Tirelizumab Plus Surgery vs Surgery Alone for Recurrent Nasopharyngeal Carcinoma
NCT ID: NCT05092217
Last Updated: 2021-10-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
80 participants
INTERVENTIONAL
2021-10-20
2024-10-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Tirelizumab plus salvage surgery
Tirelizumab: Tirelizumab treatment after salvage surgery. Salvage surgery: endoscopic nasopharyngectomy for recurrent nasopharyngeal carcinoma
Tirelizumab
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 surgery
Endoscopic nasopharyngectomy for recurrent nasopharyngeal tumor
salvage surgery alone
Salvage surgery: endoscopic nasopharyngectomy for recurrent nasopharyngeal carcinoma
salvage surgery
Endoscopic nasopharyngectomy for recurrent nasopharyngeal tumor
Interventions
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Tirelizumab
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 surgery
Endoscopic nasopharyngectomy for recurrent nasopharyngeal tumor
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. The recurrence time is more than 6 months from the end of radiotherapy.
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
4. 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.
5. Resectable recurrent regional lymph node diseases (recurrent N1-3) without prevertebral fascia, cervical vertebrae, or common/internal carotid artery involvement.
6. Given written informed consent.
Exclusion Criteria
2. Has known subjects with other malignant tumors.
3. Has participated in other drug trials within 3 months of planned start of study treatment.
4. Received a systematic or local glucocorticoid therapy within 4 weeks of planned start of study treatment.
5. Suffered from diseases need long-term treatment with immunosuppressive drugs, or required systematic or local glucocorticoid therapy with immunosuppressive doses.
6. Prior therapy with a PD-1, anti-PD-Ligand 1 (PD-L1) or cytotoxic T lymphocyte-associated antigen 4 (CTLA-4) agent.
7. 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.
8. 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.
9. Has received a live vaccine within 4 weeks of planned start of study treatment.
10. Pregnancy or breast feeding.
11. Cannot complete regular follow-up.
12. Local recurrence of nasopharyngeal carcinoma with distant metastasis
18 Years
70 Years
ALL
No
Sponsors
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Eye & ENT Hospital of Fudan University
OTHER
Responsible Party
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Dehui Wang
Professor
Central Contacts
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References
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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.
Other Identifiers
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rNPC-2021-Dehui Wang
Identifier Type: -
Identifier Source: org_study_id