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Nasopharyngeal Carcinoma (NPC)Phase 3NCT07327216

Sapylin Versus Dexamethasone Inhalation for CCRT-Induced Oral Mucositis in Nasopharyngeal Carcinoma

A Phase 3 study testing Sapylin, Dexamethasone and CCRT with Cisplatin in people with Nasopharyngeal Carcinoma (NPC), run by Affiliated Hospital of Guangdong Medical University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

Radiation therapy is the main treatment for nasopharyngeal carcinoma (NPC), and standard care for advanced NPC often includes combination chemotherapy and radiation (CCRT). However, many patients experience serious side effects, such as painful mouth sores (Radiation-Induced Oral Mucositis, RTOM). Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Nasopharyngeal Carcinoma (NPC)
What is being tested?
Sapylin, Dexamethasone and CCRT with Cisplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
180 participants
Where
1 siteChina
Study dates
15 Aug 2022to 1 Jul 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult
  1. Inclusion Criteria:
  • Stage III-IVa NPC (AJCC 8th edition) diagnosed via pathology in a tertiary hospital;
  • No previous radiotherapy, chemotherapy, surgery, immunization, or targeted therapy;
  • Karnofsky Performance Status score ≥80;
  • Intact and normal oral mucosa before treatment;
  • Age 18-75 years;
  • Voluntary participation and provision of informed consent in person;
  • Routine blood examination: white blood cell count ≥4.0×109/L, hemoglobin ≥100g/L, neutrophil count ≥1.5×10^9/L, and platelet count ≥100×10^9/L;
  • Biochemical examination: total bilirubin ≤1.5×the upper limit of the normal range (ULN), alanine aminotransferase and aspartate aminotransferase ≤2×ULN, and estimated glomerular filtration rate ≥60 mL/min.
  1. Exclusion Criteria:
  • With other malignant tumors in the past or present and/or distant metastasis during treatment;
  • Who have undergone surgery, chemoradiotherapy, and targeted immunotherapy;
  • With a history of asthma, rash, urticaria, and other allergic diseases;
  • With a history of autoimmune diseases, connective tissue diseases, and diabetes mellitus that significantly affect the healing of the oral mucosa;
  • With concomitant diseases, such as heart disease, kidney disease, and acute infectious diseases, which are judged by the investigator to seriously endanger the safety of patients or affect the completion of the study;
  • Who are breastfeeding, pregnant, or planning to become pregnant during the study;
  • With known allergies to the therapeutic agents and penicillin used in the trial;
  • Mental or nervous system diseases or poor compliance.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Haiqing Luo, PhD contact

+8613729196345

hqluo@126.com

China1 site, 1 recruiting

  • Affiliated Hospital of Guangdong Medical University

    Zhanjiang, Guangdong

    Recruiting

Other trials in China

About this study

Official title: Efficacy and Safety of Sapylin Versus Dexamethasone Atomized Inhalation for Concurrent Chemoradiotherapy-Induced Oral Mucositis in Patients With Nasopharyngeal Carcinoma: A Randomized, Parallel, Non-inferiority Clinical Trial

Radiation therapy is the main treatment for nasopharyngeal carcinoma (NPC), and standard care for advanced NPC often includes combination chemotherapy and radiation (CCRT). However, many patients experience serious side effects, such as painful mouth sores (Radiation-Induced Oral Mucositis, RTOM). These side effects can be so severe that they lower a patient's ability to adhere to treatment, potentially making the CCRT less effective. Studies have shown that a significant number of patients stop treatment early due to this toxicity.

Current clinical guidelines from organizations like MASCC/ISOO and ESMO agree that preventing RTOM is crucial, but there is currently no specific drug that works for everyone.

Read more

This study aims to investigate a new approach: using Sapylin, a biological immune regulator, delivered through an atomized inhaler. Preliminary research suggests Sapylin delivered this way may enhance the effectiveness of chemotherapy and boost the body's immunity.

The main purpose of this study is to determine the effect of Sapylin inhalation on the incidence and severity of RTOM, and to evaluate its safety and impact on the overall success of CCRT.

By participating, you will help researchers find a high-efficiency, low-toxicity method to improve CCRT outcomes and manage RTOM for future NPC patients and specialists.

Being tested
Sapylin, Dexamethasone, CCRT with Cisplatin
Keywords
Nasopharyngeal carcinoma, radiation-induced oral mucositis, Sapylin, Dexamethasone, atomized inhalation
Medical subject headings
Nasopharyngeal Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SapylinDrug

    Atomized inhalation, 1 KE/time, QD from day 1 of CCRT until the end of radiotherapy.

  • DexamethasoneDrug

    Dexamethasone (10 mg per administration) via atomized inhalation once daily (QD).

  • CCRT with CisplatinCombination product

    Patients receive cisplatin-based CCRT: cisplatin 80-100mg/m2, Q3W, three times during CCRT. Radiation dose: PTVnx: 69.96Gy/33F, PTV1: 60.06Gy/33F, PTV2: 54.12Gy/33F.

