Tirelizumab Plus Surgery vs Surgery Alone for Recurrent Nasopharyngeal Carcinoma
1 other identifier
interventional
80
0 countries
N/A
Brief 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 salvage surgery alone.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Oct 2021
Typical duration for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 12, 2021
CompletedStudy Start
First participant enrolled
October 20, 2021
CompletedFirst Posted
Study publicly available on registry
October 25, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 20, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
October 20, 2024
CompletedOctober 25, 2021
October 1, 2021
2 years
October 12, 2021
October 22, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
2 years
Secondary Outcomes (4)
Overall survival(OS)
2 years
Locoregional failure-free survival(LRRFS)
2 years
Distant metastasis-free survival(DMFS)
2 years
Incidence of treatment related complications
2 years
Study Arms (2)
Tirelizumab plus salvage surgery
EXPERIMENTALTirelizumab: Tirelizumab treatment after salvage surgery. Salvage surgery: endoscopic nasopharyngectomy for recurrent nasopharyngeal carcinoma
salvage surgery alone
ACTIVE COMPARATORSalvage surgery: endoscopic nasopharyngectomy for recurrent nasopharyngeal carcinoma
Interventions
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.
Endoscopic nasopharyngectomy for recurrent nasopharyngeal tumor
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 40413023DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
October 12, 2021
First Posted
October 25, 2021
Study Start
October 20, 2021
Primary Completion
October 20, 2023
Study Completion
October 20, 2024
Last Updated
October 25, 2021
Record last verified: 2021-10
Data Sharing
- IPD Sharing
- Will not share