NCT04769076尚未招募2 期
A Prospective Phase II Clinical Trial of Paclitaxel (Albumin-bound) Combined With Cisplatin, PD-1 Inhibitors and IMRT in the Treatment of Locally Advanced Nasopharyngeal Carcinoma
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School0 个研究点目标入组 40 人开始时间: 2021年3月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 主要终点
- Objective response rate
研究概览
简要总结
The purpose of this study in to observe the effectiveness and safety of paclitaxel (albumin-bound type) combined with cisplatin, PD-1 inhibitor and IMRT in the treatment of locally advanced nasopharyngeal carcinoma.
详细描述
This trial is a prospective, open, single-arm phase II clinical trial. The trial will enroll 40 patients with nasopharyngeal cancer stage III-IVA (UICC 8th edition). Subjects will receive paclitaxel (albumin-bound) combined with cisplatin and PD-1 inhibitor (sintilimab) neoadjuvant therapy and radical concurrent chemotherapy and radiotherapy.
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
- •Pathologically confirmed differentiated non-keratinizing carcinoma and undifferentiated non-keratinizing carcinoma
- •The stage is Ⅲ-ⅣA (UICC 8th edition)
- •Initial treatment patients without anti-tumor therapy
- •No history of other malignant tumors
- •Male or female, aged 18~70 years old
- •Sufficient liver and kidney function: total bilirubin ≤ upper limit of normal (ULN); AST and ALT ≤ 2.5 times ULN; alkaline phosphatase ≤ 5 times ULN; creatinine clearance ≥ 80 mL/min
- •Sufficient blood function: neutrophil count (ANC) ≥2×109/L, platelet count ≥100×109/L and hemoglobin ≥9 g/dL
- •No serious heart, lung, liver, kidney and other important organ dysfunction
- •Karnofsky score ≥70 points
- •No autoimmune diseases
- •Sign informed consent
排除标准
- •Has performed anti-tumor treatment, including chemotherapy, radiotherapy, and surgery
- •Discovery of distant metastases before treatment
- •Receive live attenuated vaccine within 4 weeks before enrollment or plan to receive live attenuated vaccine during the study period
- •Active, known or suspected autoimmune diseases
- •Known history of primary immunodeficiency
- •Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation
- •Women who are pregnant or breastfeeding
- •Disagree to sign the informed consent form
- •Patients who cannot cooperate with regular follow-up due to psychological, social, family and geographic reasons
- •Simultaneously accept experimental treatment of other clinical research (in the treatment period of clinical research)
- •Known allergic to possible chemotherapy drugs
- •Accompanied by serious uncontrollable infections or medical diseases
- •Major organ dysfunction, such as decompensated heart, lung, kidney, and liver failure, unable to tolerate radiotherapy and chemotherapy
- •Laboratory examination: total bilirubin>upper limit of normal (ULN); AST and/or ALT>1.5 times ULN and accompanied by alkaline phosphatase>2.5 times ULN
结局指标
主要结局
Objective response rate
时间窗: 1 month after the end of all treatments
According to European Solid Tumor Efficacy Evaluation Standard (RECIST)
次要结局
未报告次要终点
研究者
Yang Yang
Professor of medicine
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
相似试验
已完成
2 期
Albumin-Bound Paclitaxel and Gemcitabine in Patients With Untreated Stage IV or Recurrent Squamous Cell Lung CancersUntreated Stage IV or Recurrent Squamous Cell Lung CancersLung CancerNCT02525653Memorial Sloan Kettering Cancer Center40
尚未招募
2 期
Efficacy and Safety of Nab-paclitaxel-Lenvatinib-Pembrolizumab as Second-line Treatment in Advanced NSCLC PatientsAdvanced Non-squamous Non-small-cell Lung CancerRecurrent Non-Squamous Non-Small Cell Lung CancerMetastatic Non-squamous Non Small Cell Lung CancerNCT06028633Peking University First Hospital28
Unknown
2 期
Phase II Study of Albumin Bound Paclitaxel With 5-FU and CF as Second Line in Taxanes Naive Advanced Gastric CancerGastric CanerNCT02229045Sun Yat-sen University37
Unknown
2 期
Combined Simvastatin and Albumin Paclitaxel in Treating ES-SCLC Patients Relapsed From 1st ChemotherapySmall Cell Lung CancerNCT04698941Shanghai Pulmonary Hospital, Shanghai, China40
招募中
2 期
Paclitaxel (Albumin Bound),Bleomycin And Cisplatin Or Carboplatin for Recurrent Or Metastatic Squamous Cell Carcinoma Of The Head And NeckSquamous Cell Carcinoma Of The Head And NeckNCT03830385Sun Yat-sen University51