Tranilast as a Radiosensitizer in Reradiation of Nasopharyngeal Carcinoma

Study Overview
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Brief Summary
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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.

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

Conditions
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Nasopharyngeal Carcinoma, Recurrent Cancer

Intervention / Treatment
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* Drug: Tranilast


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 7) Laboratory examination confirmed good organ function, which should be carried out within 10 days before the first treatment. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tranilast<br>concurrent Tranilast 100mg 3 times per day | Drug: Tranilast<br>* Tranilast capsules 100mg 3 times per day when reradiation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the Effectiveness of Tranilast in reradiation of recurrent nasopharyngeal carcinoma | we use the objective response rate (ORR), according to the RESIST v1.0 | 12 weeks after Tranilast treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the Safety of Tranilast in reradiation of recurrent nasopharyngeal | treatment-related adverse events will be assessed by CTCAE v4.0 | 12 weeks after Tranilast treatment |