Application of Tranilast as a Radiosensitizer in the Treatment of Radiotherapy Resistant Nasopharyngeal Carcinoma: a Phase II Clinical Study
Phase: PHASE2
Conditions: Nasopharyngeal Carcinoma, Recurrent Cancer
Sponsor: Jian Guan

 
 
 
Application of Tranilast as a Radiosensitizer in 
the Treatment of Radiotherapy Resistant 
Nasopharyngeal Carcinoma: a Phase II Clinical 
Study 
 
STUDY PROTOCOL AND STATISTICAL ANALYSIS PLAN  
 
 
NCT ID: Not yet assigned  
 
2022.11.1 
 
 
 

 
 
STUDY PROTOCOL 
This study is a prospective intervention phase II trial initiated by researchers to compare 
the objective remission rate of patients with recurrent nasopharyngeal carcinoma 
treated with previous radiotherapy, and explore the safety and effectiveness of 
additional use of Tranilast.  
 
18 patients are to be recruited for this project. It includes the screening period (14 days 
from the signing of the informed consent to the first oral administration of Tranilast or 
radiotherapy), the treatment period (the first oral administration of Tranilast or 
radiotherapy, the time of intolerance or withdrawal from the trial for various reasons) 
and the follow-up period (12weeks after the last radiotherapy, in which serious adverse 
events will be 90 days or more after the end of treatment).  
 
After the subjects signed the informed consent, within 3 days before and after the start 
of radiotherapy, they orally took Tranilast 100mg  3 times a day.Evaluation during 
treatment: the adverse events were strictly monitored and the severity was graded 
according to the adverse event standard CTCAE version 5.0. For patients with recurrent 
nasopharyngeal carcinoma treated by radiotherapy, tranister was treated simultaneously 
with radiotherapy.  
 
In case of the following circumstances, it can be considered to stop medication: (1) 
unacceptable adverse events; (2) Concurrent diseases that prevent further treatment; (3) 
The researcher decided to withdraw from the subject; (5) Subjects withdraw consent; 
(6) Does not meet the requirements of the trial treatment or procedure; (7) Other 
reasons., 
 
After treatment, each subject will be followed up. Subjects should be monitored for 
adverse events for at least 30 days, and serious adverse events will be collected 12weeks 
or more after the end of treatment. The subjects will be followed up after treatment for 
3 years or until one of the following events: ⑴ death; (2) start non research cancer 
treatment; (3) withdraw the research consent; (4) loss follow-up.  
 
The main purpose of this test includes determining orr according to recist1.1, and 
evaluating safety through various adverse event parameters, including the incidence of 
adverse events and the time to reach level 3 ~ 5 adverse events for the first time. 
 
Inclusion Criteria: 
1. Sign informed consent 
2. At least 18 years old on the date of signing the informed consent 

3. Previously received standard radical radiotherapy and chemotherapy 
4. Recurrent nasopharyngeal carcinoma in situ or cervical lymph nodes confirmed by 
pathological biopsy and imaging examination 
5. 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 
6. 7) Laboratory examination confirmed good organ function, which should be 
carried out within 10 days before the first treatment. 
 
Exclusion Criteria: 
1. After evaluation, it does not meet the indications of re-radiotherapy 
2. unable to take oral medication 
3. Pregnancy or lactation 
4. Known allergy to Tranilast 
5. Patients who are judged by the researcher as unsuitable to participate in this trial 
 
 
Data Evaluation and Statistical Methods  
The study data were analyzed through IBM SPSS V23 software. In the categorical 
comparison of the groups, Yates Correction, Fisher’s Exact test, and Pearson χ2 test 
were employed.  
The risk factors were analyzed with Cox regression analysis. In the comparison of 
survival duration according to VOD status, Log Rank test was employed. The analysis 
results were presented as mean±standard deviation for the quantitative data and as 
frequency (percentage) for the categorical variables. Significance level was taken as 
p<.05.  
 
 
ETHICS 
Ethics In conducting study, universal ethical rules as well as scientific principles were 
observed. As the use of human beings in the study required the protection of individual 
rights, the principles of Helsinki Declaration of Human Rights were also observed.  
Ethics board approval was obtained from the Nanfang Hospital of Southern Medical 
University Ethics Committee (Decision No: NFEC-2022-270) and institutional 
permission was taken from the hospital where the study would be conducted.