NCT07137039尚未招募2 期
A Single-arm, Prospective, Single-center Clinical Study on Neoadjuvant Treatment of Locally Advanced Hypopharyngeal Cancer With Adebrelimab Combined With TP Chemotherapy Regimen
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Pathological complete response (pCR)
研究概览
简要总结
To evaluate the efficacy and safety of adebrelimab combined with TP chemotherapy regimen as neoadjuvant therapy for locally advanced hypopharyngeal cancer
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 18 to 70 years old, gender not limited;
- •2.ECOG PS score: 0-1 point;
- •Patients who are capable of surgical resection and willing to undergo it;
- •Hypopharyngeal cancer diagnosed by histology/cytology and imaging, with a clinical stage of T1-2, N1-3 or T3-4, any N;
- •At least one measurable lesion (in accordance with RECIST 1.1 standard);
- •The expected survival period is at least 12 weeks;
- •Other major organs (liver, kidneys, blood system, etc.) function well: Hemoglobin ≥90g/L (no blood transfusion, no use of hematopoietic factors and no drug correction within 2 weeks before the first administration); Absolute neutrophil count (ANC) ≥1.5×10^9/L; Platelet count ≥100×10^9/L; Total bilirubin ≤1.5 times the upper limit of the normal value; Alanine aminotransferase, aspartate aminotransferase and alkaline phosphatase ≤2.5 times the upper limit of the normal value; Serum creatinine ≤1.5 times the upper limit of the normal value, and endogenous creatinine clearance rate ≥60ml/min; For patients who have not received anticoagulant therapy, the international normalized ratio of prothrombin time (INR) is ≤1.5, and the activated partial thromboplastin time (APTT) is ≤1.5 times the upper limit of the normal value.
- •Female subjects with fertility must undergo a pregnancy test (serum or urine) within 72 hours before the start of the study medication, and the result must be negative. They must also be willing to use a medically approved efficient contraceptive measure (such as an intrauterine device, contraceptive pill or condom) during the study period and within 90 days after the last administration of the study drug. For male subjects whose partners are women of childbearing age, they must agree to use effective contraception or have undergone surgical sterilization during the study period and within 90 days after the last administration of the study.
- •There is no history of allergy to related drug components.
- •The subjects voluntarily joined this clinical study and signed the informed consent form.
排除标准
- •Have received any anti-tumor treatment in the past, including radiotherapy, chemotherapy, targeted therapy, immunotherapy and traditional Chinese medicine anti-tumor treatment (except for the treatment of malignant tumors that have been completely cured in the past and have no recurrence or metastasis for ≥5 years);
- •Have undergone surgical operations targeting the primary tumor or lymph nodes in the past;
- •Patients who have suffered from any malignant tumors in the past five years (except for cured basal cell carcinoma of the skin or carcinoma in situ of the cervix);
- •Patients with distant metastases;
- •Suffering from any active autoimmune disease or a history of autoimmune diseases (such as uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (can be included after hormone replacement therapy), tuberculosis) Patients with childhood asthma that has been completely relieved and do not require any intervention or systemic treatment in adulthood (such as vitiligo, psoriasis or alopecia) can be included. However, patients who need medical intervention with bronchodilators cannot be included.
- •Subjects who have received systemic treatment with corticosteroids (prednisone or other equivalent hormones >10 mg/ day) or other immunosuppressants within 2 weeks prior to the first administration. In the absence of active autoimmune diseases, inhalation or topical use of corticosteroids, as well as adrenal hormone replacement therapy with a dose of ≤10 mg/ day at the therapeutic dose of prednisone, is permitted.
- •Those who have experienced hyperactive or venous thrombosis events within 6 months prior to enrollment, such as cerebrovascular accidents (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism;
- •Within 3 months prior to enrollment, significant clinically significant bleeding symptoms or a clear bleeding tendency, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, etc., have occurred, or are currently receiving thrombolytic or anticoagulant therapy;
- •Those with hypertension who have not achieved good control through antihypertensive drug treatment (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg); Or grade II or above myocardial ischemia or myocardial infarction, poorly controlled arrhythmia (including QTc interval ≥450ms in men and ≥470ms in women); According to the NYHA standard, patients with grade Ⅲ to Ⅳ cardiac failure, or those whose left ventricular ejection fraction (LVEF) is less than 50% as indicated by echocardiography;
- •Urine routine test indicates urine protein ≥(++), or 24-hour urine protein content ≥1g, or severe liver and kidney dysfunction;
- •Allergic to the test drug;
- •Known human immunodeficiency virus (HIV) infection;
- •Pregnant or lactating women; Subjects with fertility who are unwilling or unable to take effective contraceptive measures;
- •Those who suffer from neurological or mental disorders and are unable to cooperate;
- •Other circumstances that the researchers consider unsuitable for inclusion.
研究组 & 干预措施
Experimental group
Experimental
Adebrelimab combined with albumin, paclitaxel and cisplatin
干预措施: Adebrelimab+Albumin paclitaxel +Cisplatin (Drug)
结局指标
主要结局
Pathological complete response (pCR)
时间窗: Six months
Pathological examination of the resected tissue samples did not reveal any residual tumor cells.
次要结局
- Major pathological response (MPR)(six months)
- Surgical R0 resection rate(Six months)
- Laryngeal function retention rate(six months)
- The intensity of the surgery has decreased(six months)
- Objective response rate (ORR)(one year)
- Disease Control rate (DCR)(One year)
- Recurrence-free survival time (RFS)(Two years)
- Overall survival (OS)(Two years)
- Adverse event(AE)(Two years)
研究者
San-Gang Wu
Clinical Professor
The First Affiliated Hospital of Xiamen University
研究点 (1)
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