Nasopharyngeal Cancinoma (NPC)Phase 1NCT07636499
Selective Neck Dissection Under Multimodal Assessment for N3 Nasopharyngeal Carcinoma After Radiotherapy
A Phase 1 study testing Multimodal Evaluation-Guided Surveillance-Intervention Strategy in people with Nasopharyngeal Cancinoma (NPC), run by Guiquan Zhu at 1 site in China.
Trial summary
The goal of this phase I clinical trial is to evaluate the safety and feasibility of a multimodal evaluation-guided surveillance-intervention strategy in patients with newly diagnosed N3 nasopharyngeal carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Nasopharyngeal Cancinoma (NPC)
- What is being tested?
- Multimodal Evaluation-Guided Surveillance-Intervention Strategy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 30 Aug 2022to Sep 2026
- Phase
- Phase 1
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 to 70 years.
- Pathologically confirmed nasopharyngeal non-keratinizing carcinoma (differentiated or undifferentiated, i.e., WHO Type II or III).
- Tumor staged as TanyN3M0 according to the 8th Edition of the American Joint Committee on Cancer/Union for International Cancer Control (AJCC/UICC) staging system.
- ECOG performance status 0-1.
- No previous neck dissection.
- Adequate hematologic, hepatic, and renal function, defined as: white blood cell count ≥4.0 × 10^9/L, absolute neutrophil count ≥2.0 × 10^9/L, hemoglobin ≥90 g/L, platelet count ≥100 × 10^9/L, aspartate aminotransferase and alanine aminotransferase ≤2.5 × the upper limit of normal, and creatinine clearance ≥60 mL/min
- Written informed consent provided prior to study enrollment
Who cannot join
- Ongoing receipt of other antitumor treatment or concurrent participation in another interventional clinical trial.
- Pregnancy or breastfeeding
- Severe concomitant disease that may, in the investigator's judgment, pose an unacceptable risk or compromise study compliance, including severe cardiac disease, severe pulmonary dysfunction, significant renal disease, or severe psychiatric illness.
- History of another invasive malignancy within 5 years before enrollment, except for adequately treated basal cell carcinoma of the skin, cervical carcinoma in situ, or superficial bladder tumors (Ta, Tis, or T1).
Trial locations and contacts
1 site in 1 country.
China1 site
West China Hospital of Stomatology, Sichuan University
Chengdu, Sichuan, 610041
About this study
Official title: A Phase 1 Trial of Multimodal Evaluation-Guided Surveillance-Intervention With Selective Neck Dissection for N3 Nasopharyngeal Carcinoma After Radiotherapy
The goal of this phase I clinical trial is to evaluate the safety and feasibility of a multimodal evaluation-guided surveillance-intervention strategy in patients with newly diagnosed N3 nasopharyngeal carcinoma. The main questions it aims to answer are:
- Is the multimodal evaluation-guided surveillance-intervention approach safe for patients?
- Is this approach feasible for identifying and managing residual cervical lymph nodes after radiotherapy?
Participants receive standard chemoradiotherapy. After treatment, they undergo follow-up evaluation using clinical assessment, conventional imaging, Epstein-Barr virus DNA testing, and contrast-enhanced ultrasound. Participants with suspicious residual cervical lymph nodes identified by multimodal evaluation and considered suitable for surgical intervention undergo selective neck dissection.
Read the detailed description
Patients with N3 nasopharyngeal carcinoma remain at risk of residual cervical lymph node disease after radiotherapy. Conventional imaging may have difficulty distinguishing viable residual tumor from post-radiotherapy edema, fibrosis, scarring, or inflammation. Contrast-enhanced ultrasound (CEUS) provides information on lymph node microvascular perfusion and may complement routine follow-up assessment. For patients with suspected residual cervical lymph node disease, selective neck dissection may be considered as a salvage treatment option.
This prospective, single-center, single-arm phase I study enrolled patients with pathologically confirmed N3 nasopharyngeal carcinoma. After completion of radiotherapy, participants underwent multimodal cervical lymph node follow-up evaluation, including clinical assessment, conventional imaging, Epstein-Barr virus DNA testing, and CEUS. During follow-up, participants with suspicious residual cervical lymph nodes identified by multimodal evaluation and considered suitable for surgical intervention underwent selective neck dissection. Participants were followed for adverse events, postoperative complications, disease progression, locoregional recurrence, distant metastasis, and survival outcomes. The main purpose of this study is to evaluate the safety and feasibility of this multimodal evaluation-guided surveillance-intervention strategy.