Study groups in NCT07327216
Study groupRoleWhat they receive
Sapylin GroupExperimentalCCRT combined with Sapylin atomized inhalation (1 KE/time, QD from day 1 till the end of radiotherapy).
Receives: Drug: Sapylin; Combination Product: CCRT with Cisplatin
Dexamethasone GroupActive comparatorCCRT combined with Dexamethasone atomized inhalation (10 mg/time, QD from day 1 till the end of radiotherapy).
Receives: Drug: Dexamethasone; Combination Product: CCRT with Cisplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Radiation-Induced Oral Mucositis (RIOM)

    Incidence of RIOM is defined as the number of participants developing oral mucositis of any grade. Assessment is based on the World Health Organization (WHO) Oral Toxicity Scale. Scores range from 0 to 4 for ulceration, where higher scores indicate worse outcome.

    Measured: From the start of Concurrent Chemoradiotherapy (CCRT) through the completion of radiotherapy, assessed weekly for approximately 7 weeks.

  2. Severity of Radiation-Induced Oral Mucositis (RIOM)

    To compare the severity of RlOM between the Sapylin and Dexamethasone groups using the World Health Organization (WHO) Oral Toxicity Scale. Scores range from 0 to 4 for ulceration, where higher scores indicate worse outcome.

    Measured: From Week 1 of Concurrent Chemoradiotherapy (CCRT) until the end of Radiotherapy (Week 7).

Secondary outcomes (4)

  1. Duration of Radiation-Induced Oral Mucositis (RIOM)

    Time from the first diagnosis of RIOM (any grade) until the symptoms resolve to Grade 0 or return to baseline level.

    Measured: Daily assessment during CCRT, and up to 1 month after the completion of treatment (assessed up to 3 months).

  2. Rate of Completion of Treatment Measures

    Determined by comparing the actual dose and cycle count of Concurrent Chemoradiotherapy (CCRT) administered versus the planned total treatment regimen. Includes: 1) Actual dose divided by planned total dose (%); 2) Actual completed cycles divided by planned total cycles (%).

    Measured: Measured at the end of the concurrent chemoradiotherapy (CCRT) regimen (Week 7).

  3. Incidence and Severity of Adverse Events (AEs)

    All observed adverse events will be recorded and graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

    Measured: Daily recording during treatment; Follow-up every 3 months for one year after treatment completion.

  4. Change in Body Mass Index (BMI)

    Change is defined as the difference between BMI (kg/m2) at the end of treatment and baseline BMI (Baseline BMI: before CCRT starts).

    Measured: Baseline (before CCRT starts) and at the end of treatment (End of Radiotherapy, approximately Week 7).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jan 2026
  2. Study start15 Aug 2022
  3. Primary completion1 Jul 2026 (estimated)
  4. Study completion1 Jul 2027 (estimated)

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
180 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07327216
Sponsor's protocol ID
PJKT2022-066
Status last verified
Jan 2026
First submitted
10 Dec 2025
Last updated
4 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Individual participant data that underlie the results will be shared after study completion and publication.Data will be de-identified to protect participant privacy.

Publications

  • Peterson DE, Boers-Doets CB, Bensadoun RJ, Herrstedt J; ESMO Guidelines Committee. Management of oral and gastrointestinal mucosal injury: ESMO Clinical Practice Guidelines for diagnosis, treatment, and follow-up. Ann Oncol. 2015 Sep;26 Suppl 5:v139-51. doi: 10.1093/annonc/mdv202. Epub 2015 Jul 4. No abstract available.

    PubMed 26142468

  • Chen YP, Chan ATC, Le QT, Blanchard P, Sun Y, Ma J. Nasopharyngeal carcinoma. Lancet. 2019 Jul 6;394(10192):64-80. doi: 10.1016/S0140-6736(19)30956-0. Epub 2019 Jun 6.

    PubMed 31178151

  • Kong D, Zhang D, Cui Q, Wang K, Tang J, Liu Z, Wu G. Sapylin (OK-432) alters inflammation and angiogenesis in vivo and vitro. Biomed Pharmacother. 2019 May;113:108706. doi: 10.1016/j.biopha.2019.108706. Epub 2019 Mar 4.

    PubMed 30844656

  • Nishii M, Soutome S, Kawakita A, Yutori H, Iwata E, Akashi M, Hasegawa T, Kojima Y, Funahara M, Umeda M, Komori T. Factors associated with severe oral mucositis and candidiasis in patients undergoing radiotherapy for oral and oropharyngeal carcinomas: a retrospective multicenter study of 326 patients. Support Care Cancer. 2020 Mar;28(3):1069-1075. doi: 10.1007/s00520-019-04885-z. Epub 2019 Jun 8.

    PubMed 31177394

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Sapylin, Dexamethasone and CCRT with Cisplatin in people with Nasopharyngeal Carcinoma (NPC), run by Affiliated Hospital of Guangdong Medical University 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?

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: looking for participants now, as of the sponsor's last update on 4 Mar 2026. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Haiqing Luo, PhD (+8613729196345, hqluo@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Radiation-Induced Oral Mucositis (RIOM) (time frame: From the start of Concurrent Chemoradiotherapy (CCRT) through the completion of radiotherapy, assessed weekly for approximately 7 weeks.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07327216, which also lists 4 linked publications.

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 4 Mar 2026.

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