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临床试验/NCT06669611
NCT06669611招募中3 期

Nab-TPC Versus GP Chemotherapy Combined With Camrelizumab in the Treatment of Recurrent/Metastatic Nasopharyngeal Carcinoma: Randomized Controlled, Multi Center, Phase III Clinical Study

Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 242 人开始时间: 2024年11月27日最近更新:
适应症
干预措施
相关药物

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

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

Active Comparator

Camrelizumab, cisplatin and gemcitabine

干预措施: Camrelizumab combined GP chemotherapy (Drug)

camrelizumab with nab-TPC chemotherapy

Experimental

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

发起方
Sun Yat-sen University
申办方类型
Other
责任方
Principal Investigator
主要研究者

XIANG YANQUN

Clinical Professor

Sun Yat-sen University

研究点 (1)

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