Envafolimab Plus Chemoradiotherapy for Locally Advanced Nasopharyngeal Carcinoma, a Prospective, Single Armed Phase II Trial.
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- 3-year progression free survival
研究概览
简要总结
Patients diagnosed with locally advanced nasopharyngeal carcinoma will be recruited in this study. All the patients will get 3 cycles of GP+ Envafolimab for the induction chemotherapy. After that, the patients will receive concurrent chemoradiotherapy. Radiotherapy will be given by IMRT, under the dose of GTVnx 68-70Gy/30-33f, 5d/w,6-7w, during which, every patient would receive 2 cycles of DDP+Envafolimab as concurrent chemotherapy. Then patients would receive Envafolimab every 3 weeks for maintenance treatment for a year, until disease progression or intolerance of treatment. . We aim to evaluate the three years progression free survival of these patients by the combination of Envafolimab with curative chemoradiotherapy.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •histologically confirmed non-keratinizing carcinoma (WHO type II or III) of nasal pharynx
- •stage III-IVa （AJCC/UICC 8th ）, untreated NPC patients
- •NE≥ 1.5×10E9/L, HGB ≥ 100g/L and PLT ≥100×10E9/L
- •ALT≤ 1.5 upper limit of normal (ULN), AST≤ 1.5ULN and bilirubin ≤ 1.5ULN
- •creatinine<1.5×ULN
排除标准
- •recurrent or metastatic NPC patients
- •histologically confirmed keratinizing carcinoma (WHO type I) of nasal pharynx
- •already received radiation or chemotherapy
- •pregnant or lactating women, or women of childbearing age without birth control
- •had other cancers before
- •used immune checkpoint inhibitor(CTLA-4、PD-1、PD-L1 etc.) before
- •complications requiring long-term treatment with immunosuppressive drugs or systemic or local use of corticosteroids with immunosuppressive dose
- •with immune deficiency diseases, or a history of organ transplantation (including but not limited to: interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, nephritis, hyperthyroidism and hypothyroidism; Patients with vitiligo or asthma in childhood who have completely relieved and do not need any intervention after adulthood can be included; Asthma requiring medical intervention with bronchodilators cannot be included)
- •use of massive dose of glucocorticoids within 4 weeks before enrollment
- •laboratory test values do not meet relevant standards within 7 days before enrollment
- •significantly lower functions of heart, liver, lung, kidney and bone marrow
- •serious or uncontrolled medical diseases or infections
- •participating other clinical trial in the same time
- •HBsAg (+) and HBV DNA >1×10E3 copiers /mL
- •HCV (+) unless HCV RNA PCR(-)
- •with any other treatment contraindications
研究组 & 干预措施
Envafolimab group
Envafolimab is a PD-L1 antibody by hypodermic injection. Envafolimab will be administrated with 300mg each time, every three weeks for a total of 22 cycles since the first day of induction chemotherapy.
干预措施: Envafolimab Plus Chemoradiotherapy (Drug)
结局指标
主要结局
3-year progression free survival
时间窗: 3-year
time from the randomization to the first disease progression or death
次要结局
未报告次要终点
研究者
Fei Han
professor
Sun Yat-sen University