Nasopharyngeal CarcinomaPhase 2NCT05092217
Tirelizumab Plus Surgery vs Surgery Alone for Recurrent Nasopharyngeal Carcinoma
A Phase 2 study testing Tirelizumab and salvage surgery in people with Nasopharyngeal Carcinoma, run by Eye & ENT Hospital of Fudan University.
Trial summary
Through open-label, single-center, randomised clinical trials, we intend to demonstrate that PD-1 treatment added to salvage surgery could further decrease the rate of disease progression and improve the survival outcome of patients with locally recurrent nasopharyngeal carcinoma compared with those treated with… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Nasopharyngeal Carcinoma
- What is being tested?
- Tirelizumab and salvage surgery
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 20 Oct 2021to 20 Oct 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed recurrent nasopharyngeal carcinoma
- The recurrence time is more than 6 months from the end of radiotherapy.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- According to the TNM staging criteria of nasopharyngeal carcinoma (AJCC, 8th Edition, 2017), rT1, rT2, rT3, and rT4 patients who can be completely resected by surgery as assessed by the surgical team.
- Resectable recurrent regional lymph node diseases (recurrent N1-3) without prevertebral fascia, cervical vertebrae, or common/internal carotid artery involvement.
- Given written informed consent.
Who cannot join
- Has severe medical disorder, important organ dysfunction, and/or a substantial history of mental illness.
- Has known subjects with other malignant tumors.
- Has participated in other drug trials within 3 months of planned start of study treatment.
- Received a systematic or local glucocorticoid therapy within 4 weeks of planned start of study treatment.
- Suffered from diseases need long-term treatment with immunosuppressive drugs, or required systematic or local glucocorticoid therapy with immunosuppressive doses.
- Prior therapy with a PD-1, anti-PD-Ligand 1 (PD-L1) or cytotoxic T lymphocyte-associated antigen 4 (CTLA-4) agent.
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- Has active autoimmune disease (e.g., uveitis, enteritis, hepatitis, hypophysitis, nephritis, vasculitis, hyperthyroidism, and asthma requiring bronchodilator therapy). Patients with skin disease that doesn't require systemic treatment (e.g., vitiligo, psoriasis, or alopecia) will be allowed to enroll.
- Has a known history of human immunodeficiency virus (HIV), has hepatitis B surface antigen (HBsAg) positive with hepatitis B virus (HBV) DNA copy number of ≥1000cps/ml or hepatitis C virus (HCV) antibody positive.
- Has received a live vaccine within 4 weeks of planned start of study treatment.
- Pregnancy or breast feeding.
- Cannot complete regular follow-up.
- Local recurrence of nasopharyngeal carcinoma with distant metastasis
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Tirelizumab Plus Surgery vs Surgery Alone for Recurrent Nasopharyngeal Carcinoma：a Prospecitve, Parallel, Phase II, Randomized Clinical Trial
Through open-label, single-center, randomised clinical trials, we intend to demonstrate that PD-1 treatment added to salvage surgery could further decrease the rate of disease progression and improve the survival outcome of patients with locally recurrent nasopharyngeal carcinoma compared with those treated with salvage surgery alone.
- Conditions
- Nasopharyngeal Carcinoma
- Being tested
- Tirelizumab, salvage surgery
- Keywords
- Recurrent Nasopharyngeal Carcinoma, Tirelizumab, Immunotherapy, Endoscopic surgery, Survival
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TirelizumabDrug
Also called PD-1 antibody
Tirelizumab: 200 mg, intravenous injection over 60 minutes (Q3W); Tirelizumab should be applied since 2-6 weeks after surgery until confirmed disease progression, death, unacceptable toxicity, withdrawal of consent, investigator decision, or 1 year.
salvage surgeryProcedure or surgery
Endoscopic nasopharyngectomy for recurrent nasopharyngeal tumor
| Study group | Role | What they receive |
|---|---|---|
| Tirelizumab plus salvage surgery | Experimental | Tirelizumab: Tirelizumab treatment after salvage surgery. Salvage surgery: endoscopic nasopharyngectomy for recurrent nasopharyngeal carcinoma Receives: Drug: Tirelizumab; Procedure: salvage surgery |
| salvage surgery alone | Active comparator | Salvage surgery: endoscopic nasopharyngectomy for recurrent nasopharyngeal carcinoma Receives: Procedure: salvage surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progress-free survival(PFS)
Defined as the time interval from randomization to the observation of disease progression or the occurrence of death from any cause
Measured: 2 years
Secondary outcomes (4)
Overall survival(OS)
Defined as the time interval from randomization to death due to any cause.
Measured: 2 years
Locoregional failure-free survival(LRRFS)
The LRRFS is evaluated and calculated from the date of random assignment until the day of first locoregional relapse or until the date of the last follow-up visit
Measured: 2 years
Distant metastasis-free survival(DMFS)
The DMFS is evaluated and calculated from the date of random assignment until the day of first distant metastases or until the date of the last follow-up visit.
