Nasopharyngeal CarcinomaPhase 2NCT05626829
Tranilast as a Radiosensitizer in Reradiation of Nasopharyngeal Carcinoma
A Phase 2 study testing Tranilast in people with Nasopharyngeal Carcinoma and Recurrent Cancer, run by Jian Guan at 1 site in China.
Trial 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%. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nasopharyngeal Carcinoma, Recurrent Cancer
- What is being tested?
- Tranilast
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- 20 Jul 2022to 30 Nov 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Southern medical university
Guangzhou, Guangdong, 510515
Jian Guan, M.D., 86+13632102247, guanjian5461@163.com
Jian Guan, M.D.
About this study
Official title: 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.
- Conditions
- Nasopharyngeal Carcinoma, Recurrent Cancer
- Being tested
- Tranilast
- Medical subject headings
- Nasopharyngeal Carcinoma, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TranilastDrug
Tranilast capsules 100mg 3 times per day when reradiation
| Study group | Role | What they receive |
|---|---|---|
| Tranilast | Experimental | concurrent Tranilast 100mg 3 times per day Receives: Drug: Tranilast |
What is being measured
The primary outcome is the main question the study is designed to answer.
the Effectiveness of Tranilast in reradiation of recurrent nasopharyngeal carcinoma
we use the objective response rate (ORR), according to the RESIST v1.0
Measured: 12 weeks after Tranilast treatment
Secondary outcomes (1)
the Safety of Tranilast in reradiation of recurrent nasopharyngeal
treatment-related adverse events will be assessed by CTCAE v4.0
Measured: 12 weeks after Tranilast treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2022
- Study start20 Jul 2022
- Primary completion20 Jul 2024 (estimated)
- Study completion30 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasopharyngeal CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jian Guan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jian Guan, Nanfang Hospital, Southern Medical University
- Investigators
- Guan Jian, Ph.D., Principal investigator, Nanfang Hospital, Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05626829
- Sponsor's protocol ID
- NFEC-2022-270
- Status last verified
- Oct 2023
- First submitted
- 31 Jul 2022
- Last updated
- 6 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Tranilast as a Radiosensitizer in the Treatment of Radiotherapy Resistant Nasopharyngeal Carcinoma: a Phase II Clinical Study
- ClinicalTrials.gov ID
- NCT05626829
- Acronym / sponsor ID
- NFEC-2022-270
- Conditions
- Nasopharyngeal Carcinoma, Recurrent Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Jian GuanUniversity, hospital or other
- Study start
- 20 Jul 2022 (actual)
- Primary completion
- 20 Jul 2024 (estimated)
- Study completion
- 30 Nov 2024 (estimated)
- First posted
- 25 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tranilast | Experimental | Drug: Tranilastconcurrent Tranilast 100mg 3 times per day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TranilastTranilast capsules 100mg 3 times per day when reradiation | Drug | Tranilast |
Primary outcome
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
1 secondary outcome
the Safety of Tranilast in reradiation of recurrent nasopharyngeal
Time frame: 12 weeks after Tranilast treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guan Jian, Ph.D. principal investigator
Nanfang Hospital, Southern Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tranilast in people with Nasopharyngeal Carcinoma and Recurrent Cancer, run by Jian Guan at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guan Jian, Ph.D. (+86-1363210224, 51643930@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the Effectiveness of Tranilast in reradiation of recurrent nasopharyngeal carcinoma (time frame: 12 weeks after Tranilast treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2023.