Tirelizumab Plus Surgery vs Surgery Alone for Recurrent Nasopharyngeal Carcinoma

Sponsor

Eye & ENT Hospital of Fudan University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05092217

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Nasopharyngeal Carcinoma	Drug: Tirelizumab Procedure: salvage surgery	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Tirelizumab Plus Surgery vs Surgery Alone for Recurrent Nasopharyngeal Carcinoma：a Prospecitve, Parallel, Phase II, Randomized Clinical Trial

Anticipated Study Start Date :

Oct 20, 2021

Anticipated Primary Completion Date :

Oct 20, 2023

Anticipated Study Completion Date :

Oct 20, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Tirelizumab plus salvage surgery Tirelizumab: Tirelizumab treatment after salvage surgery. Salvage surgery: endoscopic nasopharyngectomy for recurrent nasopharyngeal carcinoma	Drug: 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. Other Names: PD-1 antibody Procedure: salvage surgery Endoscopic nasopharyngectomy for recurrent nasopharyngeal tumor
Active Comparator: salvage surgery alone Salvage surgery: endoscopic nasopharyngectomy for recurrent nasopharyngeal carcinoma	Procedure: salvage surgery Endoscopic nasopharyngectomy for recurrent nasopharyngeal tumor

Arm

Intervention/Treatment

Experimental: Tirelizumab plus salvage surgery

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

Drug: 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.

Other Names:

PD-1 antibody

Procedure: salvage surgery

Endoscopic nasopharyngectomy for recurrent nasopharyngeal tumor

Active Comparator: salvage surgery alone

Salvage surgery: endoscopic nasopharyngectomy for recurrent nasopharyngeal carcinoma

Procedure: salvage surgery

Endoscopic nasopharyngectomy for recurrent nasopharyngeal tumor

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Histologically confirmed recurrent nasopharyngeal carcinoma
The recurrence time is more than 6 months from the end of radiotherapy.
Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
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.
Resectable recurrent regional lymph node diseases (recurrent N1-3) without prevertebral fascia, cervical vertebrae, or common/internal carotid artery involvement.
Given written informed consent.

Exclusion Criteria:

Has severe medical disorder, important organ dysfunction, and/or a substantial history of mental illness.
Has known subjects with other malignant tumors.
Has participated in other drug trials within 3 months of planned start of study treatment.
Received a systematic or local glucocorticoid therapy within 4 weeks of planned start of study treatment.
Suffered from diseases need long-term treatment with immunosuppressive drugs, or required systematic or local glucocorticoid therapy with immunosuppressive doses.
Prior therapy with a PD-1, anti-PD-Ligand 1 (PD-L1) or cytotoxic T lymphocyte-associated antigen 4 (CTLA-4) agent.
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.
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.
Has received a live vaccine within 4 weeks of planned start of study treatment.
Pregnancy or breast feeding.
Cannot complete regular follow-up.
Local recurrence of nasopharyngeal carcinoma with distant metastasis