Tirelizumab Plus Surgery vs Surgery Alone for Recurrent Nasopharyngeal Carcinoma

Eye & ENT Hospital of Fudan University

Status and phase: Not yet enrolling; Phase 2

Conditions: Nasopharyngeal Carcinoma

Treatments: Procedure: salvage surgery; Drug: Tirelizumab

Study type: Interventional

Funder types: Other

Identifiers

NCT05092217

rNPC-2021-Dehui Wang

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Tirelizumab plus salvage surgery

Experimental group

Description:

Tirelizumab: Tirelizumab treatment after salvage surgery. Salvage surgery: endoscopic nasopharyngectomy for recurrent nasopharyngeal carcinoma

Treatment:

Drug: Tirelizumab

Procedure: salvage surgery

salvage surgery alone

Active Comparator group

Description:

Salvage surgery: endoscopic nasopharyngectomy for recurrent nasopharyngeal carcinoma

Treatment:

Procedure: salvage surgery