Tranilast as a Radiosensitizer in Reradiation of Nasopharyngeal Carcinoma

October 4, 2023 updated by: Jian Guan

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

18

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Guan Jian, Ph.D.
  • Phone Number: +86-1363210224
  • Email: 51643930@qq.com

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510515
        • Recruiting
        • Southern Medical University
        • Contact:
        • Principal Investigator:
          • Jian Guan, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tranilast
concurrent Tranilast 100mg 3 times per day
Drug: Tranilast
Tranilast capsules 100mg 3 times per day when reradiation

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jian Guan

Investigators

  • Principal Investigator: Guan Jian, Ph.D., Nanfang Hospital, Southern Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 20, 2022

Primary Completion (Estimated)

July 20, 2024

Study Completion (Estimated)

November 30, 2024

Study Registration Dates

First Submitted

July 31, 2022

First Submitted That Met QC Criteria

November 15, 2022

First Posted (Actual)

November 25, 2022

Study Record Updates

Last Update Posted (Actual)

October 6, 2023

Last Update Submitted That Met QC Criteria

October 4, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NFEC-2022-270

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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