Clinical trial NCT05092217: Tirelizumab Plus Surgery vs Surgery Alone for Recurrent Nasopharyngeal Carcinoma
Official title: Tirelizumab Plus Surgery vs Surgery Alone for Recurrent Nasopharyngeal Carcinoma：a Prospecitve, Parallel, Phase II, Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Nasopharyngeal Carcinoma
Keywords: Recurrent Nasopharyngeal Carcinoma
Tirelizumab
Immunotherapy
Endoscopic surgery
Survival
Lead sponsor: Eye & ENT Hospital of Fudan University
Sponsor class: OTHER
First posted: 2021-10-25
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Progress-free survival(PFS)
timeFrame: 2 years
Secondary outcomes:
measure: Overall survival(OS)
timeFrame: 2 years
measure: Locoregional failure-free survival(LRRFS)
timeFrame: 2 years
measure: Distant metastasis-free survival(DMFS)
timeFrame: 2 years
measure: Incidence of treatment related complications
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
References: