Platinum-Free Neoadjuvant Chemotherapy Combined With Risk-Adapted Therapy in Nasopharyngeal Carcinoma: A Phase II Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 145
- 试验地点
- 1
- 主要终点
- Recurrence-free survival
研究概览
简要总结
This study aimed to investigate the efficacy of a platinum-free neoadjuvant regimen (gemcitabine, camrelizumab, endostar, and low-dose radiotherapy) followed by a risk-adapted therapeutic strategy in patients with locally advanced nasopharyngeal carcinoma. Specifically, the risk-adapted approach was defined as follows: patients achieving a complete response after neoadjuvant therapy received radiotherapy alone; those with a partial response received radiotherapy plus concurrent endostar; and those with stable disease or progressive disease received radiotherapy plus concurrent cisplatin.
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 at diagnosis between 18 and 70 years.
- •Histopathologically confirmed newly diagnosed nasopharyngeal carcinoma, classified as non-keratinizing carcinoma or keratinizing squamous cell carcinoma according to the World Health Organization (WHO) classification.
- •Diagnosed with stage II/III nasopharyngeal carcinoma (excluding T3N0) based on the American Joint Committee on Cancer/Union for International Cancer Control (AJCC/UICC) staging system, 9th edition. All subjects must undergo the following examinations prior to the initiation of first-line treatment to confirm clinical staging: complete medical history, physical examination, routine blood tests and biochemical assays, plasma Epstein-Barr virus (EBV) DNA titer and serological tests, nasopharyngoscopy, head and neck magnetic resonance imaging (MRI), and ¹⁸F-fluorodeoxyglucose positron emission tomography (¹⁸F-FDG PET).
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •Normal bone marrow function: white blood cell count > 4×109/L, hemoglobin > 90g/L, platelet count > 100×109/L;
- •Normal values of thyroid function, amylase and lipase examination, pituitary function, inflammation and infection indicators, myocardial enzymes, and ECG results. For patients older than 50 years with a smoking history, normal lung function are required. Patients with abnormal ECG and/or a history of vascular disease (but not meeting the
排除标准
- •listed in the exclusion criteria 7) need further testing and require normal results of myocardial function and color Doppler ultrasound.
- •Normal liver and kidney function: total bilirubin ≤ 1.5 × upper limit of normal (ULN); alanine transaminase and aspartate transaminase ≤ 2.5 × ULN; alkaline phosphatase ≤ 2.5 × ULN; creatinine clearance rate ≥ 60 ml/min;
- •Patients must sign informed consent and be willing and able to comply with the requirements of visits, treatment, laboratory tests and other research requirements stipulated in the research schedule;
- •Subjects with pregnancy ability must agree to use reliable contraceptive measures from screening to 1 year after treatment.
- •Exclusion Criteria:
- •Hepatitis B virus surface antigen (HBsAg) positive and HBV DNA > 1×10E3 copies/ml; anti-hepatitis C virus positive;
- •Anti-human immunodeficiency virus (HIV) positive or diagnosed with acquired immune deficiency syndrome (AIDS);
- •Active tuberculosis: active tuberculosis in the past 1 year should be excluded regardless with treatment; history of active tuberculosis over 1 year should be excluded except that previous regulatory anti-tuberculosis treatment is proved; Active, known or suspected autoimmune disease (including but not limited to uveitis, enteritis, hepatitis, pituitary, nephritis, vasculitis, hyperthyroidism, hypothyroidism and asthma requiring bronchiectasis). Exceptions are type I diabetes mellitus, hypothyroidism requiring hormone replacement therapy, skin disorders requiring no systemic treatment (such as vitiligo, psoriasis or alopecia);
- •Previous interstitial lung disease or pneumonia requiring oral or intravenous steroid therapy;
- •Chronic treatment with systemic glucocorticoid (dose equivalent to or over 10 mg prednisone per day) or any other form of immunosuppressive therapy. Subjects who used inhaled or topical corticosteroids were eligible;
- •Uncontrolled heart disease, for example: 1) heart failure (NYHA level ≥ 2); 2) unstable angina; 3) myocardial infarction in past 1 year; 4) supraventricular or ventricular arrhythmia requiring treatment or intervention;
- •Pregnant or lactating women (pregnancy test should be considered for women with sexual life and fertility);
- •Previous or concurrent with other malignant tumors, except for adequately treated non-melanoma skin cancer, cervical carcinoma in situ and thyroid papillary cancer;
- •Allergy to macromolecular protein preparations, or any component of camrelizumab;
- •Active infection requiring systemic treatment;
- •Receiving live vaccine within 30 days of the initial camrelizumab;
- •History of organ transplantation;
- •History of psychotropic disease, alcoholism or drug abuse; other situation assessed by the investigators that may compromise the safety or compliance of patients, such as serious disease requiring timely treatment (including mental illness), severe laboratory abnormalities, or family-social risk factors.
研究组 & 干预措施
Experimental Arm
This study aimed to investigate the efficacy of a platinum-free neoadjuvant regimen (gemcitabine, camrelizumab, endostar, and low-dose radiotherapy) followed by a risk-adapted therapeutic strategy in patients with locally advanced nasopharyngeal carcinoma. Specifically, the risk-adapted approach was defined as follows: patients achieving a complete response after neoadjuvant therapy received radiotherapy alone; those with a partial response received radiotherapy plus concurrent endostar; and those with stable disease or progressive disease received radiotherapy plus concurrent cisplatin.
干预措施: Endostar (recombinant human endostatin injection) (Drug)
结局指标
主要结局
Recurrence-free survival
时间窗: Time from enrollment to the first occurrence of disease recurrence (including distant metastasis or locoregional recurrence) or death from any cause, whichever occurs first, assessed up to 60 months.
次要结局
未报告次要终点
研究者
Chen Xiaozhong
MD
Zhejiang Cancer Hospital