NCT04539600Unknown2 期
Induction Chemotherapy Combined With Camrelizumab Followed by Chemoradiotherapy in Locoregionally Advanced Hypopharyngeal Cancer
Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2020年11月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Progression-free Survival, PFS
研究概览
简要总结
The study is a single center phase II trial. The purpose is to investigate both the efficacy and safety of chemotherapy combined with anti-PD-1 antibody Followed by chemoradiotherapy in locoregionally 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 18-75 years;
- •Hypopharyngeal squamous cell carcinoma confirmed by histopathology;
- •No distant metastases, stage III-IV (According to the 8th UICC/AJCC TNM staging system );
- •At least 1 measurable lesion (according to RECIST1.1), and the lesion has not been treated;
- •Provide tissues for biomarker analysis;
- •ECOG PS 0-1;
- •Adequate hematologic, hepatic and renal function: ANC ≥ 1.5x10^9/L, Hb ≥ 90g/L, PLT ≥ 100 x10^9/L, albumin ≥ 28g/L, total bilirubin < 1.5×ULN at diagnosis or after biliary drainage, ALT and AST < 5×ULN, BUN、CREA<1.5×ULN, creatinine clearance rate ≥ 45ml/min;
- •Contraception during the study;
- •At least 12 weeks of life expectancy;
- •Willing to join the study and sign informed consent.
排除标准
- •Allergic to any component of carrelizumab, cisplatin and other platinum drugs;
- •Have received anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137 or CTLA-4 antibody therapy in the past;
- •Received biological treatment or participated in clinical trial of other drugs or devices within 4 weeks before enrollment;
- •Have other malignant tumors within 5 years, except for fully treated basal cell/squamous cell skin cancer/cervical cancer;
- •Have corticosteroids (>10 mg prednisone equivalent dose per day) or other immunosuppressive agents for systemic treatment within 2 weeks before the first use of the study drug, except for local inflammation and prevention of allergies, nausea or vomiting;
- •Uncontrolled clinical symptoms or diseases of the heart, such as: heart failure above NYHA II, unstable angina, myocardial infarction within 1 year；
- •Have severe infections (CTCAE> Grade 2) occurred within 4 weeks before the first use of the study drug;
- •Have active autoimmune diseases, autoimmune diseases, but not including autoimmune-mediated hypothyroidism treated with stable doses of thyroid replacement hormone; type 1 diabetes with stable doses of insulin; vitiligo or cured childhood asthma/allergies;
- •A history of immunodeficiency, including a positive HIV test, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation and allogeneic bone marrow transplantation;
- •A history of interstitial lung disease (excluding radiation pneumonia that has not been treated with hormones) and a history of non-infectious pneumonia;
- •Active tuberculosis, having antituberculosis therapy at present or within 1 year;
- •Have active hepatitis B (HBV DNA ≥2000 IU/mL or 10~4 copies/mL) and hepatitis C;
- •Have other uncontrollable comorbidities;
- •Knowing a history of psychotropic drug abuse, alcohol or drug abuse;
- •Pregnant or breastfeeding, or expect to become pregnant during the clinical trial period.
研究组 & 干预措施
induction chemotherapy + anti-PD-1 antibody
Experimental
Camrelizumab (200 mg, Q3w, 2 cycles in total) combined with induction chemotherapy (taxane-containing regimen, Q3w, 2 cycles in total) followed by concurrent radiotherapy and chemotherapy.
干预措施: Camrelizumab (Drug)
结局指标
主要结局
Progression-free Survival, PFS
时间窗: 1 year
Defined as the time from randomization until disease progression or death from any cause, whichever happens first. Patients who withdraw or who are lost to follow-up will be censored at the date last known to be alive and progression free. Patients not having an event will be censored at the date last seen alive.
次要结局
- Objective Response Rate (ORR)(1 year)
- Duration of Response（DoR）(1 year)
- Disease Control Rate (DCR)(1 year)
- Overall Survival (OS)(1 year)
- Adverse events (AE)(1 year)
研究者
Zhen-Wei Peng
Associate Professor
Sun Yat-sen University
研究点 (1)
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