Tranilast as a Radiosensitizer in Reradiation of Nasopharyngeal Carcinoma

• Sponsor: Jian Guan (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05626829
• Collaborator: (none)
• Enrollment: 18
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 28.4
• Patients Per Site Per Month: 0.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Nasopharyngeal Carcinoma; Recurrent Cancer	Drug: Tranilast	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 18 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Application of Tranilast as a Radiosensitizer in the Treatment of Radiotherapy Resistant Nasopharyngeal Carcinoma: a Phase II Clinical Study
• Actual Study Start Date: Jul 20, 2022
• Anticipated Primary Completion Date: Jul 20, 2023
• Anticipated Study Completion Date: Nov 30, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. the Effectiveness of Tranilast in reradiation of recurrent nasopharyngeal carcinoma [12 weeks after Tranilast treatment]

   we use the objective response rate (ORR), according to the RESIST v1.0

Secondary Outcome Measures

1. the Safety of Tranilast in reradiation of recurrent nasopharyngeal [12 weeks after Tranilast treatment]

   treatment-related adverse events will be assessed by CTCAE v4.0

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

1. 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Southern medical university	Guangzhou	Guangdong	China	510515

Sponsors and Collaborators

• Jian Guan

Investigators

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

Study Documents (Full-Text)

• Study Protocol - Nov 1, 2022

More Information

Publications

None provided.

• Responsible Party: Jian Guan, chief physician, Nanfang Hospital of Southern Medical University
• ClinicalTrials.gov Identifier: NCT05626829
• Other Study ID Numbers: NFEC-2022-270
• First Posted: Nov 25, 2022
• Last Update Posted: Nov 25, 2022
• Last Verified: Nov 1, 2022

• 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
• Additional relevant MeSH terms: Carcinoma; Nasopharyngeal Carcinoma; Recurrence; Tranilast

Study Results

No Results Posted as of Nov 25, 2022