Tranilast as a Radiosensitizer in Reradiation of Nasopharyngeal Carcinoma

NCT05626829 | Unknown Phase 2 DMC

• 1 other identifier: NFEC-2022-270
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• the Safety of Tranilast in reradiation of recurrent nasopharyngeal

  12 weeks after Tranilast treatment

Study Arms (1)

Tranilast

EXPERIMENTAL

concurrent Tranilast 100mg 3 times per day

Drug: Tranilast

Interventions

Tranilast DRUG

Tranilast capsules 100mg 3 times per day when reradiation

Tranilast

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• \) Laboratory examination confirmed good organ function, which should be carried out within 10 days before the first treatment.

You may not qualify if:

• 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

Sponsors & Collaborators

• Jian Guan: lead

Study Sites (1)

Southern medical university

Guangzhou, Guangdong, 510515, China

RECRUITING

MeSH Terms

Conditions

Nasopharyngeal Carcinoma; Recurrence

Interventions

tranilast

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Guan Jian, Ph.D.

  Nanfang Hospital, Southern Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guan Jian, Ph.D.

CONTACT

+86-1363210224; 51643930@qq.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: chief physician

Study Record Dates

• First Submitted: July 31, 2022
• First Posted: November 25, 2022
• Study Start: July 20, 2022
• Primary Completion: July 20, 2024
• Study Completion: November 30, 2024
• Last Updated: October 6, 2023

Record last verified: 2023-10

Locations

CN (1)