A Phase 2 interventional study of Tranilast in Nasopharyngeal Carcinoma and Recurrent Cancer, sponsored by Jian Guan. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-10-06.
Sponsored by Jian Guan · Phase 2, Interventional, and Treatment
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.
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
This study's planned enrollment of 18 is below the median of 45 across 5,170 interventional studies indexed under Carcinoma.
Browse Carcinoma studies →This is the only study on the registry with Jian Guan as lead sponsor.
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Exclusion Criteria:
concurrent Tranilast 100mg 3 times per day
Drug: Tranilast
Tranilast capsules 100mg 3 times per day when reradiation
the Effectiveness of Tranilast in reradiation of recurrent nasopharyngeal carcinoma
we use the objective response rate (ORR), according to the RESIST v1.0
Time frame: 12 weeks after Tranilast treatment
the Safety of Tranilast in reradiation of recurrent nasopharyngeal
treatment-related adverse events will be assessed by CTCAE v4.0
Time frame: 12 weeks after Tranilast treatment
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