Phase Ⅰ/Ⅱ Study of Icotinib Hydrochloride Combined With Intensity-modulated Radiotherapy in Nasopharyngeal Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Phase I: the maximum tolerated dose of Icotinib in combination with IMRT for NPC
研究概览
简要总结
Nasopharyngeal carcinoma (NPC) is a prevalent disease in southeast of China. Radiation therapy with or without chemotherapy is a standard therapy for nasopharyngeal cancer. Cytotoxic chemotherapy plays an important role in the curative treatment of advanced NPC. However, concurrent chemoradiotherapy increased significantly local and systemic toxic effects, which may preclude many patients from proceeding with combined therapy. The epidermal growth factor receptor(EGFR) gene is amplified in 40% and EGFR protein is overexpressed in over 80% of NPC. EGFR overexpression is also associated with shorter survival following chemoradiotherapy in locoregionally advanced NPC. And some basic researches have proved that EGFR tyrosine kinase inhibitors(TKIs) could increase the radiosensitivity and reduce the epithelial-mesenchymal transition (EMT) in NPC cell line. Moreover, distant metastases has been the major cause of treatment failure in NPC. Icotinib hydrochloride is a novel oral EGFR TKIs with low mammalian toxicity(made in China). But base on toxic effects of Icotinib, it may increase toxic effects about skin and mucosa in combination therapy with Icotinib and Intensity-modulated Radiotherapy (IMRT). The prospective study will assess the tolerability and efficacy of Icotinib combined with IMRT in patients with NPC. This regimen is of great interest and it has potential to alleviate the adverse effects, improve patient compliance and better therapeutic ratio.
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
- •1. Patients with histological proof of squamous carcinoma of the nasopharynx.
- •2. Patients must have ECOG Performance Status of 0-1.
- •3. Patients should have adequate bone marrow function defined as an absolute peripheral granulocyte count (AGC) of \>/= 1500 cells/mm3, platelet count of \>/= 100,000 cells/mm3; adequate hepatic function with bilirubin \/= 50 ml/min and INR 0.8 - 1.2.
- •4. Patients must sign a study specific informed consent form prior to study entry.
排除标准
- •Evidence of metastases by clinical or radiographic examinations.
- •History of malignancy other than non-melanoma skin cancer.
- •Prior chemotherapy or anticancer biologic therapy for any type of cancer, or prior radiotherapy to the head and neck region except for radioactive iodine therapy.
- •Patients with uncontrolled intercurrent disease.
- •Patients with currently active malignancy.
- •Pregnant or lactating women Female patients of childbearing potential who are unwilling to practice adequate contraception during study treatment and for two months after the last administration of study drug.
结局指标
主要结局
Phase I: the maximum tolerated dose of Icotinib in combination with IMRT for NPC
时间窗: 30 days
Phase II: 2 years locoregional control rate
时间窗: Two years
次要结局
- The overall response rate (complete and partial response)(1 month following treatment and then every 3 months)
- The duration of control of locoregional disease(1 month following treatment and then every 3 months)
- The acute and late toxicity profile associated with the study regimen(1 month following treatment and then every 3 months)
- Overall survival, disease-free survival, and distant relapse rates(At time of locoregional disease progression)
- EGFR status in tissue and blood before treatment(2 week of pretreatment)
研究者
Haihua Yang
Director of Radiotherapy Dept
Taizhou Hospital