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Trial Title:
Tranilast as a Radiosensitizer in Reradiation of Nasopharyngeal Carcinoma
NCT ID:
NCT05626829
Condition:
Nasopharyngeal Carcinoma
Recurrent Cancer
Conditions: Official terms:
Carcinoma
Nasopharyngeal Carcinoma
Recurrence
Tranilast
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Tranilast
Description:
Tranilast capsules 100mg 3 times per day when reradiation
Arm group label:
Tranilast
Summary:
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.
Criteria for eligibility:
Criteria:
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
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Southern medical university
Address:
City:
Guangzhou
Zip:
510515
Country:
China
Status:
Recruiting
Contact:
Last name:
Jian Guan, M.D.
Phone:
86+13632102247
Email:
guanjian5461@163.com
Investigator:
Last name:
Jian Guan, M.D.
Email:
Principal Investigator
Start date:
July 20, 2022
Completion date:
November 30, 2024
Lead sponsor:
Agency:
Jian Guan
Agency class:
Other
Source:
Nanfang Hospital, Southern Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05626829