- Conditions
- Nasopharyngeal Cancinoma (NPC)
- Being tested
- Multimodal Evaluation-Guided Surveillance-Intervention Strategy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal Evaluation-Guided Surveillance-Intervention StrategyProcedure or surgery
All participants underwent multimodal follow-up evaluation after radiotherapy. Selective neck dissection was performed only in participants with suspicious residual cervical lymph nodes identified by multimodal evaluation and considered to have an indication for surgical intervention.
| Study group | Role | What they receive |
|---|---|---|
| Multimodal Evaluation-Guided Surveillance-Intervention Strategy | Experimental | Participants underwent multimodal follow-up evaluation after radiotherapy, including clinical assessment, conventional imaging, Epstein-Barr virus DNA testing, and contrast-enhanced ultrasound. Participants with suspicious residual cervical lymph nodes identified by multimodal evaluation and considered suitable for surgical intervention underwent selective neck dissection. Receives: Procedure: Multimodal Evaluation-Guided Surveillance-Intervention Strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events
Treatment-emergent adverse events are defined as adverse events occurring after the start of study intervention. Adverse events will be assessed and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0.
Measured: From enrollment through post-radiotherapy follow-up, up to 36 months
Secondary outcomes (4)
Completion Rate of Selective Neck Dissection Among Participants With Suspected Residual Cervical Nodal Disease
The completion rate is defined as the proportion of participants who undergo selective neck dissection as planned among participants with suspected residual cervical nodal disease identified by multimodal evaluation.
Measured: From enrollment to completion of indicated selective neck dissection or the end of follow-up, whichever occurs first, assessed up to 36 months after enrollment.
Progression-Free Survival
Progression-free survival is defined as the time from enrollment to disease progression, recurrence, distant metastasis, or death from any cause, whichever occurs first.
Measured: From enrollment to disease progression, death, or last follow-up, up to 36 months.
Distant Metastasis-Free Survival
Distant metastasis-free survival is defined as the time from enrollment to the first occurrence of distant metastasis or death from any cause, whichever occurs first.
Measured: From enrollment to distant metastasis, death, or last follow-up, up to 36 months.
Overall Survival
Overall survival is defined as the time from enrollment to death from any cause. Participants alive at the last follow-up will be censored.
Measured: From enrollment to death or last follow-up, up to 36 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2026
- Study start30 Aug 2022
- Primary completion30 Aug 2025
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasopharyngeal Cancinoma (NPC)Studies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guiquan Zhu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Guiquan Zhu, West China College of Stomatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07636499
- Sponsor's protocol ID
- WCHSIRB-CT-2022-267-R1
- Status last verified
- Jun 2026
- First submitted
- 26 May 2026
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Complete de-identified patient data set will be submitted onto an online platform.
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Trial of Multimodal Evaluation-Guided Surveillance-Intervention With Selective Neck Dissection for N3 Nasopharyngeal Carcinoma After Radiotherapy
- ClinicalTrials.gov ID
- NCT07636499
- Acronym / sponsor ID
- WCHSIRB-CT-2022-267-R1
- Conditions
- Nasopharyngeal Cancinoma (NPC)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Guiquan ZhuUniversity, hospital or other
- Study start
- 30 Aug 2022 (actual)
- Primary completion
- 30 Aug 2025 (actual)
- Study completion
- Sep 2026 (estimated)
- First posted
- 9 Jun 2026 (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.
The goal of this phase I clinical trial is to evaluate the safety and feasibility of a multimodal evaluation-guided surveillance-intervention strategy in patients with newly diagnosed N3 nasopharyngeal carcinoma. The main questions it aims to answer are:
- Is the multimodal evaluation-guided surveillance-intervention approach safe for patients?
- Is this approach feasible for identifying and managing residual cervical lymph nodes after radiotherapy?
Participants receive standard chemoradiotherapy. After treatment, they undergo follow-up evaluation using clinical assessment, conventional imaging, Epstein-Barr virus DNA testing, and contrast-enhanced ultrasound. Participants with suspicious residual cervical lymph nodes identified by multimodal evaluation and considered suitable for surgical intervention undergo selective neck dissection.
