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临床试验/NCT05626829
NCT05626829招募中2 期

Application of Tranilast as a Radiosensitizer in the Treatment of Radiotherapy Resistant Nasopharyngeal Carcinoma: a Phase II Clinical Study

Jian Guan1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2022年7月20日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
招募中
发起方
入组人数
18
试验地点
1
主要终点
the Effectiveness of Tranilast in reradiation of recurrent nasopharyngeal carcinoma

研究概览

简要总结

Nasopharyngeal carcinoma is one of the high incidence head and neck cancer in Southeast Asia. Radiotherapy is the main treatment for nasopharyngeal carcinoma, and its response rate can reach 80~90%. However, for radiotherapy resistant patients with metastasis and recurrence, the survival prognosis decreased significantly, and the 5-year overall survival rate was only 20% - 40%. Tranilast is an anti-allergic drug, which is clinically used to treat bronchial asthma and can inhibit fibroblasts α- SMA and type I collagen expression. Through experiments in vivo and in vitro, the investigators' research group has proved that Tranilast can inhibit the activity of tumor related fibroblasts, reduce the radiotherapy resistance of nasopharyngeal carcinoma, and has the radiosensitizing effect of nasopharyngeal carcinoma. This result has been published in J exp Clin cancer res (if=11.16). The investigators plan to carry out the clinical transformation of basic research, carry out a prospective intervention phase II clinical trial, compare the objective remission rate of patients with recurrent nasopharyngeal carcinoma treated with previous radiotherapy, and explore the safety and effectiveness of using Tranilast as a radiotherapy sensitizer for radiotherapy to resist the treatment of nasopharyngeal carcinoma.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Sign informed consent
  • At least 18 years old on the date of signing the informed consent
  • Previously received standard radical radiotherapy and chemotherapy
  • Recurrent nasopharyngeal carcinoma in situ or cervical lymph nodes confirmed by pathological biopsy and imaging examination
  • After multidisciplinary consultation, there was a clear indication for surgery, and the patient was informed and refused to accept surgical treatment 6)ECOG PS:0/1
  • Laboratory examination confirmed good organ function, which should be carried out within 10 days before the first treatment.

排除标准

  • After evaluation, it does not meet the indications of re-radiotherapy
  • unable to take oral medication
  • Pregnancy or lactation
  • Known allergy to Tranilast
  • Patients who are judged by the researcher as unsuitable to participate in this trial

研究组 & 干预措施

Tranilast

Experimental

concurrent Tranilast 100mg 3 times per day

干预措施: Tranilast (Drug)

结局指标

主要结局

the Effectiveness of Tranilast in reradiation of recurrent nasopharyngeal carcinoma

时间窗: 12 weeks after Tranilast treatment

we use the objective response rate (ORR), according to the RESIST v1.0

次要结局

  • the Safety of Tranilast in reradiation of recurrent nasopharyngeal(12 weeks after Tranilast treatment)

研究者

发起方
Jian Guan
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Jian Guan

chief physician

Nanfang Hospital, Southern Medical University

研究点 (1)

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