Tirelizumab Plus Surgery vs Surgery Alone for Recurrent Nasopharyngeal Carcinoma

Phase 2

Not yet recruiting

• Conditions: Nasopharyngeal Carcinoma
• Interventions: Drug: Tirelizumab; Procedure: salvage surgery

• Registration Number: NCT05092217
• Lead Sponsor: Eye & ENT Hospital of Fudan University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-10
• Study First Submitted: 2021-10-12
• Study Start: 2021-10-20
• Study First Submitted QC: 2021-10-22
• Last Update Submitted: 2021-10-22
• Study First Posted: 2021-10-25
• Last Update Posted: 2021-10-25
• Primary Completion: 2023-10-20
• Study Completion: 2024-10-20

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tirelizumab plus salvage surgery	salvage surgery	Tirelizumab: Tirelizumab treatment after salvage surgery. Salvage surgery: endoscopic nasopharyngectomy for recurrent nasopharyngeal carcinoma
salvage surgery alone	salvage surgery	Salvage surgery: endoscopic nasopharyngectomy for recurrent nasopharyngeal carcinoma
Tirelizumab plus salvage surgery	Tirelizumab	Tirelizumab: Tirelizumab treatment after salvage surgery. Salvage surgery: endoscopic nasopharyngectomy for recurrent nasopharyngeal carcinoma

Primary Outcome Measures

Name	Time	Method
Progress-free survival(PFS)	2 years	Defined as the time interval from randomization to the observation of disease progression or the occurrence of death from any cause

Secondary Outcome Measures

Name	Time	Method
Overall survival(OS)	2 years	Defined as the time interval from randomization to death due to any cause.
Locoregional failure-free survival(LRRFS)	2 years	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
Distant metastasis-free survival(DMFS)	2 years	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.
Incidence of treatment related complications	2 years	Incidence of treatment related complications of tirelizumab or surgical treatment during follow-up