Tranilast as a Radiosensitizer in Reradiation of Nasophar... | NCT05626829

Studies
Tranilast as a Radiosensitizer in Reradiation of Nasopharyngeal Carcinoma

NCT05626829

Sponsor

Jian Guan

Status

Unknown status

Last Update Posted

Oct 6, 2023Actual

Enrollment

18Estimated

Phase

Phase 2

Conditions

Nasopharyngeal Carcinoma
Recurrent Cancer

Interventions

Tranilast

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 20, 2022Actual

Primary Completion Date

Jul 20, 2024Estimated

Completion Date

Nov 30, 2024Estimated

First Submitted Date

Jul 31, 2022

First Submission Date that Met QC Criteria

Nov 15, 2022

First Posted Date

Nov 25, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 4, 2023

Last Update Posted Date

Oct 6, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

18Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Tranilast	Experimental	concurrent Tranilast 100mg 3 times per day	Drug: Tranilast

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Tranilast	Drug	Tranilast capsules 100mg 3 times per day when reradiation	Tranilast

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Guan Jian, Ph.D.	Contact	+86-1363210224		51643930@qq.com

Overall Officials

Name	Affiliation	Role
Guan Jian, Ph.D.	Nanfang Hospital, Southern Medical University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Southern medical university	Recruiting	Guangzhou	Guangdong	510515	China

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Nov 1, 2022	Nov 15, 2022	Prot_000.pdf

Condition Browse Module

MeSH Terms

ID	Term
D000077274	Nasopharyngeal Carcinoma
D012008	Recurrence

Ancestor Terms

ID	Term
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

Browse Leaves

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Browse Branches

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