontrolled cardiovascular clinical symptoms or diseases, including but not limited to: (1) NYHA grade 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;
Serious infections (CTCAE 5.0>Level 2) occurred within 4 weeks prior to the first use of the study drug, such as severe pneumonia, bacteremia, and infection complications that require hospitalization treatment; 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 antibiotic treatment, excluding prophylactic use of antibiotics;
History of interstitial lung disease (excluding radiation pneumonia and non infectious pneumonia that have not been treated with steroids);
Patients who have been diagnosed with active pulmonary tuberculosis infection through medical history or CT examination, or have a history of active pulmonary tuberculosis infection within one year before enrollment, or have a history of active pulmonary tuberculosis infection more than one year before but have not received formal treatment;
Diagnosed with any other malignant tumor within the 5 years prior to the first use of the investigational drug, excluding malignant tumors with low risk of metastasis and mortality (5-year survival rate>90%), such as basal cell or squamous cell skin cancer or cervical carcinoma in situ that has been adequately treated;
Pregnant or lactating women;
According to the researcher's judgment, there are other factors that may cause the subject to be forced to terminate the study midway, such as other serious illnesses (including mental illness) requiring concurrent treatment, severe abnormalities in laboratory test values, family or social factors, which may affect the safety of the subject or the collection of trial data.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| JJia Associate Professor | Contact | +8613277924848 | junjia@whu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| J Jia, Associate Professor | School of Stomatology Wuhan University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| School of Stomatology Wuhan University | Recruiting | Hubei | Wuhan | 430079 | China |
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| From enrollment to the end of surgery,whichever came first, assessed up to 6 months |
| ORR | Objective response rate | From enrollment to initial efficacy evaluation,assessed up to 6 months |
| mOS | Median overall survival | From enrollment to patient death,assessed up to 50 months |