Tirelizumab Plus Surgery vs Surgery Alone for Recurrent Nasopharyngeal Carcinoma

Eye & ENT Hospital of Fudan University80 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Nasopharyngeal Carcinoma

Interventions

TirelizumabDRUG

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

Endoscopic nasopharyngectomy for recurrent nasopharyngeal tumor

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Histologically confirmed recurrent nasopharyngeal carcinoma 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: 1. Has severe medical disorder, important organ dysfunction, and/or a substantial history of mental illness. 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

Outcomes

Primary Outcomes

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

Time frame: 2 years

Secondary Outcomes

Overall survival(OS)

Defined as the time interval from randomization to death due to any cause.

Time frame: 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

Time frame: 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.

Time frame: 2 years

Incidence of treatment related complications

Incidence of treatment related complications of tirelizumab or surgical treatment during follow-up

Time frame: 2 years

Central Contacts

Wanpeng Li, MD

CONTACT

13262856870 18879117831@163.com

Li Hu, MD

CONTACT

18917786049 hl318ent@163.com

Data from ClinicalTrials.gov

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