Detailed description
Patients with N3 nasopharyngeal carcinoma remain at risk of residual cervical lymph node disease after radiotherapy. Conventional imaging may have difficulty distinguishing viable residual tumor from post-radiotherapy edema, fibrosis, scarring, or inflammation. Contrast-enhanced ultrasound (CEUS) provides information on lymph node microvascular perfusion and may complement routine follow-up assessment. For patients with suspected residual cervical lymph node disease, selective neck dissection may be considered as a salvage treatment option.
This prospective, single-center, single-arm phase I study enrolled patients with pathologically confirmed N3 nasopharyngeal carcinoma. After completion of radiotherapy, participants underwent multimodal cervical lymph node follow-up evaluation, including clinical assessment, conventional imaging, Epstein-Barr virus DNA testing, and CEUS. During follow-up, participants with suspicious residual cervical lymph nodes identified by multimodal evaluation and considered suitable for surgical intervention underwent selective neck dissection. Participants were followed for adverse events, postoperative complications, disease progression, locoregional recurrence, distant metastasis, and survival outcomes. The main purpose of this study is to evaluate the safety and feasibility of this multimodal evaluation-guided surveillance-intervention strategy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Multimodal Evaluation-Guided Surveillance-Intervention Strategy | Experimental | Procedure: Multimodal Evaluation-Guided Surveillance-Intervention StrategyParticipants underwent multimodal follow-up evaluation after radiotherapy, including clinical assessment, conventional imaging, Epstein-Barr virus DNA testing, and contrast-enhanced ultrasound. Participants with suspicious residual cervical lymph nodes identified by multimodal evaluation and considered suitable for surgical intervention underwent selective neck dissection. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Aged 18 to 70 years.
- Pathologically confirmed nasopharyngeal non-keratinizing carcinoma (differentiated or undifferentiated, i.e., WHO Type II or III).
- Tumor staged as TanyN3M0 according to the 8th Edition of the American Joint Committee on Cancer/Union for International Cancer Control (AJCC/UICC) staging system.
- ECOG performance status 0-1.
- No previous neck dissection.
Key exclusion criteria (4 listed)
- Ongoing receipt of other antitumor treatment or concurrent participation in another interventional clinical trial.
- Pregnancy or breastfeeding
- Severe concomitant disease that may, in the investigator's judgment, pose an unacceptable risk or compromise study compliance, including severe cardiac disease, severe pulmonary dysfunction, significant renal disease, or severe psychiatric illness.
- History of another invasive malignancy within 5 years before enrollment, except for adequately treated basal cell carcinoma of the skin, cervical carcinoma in situ, or superficial bladder tumors (Ta, Tis, or T1).
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 |
|---|---|---|
| Multimodal Evaluation-Guided Surveillance-Intervention StrategyAll participants underwent multimodal follow-up evaluation after radiotherapy. Selective neck dissection was performed only in participants with suspicious residual cervical lymph nodes identified by multimodal evaluation and considered to have an indication for surgical intervention. | Procedure or surgery | Multimodal Evaluation-Guided Surveillance-Intervention Strategy |
Primary outcome
Incidence of Treatment-Emergent Adverse Events
Time frame: From enrollment through post-radiotherapy follow-up, up to 36 months
Treatment-emergent adverse events are defined as adverse events occurring after the start of study intervention. Adverse events will be assessed and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0.
4 secondary outcomes
Completion Rate of Selective Neck Dissection Among Participants With Suspected Residual Cervical Nodal Disease
Time frame: From enrollment to completion of indicated selective neck dissection or the end of follow-up, whichever occurs first, assessed up to 36 months after enrollment.
Progression-Free Survival
Time frame: From enrollment to disease progression, death, or last follow-up, up to 36 months.
Distant Metastasis-Free Survival
Time frame: From enrollment to distant metastasis, death, or last follow-up, up to 36 months.
Overall Survival
Time frame: From enrollment to death or last follow-up, up to 36 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Individual participant dataSharing planned: No. Complete de-identified patient data set will be submitted onto an online platform.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Multimodal Evaluation-Guided Surveillance-Intervention Strategy in people with Nasopharyngeal Cancinoma (NPC), run by Guiquan Zhu 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 7 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 20 Aug 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events (time frame: From enrollment through post-radiotherapy follow-up, up to 36 months). 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 20 Aug 2026.