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Tranilast as a Radiosensitizer in Reradiation of Nasopharyngeal Carcinoma

NCT05626829 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2023-10-06

No results posted yet for this study

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.

Conditions

  • Nasopharyngeal Carcinoma
  • Recurrent Cancer

Interventions

DRUG

Tranilast

Tranilast capsules 100mg 3 times per day when reradiation

Sponsors & Collaborators

  • Jian Guan

    lead OTHER

Principal Investigators

  • Guan Jian, Ph.D. · Nanfang Hospital, Southern Medical University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-20
Primary Completion
2024-07-20
Completion
2024-11-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05626829 on ClinicalTrials.gov