Measured: 2 years
Incidence of treatment related complications
Incidence of treatment related complications of tirelizumab or surgical treatment during follow-up
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2021
- Study start20 Oct 2021 (estimated)
- Primary completion20 Oct 2023 (estimated)
- Study completion20 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nasopharyngeal CarcinomaStudies of the same condition, open and under way.
- More trials run by Eye & ENT Hospital of Fudan UniversityThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eye & ENT Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dehui Wang, Eye & ENT Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05092217
- Sponsor's protocol ID
- rNPC-2021-Dehui Wang
- Status last verified
- Oct 2021
- First submitted
- 12 Oct 2021
- Last updated
- 25 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Li W, Wang T, Xu H, Liu Q, Zhang H, Yang Y, Sun X, Yu H, Gu Y, Li H, Ding H, Wang D. Tislelizumab as adjuvant therapy following endoscopic surgery for resectable recurrent nasopharyngeal carcinoma: a randomized clinical trial. J Immunother Cancer. 2025 May 24;13(5):e011998. doi: 10.1136/jitc-2025-011998.
PubMed 40413023
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tirelizumab Plus Surgery vs Surgery Alone for Recurrent Nasopharyngeal Carcinoma：a Prospecitve, Parallel, Phase II, Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05092217
- Acronym / sponsor ID
- rNPC-2021-Dehui Wang
- Conditions
- Nasopharyngeal Carcinoma
- Keywords
- Recurrent Nasopharyngeal Carcinoma, Tirelizumab, Immunotherapy, Endoscopic surgery, Survival
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Eye & ENT Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 20 Oct 2021 (estimated)
- Primary completion
- 20 Oct 2023 (estimated)
- Study completion
- 20 Oct 2024 (estimated)
- First posted
- 25 Oct 2021 (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.
Through open-label, single-center, randomised clinical trials, we intend to demonstrate that PD-1 treatment added to salvage surgery could further decrease the rate of disease progression and improve the survival outcome of patients with locally recurrent nasopharyngeal carcinoma compared with those treated with salvage surgery alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tirelizumab plus salvage surgery | Experimental | Drug: Tirelizumab, Procedure: salvage surgeryTirelizumab: Tirelizumab treatment after salvage surgery. Salvage surgery: endoscopic nasopharyngectomy for recurrent nasopharyngeal carcinoma |
| salvage surgery alone | Active comparator | Procedure: salvage surgerySalvage surgery: endoscopic nasopharyngectomy for recurrent nasopharyngeal carcinoma |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histologically confirmed recurrent nasopharyngeal carcinoma
- The recurrence time is more than 6 months from the end of radiotherapy.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- According to the TNM staging criteria of nasopharyngeal carcinoma (AJCC, 8th Edition, 2017), rT1, rT2, rT3, and rT4 patients who can be completely resected by surgery as assessed by the surgical team.
- Resectable recurrent regional lymph node diseases (recurrent N1-3) without prevertebral fascia, cervical vertebrae, or common/internal carotid artery involvement.
Key exclusion criteria (12 listed)
- Has severe medical disorder, important organ dysfunction, and/or a substantial history of mental illness.
- Has known subjects with other malignant tumors.
- Has participated in other drug trials within 3 months of planned start of study treatment.
- Received a systematic or local glucocorticoid therapy within 4 weeks of planned start of study treatment.
- Suffered from diseases need long-term treatment with immunosuppressive drugs, or required systematic or local glucocorticoid therapy with immunosuppressive doses.
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 |
|---|---|---|
| TirelizumabAlso: PD-1 antibodyTirelizumab: 200 mg, intravenous injection over 60 minutes (Q3W); Tirelizumab should be applied since 2-6 weeks after surgery until confirmed disease progression, death, unacceptable toxicity, withdrawal of consent, investigator decision, or 1 year. | Drug | Tirelizumab plus salvage surgery |
| salvage surgeryEndoscopic nasopharyngectomy for recurrent nasopharyngeal tumor | Procedure or surgery | Tirelizumab plus salvage surgery, salvage surgery alone |
Primary outcome
Progress-free survival(PFS)
Time frame: 2 years
Defined as the time interval from randomization to the observation of disease progression or the occurrence of death from any cause
4 secondary outcomes
Overall survival(OS)
Time frame: 2 years
Locoregional failure-free survival(LRRFS)
Time frame: 2 years
Distant metastasis-free survival(DMFS)
Time frame: 2 years
Incidence of treatment related complications
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2021.
- Derived from this study: PubMed 40413023Li W, Wang T, Xu H, Liu Q, Zhang H, Yang Y, Sun X, Yu H, Gu Y, Li H, Ding H, Wang D. Tislelizumab as adjuvant therapy following endoscopic surgery for resectable recurrent nasopharyngeal carcinoma: a randomized clinical trial. J Immunother Cancer. 2025 May 24;13(5):e011998. doi: 10.1136/jitc-2025-011998.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tirelizumab and salvage surgery in people with Nasopharyngeal Carcinoma, run by Eye & ENT Hospital of Fudan University.
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 12 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 25 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
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 Wanpeng Li, MD (13262856870, 18879117831@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progress-free survival(PFS) (time frame: 2 years). 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 NCT05092217, which also lists 1 linked publication.
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 25 Oct 2021.