Nab-TPC Versus GP Chemotherapy Combined With Camrelizumab in the Treatment of Recurrent/Metastatic Nasopharyngeal Carcinoma: Randomized Controlled, Multi Center, Phase III Clinical Study
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 242
- 试验地点
- 1
- 主要终点
- Progression-Free Survival
研究概览
简要总结
We expect to conduct a clinical trial in recurrent and metastatic nasopharyngeal carcinoma patients to explore and compare the efficacy and safety of induction chemotherapy (TPC vs. GP) with combination therapy of Camrelizumab.
详细描述
The therapeutic effect of patients with metastatic nasopharyngeal carcinoma has been further improved. Numerous previous studies have shown that anti-PD-1 immune checkpoint inhibitors (ICIs) have strong activity in treated metastatic nasopharyngeal carcinoma patients, with an objective response rate (ORR) of 20-34%. In addition, immunotherapy has also achieved good results in the first-line treatment of recurrent/metastatic nasopharyngeal carcinoma. In 2021, the clinical results of a study on the treatment of recurrent/metastatic nasopharyngeal carcinoma with pembrolizumab were published. The median PFS of the pembrolizumab combined with chemotherapy group was 9.7 months, significantly prolonging PFS, with an HR value of 0.54, and reducing the risk of disease progression by 46%. Based on this, the 2022 CSCO guidelines will use pembrolizumab combined with GP chemotherapy as a new first-line treatment for metastatic nasopharyngeal carcinoma.We conducted a study comparing the efficacy of GP regimen and nab TPC regimen, and found that nab TPC regimen significantly improved the survival of patients with metastatic nasopharyngeal carcinoma compared to GP regimen, and the nab TPC regimen group had milder grade 3-4 toxic side effects.This study aims to design a prospective phase III clinical trial on the safety and efficacy of GP combined with Carilizumab compared to nab TPC regimen combined with Carilizumab chemotherapy for recurrent and metastatic nasopharyngeal carcinoma
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age over 18 years.
- •ECOG score of 0-
- •Expected survival of at least 12 weeks.
- •Recurrent/Metastatic Nasopharyngeal Carcinoma.
- •At least 4 weeks since the previous chemotherapy.
- •At least one (according to RECIST) measurable lesion, lesions that have been previously irradiated can not be considered target lesions.
- •had adequate organ function
排除标准
- 未提供
研究组 & 干预措施
Camrelizumab with GP chemotherapy
Camrelizumab, cisplatin and gemcitabine
干预措施: Camrelizumab combined GP chemotherapy (Drug)
camrelizumab with nab-TPC chemotherapy
camrelizumab plus nab-TPC chemotherapy (nab-paclitaxel, cisplatin and capecitabine)
干预措施: Camrelizumab combined TPC chemotherapy (Drug)
结局指标
主要结局
Progression-Free Survival
时间窗: 15 months
The primary endpoint was PFS, which was assessed as the time from randomization to disease progression per RECIST v1.1 assessed by IRC or death, whichever occurred first.
次要结局
- Overall Survival(1,3,5 years)
- Safety and Adverse Events(3 months)
研究者
XIANG YANQUN
Clinical Professor
Sun Yat-sen University
